Quality Procedures PDF

Quality Procedures and
Work Instructions
Manual
Revision Number: (1)
ISSUED TO: ____________________________________
MANUAL NO: __________________________________
REVISION NO: _________________________________
ISSUE DATE: ___________________________________
_______________________ ___________
President Date
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Quality Procedures and Work Instructions Manual
Section Page Date Revision
ii. Table of Contents 1 of 4 0
Section
Number Name Revision Date
i. Title Page
ii. Table of Contents
1.0. Management Review
2.0 The Quality System
3.0. Contract Review
5.0. Document and Data Control
5.1 Document Preparation and Issue

5.2 Writing a Quality System Document
6.0. Purchasing
6.1 Approved Supplier Selection

6.2 Purchase Requisition Expenditure Authorization
6.3 Routine Purchase Request
6.4 Urgent Purchase Request
6.5 Standing Order Purchase
6.6 Petty Cash Purchase
6.7 Purchase Requisition Form Completion
6.8 Outstanding Order Progress
6.9 Using a Courier
6.10 Outside Work
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Section
Number Name Revision Date
7.0. Control of Customer-Supplied

Product
8.0. Product Identification and

Traceability
9.0. Process Control
9.1 Special Processes

9.2 Emergency Call
9.3 Inspection
9.4 Risk Assessment of Patient Care Devices
9.5 Selecting Inspection and Preventive Maintenance Items
9.6 Inspection and Preventive Maintenance Scheduling
9.7 Transferring Equipment
9.8 Using the Equipment Management Software
9.9 Training Record Creation
9.10 Training Work Order Creation
9.11 Resource Allocation
9.12 Purchasing Advice
9.13 Equipment Evaluation
9.14 Soldering
10.0. Inspection and Testing
10.1 Incoming Goods Inspection
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11.0. Control of Inspection, Measuring,

and Test Equipment
12.0. Inspection and Test Status
12.1 Equipment Status Tag Completion

12.2 Incoming Work
12.3 Work Dispatch
13.0. Control of Nonconforming Product
13.1 Customer Complaints
14.0. Corrective and Preventive Action
14.1 Performance Reports
15.0. Handling, Storage, Packaging,

Preservation, and Delivery
15.1 Stock Issue

15.2 Stock Control
15.3 Handling and Storage of Static-Sensitive Devices (SSDs)
15.4 Handling of Mercury
15.5 Handling of Contaminated Equipment
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16.0. Control of Quality Records
16.1 Computer Backup

16.2 Filing of Work Records
16.3 Medical Equipment Service Report Completion
16.4 Medical equipment Service Report and Equipment File Checking
16.5 Equipment File Completion
16.6 Part Record Creation
16.7 Project File Input
16.8 Work Order Completion
16.9 Project Work Order Input
17.0 Internal Quality Audits
17.1 Quality Assurance Program
17.2 Quality Assurance Indicators for Patient Care Devices
18.0. Training
19.0. Servicing
19.1 Maintenance of Medical Devices
19.2 Service Standards
20.0 Statistical Techniques
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Introduction
This document, Quality Procedures and Work Instructions, hereafter referred to as QPWI, contains or
references all procedures and work instructions required to ensure the satisfactory operation of Legacy
Biomedical (LEGACY BIOMEDICAL) quality system as described in our Quality System Manual.
QPWI is divided into sections (1.0 to 20.0) corresponding to the ISO 9002 Standard entitled, Quality
Systems –Model for Quality Assurance in Design, Development, Production, Installation, and Servicing,
and LEGACY BIOMEDICAL’s Quality System Manual.
Each section may contain a combination of procedures and work instructions. Procedures will detail the
who, how, when, where, and why of a particular function or process undertaken by the organization and
have a set structure (purpose, scope, references, definitions, procedure, and documentation). Work
instructions are detailed step-by-step instructions that explain how to carry out a particular task.
All procedures and work instructions are written in accordance with the “Writing a Quality System
Document” procedure (see Section 5.2 of this document).
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1.0 Management Review 1 of 4 0
A. Purpose
This procedure describes the review of the suitability and effectiveness of LEGACY BIOMEDICAL’S
quality system by management.
B. Scope
This procedure shall apply to any management review of any component of LEGACY BIOMEDICAL’S
quality system.
C. References
LEGACY BIOMEDICAL Quality System Manual

Joint Commission for the Accreditation of Healthcare Organizations (TJC)
Title 21 Code of Federal Regulations
American Society for Healthcare Engineering
D. Definitions
See LEGACY BIOMEDICAL Quality System Manual
E. Procedure
1. The need for a review
a. The need for a review of any component of the quality system may arise from one or
more of the following sources:
i) LEGACY BIOMEDICAL staff.
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Any staff member may indicate problems with, or possible improvements to, the
quality system procedures, work practices, work output, product performance,
documentation, or records.

ii) Customers.
A customer, through a suggestion, comment, or complaint, may highlight a
component of the quality system that requires review.
iii) Performance reports.
Reports produced by performance analysis of work done may indicate areas of the
quality system that should be reviewed.
iv) Internal and External Audits.
Regular audits of the quality system may highlight components that need review.
b) Matters requiring review arising from any of the above sources shall be directed for
discussion and action, if necessary, to the Quality Assurance Council.
c) Information on such matters shall be provided to the Council through one of the Council
members. Our staff members shall direct their comments to their Site Manager who sits
on the Council. Council members shall then pass this information on to the Director,
Quality Assurance, who shall include it on the agenda for the next Quality Assurance
Council meeting.
d) The agenda for each meeting shall be made available to each Council member, with a
copy placed on LEGACY BIOMEDICAL’ general bulletin board, no later than three
days before each meeting.
2. Quality Assurance Council
a) The function of the Quality Assurance Council is to discuss, investigate, and resolve all
matters affecting the quality system, the effectiveness of the quality system, the stability
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of the system in adapting to customer and business needs, and its compliance with the
quality standard and quality system objectives.

b) This can include work practices, procedures, documentation, suppliers, complaints,

corrective and preventive actions, resource allocation, training, performance, and
objectives. Its main purpose is to maintain and improve LEGACY BIOMEDICAL’
quality of service.
c) The Council consists of the Director, Quality Assurance, the Purchasing Manager, and
the Site Managers. Other staff members may be asked to attend, if appropriate, or may
raise matters through an appropriate Council member.
d) The Director, Quality Assurance shall chair and may designate another member to take
minutes during the Council meetings.
e) The Council shall meet every month but can meet more often if necessary.
f) The December Council meeting each year shall be used to review LEGACY
BIOMEDICAL’ performance over the previous 12 months and to formulate objectives
for the next year.
g) The Council shall decide whether a matter placed on the meeting’s agenda requires
further action.
3. Responsibility for Review
a) Matters raised during a Quality Assurance Council meeting that require action shall be
directed to the appropriate Council member who shall be responsible for investigating,
responding to, and, if necessary, correcting the matter.
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b) Other procedures, such as “Document and data Control” (see Section 5.0), “Control of
Nonconforming Product” (see Section 13.0), or “Corrective and Preventive Action” (see
Section 14.0) may need to be invoked.

4. Records of Review
a) Minutes of the Quality Assurance Council meetings shall be taken as a record of all
reviews undertaken.
b) The minutes shall be signed by the Director, Quality Assurance to authorize any actions
arising from the meeting.
c) The minutes of each meeting shall be circulated to all staff members, and copies of all
minutes shall be kept for reference in the Quality Assurance Council meetings file in the
Director, Quality Assurance’s office.
5. Verification of Action
a) Matters requiring action shall stay on subsequent Council meeting agendas until the
Council is satisfied that the matter has been adequately resolved and that the proper
corrective actions have been carried out.
b) Verification of action shall be confirmed by consulting the source of the review (i.e., staff
member or customer). This person shall be consulted to determine whether he or she is
satisfied with the outcome of the review, measuring the success of the action from
performance reports, or verification of the action through the next internal or external
audit. This verification shall be recorded by the source of the review initialing the
relevant entry in the Quality Assurance Council meeting minutes.
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F. Documentation
 Documentation and Data Control Procedure (Section 5.0)

 Control of Nonconforming Product Procedure (Section 13.0)
 Corrective and Preventive Action Procedure (Section 14.0)
 Quality Assurance Council meetings file

2.0 The Quality System 1 of 5 0
A. Purpose
This procedure describes the establishment and maintenance of the quality system documentation
required to meet the quality policy.
B. Scope
This procedure shall apply to any component of LEGACY BIOMEDICAL’ Quality system. These
components include the Quality System Manual, quality procedures, and specific work instructions.
C. References
LEGACY BIOMEDICAL’ Quality System Manual
D. Definitions
None
E. Procedure
1. General
a) LEGACY BIOMEDICAL’ quality system has been established and shall be maintained
in accordance with the requirements of ISO 9002. The quality system shall include the
following elements:
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i) The Quality System Manual

ii) QPWI
ii) Nationally recognized standards
iv) Third-party documentation
v) Quality forms
vi) Test specifications
vii) Quality records
viii) Management review of the quality system
ix) Audits
b) All quality documentation, including electronic data, shall be controlled as per the
“Document and Data Control” procedure (see Section 5.0), and all new documentation
shall be logged and recorded as per the “Document Preparation and Issue” procedure (see
Section 5.1). The format of all quality documents shall be as per the “Writing a Quality
System Document” procedure (see Section 5.2). A complete list of all controlled quality
system documentation, detailing current revision and distribution, is given in the
documentation database.
c) All staff members are required to be aware of quality system requirements and to
implement those parts of the quality system that are applicable to them.
d) The Quality Assurance Council shall ensure that the following steps take place:
i) The procedures developed comply with the objectives of the quality system and
the requirements of ISO 9002.
ii) Those activities that should be subject to procedures have properly documented
procedures and instructions written for them.
iii) The quality system and its documented procedures are effectively implemented.
Refer to the “Management review” procedure (see Section 1.0).
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e) Regular audits, as described in the “Internal Quality Audits” procedure (see Section
17.0), shall ensure that the quality system procedures and instructions are being
implemented in practice.
f) All staff should be aware of changes in technology, instrumentation, and techniques that
may bring an improvement in quality assurance.
g) Whenever possible, a standard of acceptability will be defined for each aspect of

LEGACY BIOMEDICAL’ work that affects quality. This may be to a nationally
recognized standard, a manufacturer’s specification, or a standard set by management.
h) All controls, processes, equipment, personnel, training, and other resources required to
achieve the required quality shall be identified and acquired.
i) New processes, inspections, or tests shall be checked for compatibility with current
practice. Refer to the “Process Control” procedure (see Section 9.0)
j) All records that verify that the requirements of the quality system are being met shall be
identified and maintained as per the “Control of Quality Records” procedure (see Section
16.0)
k) When changes are made to the structure of LEGACY BIOMEDICAL, the quality system
may need to be updated by agreement with the Director, Quality Assurance.
2. Production of Quality Plans
a) Quality plans are usually in the form of a reference to the appropriate documented
procedures that form an integral part of our quality system. However, a quality plan may
be produced for groups of products and services or individual products and services
when:
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i) New processes, services, or products are developed;

ii) A major improvement in a product or service is required;
iii) Major changes in purchasing or subcontracting are made; and/or
iv) A major new assignment is undertaken or a proposal for a major project is
prepared.
b) With regard to design and development work, a quality plan, known as a design plan,
shall be produced for each project.
c) With major customers or with new types of work not undertaken before, the customer
shall be offered the opportunity to participate in the preparation of the quality plan.
d) The quality plan needs to address the following issues:
i) Assessment of current situation (e.g., existing production, competitors)

ii) Assessment of desired performance (e.g., customer requirements, competitor
performance, market need)
iii) Assessment of tasks and processes necessary to reach desired performance
iv) Resources required and staff responsible for these resources and carrying out
tasks
v) Documents and other records that will be created and how they will be managed
vi) Equipment required, if any
vii) Costs of these resources and date when they will be required
viii) Specification of measurements, tests and inspections for input, processes, and
final product
ix) Specification of process control
x) How satisfactory achievement of quality plan will be measured
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F. Documentation
 LEGACY BIOMEDICAL’ Quality System Manual

 Document and Data Control Procedure (Section 5.0)
 Document Preparation and Issue Procedure (Section 5.1)
 Writing a Quality System Document Procedure (Section 5.2)
 Internal Quality Audits Procedure (Section 17.0)
 Process Control Procedure (Section 9.0)
 Control of Quality Records Procedure (Section 16.0)
 Quality Plan Cover Sheet
 Quality Plan File
 Project file
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3.0 Contract Review 1 of 6 0
A. Purpose
This procedure describes the process that ensures that contract requirements between LEGACY
BIOMEDICAL and its customers are documented and understood and that the resources are available to
fulfill the contract. It also details how records of the review are maintained.
B. Scope
This procedure shall apply to any repair, design, development, or service contract supplied by LEGACY
BIOMEDICAL to its customers.
C. References
LEGACY BIOMEDICAL Quality System Manual.
D. Definitions
None
E. Procedure
1. Definition and Documentation of Requirements
a) All staff members are responsible for ensuring that requests from customers are correctly
processed and recorded as described in this procedure. If a request is received directly by
a staff member who is not familiar with the type of work requested, then he or she shall:
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i) Redirect the customer to a staff member who can process the request, or, if this is
not possible,
ii) Record the basic details of the request (i.e., location, contact name, contact
number) on a Medical Equipment Service Report (MESR) and pass that MESR on
to the appropriate senior technician or Site Manager.
b) All maintenance, repair, installation, training, and commissioning work shall be initiated
by filling out an MESR. This MESR shall be processed as follows:
i) If the work is physically received, such as work being delivered to the depot
receiving area, the “Incoming Work” work instruction (see Section 12.2) shall be
followed.
ii) If the work request is received by telephone, mail, or in person, step no. 1 of the
“MESR Completion” work instruction (see Section 16.3) shall be followed.
c) All design and manufacturing work shall be processed and recorded as per the “Design
Control” procedure (see Section 4.0)
d) A customer’s requirements shall be fully understood, any uncertainties clarified, and the
contract or order documented before undertaking the work. This requires the following:
i) The customer shall define exactly what is required. For work received
accompanied by an Equipment Service Request (ESR), if the details conveyed on
the ESR are unclear or conflict with any problems found, the customer shall be
consulted to properly define the work request.
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ii) For work requests made by telephone and other relatively simple requests, the
customer’s work details shall be recorded on an MESR and confirmed by
summarizing the work done on the Equipment Status Tag attached to the work
when returned to the customer. If the work is delivered to the customer
personally, the work done shall be confirmed verbally.
iii) For more complex products and services, such as design and manufacturing, a
written specification from the customer shall be requested or the customer shall be
aided by LEGACY BIOMEDICAL staff in the preparation of the specification.
The specification shall be reviewed with the customer to ensure that it is accurate.
This process is outlined in the “Design Control” procedure (see Section 4.0).
iv) Special delivery and packaging instructions, if requested, shall be recorded on the
“Equipment Status Tag”.
v) Any cost to be incurred by the customer shall be clearly srated and understood by
the customer.
vi) Contingencies affecting the cost or delivery schedule shall be identified, and the
customer shall be made aware of the effect on cost and delivery.
vii) Contracts or orders shall be properly authorized by the customer.
2. Resource Requirements
a) Contracts and specifications shall be reviewed to ensure that the equipment, staff, and
other resources required to carry out the work are available. This process is outlined in
the “Resource Allocation” procedure (see Section 9.11) These resources may include the
following:
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i) Personnel availability
ii) Personnel capability
iii) Personnel training requirements
iv) Material availability
v) Facilities and equipment availability
vi) Facilities and equipment capabilities
vii) Subcontractor requirements
viii) Response time or delivery date requirements
b) If deficiencies exist, these shall be discussed with the customer.
c) Customers shall be advised of any likely delays in delivery of goods or services as soon
as possible after LEGACY BIOMEDICAL becomes aware that the delays are possible.
d) For all major assignments and proposals prepared, such as design or manufacturing, a
plan is prepared that describes what will be done, when it will be done, and the resources
it will require. This includes, if applicable, an estimate of the number of work-hours and
the cost of materials required. Refer to the “Design Control” procedure (see Section 4.0).
e) If staff require training before they carry out an assignment, this shall be identified,
scheduled, and carried out before they work on the contract.
3. Use of Suppliers and Subcontractors
a) The procedures and policy set out in the “purchasing” procedure (see Section 6.0) shall
be used to asses and select suppliers. If a supplier shall be involved in a contract
undertaken by LEGACY BIOMEDICAL, it shall be confirmed that the supplier can carry
out its requirements of the contract.
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b) If a subcontractor or supplier is making a key input to a customer contract, the supplier

shall be required to apply duplicate conditions to those required of LEGACY
BIOMEDICAL by the customer.
c) For each supplier and subcontractor of quality-related inputs, there shall be a designated
contact in LEGACY BIOMEDICAL. This shall usually be the Site Manager that is using
the output of the supplier. The Site Managers shall be provided with a copy of any
contracts with suppliers relevant to their work.
4. Contract Changes
a) If any change occurs that has an effect on a contract (e.g., a delay), the staff member
undertaking the work shall:
i) Advise and review with the customer how this change will affect the contract;
ii) Obtain agreement from the customer for the change;
iii) Document the change and customer notification and agreement on the applicable
MESR or project file as per the “MESR Completion” work instruction (see
Section 16.3) and “Design Control” procedure (see Section 4.0), respectively; and
iv) Notify all appropriate staff of the changes.
b) When an agreement on a change cannot be satisfactorily reached with the customer, the
staff member undertaking the work shall pass the negotiations on to the appropriate
management member.
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5. Records
All records of contracts and contract reviews, such as ESR’s, MESR’s, and project files, shall be
stored and maintained according to the record storage policy set out in the “Control of Quality
Records” procedure (see Section 16.0)
F. Documentation
 ESR
 MESR
 Equipment Status Tag
 Purchasing Procedure (Section 6.0)
 Design Control Procedure (Section 4.0)
 Resource Allocation Procedure (Section 9.11)
 MESR Completion Work Instruction (Section 16.3)
 Incoming Work Work Instruction (Section 12.2)
G. Appendix
Figure 3.1 represents a diagram of the contract review processes.
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4.0 Design Control 1 of 1 0
LEGACY BIOMEDICAL is not engaged in design and development. If, at a future date LEGACY
BIOMEDICAL engages in design and development, Policies and Procedures will be written at that time.
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5.0 Document and Data Control 1 of 8 0
A. Purpose
This procedure describes the approval, issue, and modification of quality system documentation.
B. Scope
This procedure shall apply to all quality system documentation used by LEGACY BIOMEDICAL. This
documentation shall include the following:
 Externally supplied documents (e.g., third-party manuals, standards)

 Documentation written in-house (e.g., procedures, work instructions, design plans, contract
specifications, drawings, audit schedules)
 Computer software (e.g., work records, procedure generating programs, databases)
 Records (e.g., work records, audit reports, forms, purchasing data)
C. References
D. Definitions
None
E. Procedure
1. General
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a) All controlled documents shall be identified and listed in the documentation database.
These documents shall be monitored and updated when necessary. Information in
controlled documents can be reliably considered accurate and up to date.

b) Uncontrolled documents (i.e., not in the documentation database) may be held in

LEGACY BIOMEDICAL and referred to. However, before using information from an
uncontrolled document for repair, design, or purchase, the information must be confirmed
to be correct by contacting the supplier or originator of the document. Examples of
uncontrolled documents include pamphlets, brochures, and catalogs.
2. Document Approval
a) All documents associated with the quality system shall be reviewed for accuracy and
correctness.
b) The Quality Assurance Council is authorized to delegate the review and approval of
quality system documentation to selected personnel. These personnel and the documents
they are authorized to approve are detailed in table 5.1.
c) The Quality Assurance Council shall approve the format of all quality documents,
including forms and software.
d) The reviewing and approving officer reviews the document to ensure that
i) The document expresses the quality policy,

ii) Suppliers and customers receive due consideration, and
ii) The document is practicable.
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e) Where applicable, new documents shall have their status sheets signed by the appropriate
approving officer before being released for use. For software, the accompanying
manual’s status sheet shall be signed.

Table 5.1. Review and Approval
Review and Approval Document Type
Director, Quality Assurance Procedures and work instructions

Forms
Purchase data and specifications
Contract specifications
Quality plans
Training schedules
Quality Control Managers Standards
Audit schedules
Software
Site Managers Third-party manuals
In-house manuals
In-house maintenance procedures
Reference manuals
Drawings
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f) Any staff member may make comment on the need for new documentation. These
comments shall be directed to a Site Manager for review.
g) The procedure for the writing of new documentation is described in the “Writing a
Quality System Document” procedure (see Section 5.2).
h) The control of quality records is as defined in the “Control of Quality Records” procedure
(see Section 16.0).
3. Document Issue and Distribution
a) A list of all quality system documents is maintained in the documentation database.

Site Managers are responsible for recording documents in the database.
b) Depending on the type of document, the documentation database shall indicate for each
document such information as the document number, title, revision, issue date, and
distribution. The database shall also provide a label for each controlled document that
uniquely identifies that document. The process of recording and issuing documentation is
detailed in the “Document Preparation and Issue” procedure (see Section 5.1).
c) The Quality Control Managers shall check that the Site Managers prepares, issues, and
maintains documents in accordance with procedures.
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d) All revisions to a document shall be distributed to locations or individuals as listed in the
documentation database.
e) Site Managers shall ensure that appropriate documentation is available at the required
locations.
f) Controlled documents are issued only to staff who are authorized to receive them and
who have agreed to respect the confidentiality of these documents.

4. Document and Data Changes
a) Documents may be changed and updated in response to requests from customers, audits
or reviews. The original authors of documents and data shall be responsible for the
updating of documents.
b) Changes to documentation shall be reviewed for accuracy and correctness and approved
for adequacy by staff authorized by the Quality Assurance Council. This authorization is
as detailed in paragraph 2(b) of this procedure.
c) Where applicable, changes to documents shall be reflected in the following ways:
i) On their status sheets, which shall be signed accordingly by the approving officer;
ii) By a vertical line in the right-hand margin opposite the change; and
iii) By a new issue number, which shall be allocated as per the “Document
Preparation and Issue” procedure (see Section 5.1).
d) Any staff member may comment on the need for changes to documentation. These
comments shall be directed to their immediate supervisor for review with the applicable
officers and action if agreed.
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e) Particular care shall be given to the effect of a change in a document on other related
documents.
f) If, in reviewing a change to documentation, the approving officer believes that proposed
changes may have cost ramifications, a major effect on normal procedures, or an effect
on other processes not under his/her supervision, then these changes shall be discussed
with, and approved by the Quality Assurance Council.

g) The current issue status (revision) of all quality system documentation is recorded and
maintained in the documentation database.
h) The documentation database indicates the location of all copies of documentation that
require reissue and produces this list on a document update sheet. This procedure also
produces a record of the document updates (the document update sheet), which is
maintained by the Director, Quality Assurance. A new document or an amendment shall
be issued to all those locations or individuals named on this sheet.
i) Revised documents shall be given a new issue number, and the entire document shall be
reissued when more than half of the individual pages have been changed.
j) Status sheets shall be updated to reflect the revision status of, and changes to,
documentation.
k) Customers shall be advised of changes to documents normally issued to them and shall be
sent the revised copy if the document is a controlled document. If changes to a document
will have a significant impact on the nature or quality of product or service, the customer
shall be advised of the impact of these changes.
5. Removal of Obsolete Documents
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a) Documents that are obsolete shall be clearly stamped “Obsolete” or “Superseded” on
their cover. The document’s obsolete status shall be noted in the documentation database.

b) Site Managers shall ensure that obsolete documents are promptly removed.
c) Quality Control Managers shall regularly conduct inspections to ensure that no

uncontrolled copies of documents are in use.
d) Quality Control Managers shall maintain copies of all obsolete documentation for
reference, legal, and other purposes.
e) The Quality Assurance Council shall monitor the use of documents and follow up any
misuse of documents as advised by the Quality Control Managers or others. It shall also
monitor any corrective action arising from misuse of documents. Any outstanding
corrective action that is more than two months old shall be referred to the Director,
Quality Assurance.
6. Storage of Documents
a) All documents, including completed forms and other records, both computer based and
hard copy, shall be stored so that they are easily retrieved. All controlled documents shall
be recorded in the documentation database as outlined in the “Document Preparation and
Issue” procedure (see Section 5.1) and the Documentation database User Manual.
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b) Computer records shall be backed up using the “Computer Backup” procedure (see
Section 16.1), and backups shall be recorded in the computer backup file. Where
possible, computer-based backup copies of documents shall be stored at a location remote
from the location of the original file. Refer to the “Computer Backup” procedure (see
Section 16.1) for the current storage location.
F. Documentation
 Document Preparation and Issue Procedure (Section 5.1)

 Writing a Quality System Document Procedure (Section 5.2)
 Documentation Database
 Document Update Sheet
 Computer Backup Procedure (Section 16.1)
 Computer Backup File
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5.1 Document Preparation and Issue 1 of 8 0
A. Purpose
This procedure describes the method of preparation and update of quality system documentation.
B. Scope
This procedure shall apply to all quality system documents used in LEGACY BIOMEDICAL. This
documentation shall include the following:
 Externally supplied documents (e.g., third-party manuals, reference books, standards)

 Documentation written in-house (e.g., procedures, work instructions, contract specifications,
drawings, audit schedules)
 Computer software (e.g., work record programs, procedure- generating programs, databases)
 Records (e.g., work records, audit reports, forms, purchasing data)
C. References
LEGACY BIOMEDICAL’ Quality System Manual
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D. Definitions
None
E. Procedure
1. General
a) Officers responsible for the review and approval of quality system documentation are as
defined in the “Document and Data Control” procedure (see Section 5.0)

b) Each quality system document shall have a unique number assigned by the appropriate
responsible officer.
c) All quality system documentation shall be logged into the documentation database,
providing information such as issue, storage location, etc. For instructions on using the
documentation database, refer to Documentation Database User Manual.
2. Externally Supplied Documentation
a) Installation, Operation, and Service Manuals.

Inspection, preventive maintenance, and repair will normally be carried out in accordance
with the original manufacturer’s/supplier’s manuals and drawings (including, where
applicable, authorized modifications). Newly received manuals shall be logged into the
technical documentation section of the documentation database and marked with a label.
This database holds the following information (information on label as indicated):
i) Unique identification number

ii) Device type
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iii) Manufacturer
iv) Model number
v) Document type
vi) Storage location
vii) Status
viii) Revision
ix) Issue date
x) Date received
xi) Notes

b) Technical Reference/Information
Technical data books and other reference material shall be logged onto the operational
documentation section of the documentation database and marked with a label. This
database holds the following information (information on label as indicated):

ii) Title
iii) Author
iv) Number – optional
v) Document type
vii) Status
viii) Revision
ix) Issue date
x) Date received
xi) Notes
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3. In-House Documentation
a) All quality system documents written in-house, such as the Quality system manual,
Quality Procedures and Work Instructions (QPWI), and customized inspection and
preventive maintenance procedures, shall be logged into the operational documentation
section of the documentation database and marked with a label. Each file shall have a
status sheet as described in section 6 of this procedure. This database holds the following
information (information on label as indicated):


ii) Title
iii) Author
iv) Number
v) Document type
vii) Status
viii) Revision
ix) Issue date
x) Date received
xi) Notes
b) Files
All files compiled from the quality system documents, such as the training, contract
review, complaints, incomplete orders, and internal audit files shall be logged into the
operational documentation section of the documentation database and marked with a
label. This database holds the same information as in 3 a) above.
34
c) Forms and labels
All forms and labels used by the quality system shall be identified in the appendix of this
document (QPWI) and shall be identified by a number and a date of issue.
4. Drawings
a) All drawings produced in-house shall be referenced appropriately (using a project

number, equipment control number, order number, etc.)

b) All drawings produced in-house shall be kept with the relevant project or equipment file,
or service manual.
c) Software masters of drawings produced by CAD packages shall be stored as indicated in

section 5 (below) of this procedure.
5. Software
a) Manufacturer-supplied or in-house software diskettes and their corresponding operation

manuals related to customer or test equipment shall be logged into the technical database
section of the documentation database and marked with a label. This database holds the
same information as described in section 3 a) above.
b) Operational third-party or in-house software diskettes and their corresponding operation

manuals (Four Rivers, word processing programs, etc.) shall be logged into the
operational database section of the documentation database and marked with a label. This
database holds the same type of information as in section 3 a) above.
c) Master copies of in-house software files for procedures, manuals, or drawings produced
in house shall:
35
i) be saved to a specific directory on LEGACY BIOMEDICAL’ Network Server as
shown in Table 2.
ii) be uniquely identified by its file name as shown in Table 3.
iii) in the case of individual project subdirectories, include a text file which shall list
all files located in the subdirectory, together with a brief description of the file
contents.

iv) be backed up as per the “Computer Backup” work instruction (see Section 16.1).
6. Status Sheet
The status sheet shall be used whenever possible with in-house documentation to indicate
the current issue status (i.e., revision number) of each page in the document. This allows
changes to be made without the need for the entire document to be reissued.
7. Document Updating
If a change has to be made to a controlled document, whether on one page or throughout

the document, the following procedure shall be followed:
a) Using the document database, choose the appropriate area (technical or

operational) and select “Update Sheets” from the menu.
b) Conduct a search to identify all distributed copies of the document requiring an

update.
36
c) When satisfied with the search results, print out an update sheet.
d) Produce a new status sheet for the document that reflects the changes made and
the new revision number. Make the appropriate number of copies of this status
sheet as indicated by the update sheet.

e) Using the documentation database, update the revision information of each

document copy affected by the change. As this is done for each document copy,
check the box marked “COMP.” On the update sheet to record that this change
has been made.
f) Locate each document copy, make the required change, and put in the new status
page. As this is done for each document copy, check the box marked “DOC” on
the update sheet to record that this change has been made.
g) On completing all changes, sign and date the update sheet and send it to the
Director, Quality Assurance for storage in the document update file.
F. Documentation
 Document Control Procedure (Section 5.0)

 Documentation Database
 Computer Backup Work Instruction (Section 16.1)
 Documentation Database User Manual
 Document Update File
37
Table 2. Document Type Directory
Section Document Type Directory

Quality System Manual,
General procedures, work instructions,
forms, etc.
Electronic Design Drawings and manuals
Mechanical Design Drawings and manuals
Inspection and Preventive
IPM procedures
Maintenance (IPM)
Table 3. File Name Directory
38
Document Type File Name Structure File Name
Quality System Manual,
procedures, work instructions, Document No. File Name
forms, etc.
Operator manuals Project No. File Name
Service manuals Project No. File Name
Drawings Project No. + drawing No. File Name
Bill of Materials Project No. + bom extension File Name
IPM procedures Procedure No. File Name

5.2 Writing a Quality System Document 1 of 14 0
A. Purpose
This procedure describes the method of writing a quality system document. A documented quality
system encourages uniformity in processes, and it establishes a starting point for continuous
improvement activity.
B. Scope
This procedure shall apply to all quality system documentation written by the staff of LEGACY
BIOMEDICAL.
C. References
D. Definitions
None
39
E. Procedure
1. General
a) The procedure detailed in this document shall be used when preparing quality system
documents such as the following:

i) Quality procedures
ii) Work instructions
iii) Inspection and preventive maintenance procedures
iv) Manuals
v) Files
vi) Forms
vii) Labels
viii) Software
b) If this format is found to be inappropriate, it shall be brought to the attention of the

Director, Quality Assurance. It is the Director, Quality Assurance’s responsibility to
make changes to this procedure.
c) All quality system documents shall be entered into the documentation database in
accordance with the “Documentation Preparation and Issue” procedure (see Section 5.1).
40
d) Where quality documents become records, their storage and retention are as defined in
the “Control of Quality Records” procedure (see Section 16.0).
2. Quality Procedures
a) Quality procedures explain the how, who, why, when, and where of quality processes
carried out by LEGACY BIOMEDICAL.

b) The Quality Assurance Council shall decide on the need for a new procedure, basing its
decision on the following factors:
i) The importance of the activity in the running of LEGACY BIOMEDICAL,

particularly in its relation to customers and suppliers and the means of producing
the goods or services produced and as required by ISO 9002.
ii) The need to clarify the exact process to be followed, particularly for production of
goods and services and documentation of production.
iii) The infeasibility of modifying an existing procedure to incorporate new
information. If possible, existing procedures shall be modified rather than
developing new ones. However, making a procedure too lengthy can mean that it
is subject to constant revision merely because its scope is too broad.
c) Procedures may be written in response to a number of events in the quality system:
41
i) Management review, audits, and customer complaints. Management review and
audits are likely to indicate the need for new procedures or for substantial
alteration of existing procedures. Customer complaints are usually an input to
reviews, and these are a source of information about the need for procedures.
Other inputs to this review process are identified customer, supplier, market, and
legislative requirements.
ii) New products and services developed. Development of procedures is an integral
part of the development of new products and services.
iii) Management and quality system changes. Management changes and other
changes in the business can prompt the need for new procedures.
iv) Quality planning. A procedure is often one of the outcomes of a quality plan.

d) The Quality Assurance Council shall select the person responsible for writing and
implementing the procedure. Normally, this will be the person with functional control for
the activity described in the procedure.
e) All quality procedures shall be filed in the QPWI. The master software file of this
document shall be stored and named as described in item 5 of the “Document Preparation
and Issue” procedure (see Section 5.1).
f) Each quality procedure shall be given a title and unique number by the Director, Quality
Assurance.
g) Each page of a quality procedure shall have a header showing its title and section
number.
42
h) Each page of a quality procedure shall have a header showing its page number, total
number of pages, revision number, and revision date.
i) Quality procedures shall have printed at the header a RED logo to differentiate controlled
copies from photocopies.
j) Each quality procedure shall have the following format:
i) Purpose. Describes the essential and fundamental reason for the procedure’s
existence.
ii) Scope. Briefly describes the area and application of the procedure.
iii) References. Refers to information that may be useful to understand the procedure.
This can include glossaries.
iv) Definitions. Define unique terms or language used in the procedure.

v) Procedure. Sets out a concise and objective way exactly what is to be done to
ensure that an activity is carried out to the quality standards required. Where
possible, flowcharts shall be used to assist in explaining the procedure.
Procedures are worded so that each action or process is described clearly; the
inputs and outputs to each process or action are identified; the person or persons
responsible for each action are identified; and an auditor can use the procedure to
check whether the procedure is being followed.
vi) Documentation. Lists documentation referred to in the procedure.
vii) Appendix. Includes information that serves only to provide help to the reader but
is not essential for understanding the procedure.
k) Once completed, a procedure’s correctness shall be confirmed by a staff member whose

normal duties include the process described by the procedure.
43
l) Before release for general use, the procedure shall be approved and reviewed as per the
“Document and Data Control” procedure (see Section 5.0)
m) Changes to the QPWI and other documents due to the addition of a new procedure shall
be reflected in the relevant page status sheets.
n) All staff affected by the procedure shall be briefed by the author about the intent and
content of the procedure. Training, if required, is provided by the author with the
assistance of the Site Managers.

3. Work Instructions
a) Quality procedures are general documents that may not always provide detailed work
instructions. Where it is necessary to supplement procedures, either to train new workers
or to ensure that existing workers carry out the detailed requirements of the job, work
instructions are written. Work instructions give a step-by-step account of how to carry out
a task.
b) Site Managers shall decide on the need for a new work instruction.
c) Site Managers shall select the person responsible for writing and implementing the work
instruction, Normally, this will be the person with functional control for the activity
described in the work instruction.
44
d) All work instructions shall be filed in the QPWI. The master software file of this
document shall be stored and named as described in item 5 of the “Document Preparation
and Issue” procedure (see Section 5.1)
e) Each work instruction shall be given a title and unique number by the Director, Quality
Assurance.
f) Each page of a work instruction shall have a header showing its title and section number.
g) Included in the header of the work instruction shall be its page number, total number of
pages, revision number, and revision date.

h) Work instructions shall have printed at the header a BLUE logo to differentiate controlled
copies from photocopies.
i) Each work instruction shall have the following format:
i) A brief paragraph outlining the purpose of the work instruction.

ii) A numbered step-by-step instruction forming the body of the work instruction.
iii) A list of documents related or referred to by the work instruction.
iv) An appendix may be included to provide information that serves only to provide
help to the reader but is not essential for understanding the instruction.
45
j) Once completed, a work instruction’s correctness shall be confirmed by a staff member
whose normal duties include the task described.
k) Before release for general use, the work instruction shall be approved and reviewed as
per the “Document and Data Control” procedure (see Section 5.0).
l) Changes to the QPWI and other documents due to the addition of a new work instruction
shall be reflected in the relevant page status sheets.
m) All staff affected by the work instruction shall be briefed by the author about the intent
and content of the instruction. Training, if required, is provided by the author with the
assistance of the Site Managers.

4. Inspection and Preventive Maintenance Procedures
a) IPM procedures are work instructions that specifically describe the tasks and methods
involved in the inspection and/or preventive maintenance of individual types of
equipment under the care of LEGACY BIOMEDICAL.
b) IPM procedures consist of those procedures published in the Maintenance Management

for Medical Equipment Manual published by the American Society for Healthcare
Engineering and new and customized procedures developed by LEGACY
BIOMEDICAL. All procedures shall be stored and named as described in item 5 of the
“Document Preparation and Issue” procedure (see Section 5.0).
46
c) Site Managers shall determine the need for a new or customized IPM procedure.
d) Site Managers shall select the person responsible for writing and implementing the IPM
procedure. Normally, this will be the person with the responsibility for maintaining the
equipment involved.
e) Each IPM procedure shall be given a title and date-coded procedure number by the
appropriate Site Manager. This number and title shall be entered into the IPM Procedure
Table of the database by the Director, Quality Assurance.
f) IPM procedures shall have a blue logo imprinted in the upper corner to differentiate
controlled copies from photocopies.

g) Each IPM procedure shall have the format provided by the current database.
h) Once completed, an IPM procedure’s correctness shall be confirmed by a staff member

who is experienced with the subject device of the procedure.
i) Before release for general use, the procedure shall be reviewed and approved as per the
“Document and Data Control” procedure (see Section 5.0).
j) Changes to the IPM Procedures Table in the database due to the addition of a new IPM
procedure shall be reflected in the appropriate page status sheets.
47
k) All persons affected by the IPM procedure shall be briefed on the procedure by the
author. Training, if required, is provided by the author with the assistance of the Site
Manager.
5. Manuals
a) Manuals are written to explain the use, operation, or maintenance of products (hardware
and software) developed by LEGACY BIOMEDICAL.
b) Site Managers shall decide on the need for a new manual.
c) Site Managers shall select the person responsible for writing and implementing the
manual. Normally, this will be the person with the responsibility for using, designing,
manufacturing, or maintaining the equipment or software involved.

d) Once completed, a manual’s correctness shall be confirmed by a staff member whose

normal duties include the equipment or software associated with the manual.
e) The master software file of the manual shall be stored and named as described in item 5
of the “Document Preparation and Issue” procedure (see Section 5.1).
f) Before release for general use, the manual shall be reviewed and approved as per the
“Document and Data Control” procedure (see Section 5.0).
g) All staff affected by the manual shall be briefed by the author. Training, if required, is
provided by the author with the assistance of the Site Manager.
48
6. Files
a) Files are used to collate reports, records, and other quality documentation.
b) The LEGACY BIOMEDICAL Quality Assurance Council shall decide on the need for a
new file.
c) Each file shall be given a title and unique number by the Director, Quality Assurance.
d) Files shall be maintained by the officer named in the appendix of the “Control of Quality
Records” procedure (see Section 16.0).

7. Forms
a) Forms are used as the basis for most quality records produced by LEGACY
BIOMEDICAL.
b) The LEGACY BIOMEDICAL Quality Assurance Council shall decide on the need for a
new form.
49
c) The LEGACY BIOMEDICAL Quality Assurance Council shall select the person
responsible for writing and implementing the form. Normally, this will be the person with
functional control for the activity related to the form.
d) All quality forms shall be listed in the QPWI appendix. The master software file of these
forms shall be stored and named as described in item 5 of the “Document Preparation and
Issue” procedure (see Section 5.1).
e) Each form shall be given a title and unique number by the Director, Quality Assurance.
This number shall be printed on the bottom of the form, along with its revision date, if
possible.
f) Once completed, a form’s correctness shall be confirmed by a staff member whose

normal duties include the process affected by the form.
g) Before release for general use, the form shall be reviewed and approved by the LEGACY
BIOMEDICAL Quality Assurance Council.
h) Changes to the QPWI and other documents due to the addition of a new form shall be
reflected in the appropriate page status sheets.

i) All staff affected by the form shall be briefed by the author about the intent, completion,
and use of the form. Training, if required, is provided by the author with the assistance of
the Site Manager.
8. Labels
50
a) Labels are used as the basis for traceability and/or status of goods and work within
LEGACY BIOMEDICAL.
b) LEGACY BIOMEDICAL Quality Assurance Council shall decide on the need for a new
label.
c) LEGACY BIOMEDICAL Quality Assurance Council shall select the person responsible
implementing the form. Normally, this will be the person with functional control for the
activity related to the label.
d) Each label shall be given a title and unique number by the Director, Quality Assurance.
This number shall be printed on the bottom of the label, along with its revision date, if
possible. This shall depend on the label’s size and use.
e) Once completed, a label’s correctness shall be confirmed by a staff member whose

normal duties include the process affected by the label.
f) Before release for general use, the label shall be reviewed and approved by the LEGACY
BIOMEDICAL Quality Assurance Council.
g) Changes to the QPWI and other documents due to the addition of a new label shall be
i) All staff affected by the label shall be briefed by the author about the intent, completion,
and use of the form. Training, if required, is provided by the author with the assistance of
the Site Manager.

9. Software
a) Software may be written by LEGACY BIOMEDICAL for record keeping, data

interrogation, testing, or design.
b) The need for software may be initiated by
51
i) The Quality Assurance Council as a requirement of the quality system,
ii) a customer as a request for work, and/or
iii) a staff member as a work aid.
c) The person assigned responsibility for writing and implementing the software will
depend on the origin and type of request for the software. Normally, this will be the
person with functional control for the activity related to the software.
d) All software shall have an associated manual, written in accordance with paragraph 5 of
this procedure.
e) The original file shall be stored and named as described in Section 5.0 of the “ Document
Preparation and Issue” procedure (see Section 5.1). The number and the current revision
date shall be printed on any copies, together with any associated documentation.
f) Once completed, the software’s correctness shall be confirmed by a staff member whose
normal duties include the process affected by the software.

g) Changes to the QPWI and other documents due to the addition of a new software shall be
52
i) All staff affected by the software shall be briefed by the author about the intent,
completion, and use of the software. Training, if required, is provided by the author with
the assistance of the Site Manager.
F. Documentation
 Document Preparation and Issue procedure (Section 5.1)

 Control of Quality Records procedure (Section 16.0)
 Document and Data Control procedure (Section 5.0)

6.0 Purchasing 1 of 5 0
A. Purpose
53
This procedure describes the purchasing methods used to ensure that purchased products conform to
specified requirements.
B. Scope
This procedure shall apply to any goods or services purchased by LEGACY BIOMEDICAL to enable it
to carry out its functions. The goods may be spare parts, test equipment, raw materials, etc. Services may
include maintenance contracts or manufacturing work supplied by outside organizations.
C. References
LEGACY BIOMEDICAL Quality System Manual.
D. Definitions
 Supplier. Any outside organization providing goods and/or services to LEGACY BIOMEDICAL.
 Subcontractor. Any outside organization carrying out work on behalf of LEGACY
BIOMEDICAL.
E. Procedure
1. General
Goods or services purchased by LEGACY BIOMEDICAL shall be initiated and processed by

one of the following methods:

a) Routine purchase request (Section 6.3)
54
b) Urgent purchase request (Section 6.4)
c) Standing order purchase (Sections 6.5 and 6.10)
d) Petty cash purchase (Section 6.6)
2. Supplier and Subcontractor Evaluation
a) LEGACY BIOMEDICAL shall select suppliers and subcontractors on the basis of their
ability to meet purchase or subcontract requirements, including quality requirements as
per the “Approved Supplier Selection” procedure (See Section 6.1)
b) Selected suppliers and subcontractors shall be listed in the supplier section of the
LEGACY BIOMEDICAL database (known as the “supplier catalog”), where their
acceptability and scope of product shall be identified as specified in the “Approved
Supplier Selection” procedure (See Section 6.1).
c) Purchasing data shall be monitored by the Director, Purchasing to ensure that only
approved suppliers are used.
3. Purchasing Data
a) All purchasing documents shall contain clear and accurate descriptions of the item or
service required.

55
b) Purchase requisitions shall only be raised on suppliers rated as acceptable (A) or
conditionally acceptable (C) and whose scope of product is suitable as defined in the
supplier catalog. An exception to this shall be if the requisition is to be raised on a new
supplier. In this case, the new supplier shall be evaluated as per the “Approved Supplier
Selection” procedure (See Section 6.1).
c) The person initiating a requisition is responsible for the accuracy of the data on the
requisition.
d) A purchase requisition form shall be completed and processed as per the “Purchase
Requisition Form Completion” work instruction (See Section 6.7).
e) Purchase requisitions completed by staff members shall be reviewed and approved by

their immediate supervisor.
f) All purchase requisitions must be authorized as described in the “Purchase Requisition

Expenditure Authorization” procedure (See Section 6.2) before any commitment of
expenditure.
4. Documentation Control and Progress
a) All officer(s) responsible for controlling purchase documentation shall be provided with a
copy of the work instruction applicable to the purchase method used (See Sections 6.3,
6.4, 6.5, 6.6, or 6.10).
b) The Director, Purchasing shall be responsible for monitoring the progress of requisition
documentation and orders for conformance to promised delivery dates as per the
“Outstanding Order Progress” work instruction (See Section 6.8).

5. Purchased Product Verification
56
a) All purchased products received by LEGACY BIOMEDICAL shall be inspected to
confirm that the product conforms to the documentation and all other specifications
issued. This process is detailed in the “Incoming Goods Inspection” procedure (See
Section 10.1).
b) Where specified by the contract, clients or their representatives have the right to check
purchased products to verify they meet specified requirements.
c) When a contract is reviewed (See “Contract Review” procedure, Section 3.0), customer
verification of purchased product shall only be included if required by the customer.
d) The Director, Quality Assurance is responsible for arranging verification by a customer

and shall be contacted when this is required.
e) LEGACY BIOMEDICAL staff members may visit the premises of its suppliers and
subcontractors to verify that products supplied meet specified requirements. The Director,
Quality Assurance is responsible for arranging these inspections when deemed necessary
by the Director, Purchasing or other officers of LEGACY BIOMEDICAL.
F. Documentation
 Routine Purchase Request work instruction (Section 6.3)

 Urgent Purchase Request work instruction (Section 6.4)
 Standing Order Purchase work instruction Section 6.5)
 Petty Cash Purchase work instructions (Section 6.6)
 Outside Work work instruction (Section 6.10)

57
 Approved Supplier Selection procedure (Section 6.1)
 Purchase Requisition Form
 Purchase Requisition Form Completion work instruction (Section 6.7)
 Purchase Requisition Expenditure Authorization procedure (Section 6.2)
 Outstanding Order Progress work instruction (Section 6.8)
 Incoming Goods Inspection procedure (Section 10.1)
 Contract Review procedure (Section 3.0)

6.1 Approved Supplier Selection 1 of 7 0
58
A. Purpose
This procedure describes the methods for ensuring that LEGACY BIOMEDICAL’ suppliers of goods
and services are able to meet the required quality standards.
B. Scope
This procedure shall apply to all suppliers of goods and services purchased against purchase requisitions
raised in LEGACY BIOMEDICAL.
C. References
D. Definitions
None
E. Procedure
1. General
a) A list of suppliers used by LEGACY BIOMEDICAL, detailing their approved scope of

products or services and their current acceptability rating, shall be maintained in the
supplier catalog section of the LEGACY BIOMEDICAL computer database. This
procedure details the process for determining the approved scope of product or service
and acceptability rating of each new supplier.
b) The Director, Purchasing shall be responsible for monitoring purchasing data to ensure
that only approved suppliers are used.
59
2. New Suppliers
a) When a purchase requisition is to be raised on a new supplier, the ability of the supplier
to provide a suitable and quality product shall be evaluated by completing an Evaluation
of Suppliers and Subcontractors Form. This form shall be completed by the person filling
out the requisition and requires that the following information be given in the
prepurchase evaluation section:
i) The product or range of products to be assessed.

ii) The impact, if any, the product(s) will have on the final product.
iii) Whether the supplier or its products are certified to any recognized quality
standards.
iv) Whether there is any reference, prior experience, or other information relevant to
the products suitability and quality.
b) Upon completion of the Prepurchase Evaluation section, the Evaluation of Suppliers and
Subcontractors form shall be stapled to the accompanying purchase requisition and the
requisition shall be processed as usual.
c) The Evaluation of Suppliers and Subcontractors form shall remain attached to the copy of
the purchase requisition in the Outstanding Requisition file while awaiting delivery of the
goods.
d) Upon receipt of the goods, the goods shall be inspected by the Warehouse Clerk as per
the “Incoming Goods Inspection” work instruction (See Section 10.1), and the Director,
Purchasing shall complete the incoming inspection section (delivery date, documentation,
and packaging) of the Evaluation of Suppliers and Subcontractors form.
60
e) The goods and the Evaluation of Suppliers and Subcontractors form shall then be
forwarded to the requestor, who shall carry out a technical and quality evaluation of the
goods. A summary of this inspection shall be completed in the Incoming Inspection
section of the Evaluation of Suppliers and Subcontractors form.
f) If the performance of the supplier and the quality of goods are considered satisfactory,
the requestor shall indicate on the Evaluation of Suppliers and Subcontractors form that
the supplier is recommended for approval in the supplier catalog.
g) The Evaluation of Suppliers and Subcontractors form shall then be forwarded to Director,
Quality Assurance for authorization and data entry into the supplier catalog.
h) Suppliers new to LEGACY BIOMEDICAL shall initially be rated as acceptable (A),

conditionally acceptable (C), or unacceptable (X), depending on the outcome of the
evaluation process. See item 5 for definitions of these ratings.
i) After data entry, the Evaluation of Suppliers and Subcontractors form and any other
associated information shall be filed in the Approved Supplier Selection file in the
Quality Assurance department.
3. Supplier Catalog Data Entry
a) The acceptability and scope of product of all evaluated suppliers and subcontractors shall
be identified in the company section of the LEGACY BIOMEDICAL computer database
(known as the “company catalog”).
61
b) The format of this information shall be as follows:
i) Suppliers and subcontractors shall be listed in the Purchasing, Vendors section.
ii) All relevant details, such as addresses, telephone numbers, and contact names,
shall be entered and kept up to date.
iii) The Details tab shall be used to identify the acceptability rating and scope of the
product.
iv) Additional concise comments may be added to assist in supplier or product
selection under the Details tab.
4. Supplier Performance Monitoring
a) Upon receipt of goods, the Director, Purchasing shall consider the performance of the
supplier against the following criteria:
i) Were the goods delivered within the period promised?
ii) Were the goods delivered with the correct documentation?
iii) Were the goods shipped in a manner that ensured their arrival in an as-new
condition?
iv) Were the goods supplied as described in the order?
v) Were the goods found acceptable as per the “Incoming Goods Inspection” work
instruction (See Section 10.1)?
62
b) The Director, Purchasing, in cooperation with the originator, shall on each occasion of
nonconformance, bring the matter to the attention of the supplier and note this on a copy
of the purchase requisition.
c) When delivered to the originator of the requisition, the goods shall be inspected for
acceptability. Any nonconformances shall be processed as per the “Control of
Nonconforming Product” procedure (See Section 13.0), and the nonconformance noted
on the copy of the purchase requisition.
d) Upon completion of an order involving a nonconformance, copies of the requisition are to

be filed in the nonconforming received order file (in numerical order), in the Director,
Purchasing’s office.
e) The nonconforming received order file shall be reviewed by the Director, Purchasing and
the Director, Quality Assurance every six months (December and July) or for a particular
supplier at the request of either officer to establish the current rating of the supplier (See
Section 5, below). Any changes to a supplier’s rating or scope of product shall be
reflected in the supplier catalog. All documentation associated with the review shall be
filed in the supplier deficiency reports file located in the Director, Purchasing’s office.
f) Following the six-month review, copies of the requisition held in the nonconforming
received order file shall be placed in the orders received file (in requisition number order)
located in the Director, Purchasing’s office.
5. Supplier Ratings
a) Suppliers are to be rated according to the following table:
63
Rating Explanation
A Acceptable Supplier
C Conditionally Acceptable Supplier
X Unacceptable Supplier
b) “A” Rating. An “A” rating will be attributed to a supplier who consistently provides
goods or services of an acceptable quality.
c) “C” Rating.
i) A “C” rating will be given to those suppliers who, in the opinion of the Director,
Purchasing, fail to qualify for the “A” rating. The Director, Purchasing will
discuss those areas of deficiency with the supplier so that corrective action can be
undertaken. A summary of noted deficiencies shall be recorded on a supplier
deficiency report and retained by the Director, Purchasing in the supplier
deficiency report file for subsequent review of that supplier’s rating.
ii) Purchase requisitions may be raised on these suppliers.
d) “X” Rating
i) An “X” rating is given to those suppliers who have failed to qualify for an A or C
rating and who, in the opinion of the Director, Purchasing, are unable or unwilling
to remedy significant supply deficiencies.
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ii) Purchase requisitions may NOT be raised on these suppliers without approval by
the Director, Purchasing.
iii) Before giving approval, the Director, Purchasing must audit the supplier’s supply
record and complete a supplier deficiency report form.
iv) When required, the Director, Purchasing or his or her representative will discuss
those areas of deficiency with the supplier.
v) Copies of the supplier deficiency report form will be given to the company
concerned for agreement on corrective action.
vi) Copies of all supplier deficiency reports shall be maintained by the Director,
Purchasing in the supplier deficiency reports file located in the Director’s office.
F. Documentation
 Evaluation of Suppliers and Contractors Form

 Incoming Goods Inspection Work Instruction (Section 10.1)
 Nonconforming received order file
 Approved supplier selection file
 Supplier Deficiency Report
 Supplier Deficiency Reports File
65
6.2 Purchase Requisition Expenditure
1 of X 0
Authorization
A. Purpose
This procedure describes the method of authorizing purchase requisition expenditures.
B. Scope
This procedure shall apply to purchase requisitions raised within LEGACY BIOMEDICAL.
C. References
 LEGACY BIOMEDICAL Quality System Manual
D. Definitions
None
E. Procedure
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6.3 Routine Purchase Request 1 of X 0
A. Purpose
This procedure describes the method of making routine purchase requests.
B. Scope
This procedure shall apply to purchase requests raised within LEGACY BIOMEDICAL.
C. References
D. Definitions
None
E. Procedure
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6.4 Urgent Purchase Request 1 of X 0
A. Purpose
This procedure describes the method of making urgent purchase requests.
B. Scope
This procedure shall apply to urgent purchase requests raised within LEGACY BIOMEDICAL.
C. References
D. Definitions
None
E. Procedure
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6.5 Standing Order Purchase 1 of X 0
A. Purpose
A standing order opens an account with an approved supplier to supply goods or services for a specified
period. It is typically used when goods of low value are purchased frequently from one supplier. The
standing order avoids the excessive use of petty cash and the payment of sales tax. The “Routine
Purchase Request” procedure (See Section 6.3) is used to initiate a standing order.
B. Scope
This procedure shall apply to standing order purchase requests raised within LEGACY BIOMEDICAL.
C. References
D. Definitions
None
E. Procedure
1. The requestor shall do the following:
a) Complete the purchase requisition form as per the “Purchase Requisition Form
Completion” work instruction (See Section 6.7).
69
6.5 Standing Order Purchase 2 of X 0
b) If applicable, notes the requisition number on the Medical Equipment Service Report
associated with the purchase as a reference.
c) Obtains the Director, Purchasing’s approval.
2. The Director, Purchasing will do the following:
a) Obtains expenditure authorization signature from the President LEGACY BIOMEDICAL

for expenditures above _____________.
b) Places the order with the supplier by fax or phone and arranges delivery. Some services
may require goods to be forwarded to the supplier under cover of a Returned Goods
Authorization.
c)
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6.6 Petty Cash Purchase 1 of X 0
71
6.7 Purchase Requisition Form Completion 2 of X 0
72
6.8 Outstanding Order Progress 1 of X 0
73
6.9 Using a Courier 1 of X 0
74
6.10 Outside Work 1 of X 0
A. Purpose
This procedure describes the method of engaging the services of suppliers (e.g., for repair of medical
equipment).
B. Scope
This procedure shall apply to obtaining services from suppliers outside LEGACY BIOMEDICAL.
C. References
D. Definitions
None
E. Procedure
75
7.0 Control of Customer-Supplied Product 1 of 4 0
A. Purpose
This procedure describes the documentation, verification, and storage of items supplied by the customer.
B. Scope
This procedure shall apply to any item supplied to LEGACY BIOMEDICAL by its customers.
C. References
D. Definitions
None
E. Procedure
1. Documentation
a) The customer-supplied product shall be identified and documented as described in the

“Contract Review” procedure (See Section 3.0). The documentation shall provide:
76
i) a description of what is being received;
ii) the customer’s name, contact information, and phone number; and
iii) the purpose for which we received the product.
b) All customer-supplied product received by LEGACY BIOMEDICAL for acceptance,

installation, repair, inspection, or preventive maintenance shall be processed as incoming
work as described in the “Incoming Work” work instructions (See Section 12.22). This
will result in
i) a Medical Equipment Service Report being raised for this product, and
ii) an Equipment Status Tag being attached to the product for identification and
tracking.
c) All customer-supplied product received by LEGACY BIOMEDICAL for design or

modification shall have a project file opened, and an Equipment Status Tag will be
attached to it for identification and tracking.
2. Discrepancies Check
a) The Site Manager is responsible for ensuring that all customer-supplied product shall,
upon arrival, be inspected for conformance to the items specified and agreed to by
LEGACY BIOMEDICAL with the customer.
b) If the customer-supplied product does not conform to specification, or is unsuitable for

other reasons, it shall be processed as per the “ Control of Nonconforming Product”
procedure (See Section 13.0).
77
c) The customer shall immediately be informed of a nonconformance by the Site Manager,

and a course of action shall be agreed upon.
d) The accompanying Medical Equipment Service Report or project file and Equipment
Status Tag shall be updated to reflect the discrepancies found, the action to be taken, and
the current status.
3. Storage
a) While in the care of LEGACY BIOMEDICAL, the customer-supplied product shall be

handled and stored as per the “Handling, Storage, Packaging, Preservation, and Delivery”
procedure (See Section 15.0).
b) Customer-supplied product shall be identifiable by its accompanying Equipment Status

Tag.
c) If a customer-supplied product is lost or damaged, the customer shall be informed by the

Site Manager. The details of the loss or damage shall be recorded on the accompanying
Medical Equipment Service Report or project file.
d) In response to loss, damage, or nonconformance, a course of action shall be agreed upon

by the Site Manager and the customer, and the change in instructions shall be recorded on
the Medical Equipment Service Report or project file.
78
F. Documentation
 Contract Review procedure (Section 3.0)

 Incoming Work work instruction (Section 12.2)
 Medical equipment Service report
 Project File
 Handling, Storage, Packaging, Preservation, and Delivery procedure (Section 15.0)
 Control of Nonconforming Product procedure (Section 13.0)
79
8.0 Product Identification and Traceability 1 of 3 0
A. Purpose
This procedure describes the identification and, where specified, traceability of all items of product from
applicable drawings, specifications, or other documents during all stages of repair, inspection,
preventive maintenance, production, testing, and installation.
B. Scope
This procedure shall apply to items coming under the control of LEGACY BIOMEDICAL.
C. References
D. Definitions
None
E. Procedure
1. The Director, Quality Assurance is responsible for setting the levels of identification.
2. Any unidentified item, such as customer equipment, parts, or materials, shall not be processed or
used until identified and inspected for suitability for purpose. Any such item determined to be
unsuitable shall be processed as per the “Control of Nonconforming Product” procedure (See
Section 13.0).
3. The Director, Purchasing is responsible for identifying all incoming goods as described in the
“Incoming Goods Inspection” work instruction (See Section 10.1).
80
4. All equipment entering LEGACY BIOMEDICAL for work shall be labeled with an Equipment
Status Tag as per the “Incoming Work” work instruction (See Section 12.2) and shall be
accompanied by a corresponding Medical Equipment Service Report.
5. The Site Manager is responsible for ensuring that all items are suitably identified as follows:
a) All incoming equipment identified as under contract and owned by a LEGACY

BIOMEDICAL client shall be given a unique control number and labeled with the same
control number as per the “Equipment File Completion” work instruction (See Section
16.5).
b) All incoming equipment not owned by the client (equipment for evaluation or on loan)
shall be labeled with an on-loan label as per the “Process Control” procedure (See
Section 9.0). Verification of ownership and authorization to bill the client must be
obtained prior to any work being performed on the device.
6. All nonstock parts and materials used on a job shall be identified on the Medical equipment
Service Report and shall be traceable back to the original supplier by the purchase order number
or purchase requisition number as detailed in the “Medical Equipment Service Report
Completion” work instruction (See Section 16.3).
7. All documents produced by LEGACY BIOMEDICAL, such as manuals and drawings, shall be
uniquely identified with a document or drawing number and stored in the document’s update file
located in the Site Manager’s office so that they can be easily retrieved.
8. Documentation and Data identification shall be organized according to the policy set out in the
“Document and Data Control” procedure in Section 5.0 of LEGACY BIOMEDICAL’ Quality
System Manual.
81
F. Documentation

 Incoming Goods Inspection work instruction (Section 10.1)
 Medical Equipment Service Report
 Equipment File Completion work instruction (Section 16.5)
 Process Control procedure (Section 9.0)
 Project file
 Design Control procedure (Section 4.0)
 Medical Equipment Service Report Completion work instruction (Section 16.3)
 Document and Data Control procedure (Section 5.0)
82
9.0 Process Control 1 of 11 0
A. Purpose
This procedure identifies the necessary quality procedures, work instructions, and test procedures to be
used by LEGACY BIOMEDICAL for inspection and preventive maintenance (IPM) tasks, repairs, and
projects.
B. Scope
This procedure shall apply to all Inspection and Preventive Maintenance (IPM) processes carried out by
LEGACY BIOMEDICAL.
C. References
D. Definitions
MESR Medical Equipment Service Report
IPM Inspection and Preventive Maintenance
E. Procedure
1. General
a) All items of equipment in LEGACY BIOMEDICAL’ care shall have a pending work
order number and associated MESR filled out as per the “Incoming Work” work
instruction (See Section 12.2), and its current work and test status shall be identified by
83
an Equipment Status Tag as per the “Inspection and Test Status” procedure (See Section
12.0). This will include LEGACY BIOMEDICAL’ own equipment.

b) All inspections, preventive maintenance, repairs, modifications, and work on project

tasks shall be undertaken by staff meeting the qualifications, skill, and experience levels
required by the position responsible for carrying out that task.
c) All repairs and project tasks shall be performed to the standards of good general practice.
This includes the identification and segregation of dismantled parts to facilitate accurate
reassembly.
d) In the interests of personal hygiene and equipment safety, no food or drink may be
consumed in the workshops of LEGACY BIOMEDICAL, and all staff shall adhere to the
infection control policy.
e) Wherever possible, work priorities shall be determined, recorded on the MESR, and
followed. If a change of priority is required, the Site Manager shall be notified.
f) Site Managers shall monitor and act upon any work that fails to meet its scheduled
priority.
g) All documents, manuals, drawings, and specifications shall be logged and filed by the
Multi-Vendor Site undertaking the work.
h) All test equipment and tools used by LEGACY BIOMEDICAL’ staff must be in good
working order and have a current calibration label where appropriate (refer to the
“Control of Inspection, Measuring, and Test Equipment” procedure, Section 11.0).
i) The equipment number of each item of calibrated equipment used shall be recorded on
the work’s MESR.
84
j) All parts and supplies used in repairs, preventive maintenance, or projects shall be
obtained as described by the “Purchasing” procedure (See Section 6.0).

k) Spare parts shall be accessible from any Multi-Vendor Site as per the “Stock Issue” work
instruction (See Section 15.1) and shall be stocked and maintained in accordance with the
“Stock Control” work instruction (See Section 15.2).
l) Where required by contract, parts shall be ordered to a relevant National standard or

manufacturer’s specification.
m) All inspecting and testing of parts shall be carried out as described in the “Inspection and
Testing” procedure (See Section 10.0)
n) All work done shall be carried out in conformance to the following:
i) All relevant requirements of National Regulatory standards

ii) All relevant requirements of Regional Governmental Regulatory standards
iii) All relevant requirements of local (Municipality, County, etc.) authorities relating
to performance, safety, approval, testing, and licensing.
o) Details of work done, parts and materials used, and test results shall be recorded on the
associated MESR as per the “Medical equipment service report Completion” work
instruction (See Section 16.3), and these records shall be kept for the period of time
specified in the “Control of Quality Records” procedure (See Section 16.0).
p) In the case of fixed equipment or work done on site, all tests must be done before
returning the device to use and, again, records MUST be kept.
85
q) All records and test results (MESR’s) shall be checked by the Site Manager as per the
“Medical Equipment Service report and Equipment File Checking” work instruction (See
Section 16.4).

r) Where any equipment, work, part, or material does not conform with the required
specification, tests, or inspections, the “Control of Nonconforming Product” procedure
(See Section 13.0) shall be followed.
s) All equipment, parts, and materials in LEGACY BIOMEDICAL shall be stored during a
repair, maintenance, project task, or as stock in accordance with the “Handling, Storage,
Packaging, Preservation, and Delivery” procedure (See Section 15.0).
t) Where equipment undergoing work in LEGACY BIOMEDICAL is to be stored for any

length of time, care shall be taken that the condition of the equipment does not deteriorate
during its stay (e.g., batteries should be charged, reservoirs filled, surfaces cleaned).
u) In the case of software controlled equipment, great care must be taken to maintain the
integrity of the software. Backups of the software shall be made where possible.
v) Any markings, dust, grease, etc. on the equipment’s surfaces that may have been incurred
during its stay in LEGACY BIOMEDICAL shall be removed, and the equipment shall be
in a clean and tidy condition before return to the client.
w) Upon successful completion of work and final inspection and tests (See Section 9.3,
“Inspection”), equipment shall be forwarded to the customer as per the “Work Dispatch”
work instruction (See Section 12.3).
x) During the course of their work, LEGACY BIOMEDICAL staff may be required to go to
several hospitals and departments and may have access to confidential information. All
86
information received must be held in strict confidence and not be passed on to a third
party without permission of the Vice President, LEGACY BIOMEDICAL.
y) Site Managers shall conduct regular monitoring of work and workmanship.

z) The Vice President, LEGACY BIOMEDICAL shall conduct regular monitoring of the
work done by the Director, Quality Assurance and the Site Managers.
2. Installation
a) Where LEGACY BIOMEDICAL is to be involved in a large installation of equipment

(e.g., lasting more than two days), the Site Manager will ensure that this procedure is
followed.
b) The Site Manager shall attend or call a preinstallation meeting. This meeting shall include
the Center’s staff undertaking the work, together with staff from the client’s departments,
such as planning, engineering, etc., and from outside suppliers, if applicable. The
Director, Quality Assurance and/or the Vice President LEGACY BIOMEDICAL may
attend these meetings.
c) An installation file shall be created containing copies of specifications, plans, installation

drawings, etc.
d) A time plan of LEGACY BIOMEDICAL’s involvement shall be agreed upon and

documented.
e) Regular progress meetings must be held by the Site Manager and staff undertaking the
installation.
87
f) Where LEGACY BIOMEDICAL staff are working with an outside supplier, the role of
LEGACY BIOMEDICAL must be agreed upon in advance.
g) Commissioning and acceptance must always be carried out in conjunction with LEGACY
BIOMEDICAL. Records of these tests shall be maintained.

h) Before using the equipment on patients, the equipment shall be tested as per the
manufacturer’s manual or in-house test procedures (whichever is appropriate) and to the
relevant National standards for electromedical equipment.
i) At the end of the installation, the Site Manager must ensure that the installation file is up-
to-date, complete, and filed appropriately.
3. Acceptance Test
a) Medical, surgical, and laboratory equipment that is purchased, evaluated, or on loan to a

client’s facility and the client wants to include those devices into the Equipment
Management Program must undergo acceptance testing by LEGACY BIOMEDICAL
before use.
b) Equipment received for evaluation shall be processed in accordance with the “Equipment
Evaluation” work instruction (See Section 9.8).
c) All equipment included in the contract between LEGACY BIOMEDICAL and its client
must be allocated a unique control number, a corresponding unique control number label,
and a unique equipment file as per the “Equipment File Completion” work Instruction
(See Section 16.5).
88
d) Any equipment owned by the client’s facility and to be included in the equipment
management program but located in another facility for longer than six months shall be
allocated a control number, a corresponding control number label, and an equipment file
as per the "Equipment File Completion" work instruction (See Section 16.5).

e) Except as provided for in (d) above, all equipment not included in the equipment
management program (and not under contract with LEGACY BIOMEDICAL), but shall
be used within the facility (e.g., on loan or on evaluation), at the request of the client,
may be temporarily included in the Equipment management program. This equipment
shall have an On-Loan label attached and completed with the following information:
i) Reason. The reason for the equipment to be in the client’s facility (e.g.,
evaluation, loan).
ii) Department. The department in which the equipment will be used.
iii) Valid Until. The date after which the acceptance tests are no longer valid.
For equipment being evaluated, this date will correspond to the end of the
evaluation period.
iv) Number. The work order number associated with the equipment.
f) All equipment selected for entry into the LEGACY BIOMEDICAL Equipment
Maintenance Program
(See Section 9.3) and has a Risk Assessment number assigned must have an asset number
allocated and be identified with an asset number sticker as per the “Equipment File
89
Completion” work Instruction (See Section 16.5).
g) The staff member undertaking the acceptance testing shall ensure that the equipment has
been supplied with full documentation and that its electrical safety and patient circuit
classifications, if applicable, are identified. If applicable, these details shall be noted in
the equipment file.
g) Before returning to use, the equipment shall be tested as per the manufacturer’s
instructions or LEGACY BIOMEDICAL test procedures (whichever is appropriate), and
to the relevant ANSI standards for electromedical equipment.

4. Scheduled Inspections
a) Inspections shall be carried out by LEGACY BIOMEDICAL on designated medical,

surgical, and laboratory equipment in accordance with schedules determined by the Site
Manager utilizing the methodology of risk assessment (See Section 9.3).
b) Equipment designated for these inspections shall be determined by the Site Manager
based on the criteria established in Section 9.3, “Risk Assessment of Patient Care
Devices”.
c) The procedure to be followed when carrying out inspections is described in the

“Inspection” work instruction (See Section 9.4).
d) All work details of the inspections must be recorded either on a Medical Equipment
Service Report as per the “Medical Equipment Service Report Completion” work
instruction (See Section 16.3) or on an equipment multiple work order sheet as per the
90
“Equipment Work Order Completion” work instruction (See Section 16.8), whichever is
most appropriate.
e) Any item of equipment failing an inspection must be repaired in accordance with the
procedure detailed in Section 6, below.
5. Preventive Maintenance
a) Preventive maintenance shall be carried out by Legacy Biomedical, or a designated

outside supplier, on client’s equipment that has a high maintenance requirement and is
included in the equipment management contract. The process for determining the need
for preventive maintenance is described in the “Risk Assessment of Patient Care
Devices” work instruction (See Section 9.3)

b) A preventive maintenance procedure for an item must be completed and approved by the
Site Manager with review by the Legacy Biomedical Quality Assurance Council.
c) Preventive maintenance schedules shall be generated as per the “IPM Scheduling” work
instruction (See Section 9.5).
d) The Site Manager is responsible for coordinating staff to undertake preventive

maintenance on the equipment under their control.
e) The relevant procedure must be followed when performing preventive maintenance on an

item of equipment, and all work details and test results must be recorded on a Medical
Equipment Service Report. This shall include testing to the applicable ANSI standards
for medical devices.
91
6. Repairs and Modifications
a) Technicians shall be assigned individual repairs based on their respective training and
experience.
b) Whenever possible and practical, a technician shall work on one repair at a time.
c) Technicians shall attempt to meet the following objectives when undertaking a repair:
i) Meet the client’s priority

ii) Achieve a low cost for the repair
iii) Achieve a high quality of repair

d) All parts and materials used to repair an item shall be identical or equivalent in both
specifications and quality to those replaced.
e) A modification shall NOT be made to an item without the permission of the appropriate
Legacy Biomedical Corporate Director with consent from the client’s representative.
f) Any modification so approved shall be fully documented in the item’s equipment file and
the applicable test and maintenance procedures and user and maintenance manuals shall
be updated accordingly.
g) Before dispatch, the equipment shall be tested as per manufacturer’s manual, in-house
test procedure (whichever is appropriate), and to the relevant ANSI standards for
electromedical equipment.
h) The Site Manager shall monitor the methods, efficiency, and effectiveness of the repairs
and modifications carried out by the technicians.
92
7. Projects
a) All requests for projects from customers shall be directed to the appropriate Site
Manager.
b) Projects (design, modification, and/or fabrication) shall follow the “Design Control”
procedure (See Section 4.0)

F. Documentation

 Inspection and Test Status Procedure (Section 12.0)
 Infection control Policy
 Inspection, Measuring, and Test Equipment procedure (Section 11.0)
 Purchasing Procedure (Section 6.0)
 Stock Issue work instruction (Section 15.1)
 Stock Control work instruction (Section 15.2)
 Inspection and Testing procedure (Section 10.0)
93
 Medical Equipment Service Report and Equipment File Checking work instruction (Section 16.4)
 Handling, Storage, Packaging, Preservation, and Delivery procedure (Section 15.0)
 Work Dispatch work instruction (Section 12.3)
 Equipment Evaluation procedure (Section 9.8)
 Equipment File Completion work instruction (Section 16.5)
 Inspection work instruction (Section 9.3)
 Equipment work order sheet
 Equipment Work Order Completion work instruction (Section 16.8)
 Selecting IPM Items work instruction (Section 9.4)
 IPM Scheduling work instruction (Section 9.5)

9.1 Special Processes 1 of 2 0
A. Purpose
This procedure describes how Legacy Biomedical, Inc. undertakes processes that cannot be fully
verified by subsequent inspection and testing, and where any deficiencies become obvious only after the
product is in use.
B. Scope
This procedure shall apply to special processes carried out in Legacy Biomedical, Inc.
C. References
Legacy Biomedical Quality System Manual
D. Definitions
94
None
E. Procedure
1. Where there are special processes that cannot be verified by subsequent inspection and testing,
and where any deficiencies become obvious only after the product is in use, Legacy Biomedical
Staff must inform their Site Manager.
2. The Site Manager will issue a procedure detailing instructions for the special process. This
procedure shall be written as per the “Writing a Quality System Document” procedure (See
Section 5.2).

9.1 Special Processes 2 of 2 0
3. This procedure shall be given a unique number and shall detail:
a) the process involved,
b) the sequence to be followed,
c) the equipment to be used, and
d) the workmanship standards to be met in completing the task or process.
4. The procedure shall be kept in the appropriate maintenance procedures file.
5. The Medical equipment Service Report or project file associated with the work on which the
process is being used shall be used to record all work and tests performed.
95
6. Special processes shall be carried out by suitably qualified staff using qualified procedures and
equipment so as to comply with the “Process Control” procedure (See Section 9.0).
7. All records associated with each process shall be maintained in accordance with the “Control of
Quality records’ procedure (See Section 16.0).
F. Documentation
 Writing a Quality System Document procedure (Section 5.2)

 Maintenance procedures file
 Project file
 Process Control procedure (Section 9.0)
 Control of Quality Records procedure (Section 16.0)

9.2 Emergency Call 1 of 2 0
A. Purpose
This procedure describes the method of providing emergency service.
B Scope
This procedure shall apply to all service that is required outside the Legacy Biomedical’ normal hours of
operation.
C. References
D. Definitions
96
None
E. Procedure
1. All requests for service beyond the normal working hours of Legacy Biomedical shall be
directed through Legacy Biomedical Corporate offices via either the LEGACY BIOMEDICAL
web site or via telephone.
2. Legacy Biomedical Site Managers shall ensure that a technician shall be on-call via pager after
normal working hours.
3. Once a request for emergency service is received, the corporate Multi-Vendor Site shall page the
technician on-call for his area. A notation of the time and date shall be recorded of any attempt to
page.

9.2 Emergency Call 2 of 2 0
4. Response time for the technician on-call to contact corporate shall be less than thirty (30)
minutes. Information about the client, hospital, department, and problem shall be forwarded to
the on-call technician who shall then contact the client and inform them of his estimated arrival
time at the location.
5. Unless emergency calls are covered in a contract with the client, all such calls shall be billed at
PREMIUM rates. All travel times to and from shall also be billed at these rates.
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9.3 Inspection 1 of 2 0
A. Purpose
This procedure describes the method of inspection of medical equipment and systems.
B. Scope
This procedure shall apply to acceptance tests and scheduled inspections performed by LEGACY
BIOMEDICAL personnel.
C. References
98
JCAHO Accreditation Manual for Healthcare Organizations
ASHE Maintenance of Medical Equipment Manual
Title 21 CFR
D. Definitions
 Acceptance Test. A detailed procedure used to verify the safety and performance of a device before
use, either after initial receipt (i.e., incoming inspection) or following major repairs, modifications,
or overhaul.
 Inspection. A procedure to check the physical integrity of a device and to ensure that it meets
appropriate safety and performance requirements, including those of regulatory, licensing, and
accrediting agencies, as well as those of the manufacturer and any special requirements of the client.

9.3 Inspection 2 of 2 0
E. Procedure
1. An acceptance test is performed on all newly purchased, rented, or loaned equipment, including
devices to be evaluated by the client’s staff if said equipment is to be included in a contractual
agreement between LEGACY BIOMEDICAL and the client. Conformance with purchase
requisitions and manufacturer’s specifications shall be checked during these incoming
inspections.
2. Following the acceptance tests, the Site Manager shall determine whether the equipment will
require scheduled inspections as described in section 9.4, “Risk Assessment of Patient Care
99
Devices”, and if it will, an appropriate time interval and procedure are identified. This
information shall be conveyed to the client for approval and inclusion in the contractual
agreement.
3. The current scheduled inspection intervals shall be maintained in the equipment control system.
4. Procedures for acceptance tests and scheduled inspections are provided in the ASHE
Maintenance of medical equipment guidelines and shall conform with JCAHO and Federal
standards. These procedures shall be revised when necessary by the LEGACY BIOMEDICAL
Quality Assurance Council. If a new procedure is required, it shall be requested of the Quality
Assurance Council.
F. Documentation
 “Maintenance Management for Medical Equipment” American Society for Healthcare Engineering
 ECRI “Health Devices Inspection and Preventive Maintenance System.”
 Legacy Biomedical Quality System Manual

9.4 Risk Assessment of Patient Care
1 of 13 0
Devices
A. Purpose
This procedure establishes the methodology to assess the risks associated with use of patient care
devices and to determine the service requirements that satisfy regulatory and accreditation standards.
B. Scope
100
This procedure shall apply to all patient care devices to be entered into Legacy Biomedical’ Equipment
Management Program or LEGACY BIOMEDICAL’ Year 2000 database.
C. References

JCAHO Hospital Accreditation Standards (EC.1.8)
D. Definitions
Patient care device Any device listed in the American Pharmacopoeia used in
the treatment, diagnosis, and/or therapy of patients.
Equipment function The role the device plays in the care of the patient (i.e., Life
support, Therapeutic, Diagnostic, etc.)

2 of 13 0
Devices
Clinical Application The physical risk associated with the clinical application
(i.e., Death, Injury, Mis-Diagnosis)
Maintenance requirements Level and frequency of preventive maintenance required as

suggested by the manufacturer of the device or based upon
the history of the device.
101
Likelihood of equipment failure How often a device fails based upon experience with the
device and its mean-time-between-failure (MTBF)
Environmental Use The primary areas in which the device is to be used.
E. Procedure:
1) General
a) Patient care devices will be ranked by criteria to determine its placement in the LEGACY
BIOMEDICAL equipment management program.
b) Devices placed in the criteria based equipment management program will be scheduled
for routine preventive maintenance.
c) At the discretion of the client, devices not meeting the criteria may be placed on the
equipment management program for purposes of management.

3 of 13 0
Devices
2) Criteria
a) Criteria for placement of devices into the criteria based equipment management program
will consist of the following four areas:
i) Equipment Function
102
The role the equipment plays in patient care.
ii) Clinical Application
Considers the results to the patient or user in the event the equipment fails; the
physical risk associated with the clinical application.
iii) Maintenance Requirements
Maintenance requirements on equipment vary with the type of equipment. Some
devices like ventilators, dialysis machines, and similar items require extensive
maintenance. Mechanical, pneumatic, or hydraulic equipment requires routine
alignment or calibration. Devices like physiological monitors and infusion pumps
have average maintenance requirements and need only performance and safety
inspections.
iv) Equipment Incident/Failure History
This criteria will be evaluated by the Site Manager and the client’s representative
on a scheduled basis to determine trends and requirements. Items on the criteria
based equipment management program may be removed from the program if the
history suggests that they do not pose a threat to quality patient care. Equipment
not on the program but having a poor repair history may be placed on the
program.

4 of 13 0
Devices
v) Environmental Use
Understanding that patient care devices, in general, are mobile, this category
determines the PRIMARY area of use.
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b) There are four equipment categories whose intervals shall not be flexible, regardless of
service history:
i) Equipment for direct life support,

ii) Equipment with mandatory parts replacement at set intervals,
iii) Equipment that delivers high levels of energy, and
iv) Equipment with maintenance intervals subject to regulatory requirements.
c) Criteria Tables
Tables 1 through 5 shall be used to rank equipment for inclusion or exclusion in the
criteria based equipment management program:

5 of 13 0
Devices
Table 1 Equipment Function
Numerical
Equipment Function
Ranking
Life Support Equipment 10
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Surgical and Intensive Care Devices 9
Surgical and Intensive Care Monitoring 8
Analytical Laboratory 7
Other Physiological Monitoring and Diagnostics 6
Physical Therapy and Treatment 5
Laboratory Accessories 4
Computer and Related Equipment 3
Patient Related and Other 2

6 of 13 0
Devices
Table 2 Clinical Applications
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Numerical
Clinical Application
Ranking
Patient Death 5
Patient or Operator Injury 4
Inappropriate Therapy or Misdiagnosis 3
Minimal Risk 2
No Significant Risk 1

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Devices
Table 3 Maintenance Requirements
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Numerical Ranking
P.M. Frequency
Monthly 8
Quarterly 7
Semi-Annually 6
Annually 5
Not Required 4

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Devices
Table 4 Likelihood of Failure
107
Numerical
Mean time Between failure
Ranking
Less than three months 8
Approximately six months 7
Approximately one year 6
Approximately three years 5
Greater than five years 4

9 of 13 0
Devices
Table 5 Environmental Use Classification
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Primary Area of Equipment Use Numerical
Ranking
Anesthetizing Locations 8
Critical Care Areas 7
Wet Locations/Labs/Exam Areas 6
General Care Areas 5
Non-Patient Care Areas 4

10 of 13 0
Devices
3) Priority Description
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All patient care devices shall be categorized according to the following priority of testing and degree
of risk:
a) Priority I.
Equipment that scores 18 and above points on the criteria evaluation system. This
equipment is given the highest priority for testing, calibration, and repair. Equipment in
this group is tested on at least a semi-annual basis and is noted as “HIGH PRIORITY” in
the database.
b) Priority II
Equipment that scores between and including 15 to 17 points on the criteria evaluation
system. Every effort should be made to test, calibrate, and repair this equipment
promptly, but only after Priority I equipment requirements have been completed.
Equipment in this group is tested on at least a semi-annual basis and is noted as
“MEDIUM PRIORITY” in the database.
c) Priority III
system. Every effort should be made to test, calibrate, and repair this equipment
promptly, but only after Priority I and II equipment requirements have been completed.
Equipment in this group is tested on at least a semi-annual basis and is noted as “LOW
PRIORITY” in the database.

11 of 13 0
Devices
d) Hazard Surveillance
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system. Devices in this category are placed on the equipment inventory, but are visually
inspected on an annual basis during annual surveillance rounds.
e) Equipment Management Program Deletion
Equipment and devices that pose little risk and scores 5 or less points may be deleted
from the equipment management program.
f) Priority Reclassification
In situations where it is desired to place equipment in a higher priority level than is

indicated by the scoring formula, a recommendation must be made by the Client’s
representative and approved by the Director, Quality Assurance. When it is desired to
place equipment in a lower priority level than is indicated by the scoring guide, a
recommendation must be made by the Client’s representative and approval must be
obtained from the Director, Quality Assurance, Multi-Vendor Site Directors, Quality
Assurance Council, and the Client’s Safety Committee.
End of Policy

12 of 13 0
Devices
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CLINICAL EQUIPMENT RISK ASSESSMENT EVALUATION FORM
Model ID Number: ____________________
Manufacturer: ____________________________________
Nomenclature: ____________________________________
Model: _________________________ Version: __________________________
Evaluation Information:
Risk Category I: Equipment Function (E) Score:

____________
Risk Category II: Clinical Application (A) Score: ____________
Risk Category III: PM Requirement (P) Score: ____________
Risk Category IV: Likelihood of Failure (F) Score: ____________
Risk Category V: Environmental Use Area (U) Score: ____________
Evaluation Scoring:
Total = E + A + [(P + F + U) / 3] Total Score: _____________

13 of 13 0
Devices
112
Inventory Classification Result:
______ Priority I (Score is in the 18 and above range)
______ Priority II (Score is in the 15 – 17 range)
______ Priority III (Score is in the 12 – 14 range)
______ Hazard Surveillance check only (Score is in the 6 – 11 range )
______ Deleted from the Equipment Management Program Inventory (Score is 5 or less)
Additional Comments:
Approval and Responsibility:
Reviewed By: __________________________ Date:_________________
Approved By: ___________________________ Date: _____________________

9.5 Selecting IPM Items 1 of 2 0
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A. Purpose
This procedure describes the method of determining which equipment requires scheduled support in
the form of inspection and/or preventive maintenance.
B. Scope
This procedure shall apply to all medical equipment in Legacy Biomedical’s equipment
control system.
C. References

ASHE Maintenance Management for Medical Equipment
D. Definitions
None
E. Procedure
1. Following the initial acceptance test for a device being inserted into the Marconi Technology
Management equipment control system, the Site Manager determines whether it will require
scheduled inspection and/or preventive maintenance. All such determinations are made with the
consent of the client’s representative.
2. The Clinical Equipment Risk Assessment Evaluation Form is used to document whether
scheduled support is indicated for a given device model or equipment category, and if it is,
what should be done, the appropriate support interval(s), and the responsible person and/or
Multi-Vendor Site.

9.5 Selecting IPM Items 2 of 2 0
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3. Instructions for the use of the Clinical equipment Risk Assessment Evaluation Form is included
in Section 9.4 of this Manual. It shall be updated annually to reflect any change in the design in
equipment use that effects scheduled support or when experience demonstrates that the
equipment does or does not appear to deteriorate or fail in a predictable manner.
F. Documentation

9.6 IPM Scheduling 1 of 1 0
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A. The Computerized Equipment Control Program used by Legacy Biomedical to control
scheduling of inspection and preventive maintenance activities on specific equipment identified by the
“Selecting IPM Items” work procedure (See Section 9.5). On the last working day of each month, each
Site Manager shall schedule inspections and/or preventive maintenance activities using the equipment
control program.
B. Each Multi-Vendor Site shall have a copy of the user’s manual for the Equipment Control Program
which details how to enter into the program and print out copies of each work order assigned to IPM’s.
C. Each Site Manager shall be responsible for manpower allocations assigned to work load under each
manager’s jurisdiction. AT NO TIME shall an IPM be more than sixty (60) days overdue. Each month,
the Site Manager shall make a determination of his manpower requirements and convey that
information to the Legacy Biomedical Area Manager. If a determination is
made that workload exceeds manpower, the Area Manager shall then have the responsibility of
providing resources to accommodate these requirements whether it shall be temporarily transferring
personnel from one location to another, or hiring additional personnel either temporary or permanent.

9.7 Transferring Equipment between 1 of 1 0
Multi-Vendor Sites
116
Multi-Vendor Sites
From time to time, it may be necessary to transfer the control of an item from one Multi-Vendor Site
another. This decision will usually be based on a review of the work commitment to the item by the
Area Manager. When this transfer is required, the following procedure shall be followed:
1. Approval for the transfer shall occur only after discussion and agreement by the Area Manager.
2. All accessories, disposables and manuals necessary to operate the device must be passed on to
the receiving Multi-Vendor Site.
3. If the transfer is to be permanent, the LEGACY BIOMEDICAL Computerized Equipment

Management records shall be amended to reflect this transfer.
4. Packaging of the device shall conform with Section 15.0 “Handling, Storage, Packaging,
Preservation and Delivery” work instruction.
5. Shipping of the device shall be determined by the Area Manager. Depending upon the urgency of
the situation, it may be necessary to ship FEDEX, courier, or regular ground shipment.
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9.8 Using LEGACY BIOMEDICAL
Computerized Equipment Management 1 of 1 0
Program
The LEGACY BIOMEDICAL Computerized Equipment Management Program is used for equipment
inventory control, Inspection and Preventive Maintenance, Scheduling, and storage and analysis of data.
The LEGACY BIOMEDICAL Equipment Management Program is password protected at various levels
of entry. You will be informed of any restrictions and at what levels you will be able to access.
Deletions of any records is prohibited unless at upper level management with the consent of the Director
of Quality Assurance.
You will be given an instruction manual and shown how to use the Equipment Management Program.
You may be given the authority to correct factual errors (e.g., serial numbers, descriptions, locations,
etc.) yourself. Any administrative errors (e.g., assignee, procedure code, etc.) you must discuss with
your Site Manager.
The integrity of the information contained within the LEGACY BIOMEDICAL Equipment
Management Program is extremely important. It is subject to review by the Food and Drug
Administration , JACHO, OSHA, Texas Department of Health, and any other regulatory agency that so
chooses. While staff are encouraged to interact with the system, please take care when adding or
changing data.
Comments may be entered on work orders by technicians as an aid in explaining the history or status of
equipment or work.
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9.9 Training Record Creation 1 of 5 0
A. Purpose
This procedure describes the method for documenting and providing clinical staff with specialized
training.
B. Scope
This procedure applies to all clinical staff training given by Legacy Biomedical. This includes practical
and
theoretical training on the use, IPM, repair, clinical application, and safety of equipment.
This procedure is not intended to cover spontaneous or informal talks by Legacy Biomedical’s staff to
its
customers.
C. References
D. Definitions
None
E. Procedure
1. Identifying the Need for Clinical Staff Training
a) It is the responsibility of the Site Managers to identify, manage, and initiate clinical staff
training.
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b) Clinical staff training needs may be identified in the following manner:
i) A request from a clinical staff member.

ii) Observation by Legacy Biomedical staff on the use and/or knowledge of a
particular skill, topic, or items of equipment.
iii) Performance reports that highlight user errors or problems that may be rectified
by training and/or education.
iv) Commissioning of new equipment.
c) Once a training need has been identified, the Site Manager shall contact the Director of
Quality Assurance who shall delegate an officer to meet with the client’s representative
to discuss training solutions. The following points shall be considered:
i) Is the training really required?

ii) What should be the content of the training program?
iii) What should be the format of the training program?
iv) Who requires the training?
v) Should this training be coordinated with other programs?
vi) When should the training program be scheduled?
d) The Director of Quality Assurance shall designate the officer(s) responsible for
documenting, organizing, and coordinating a particular training program. Only those
officers with the appropriate skills or training shall be given this responsibility.
2. Identifying the Need for Biomedical Staff Training
a) It is the responsibility of the Site Managers to identify, manage, and initiate biomedical
staff training.
120
b) Biomedical staff training needs may be identified in the following ways:
i) Observations by Legacy Biomedical staff on the use and/or knowledge of a

particular skill, topic, or item of equipment.
ii) Performance reports that highlight maintenance errors or problems that may be
rectified by training and/or education.
iii) Commissioning of new equipment.
c) Once a training need has been identified, the Director of Quality Assurance shall assign a
staff member to organize the training. The following points shall be considered:
i) Is the training really required?

ii) What should be the content of the training program?
iii) What should be the format of the training program?
iv) Who requires the training?
v) Should this training be coordinated with other programs?
vi) When should the training be scheduled?
d) The Director of Quality Assurance shall assign a staff member to be responsible for
documenting, organizing, and coordinating a particular training program. Only those
officers with the appropriate skills or training shall be given this responsibility.
121
3. Documenting a Training Program
a) The level of documentation associated with a training program shall depend on the nature
of the training. For example, a unique instructional talk may have no notes associated
with it, whereas a regular lecture may require structured notes to ensure continuity and
consistency in the subject material.
b) All work associated with a customer training program shall have a Medical Equipment
Service Report filled out for it. This Service Report shall be given a Work Type
designating “Training”, and an Action taken designating “User In-Service Given”.
c) Copies of any lecture notes, overheads, and handouts together with the Service Reports
and any other correspondence associated with the training program shall be lept and
maintained in the training file associated with the Project Number.
4. Manufacturer’s Training Classes (Factory Locations)
a) Occasionally, Legacy Biomedical may arrange to send employees to Factory Service

schools. These schools and the personnel sent to these shall be determined at the
Corporate level and based upon the qualifications and possible retention of these
employees. Many training programs may cost in the thousands of dollars. To ensure
retention of those employees and to recoup some of the expenses involved should an
employee decide to leave after attending one of these schools, the following policy will
apply.
i) Any employee scheduled to attend a service school shall sign an agreement to

remain in the employ of Legacy Biomedical for a minimum of six months for
every thousand dollars spent on his schooling. The time commences upon his
completion of the course.
122
ii) Should the employee elect to terminate his employment prior to the expiration of
this agreement, he shall reimburse Legacy Biomedical at the rate of 75% of total
expenses for every six months left in his period. For example, if $2,000.00 was
spent on his courses and he decided to leave after six months, he would have to
reimburse Legacy Biomedical $750.00.
b) All training materials given to the employee are the property of Legacy Biomedical. He
may make copies if he so chooses, but all notes, books, handouts and overheads become
the property of Karta. These shall be sent to the Director of Quality Assurance for
inclusion in any training files for future use.
c) Within two weeks of the employees return, he must conduct an abbreviated training
session for the remainder of his peers. This is to ensure that even though he will be
considered the primary contact repair person, there will be coverage in the event of
illness or such.
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9.11 Resource Allocation 1 of 1 0
A. Purpose
This procedure describes the method for allocating resources within Legacy Biomedical to meet the
requirements
of its customers.
B. Scope
This procedure applies to all work undertaken by Legacy Biomedical.
C. References
D. Definitions
None
E. Procedures
1. Work Types
a) For IPM, the available work can be classified as one of the following:
i) Routine Work. Work that is received by routine requests by customers.

ii) IPM Work. Due and overdue maintenance on equipment as planned maintenance.
iii) “Emergency” work. Work that may be encountered during on-site visits,
extremely high-priority requests, etc.
124
b) For design and development activities, all work is classified as either design or
modification.

2. Priorities
a) The person assigned the work orders shall be aware of their priority and shall strive to
meet that priority.
b) For all IPMs, the Site Managers are responsible for assigning work on a daily basis. The
priorities given to this work shall be assessed as follows:
i) Customer’s Priority. This may be indicated on the Service Report, by some other
written instruction, or by verbal request.
ii) Staff Availability. Work priorities may have to be adjusted so that experienced
staff may become available, or inexperienced staff needing training become
available.
iii) Equipment Type or Customer. Life-Support equipment (e.g., defibrillators, heart-
lung bypass units) and critical care areas (e.g., ICU, CCU, OR) will require
greater priority. Also, certain types of equipment or customers may be delegated
to particular staff members.
iv) Previous Experiences. The expectations of a customer or experience with
previous work of a similar nature should be taken into account, particularly when
the customer has not specified a priority.
v) Work Type. Those work types identified in section 1, above.
c) The Site Managers are responsible for monitoring that all IPM defined priorities are met.
This is done by reviewing all current outstanding work on a weekly basis. The pending
125
demand work orders and IPM reports generated by the Karta Equipment Management
program shall be used as an aid to this review.
d) The aim of all activities shall be to complete all work in compliance with the customer’s
priorities.

3. Available Resources
a) The following resources shall be considered when assigning priorities, together with the
possible courses of action when a lack of resources may cause delays:
i) Staff. How many staff members are available? Note that when approving time off,
a minimum number of employees must be available during normal working hours.
Consider: Is overtime an option? Are temporary staff available? Can the work be
subcontracted out? Are staff available from another Multi-Vendor Site?
ii) Equipment. Is there sufficient and suitable test/calibration/repair/manufacturing
equipment available?
Consider: Can equipment be borrowed or rented? Can equipment be brought in
from another Multi-Vendor Site?
iii) Spare Parts and Materials. Is there a sufficient stock of suitable supplies
available?
Consider: Is an alternate source available? Can another part be temporarily and
SAFELY substituted?
iv) Facilities. Are there sufficient and suitable work areas available (e.g., Cleaning
areas, gas, electricity, water)
Consider: Can temporary facilities be used?
v) Training. Are there suitably trained staff available?
Consider: Is it possible to arrange training?
b) Any requirements for additional resources shall be brought to the attention of the Area
Manager who shall then, if deemed necessary, take up the request with the President of
Legacy Biomedical.
126
4. Delays
The customer shall be informed verbally if work will not be completed within the customer’s
expected or promised priority. In the case of repair and maintenance work, this notification shall
be recorded in the Service Reports and in the Equipment Control Program.
5. Reviews
a) Work priorities, delays, and outstanding work are discussed weekly with the BMET
Supervisors and the Site Managers.
b) The Director of Quality Assurance shall monitor the overall performance and ability of
Legacy Biomedical in meeting the customer’s priorities and reacting to delays to these
priorities. As an aid to this process, the following Utilities reports shall be used:
i) Pending Demand Work Orders

ii) IPM Reports
iii) Project Reports
iv) Response to Assigned Priorities Performance Report
v) Meeting Planned Maintenance Objectives Performance Report
F. Documentation
127
 MESR
 Project Files
 Database Utilities Manual

9.12 Purchasing Advice 1 of 3 0
A. Purpose
This procedure describes advising customer departments about the selection of medical or laboratory
equipment to be purchased.
B. Scope
This procedure will apply to all formal requests for assistance in the selection of medical or related
equipment received by LEGACY BIOMEDICAL staff. The procedure is not intended to cover informal
requests for
information, except where the staff member considers it appropriate to invoke this procedure.
C. References

 JCAHO Accreditation Manual for Healthcare Organizations
 Title 21 CFR
D. Definitions
None
E. Procedure
128
1. It is the responsibility of the Site Managers or those delegated by them to investigate
and recommend equipment in their area of expertise. This shall be done in consultation with the
Director, Quality Assurance for equipment new to LEGACY BIOMEDICAL’ Client facilities with a
purchase value of greater than $500.00.

2. A copy of any report recommending equipment will be sent to the Director, Quality Assurance
for information. These reports are to be retained for reference in the Equipment Purchase
Recommendation file in the Director, Quality Assurance’s office.
3. At the time of the request or at a subsequent briefing, obtain as much information as possible
relevant to the selection of the equipment to be recommended. Depending on the size and
complexity of the equipment, be prepared to recommend additional discussions. This may
require one or more meetings to establish a working specification. Two questionaires may be
developed from these working specifications to be given to the Nursing staff and to the physician
staff.
4. Involve all staff members who may have information and experience pertinent to the selection
process. These questionaires will be tabulated and used as user specifications to compare against
technical specifications provided by equipment manufacturers. These user specifications will be
treated as confidential information. Any manufacturer’s specifications that do not meet these
criteria will not be evaluated in clinical trials.
5. Once the tabulations are made and those manufacturers not meeting the selection criteria are
eliminated, estimates of pricing shall be conducted of list prices ONLY. This information shall
129
be conveyed to the client at which time a selection of three (minimum ) manufacturers will be
made to undergo clinical evaluations.
6. LEGACY BIOMEDICAL personnel shall conduct an engineering evaluation of all equipment

submitted for
evaluation. This evaluation shall consist of the following:
a) Electrical safety evaluation
b) Conformance to any applicable standards
c) Applicability (Will it do what the medical staff wants it to do?)

d) Human Factors Engineering (Ease of operation, location of controls, buttons, etc)
e) Maintainability (How difficult is it to maintain, any special parts needed, etc)
f) Cost of ownership ( How much are the disposables, transducers, etc)
7. Any equipment failing the engineering evaluation shall be eliminated from any further
evaluation. This information shall be conveyed to the client for approval.
8. LEGACY BIOMEDICAL personnel shall oversee the clinical evaluations and submit
questionaires to operator
personnel concerning any shortcomings and/or advantages of equipment undergoing evaluation.
9. At the end of the clinical evaluations, all data shall be compiled and listed in the order of
preference. Pricing shall then be negotiated with the manufacturers either by LEGACY
BIOMEDICAL or the client’s
purchasing department.
130
10. All data collected in any evaluation shall be entered in the LEGACY BIOMEDICAL database
according to
manufacturer, model, pricing, any discrepancies, etc.
11. All medical equipment evaluations and recommendations shall be approved by the Director,
Quality Assurance prior to a final report being released to the client.
12. ALL reports shall be considered confidential to LEGACY BIOMEDICAL and the customer
requesting the evaluation.
Reports shall NOT be provided to commercial organizations without the approval of the
President LEGACY BIOMEDICAL.
F. Documentation
Equipment Purchase Recommendation File

9.13 Equipment Evaluation 1 of x 0
A. Purpose
This procedure describes the method of evaluating medical devices for LEGACY BIOMEDICAL’s
clients for their purchase.
B. Scope
This procedure shall apply to any request for an evaluation by a LEGACY BIOMEDICAL Client for
any medical device being considered for purchase and will potentially fall within the purview of
LEGACY BIOMEDICAL for maintenance.
131
9.14 Soldering 1 of 3 0
A. Purpose
This document describes the procedure for soldering to ensure consistency and quality of electronic
construction and repair.
B. Scope
Soldering of electronic components, semiconductors, printed circuit boards (PCBs), connectors, cables,
and assemblies.
C. References
 Operator’s manuals
 Manufacturer’s application notes
132
D. Definitions
None
E. Procedure
1. Approved workshop tools. The following tools shall be used when soldering:
 Pace Brand desoldering station

 Wellar Brand soldering stations located at work benches
 Portable soldering station
 Technician tools
 Antistatic kits

2. Standard of work
a) In all cases, the PCBs and assemblies are to be handled with care. Components are
generally low-cost items, whereas the PCB is expensive or not replaceable.
b) The Pace brand desoldering station will melt solder and cool the surrounding area as
the solder is removed. This is the preferred method for extracting devices. Another
approved method is to carefully cut individual pins of a device, remove the device, and
then remove the pins individually using the Wellar brand desoldering station.
c) In general, a temperature of 316 degrees Centigrade for a maximum of 10 seconds is

considered safe, and component damage will not occur.
133
d) Precleaning of the PCB and the soldering bit before soldering is essential.
e) Soldering sequence shall be as follows:
i) Tin the soldering tip

ii) Apply soldering iron tip to heat the joint.
iii) Feed solder onto opposite side of the joint.
iv) When the solder has melted and run around the joint, remove the solder and then
the iron.
f) Cleaning using a suitable cleaning solvent to remove residues from the joint. All
soldering joints shall have flux and sharp points removed and inspected.
g) Check joints for defects, voids, dry joints, and bridging.

3. Approved Brands of soldering tips:
a)
b)
4. Approved solder and flux:
a) 60/40 tin/lead solder alloy shall be used for common electronics, and general-purpose
work.
134
b) _______________ Brand soldering cream shall be used for surface mount work, with
liquid rosin flux.
F. Documentation
None

12.0 Inspection and Test Status 1 of 3 0
A. Purpose
This document describes the procedure for identifying the inspection and test status of work, supplies,
parts, and materials in the care of Legacy Biomedical.
B. Scope
This procedure shall apply to all work, supplies, parts, and materials while in LEGACY BIOMEDICAL.
C. References
135
D. Definitions
None
E. Procedure
1. All incoming supplies, parts, and materials shall be clearly identified, and their inspection status
shall be recorded as per the “Incoming Goods Inspection” procedure (See Section 10.1).
2. All work coming into LEGACY BIOMEDICAL shall have
a) a unique work order number assigned to it; and
b) an Equipment Status Tag attached, and the status recorded on this tag as per the
“Equipment Status Tag Completion” work instruction (SEE Section 12.2).

3. The Site Manager of the Multi-Vendor Site shall be responsible for the tagging of all
incoming goods needing acceptance or repair as per the “Incoming Work” work instruction (See
Section 12.2).
4. Each technician is responsible for tagging items handed into his or her care and for showing the
current status.
5. The Site Manager is responsible for ensuring that quarantined, rejected, or scrapped goods are
adequately tagged and segregated as per the “Control of Nonconforming Product” procedure
(See Section 13.0).
136
6. Projects shall be tracked and tagged as per the “Design Control” procedure (See Section 4.0).
7. Upon the successful completion of final inspection and testing and before dispatch, the
Equipment Status Tag must be signed and dated by the technician carrying out the work as ready
for use.
8. Outgoing work shall be recorded as per the “Work Dispatch” work instruction (See Section
12.3).
9. A record of the work done and the final inspection and test results shall be recorded on the
accompanying Medical Equipment Service report and shall be referenced to the Equipment
Status Tag by the work order number.
10. This procedure shall also apply to equipment owned or manufactured by Legacy Biomedical,
Inc.

F. Documentation
 Incoming Goods Inspection procedure (Section 10.1)

 Equipment Status Tag Completion work instruction (Section 12.1)
137
 Medical Equipment Service Report (MESR)
 Work Dispatch work instruction (Section 12.3)

12.1 Equipment Status Tag Completion 1 of 2 0
The Equipment Status Tag is used to monitor an item’s status while undergoing work in the LEGACY
BIOMEDICAL
Multi-Vendor Sites. An Equipment Status Tag will be attached to each job and shall be maintained by
the
technician or technicians carrying out the work.
The Equipment Status Tag shall be completed by entering the appropriate codes and data in the spaces
provided as follows:
138
1. Work Order Number. If no work order label is present, record the work order number printed on
the associated Medical Equipment Service Report.
2. Control Number. If no work order label is present, record the control number of the equipment of
the equipment related to the request. If no control number exists for the equipment, assign one as
per the “Equipment File Completion” work instruction (See Section 16.5).
3. Status and Date. Record the current status of the work and the date the status was reached. A
selection of codes are printed on the front of the card as follows:
 Work in Progress – Work on this job has started

 Inspection – awaiting inspection
 Repair – awaiting repair
 Maintenance – awaiting maintenance
 Modification – awaiting modification
 Installation – awaiting installation
 Parts/Information – awaiting parts or information before work can continue
 Other – other (Specify status on the line next to the status box).
4. Ready for Use. The technician completing the job must record his or her signature and the date to
indicate that the request has been completed, the equipment has passed all final inspection and
tests, and is ready to be returned to the user.

12.1 Equipment Status Tag Completion 2 of 2 0
5. Return To. Record the return location for the completed work.
6. Add brief comments on the work done if:
a) the work done differs from the initial written request, and/or
139
b) the work request was verbal and was not summarized on a work order label. This then
allows confirmation of the work request.
7. The Equipment Status Tag shall remain affixed on the equipment for further processing by the
Site Manager.
Other Relevant Documentation

 Inspection and Test Status procedure (Section 12.0)

12.2 Incoming Work 1 of 1 0
When equipment enters a LEGACY BIOMEDICAL Multi-Vendor Site, A Medical Equipment Service
Report MESR)
and an Equipment Status Tag must be initiated. This is usually done by the Site Manager, but
may be done on occasion by other staff. The procedure for the completion of the MESR and an
Equipment Status Tag is described as follows:
140
1. Obtain a blank MESR and an Equipment Status Tag.
2. Enter ALL pertinent data into the LEGACY BIOMEDICAL Medical Equipment Maintenance
Database.
a) If this equipment is new to the LEGACY BIOMEDICAL database
i) Create a new asset account, with all data fields necessary for billing purposes (i.e.,
account codes, locations , etc).
ii) Create a work order for Acceptance Testing
b) Create a work order for work to be performed
c) Attach the work order form to the MESR
d) The equipment shall then be forwarded with its MESR to the appropriate technician for
servicing.
3. It shall be the responsibility of the Site Manager to ensure that at no time will any
device remain in a receiving area more than 2 hours without being processed into the KARTA
MED Database and a work order created for it.

12.3 Work Dispatch 1 of 1 0
A. Purpose
This procedure describes the method of returning equipment to the customer upon completion of
141
inspection, Preventive maintenance, and/or repair.
B. Scope
This procedure shall apply to all equipment supported by LEGACY BIOMEDICAL.
C. References
D. Definitions
None
E. Procedure

13.0 Control of Nonconforming Product 1 of 5 0
A. Purpose
This procedure describes the controls for ensuring that any nonconforming equipment is identified,
142
removed from use, and repaired or disposed of.
B. Scope
This procedure shall apply to all products for which LEGACY BIOMEDICAL has service
responsibilities.
C. References
D. Definitions
None
E. Procedure
1. Identification
a) All LEGACY BIOMEDICAL staff are responsible for the quality of their own work and
for identifying nonconformances in their work.
b) If unacceptable equipment or parts are received or found, or a complaint is received about

an installation, repair, maintenance, or project, the Site Manager must be informed.

143
c) The Site Manager is responsible for monitoring all work done and to ensure that staff
have the training, information, and resources required to identify nonconformances.
d) Once identified, a nonconforming product shall be removed from further processing.
e) Upon receipt of any complaint from a customer, the “Customer Complaints” procedure
(See Section 13.1) must be followed. If a piece of equipment is the subject of the
complaint, it must be processed as described in this procedure.
2. Isolation
a) The Site Manager is responsible for ensuring that nonconforming product is isolated from
further processing.
b) Nonconforming product shall be clearly identified as such on its associated Equipment

Status Tag.
c) An area shall be set aside in each section in which nonconfroming product shall be held
while awaiting further action.
3. Recording
a) The current status and nonconforming details of a nonconforming product shall be

recorded on its associated Equipment Status Tag and Medical Equipment Service Report,
Purchase Requisition or project file.

144
b) Associated documentation reflecting inspections or actions, such as a GRA form,
complaints, and scrap notes, for a nonconforming product shall be attached to the
Medical Equipment Service Report, purchase requisition, or the project file.
c) The Site Manager is responsible for maintaining these records.
4. Disposal
Once isolated, nonconforming product shall be processed in one of the following ways:
a) Any faulty spare parts or materials shall be isolated, recorded, and processed as per the
“Inspection and Testing” procedure (See Section 10.0). If the recording or resourcing of
the part will result in a delay to the expected work schedule, the customer shall be
notified of the delay. A record of this notification shall be made on the work’s Medical
Equipment Service Report.
b) Items received by LEGACY BIOMEDICAL for repair and which are subsequently
determined to be unrepairable, shall be processed as follows:
i) Their Equipment Status Tag’s shall be clearly marked “unrepairable.”
ii) Their owner shall be informed by an “Equipment replacement Memorandum” and

provided with an “Asset Disposal form”.
iii) When LEGACY BIOMEDICAL receives the completed “Asset Disposal Form”
from the owner, the item’s history shall be annotated in the LEGACY
BIOMEDICAL’s Equipment Management Program and P.M. scheduling shall be
discontinued.

145
c) If, for a manufactured or repaired item, the installation or maintenance is found
unacceptable to the customer, then a remake/repair shall be initiated as follows:
i) The Site Manager responsible for the item will arrange with the customer for a
suitable time for retrieval to LEGACY BIOMEDICAL. If the customer wishes to
continue using the item until remake/repairs can be affected or to forego any
remake/repairs altogether, and if, in the opinion of the Site Manager, continued
use of the item is acceptable, then a concession shall be granted; and
ii) A Medical Equipment service Report and Equipment Status Tag shall be raised as
per normal for the remake/repair. The work required section shall highlight the
details of the reported nonconformance.
iii) The Medical Equipment Service Report shall remain active until the job has been
recalled and the unsatisfactory goods replaced/rectified. The Site Manager shall
be responsible for monitoring the progress of all recalls associated with work
under their control.
F. Documentation

 Inspection and Testing procedure (Section 10.0)
 Equipment Replacement Memorandum
 Asset Disposal Form
 Customer Complaints procedure (Section 13.1)
146
G. Appendix
Figure 13.1 presents a diagram of the control of nonconforming product process.
147
13.1 Customer Complaints 1 of 3 0
A. Purpose
This document describes the procedure to be undertaken upon receipt of a customer complaint.
B. Scope
This procedure shall apply to any complaint received from a customer regarding the services provided
by LEGACY BIOMEDICAL.
C. References
D. Definitions
None
E. Procedure
1. It is the responsibility of any staff member of LEGACY BIOMEDICAL receiving a complaint to

inform his or her supervisor immediately.
2. It is the responsibility of the appropriate Multi-Vendor Site Supervisor to ensure that complaints
are documented and followed up as described in this procedure.
3. The Director, Quality Assurance shall be made aware of all complaints and subsequent proposed
actions.
148
4. All complaints shall be logged by initiating a Medical Equipment Service Report as per the
“Medical Equipment service report Completion” work instruction (See Section 16.3). Any
associated correspondence concerning the complaint shall be attached to the Medical equipment
service report.
5. A complaint shall be given a priority of 3 (“THIS WEEK”).
6. The Site Manager shall inform the Director, Quality Assurance of the complaint. If considered
appropriate, the complaint shall be treated as a nonconformance and acted upon in accordance
with the “Control of Nonconforming Product” procedure (See Section 13.0).
7. If corrective action is required, then this shall be implemented as per the “Corrective and
Preventive Action” procedure (See Section 14.0).
8. Only when the corrective action is certified by the Director, Quality Assurance to be satisfactory
will the complaint procedure be closed.
9. A copy of the completed Medical Equipment Service Report and any associated correspondence
shall be sent to the Director, Quality Assurance for filing in the complaints file and entry in the
complaint log at the front of the complaints file. The Director, Quality Assurance shall record the
details of the Medical Equipment Service Report in the LEGACY BIOMEDICAL Equipment
Management Program and raise the complaint at the next LEGACY BIOMEDICAL Quality
Assurance Council Meeting. The current status of the complaint shall be recorded and
maintained in the complaints file by the Director, Quality Assurance.
10. If the complaint is not resolved within thirty (30) days, the Director, Quality Assurance will
personally take charge of the situation.
149
F. Documentation

 Corrective and Preventive Action Procedure (Section 14.0)
 Complaints file
 Complaint log
150
16.1 Computer Backup 1 of 2 0
A. Purpose
This procedure describes the method of backing up LEGACY BIOMEDICAL computer files. It Applies
specific guidelines for maintaining integrity and security of the database in case of mechanical or
electrical failure.
B. Scope
This procedure shall apply to all LEGACY BIOMEDICAL projects and back office databases on NT04
server used for this purpose.
C. References
D. Definitions
None
E. Procedure
The Director, Research and Database Design of LEGACY BIOMEDICAL shall have the primary
responsibility for ensuring that LEGACY BIOMEDICAL maintains an effective procedure for backups
of the database. The LEGACY BIOMEDICAL Quality Assurance Council shall monitor the Director,
Research and Database Design in this function. Appropriate staff shall be assigned responsibility to
provide assistance in determining policies for specific parts.
151
16.1 Computer Backup 2 of 2 0
1. Full backups shall be performed on scheduled intervals for maximum reliability and security of
the database.
2. Backups shall be performed on a daily basis. The entire NT04 server containing the database and
project folders shall be backed up using Backup Exec. These tapes may be rotated on a biweekly
basis. Two sets of four tapes will be used for this procedure.
3. Weekend backups will occur for the entire server and rotation shall occur on a monthly basis.
4. End of month backups shall occur and be stored indefinitely in an appropriate off site location.
5. Backups are a critical systems maintenance task and are often the final recourse after a total
systems failure or disaster.
6. A complete and recent set of backups for each system should be kept off-site.
7. A hard-copy summary of how to create and restore a backup for a given system must be filed
with easy access for systems staff.
8. Tapes must be clearly labeled with the current date of the backup and a sequence number.
9. A copy of the backup script should be kept on floppy disk and stored as a hard copy.
10. Backup media and devices are to be taken into consideration with new equipment purchases.
11. Backup devices are to be cleaned and maintained are per the manufacturer instructions.
12. The backup material is to be kept in a location separate from the original system to protect it
from the same hazards.
152
13. Media degeneration implies that files should be copied to fresh media as the manufacturer
recommends.

17.1 Quality Assurance Program 1 of 4 0
A. Purpose
Quality Assurance (QA) is a comprehensive, on-going assessment of Legacy Biomedical, Inc.

(LEGACY BIOMEDICAL) services, responsibilities, and methods of operation that will help assure
quality patient care for our client’s medical facilities. This quality assurance plan is intended to identify
problems or potential problems concerning the safe and effective use of patient care equipment, the
acquisition of appropriate new equipment, and to provide methods for evaluating and solving any of
these problems for our clients.
This Quality Assurance Program acknowledges the importance of sustaining the high quality of patient
services provided by our client medical facilities. Quality is defined as the accomplishment of
achievable, feasible, patient-care and management goals. Assurance means to inspire confidence by
providing objective evidence of effective and efficient performance.
Authority:
The LEGACY BIOMEDICAL Administration and Governing Board have authorized the Director
Quality Assurance to manage, monitor, evaluate and change, as necessary, the Quality Assurance Plan.
Quality Assurance Coordinator:
A Quality Assurance Coordinator shall be appointed to each Regional Multi-Vendor Site location. This
position shall report to the Legacy Biomedical, Inc (LEGACY BIOMEDICAL) Quality Assurance
Director. The Quality Assurance Coordinator shall have the same authority as the Regional Site
Manager in order to make changes to assure the quality of work being performed.
The Quality Assurance Coordinator shall coordinate the review of service histories, overdue equipment
inspections, investigations of safety issues or equipment-related incidents, and will summarize QA and
153
safety activities for the Karta Quality Assurance Committee and the Client Hospital’s Quality Assurance
and Safety Committees.

B. Scope
The objectives of quality assurance for LEGACY BIOMEDICAL are:
1. To review equipment maintenance operations and to review any equipment or technology issues
that may impact quality of patient care.
2. To define a system for resolving identified problems.
3. To communicate with our client’s departments, such as Quality Assurance, Risk Management,
and Safety Committees to investigate and resolve problems.
C. References

Title 21 CFR
JCAHO Accreditation Manual for Healthcare Organizations
D. Definitions
None
E. Procedure
The QA Coordinator shall examine summaries of service histories quarterly for each client, involving
other LEGACY BIOMEDICAL personnel, as needed, to investigate and resolve QA issues. A summary
of these equipment-related issues will be presented to the client’s Safety Committee. QA activities
154
specific to the Multi-Vendor Site will be summarized in a monthly Report to the Director of Quality
Assurance.
1. Identification. Problems or potential problems will come to the QA Coordinator’s attention

from the following sources:

a) On-going quality assurance monitoring of repair and performance assurance functions.

b) On-going quality assurance review of consultation functions (incident investigations,
safety issues, etc.)
c) Multi-Vendor Site Departmental meetings.
d) Comments/complaints from clinical departments.
e) Reports of various client’s committees (Safety & Disaster Planning, Risk Management &
Loss Control)
f) Monitoring of Equipment Hazard Alerts.
g) Electrical Safety Issues.
2. Analysis of cause and scope of problems
Identified problems will be assessed on their potential impact on patient care and a
determination of developing trends.
3. Resolution of problems and implementation of corrective actions.
a) Implementation of corrective actions for problems identified by on-going monitoring of

repair and performance assurance functions will be the responsibility of the BMET
Supervisors.
b) Implementation of corrective actions for Hazard Alerts will be the responsibility of the
Quality Assurance Coordinator.
c) Implementation of corrective action for all other problems will be the responsibility of
the Site Manager.
155
4. Monitoring, Evaluation, and Documentation of results.
a) Each quarter, the Karta QA Coordinator will review patient care equipment service
activities and will monitor the following indicators:
i) Service calls in which NO PROBLEM was found or OPERATOR ERROR was

indicated. Also, service reports of DAMAGED equipment will be reviewed.

ii) Repeat Service Calls on the same device or repeated calls indicating a
developing trend.
iii) Hazard Alerts on patient care equipment.
iv) Safety Issues or Incidents.
b) An action plan will be developed to address the issues raised.

c) Verification of the results of corrective action plans will be determined by a follow-up
review.
d) Reports summarizing the quality assurance indicators listed above will be issued to all
applicable LEGACY BIOMEDICAL personnel and to the client’s Quality Assurance
Committee for review, discussion, and action as needed.
e) The Multi-Vendor Site Quality Assurance activities shall be reviewed by the Karta
Quality Assurance Committee each quarter with regard to:
i) Impact on patient care

ii) Effectiveness of monitoring and reporting mechanisms
iii) Resolving equipment-related safety issues and incidents.
f) Every 30 days, the QA Coordinator shall also review the 90-day overdue scheduled
maintenance inspections and coordinate with the Site Manager and the Regional Director
of the Multi-Vendor Sites to minimize this QA indicator.
156
17.2 Quality Assurance Indicators for
1 of 5 0
Patient Care devices
I. Compliance Measurements
A. Unweighted Compliance
Number of items in compliance with PM schedule by number of items on inventory
B. Compliance weighted by Risk
Perceived risk vs compliance
II. Count of Inspections Performed
A. Relative number of inspections
Number of inspections completed vs number assigned
B. Equipment not located
Percentage of total inspections scheduled
157
C. Equipment in use
Percentage of total inspections scheduled
D. Other reasons
Lack of time, test equipment, higher demand for work

2 of 5 0
E. Inspections Failed
Measurement of value of inspections
F. Compilation of failures
Identifies types of failures (i.e., component, calibration, calibration drift, etc.)
G. Lack of failures
Documentation of lack of failures of particular class of equipment could justify extended

intervals
H. Downtime
Most critical for hospitals – loss of revenues
III. Documentation
A. Presence or absence of documentation
158
Missing documents?
B. Quality of completed documents
Accuracy and completeness

3 of 5 0
C. Compliance with required procedures
Degree to which work was properly performed
IV. Specific Equipment Failures
V. Number of Repairs
A. Average time per repair
Time spent on repairs/number completed repairs
B. Average time per repair for specific types of equipment
Pinpoints problems associated with equipment types (training, device design, etc.)
VI. Downtime due to repairs
VII. Repair turnaround time
159
A. Classification by repair times
Indication of changes in workload, training, parts inventory, etc.
B. Mean time to repair
Device problems, training?

4 of 5 0
C. Response time
Time between receipt of service call vs time tech arrives at site
VIII. Repeat repairs
IX. Repair Types
Equipment failure (electronic), equipment failure (mechanical), equipment failure (unknown), operator
error, and no problem found.
X. Repairs delayed due to parts orders
XI. Downtime associated with parts orders
XII. Complaints
160
A. Classification by type of complaint
Response time, equipment downtime, courtesy, inability to meet deadlines, other
B. Frequency of complaints
C. Response to complaints

5 of 5 0
XIII. User-related problems
A. Number of user errors
B. Percentage of user errors associated with high risk devices
C. Number of repairs caused by user misuse or abuse
D. Frequency of repairs caused by user errors
E. Frequency of similar user errors on same shifts on same unit
XIV. User Instruction Time
XV. Customer Surveys
XVI. Technical competence
161
A. Educational background
B. Certification
C. Continuing education
162
19.1 Maintenance of Medical Devices 1 of 4 0
A. Purpose
This procedure outlines the intent of the LEGACY BIOMEDICAL Quality System to assure that
servicing is correctly performed and verified according to manufacturer’s specified requirements such
that the serviced device is suitable for the intended use and that service information is collected and
analyzed to help correct any quality issues
B. Scope
All Legacy Biomedical, Inc. (LEGACY BIOMEDICAL) Multi-Vendor Sites will manage and document
the repairs, electrical safety testing, performance assurance testing, and preventive maintenance of all
patient care equipment under contract with Karta’s client medical facilities. This service will include
after-hours service support for emergency situations as well as a periodic quality assurance review of
patient care equipment for service-related anomalies and equipment-related safety issues.
163
C. References
ASHE Maintenance Management for Medical Equipment

JACHO Accreditation Manual for Healthcare Organizations
D. Definitions
None
E. Procedure
1. Inventory of Patient Care Devices
a) All patient care devices included under contract between LEGACY BIOMEDICAL and a
client will be inventoried and ranked by criteria to determine its placement in the
LEGACY BIOMEDICAL equipment management program.

b) Equipment placed in the criteria based equipment management program shall be

inspected for electrical safety and performance tested and documented on a work order
form.
c) A unique barcode tag will be affixed to the device and all pertinent data shall be recorded
and entered into the equipment management program.
d) All patient care devices placed into the criteria based equipment management program
shall be scheduled for periodic preventive maintenance.
e) Patient care devices not meeting the criteria for the equipment management program may
still be placed into the program at the client’s wishes.
164
2. Preventive Maintenance/Performance Assurance Testing
a) Frequency of Inspection
Each patient care device shall be evaluated upon entry into the database as determined by
the Preventive Maintenance (PM) Evaluation Score Sheet. Clinical and service
experience with the type of instrument as well as manufacturer recommendations will be
considered in establishing the maintenance schedule for this device. The Client hospital’s
clinical departments may request re-evaluation of any medical device’s inspection
program based upon their own quality improvement efforts.
b) Nature of Inspection
i) Specific procedures for accomplishing testing of patient care devices shall be

determined by the manufacturer’s instructions, industry standards, and
recommended practices such as:

 ANSI/AAMI – Standards and Recommended Practices

 JACHO – Accreditation Manual for Hospitals
 NFPA – Health Care Facilities Code (NFPA 99)
 NEC – National Electrical Code
ii) In general, PM instructions will be listed on PM work orders. Complete

procedures will be listed in the Karta PM manual as well as in equipment service
manuals.
iii) A visual inspection shall be performed to determine that the instrument is
mechanically intact, properly assembled and free of extraneous materials.
iv) An Electrical Safety Inspection shall be conducted on each device (in accordance
with NFPA 99) included in the equipment management program at a frequency
determined by the JCAHO risk based management system.
165
v) The instrument shall be operated with a known input, where appropriate, and its
output and the functional status of its control observed. The values of all
instrument parameters related to patient care shall be within tolerances specified
by the manufacturer of each instrument.
vi) Minor maintenance such as lubrication, replacement of bulbs, filters; etc. shall be
performed at the time of inspection.
c) Documentation of Inspection
i) A tag or sticker shall be affixed to the instrument in a prominent location. The tag
or sticker shall display the date of inspection and the initials of the inspector.
ii) The PM work order will be completed and entered into the computerized
equipment maintenance system.

d) Failure to Meet Inspection Criteria
i) In the event that any instrument shall be shown to be unsafe or to not operate
according to manufacturer’s specifications, it shall be removed from service and a
work order generated to track the repair of the instrument. Before the device is
removed from the area, the responsible charge person MUST sign a copy of
the work order. A reasonable effort must be made to supply a replacement
device during the time repairs are to take place. Trained personnel shall perform
all repairs and the inspection process MUST be repeated before the instrument is
returned to service.
3. Repairs
166
a) LEGACY BIOMEDICAL service personnel will respond to requests for service
according to the following priority:
i) Emergency repairs, safety issues.

ii) 90-day overdue PM’s.
iii) Routine service requests.
iv) Performance Assurance/ Preventive Maintenance Inspections.
v) Special projects (as assigned by Branch Manager)
b) After-hours Emergency Service on Mission Critical Patient Care Equipment
LEGACY BIOMEDICAL service personnel will provide after-hours coverage for true
equipment emergency situations when the Multi-Vendor Site is closed on weekday
evenings (4:30 PM – 8:00 am) and on a 24-hour basis on weekends and major Karta
holidays.
NOTE: If written into the contract with client hospital, the Multi-Vendor Site will
maintain two shifts to cover emergency situations and to be able to access critical
equipment for maintenance.
c) All service work will be documented on Work Order Forms and this documentation will
be maintained in the computerized Equipment Maintenance System.

19.2 Service Standards 1 of 4 0
A. Purpose
This procedure establishes the minimum criteria for “turn-around” times and warranty repairs on
medical devices worked on by LEGACY BIOMEDICAL personnel.
B. Scope
This procedure applies to all devices worked on by Legacy Biomedical, Inc personnel.
C. References
167
D. Definitions
None
E. Procedure
1. Initial Assessment of Repair Work - Legacy Biomedical Multi-Vendor Sites
a) All work arriving at a LEGACY BIOMEDICAL Multi-Vendor Site shall be processed in

accordance with the “Incoming Work” work instruction (See Section 12.2). All work as
detailed in these instructions shall be processed within two (2) hours of its arrival within
a LEGACY BIOMEDICAL facility. Special notations of any priorities assigned by the
client shall be noted on the work order.
b) All work shall be assigned to a designated technician who shall perform an initial
assessment of the device(s). Dependent upon the complexity of the device, this
assessment should be completed within 2 hours of receipt by the technician.

c) Any discrepancies noted shall be processed in accordance with “ Control of

Nonconforming Product” work instruction (See Section 13.0). Any delays in repairing
the device(s) (i.e., workload, parts, information) shall be conveyed to the appropriate Site
Manager who in turn, will report these delays to the appropriate client. This information
shall also be entered into the LEGACY BIOMEDICAL Database and noted on the
Equipment Status Tag.
168
d) All equipment designated as delayed shall be flagged in the LEGACY BIOMEDICAL
Database and weekly reports generated showing all delayed equipment. The Site
Manager shall act upon these reports and attempt to expedite any equipment remaining in
the Multi-Vendor Site longer than three (3) working days. All clients shall be informed of
any further delays and given an estimated time the equipment can be returned.
e) If the device is designated “critical”, the Site Manager should attempt to assist the client
in locating replacement equipment for the duration of the repairs. Unless written into a
service contract, any charges for rentals will be billed directly to the client. A LEGACY
BIOMEDICAL technician shall inspect, inventory and test the device prior to its use in
the client’s facilities (See Section 9.3 “Inspection” work instruction).
2. Initial Assessment of Repair Work – At Client’s Facilities
a) Upon arrival at a client’s facility, a LEGACY BIOMEDICAL technician shall perform an

initial assessment of any repair work needed to bring a device back into operation.
Depending upon the complexity of the equipment, this assessment shall take no longer
than two hours of his/her arrival at the client’s facility.
b) If the device is deemed critical (O.R., I.C.U., etc, equipment), the LEGACY
BIOMEDICAL technician shall notify the client and the applicable LEGACY
BIOMEDICAL Site Manager of the time it would take him to repair the device.

c) Working with the client’s representative, the LEGACY BIOMEDICAL technician shall
attempt to locate similar devices within the client’s facility to substitute for the defective
device. This is of critical importance if the estimated repair time exceeds two hours.
d) If no similar devices are located within the client’s facilities, the LEGACY
BIOMEDICAL technician shall notify the LEGACY BIOMEDICAL Site Manager who
shall work with the client’s representative to obtain either loaner or rental equipment.
169
Any charges stemming from this shall be billed direct to the client, unless covered under
contract.
e) If replacement equipment is found, the LEGACY BIOMEDICAL technician should

confer with the client’s representative and inform him of the repair problems (i.e., repair
parts, information, supplies). Depending upon size, complexity, etc, the LEGACY
BIOMEDICAL technician may elect to remove the device from its location and return
with it to his/her Multi-Vendor Site for repair. The device shall be logged in and an
Equipment Status Tag shall be attached to the device according to the “Incoming Work”
work instruction (See Section 12.2).
3. All repairs effected by LEGACY BIOMEDICAL shall carry a warranty of ninety (90) days parts
and labor provided
that the device failed for the exact same reason as the original problem. In the case of equipment
which have repetitive malfunctions but no problems can be found, the LEGACY BIOMEDICAL
technician shall:
a) Contact the applicable Site Manager and arrange to procure loaner equipment with the
consent of the client’s representative.
b) The equipment in question should be taken to the applicable Multi-Vendor Site and
stressed to attempt a failure (i.e., application of heat, vibration, etc.). Overnight “burn-in”
would be appropriate in such cases.

170
c) If no problems still can not be found, the technician should question the operator(s) of the
equipment to determine exactly what s/he did to cause the problem. An attempt to
duplicate the exact circumstances shall take place. If still no problem can be found, the
device shall be returned and the service report shall be annotated as "No problem found".
d) Consistent problems with like equipment where no problems can be found shall be
reported through the reporting mechanism the client has established (i.e., Risk
Management, Q.A. Committee, Safety Committee).
171

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Quality Procedures and

ISSUED TO: ____________________________________

MANUAL NO: __________________________________

REVISION NO: _________________________________

ISSUE DATE: ___________________________________

ii. Table of Contents

1.0. Management Review

2.0 The Quality System

3.0. Contract Review

5.0. Document and Data Control

5.1 Document Preparation and Issue

6.1 Approved Supplier Selection

Section Page Date Revision

7.0. Control of Customer-Supplied

8.0. Product Identification and

9.0. Process Control

9.1 Special Processes

10.0. Inspection and Testing

10.1 Incoming Goods Inspection

11.0. Control of Inspection, Measuring,

12.0. Inspection and Test Status

12.1 Equipment Status Tag Completion

13.0. Control of Nonconforming Product

13.1 Customer Complaints

14.0. Corrective and Preventive Action

14.1 Performance Reports

15.0. Handling, Storage, Packaging,

15.1 Stock Issue

16.0. Control of Quality Records

16.1 Computer Backup

17.0 Internal Quality Audits

17.1 Quality Assurance Program

17.2 Quality Assurance Indicators for Patient Care Devices

19.1 Maintenance of Medical Devices

19.2 Service Standards

20.0 Statistical Techniques

LEGACY BIOMEDICAL Quality System Manual

See LEGACY BIOMEDICAL Quality System Manual

1. The need for a review

Quality Procedures and Work Instructions Manual

2. Quality Assurance Council

Quality Procedures and Work Instructions Manual

b) This can include work practices, procedures, documentation, suppliers, complaints,

3. Responsibility for Review

Quality Procedures and Work Instructions Manual

 Documentation and Data Control Procedure (Section 5.0)

Quality Procedures and Work Instructions Manual

LEGACY BIOMEDICAL’ Quality System Manual

i) The Quality System Manual

g) Whenever possible, a standard of acceptability will be defined for each aspect of

2. Production of Quality Plans

i) New processes, services, or products are developed;

d) The quality plan needs to address the following issues:

i) Assessment of current situation (e.g., existing production, competitors)

 LEGACY BIOMEDICAL’ Quality System Manual

LEGACY BIOMEDICAL Quality System Manual.

1. Definition and Documentation of Requirements

vii) Contracts or orders shall be properly authorized by the customer.

b) If deficiencies exist, these shall be discussed with the customer.

3. Use of Suppliers and Subcontractors

b) If a subcontractor or supplier is making a key input to a customer contract, the supplier

Figure 3.1 represents a diagram of the contract review processes.