Professional Documents
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Sample Quality Manual Service
Sample Quality Manual Service
Airlines
Date: 2014-08-29
This document is authenticated in whole by verification of the above digital signature, using the signer's public key.
This is a complete re-issue of the manual with all previous changes incorporated,
therefore there are no revision marks. This version replaces all prior issues.
This manual is the property of Mythical True Value Metrology. It must not be
reproduced in whole or in part or otherwise disclosed without prior written
consent from Mythical True Value Metrology.
The official controlled copy of this manual is the digitally signed PDF document
on the Mythical True Value Metrology network server and visible to all
authorized users. All printed copies, and all electronic copies and versions except
the ones described above, are considered uncontrolled copies used for reference
only.
242554580.doc
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1. TABLE OF CONTENTS
Business Operating Manual: Table of Contents
1. TABLE OF CONTENTS............................................................................................................2
2. INTRODUCTION......................................................................................................................5
2.1 Conformance and Compliance Standards.......................................................................5
2.2 Other Relevant Standards ...............................................................................................5
2.3 Abbreviations, Acronyms and Definitions......................................................................6
2.4 Services Offered..............................................................................................................6
2.5 Parent Organization ........................................................................................................7
2.6 Purpose of This Manual...................................................................................................7
2.7 Scope of the Business Management System and Exclusions..........................................8
2.7.1 Business Operating Manual ................................................................................8
2.7.2 Subsidiary Level 2 Documents............................................................................8
2.7.3 Laboratory Network.............................................................................................9
2.7.4 Permissible Exclusions and Mitigation ...............................................................9
3. DISTRIBUTION AND REVIEW.............................................................................................10
3.1 Circulation List..............................................................................................................10
3.2 Procedures for Updating the Business Operating Manual............................................10
4. QUALITY MANAGEMENT SYSTEM..................................................................................10
4.1 General Requirements...................................................................................................10
4.2 Documentation Requirements.......................................................................................11
4.2.1 General...............................................................................................................11
4.2.2 Business Operating Manual...............................................................................13
4.2.3 Control of Documents .......................................................................................14
4.2.3.1 Document and Data Approval and Issue: .......................................................14
4.2.3.2 Document and Data Changes ..........................................................................14
4.2.3.3 Obsolete Documents........................................................................................15
4.2.3.4 Documents of External Origin.........................................................................15
4.2.4 Control of Quality Records................................................................................16
5. MANAGEMENT RESPONSIBILITY.....................................................................................16
5.1 Management Commitment............................................................................................16
5.2 Customer Focus.............................................................................................................16
5.3 Quality Policy................................................................................................................17
5.4 Planning.........................................................................................................................18
5.4.1 Quality Objectives .............................................................................................18
5.4.2 Quality Management System Planning .............................................................18
5.5 Responsibility, Authority and Communication.............................................................20
5.5.1 Responsibility and Authority.............................................................................20
5.5.2 Management Representative..............................................................................20
5.5.3 Internal Communications ..................................................................................21
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Mythical Airlines
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2. INTRODUCTION
This Quality Manual demonstrates and documents Mythical True Value Metrologys
commitment to maintaining a high-level of quality and strong customer service within an
environment that has safety as a first priority, is focused on the customers, and fosters continual
improvement.
Since the philosophy of Mythical True Value Metrology is that Quality is an integral part of the
entire business operation, hereafter this Quality Manual will be referred to as the Business
Operating Manual. The organization is in the process of implementing that change. As part of
the implementation, the term Quality Management System is also being changed to Business
Management System.
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With the exception of ISO/IEC 17025, these are not auditable standards and are used solely for
guidance. ISO/IEC 17025 is currently used only for guidance as it is part of the laboratory's
continual improvement process to become accredited to that standard at a future date.
ASQ
FAA
Federal Aviation Administration (the USA regulatory agency for aviation and
aerospace operations.)
IEC
ISO
Metrology
NCSL
QMS
RSA
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equipment and testing equipment. The department performs, or arranges for, the calibration of all
such equipment owned by or used by Mythical Airlines in all operating stations, as well as that of
other aviation customers as arranged by contract. The department was created in 1995 and has
been registered to ISO 9001 since August 2001. The departments vision is to be the leading
metrology facility in the airline industry and provide strong support toward continually building
a superior Mythical Airlines team.
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Calibration service for tools, precision measuring equipment and testing equipment
for Mythical Airlines and other customers.
The scope of the QMS is specifically defined as everything within the direct
control and authority of Mythical True Value Metrology only. Many functions are
performed by other departments of Mythical Airlines; these departments are
treated as customers and/or suppliers, as appropriate.
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Level 2 documents are referenced in this Business Operating Manual but are not part of it.
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Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.
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Mythical Airlines
Receiving Process
Evaluation Process
Calibration Process
Repair Process
Process for control of Outside Services
Out-Processing Process
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(QP 4101)
(QP 4102)
(QP 4103)
(QP 4104)
(QP 4105)
(QP 4106)
Support Processes:
Mythical True Value Metrology Support Processes describe all other business requirements that
are necessary to manage and control resources, and to conduct business in an orderly manner.
The support processes are implemented and managed in accordance with the applicable
requirements of the International Standard. They include:
Quality Management
(Business Operating Manual)
Document Management
(QP 4230, QP 4240)
Facility and Equipment Management
(QP 6300, QP 6400)
Information Technology Management
(QP 6301)
Measurement Standards
(QP 7600)
Human Resources
(QP 6220)
The sequence and interaction of the Core and Support Business Processes are described in
section 5.4.2 QMS Planning and QP 4100.
The criteria and methods required to ensure the effective operation and control of these processes
are defined and documented.
The entire QMS documentation and other key information necessary to support the operation and
monitoring of the department business processes are available to all department employees, and
other parties requiring access, on the Laboratory network.
Appropriate levels and types of monitoring and measurement of core and supplemental processes
have been determined and are documented in relevant policies and procedures.
The QMS includes policies and procedures for implementation of actions required to achieved
planned results, and for continual improvement of the business processes.
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includes other documents and records required by the organization to ensure the effective
operation and control of the business processes. The degree of documentation is consistent with:
the methods used,
the complexity and interaction of the business processes, and
skills needed and training required by the personnel involved in carrying out these
activities.
An outline of the department QMS documentation is shown in Figure 1.
Figure 1: Documentation
The QMS is maintained, updated, and continually improved as the department seeks better
business practices. Mythical True Value Metrology employees have been trained on:
which procedures apply to them,
how to access those procedures,
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effective functioning of the Business Management System are performed, or they may be readily
obtained.
4.2.3.2 Document and Data Changes
All personnel are required to identify required changes in documents and are encouraged to
suggest improvements. Changes to documents and data are reviewed and approved by the same
function/organizations that performed the original review and approval, unless specifically
designated otherwise. Access to appropriate background information is provided. The nature of
the changes is recorded.
When practical, the changes are highlighted in the document and/or on attachments.
4.2.3.3 Obsolete Documents
Electronically maintained documents are promptly removed from active files when they become
obsolete. They may be maintained for the document retention period, in file areas not accessible
to general users.
After a revision issue, obsolete hard copy documents are promptly removed from points of issue
and use. The obsolete master document is archived and may be retained for legal and/or
knowledge preservation purposes. The obsolete point of use copy is destroyed.
NOTE: Due to the nature of work performed by Mythical True Value Metrology
(calibration and repair of precision tools, inspection, measuring and test
equipment) there may be multiple versions of Level 3 documents for a given
manufacturer/model of equipment. This is an acceptable situation because: it is
due to version changes during production by the manufacturer of the equipment
being calibrated and is outside the control of Mythical True Value Metrology; and
the metrology technicians are responsible for selecting the correct document
version based on the specific version or serial number of the item being
calibrated.
These documents are also exempt from the requirement to destroy old copies,
unless and until it can be demonstrated that there will never again be a
requirement to calibrate or repair that specific instrument from any current or
potential future customer. The primary reason for this exemption is that some of
the workload items may be several decades beyond their manufacturer's support
life and the data owned by Mythical True Value Metrology may well be the only
data available anywhere.
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Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.
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5. MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
The top management of Mythical True Value Metrology is committed to the development and
improvement of an effective Quality Management System. This commitment is demonstrated by:
Communicating to the organization the importance of meeting all customer, regulatory,
and legal requirements. (Section 5.5.3 Internal Communications.)
Establishing the Mythical True Value Metrology Quality Policy for total commitment to
excellence and the associated quality objectives. The Quality Policy and the Quality
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Objectives are published and displayed on the Laboratory network sign-in page and the
office notice board. (Sections 5.3 Quality Policy and 5.4.1 Quality Objectives.)
Conducting Management Reviews. (Section 5.6 Management Review.)
Identifying and acquisition of controls, processes, equipment, fixtures, resources, and
skills need to achieve the required quality. The associated quality management activities
are described in Section 6 Resource Management.
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The quality policy and quality objectives are relevant to the departments organizational goals
and the expectations and needs of its customers. These concepts have been communicated to all
employees within the scope of the QMS. Quality concepts have been integrated into Mythical
True Value Metrologys culture.
The top management of Mythical True Value Metrology ensures that its Quality Policy is
understood. This is accomplished through training, communication, and displays. The Policy is
implemented by means of documentation, and training about the Business Management System
to meet the requirements of the Standard. The Policy is maintained through Business
Management Systems audits and corrective and preventive action, and reviewed for continuing
suitability through periodic Management Reviews. Further, this Quality Policy is supported by
the quality objectives listed in this Business Operating Manual. (Section 5.4.1 Quality
Objectives).
5.4 Planning
5.4.1 Quality Objectives
Top management of Mythical True Value Metrology establishes quality objectives at all relevant
functions and levels within the organization. The objectives are derived from Mythical True
Value Metrologys Quality Policy and Mythical Airlines corporate policies. The quality
objectives are documented (Annual Quality Objectives) and are reviewed by top management.
The quality objectives are measurable and consistent with the quality policy, including
commitment to continual improvement. Quality objectives include those needed to meet all
contracted requirements. Inherent in the entire set of quality objectives is a focus on customer
satisfaction.
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Processes represent how we turn opportunity into profitable outcomes. Its effectiveness is
maintained and enhanced by Support Processes. The identified Core and Support business
processes are indicated in Figure 2.
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The Quality Plan is assessed for on-going suitability and effectiveness during management
review meetings.
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Report to top management on the performance of the QMS, including needs for
improvement.
Promote awareness of customer requirements throughout the organization.
The Management Representative also acts as the liaison between the department and other third
parties on matters concerning the department Business Management System.
The Metrology Engineering and Support Manager is the Deputy Management Representative.
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All printed copies, and all electronic copies and versions except the one accessible on the
Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.
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6. RESOURCE MANAGEMENT
6.1 Provision of Resources
Top management of Mythical True Value Metrology determines and provides, in a timely
manner, the resources needed:
to implement, maintain and improve the effective operations of the QMS processes, and
to enhance customer satisfaction by meeting requirements.
These resources are assessed and reviewed on a periodic basis consistent with annual and
strategic business planning activities.
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6.3 Infrastructure
Top management of Mythical True Value Metrology identifies, provides and maintains the
facilities and infrastructure it needs to achieve service quality, including:
workspace and associated facilities, including utilities;
process equipment, hardware and software;
supporting services such as telephone, computer networks, etc.
QP 6300 and QP 6301 have been established to further describe and implement the above
policies.
7. SERVICE REALIZATION
NOTE: The product of Mythical True Value Metrology is the service of providing
calibration of tools, precision measuring equipment, and testing equipment.
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Identify and acquire controls, processes, equipment, fixtures, total calibration resources,
and skills that are needed to achieve the required quality.
Address for compatibility the delivery of service, calibration process, installation,
servicing, inspection and test procedures, and the applicable documentation.
Address the need to develop and implement new techniques, and the criteria for
acceptance, as necessary.
Address measurement requirements involving capability that exceeds the known state of
the art.
Clarify standards of acceptability, including those that contain a subjective element.
Identify quality records that are necessary to provide confidence of conformity of the
processes and results, and the records are maintained as described in documented
procedures.
Quality Procedure QP 7100 describes the planning for service delivery and refers to other
Mythical True Value Metrology quality procedures involved in the process.
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All printed copies, and all electronic copies and versions except the one accessible on the
Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.
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7.4 PURCHASING
Purchasing of outside materials, supplies, and services is not a burdensome requirement for
Mythical True Value Metrology. In most cases, Mythical Airlines is considered the supplier of all
purchasing services.
All purchases of capital items, high volume consumables, items or services requiring a
purchase order, contracted services, and so on are largely handled by other Mythical
Airlines departments and are under the control of Mythical Airlines policies and
procedures and therefore outside the scope of this QMS.
Much of the purchasing process uses Mythical Airlines requirements, controls and staff,
which are outside the scope and controls of the Mythical True Value Metrology QMS.
Suppliers that may be used with a purchase order or through the electronic business-tobusiness system are controlled by the Mythical Airlines corporate purchasing and
accounting departments, which are outside the scope of this QMS.
Some materials and supplies are obtained from the Mythical Airlines stock system.
Support processes are supplied and controlled by other Mythical Airlines departments.
Mythical True Value Metrology directly purchases some materials, supplies, and services from
other companies by using Mythical Airlines corporate purchase card. Almost all such purchases
are infrequent or non-recurring retail purchases of very small quantities of cataloged or other
commercial off-the-shelf products. All purchases must follow the policies and procedures of
Mythical Airlines, which are outside the scope of this QMS.
Mythical True Value Metrology maintains a local list of active outside (non-Mythical Airlines)
suppliers and the materials or services they provide, but suppliers are primarily managed at the
corporate level and must be listed in the corporate enterprise management system database.
Mythical Airlines provides for the inspection and auditing of suppliers, when a need is
determined, according to Mythical Airlines policy. In this respect Mythical Airlines is a supplier
of this service to Mythical True Value Metrology.
Mythical True Value Metrology, where practical, verifies purchased material, supplies, and
services before use or redistribution.
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Mythical True Value Metrology has established and maintains local records of acceptable
suppliers. An approved supplier list (ASL) is maintained. A critical supplier list is also
maintained.
QP 7400 defines the Mythical True Value Metrology process for purchasing controls over its
suppliers. Separate procedures detail the processes for purchasing and materials, supplies and
services other than calibration (QP 7410.1), and subcontracted calibration services (QP 7410.2).
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does become a requirement, this process will be re-evaluated. However, this does not absolve
Mythical True Value Metrology of the responsibility to provide acceptable product, nor will it
preclude subsequent rejection by the customer.
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includes any processes where deficiencies may become apparent only after the equipment is in
use or the service has been delivered. Currently there are no special processes in use by Mythical
True Value Metrology where the results cannot be fully verified by subsequent inspection or
testing.
Validation demonstrates the ability of the processes to achieve planned results. Mythical True
Value Metrology defines arrangements for validation, including the following, as applicable:
qualification of processes;
qualification of equipment and personnel;
use of defined methodologies and procedures;
requirements for records;
re-validation.
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Since all operations are performed on unique single items, any method relating to a lot of
more than one item is by definition not appropriate.
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are calibrated on a defined periodic basis and adjusted when the need is indicated, against
devices traceable to nationally recognized standards. Where no such standards exist, the
basis used for calibration is agreed upon and recorded;
are safeguarded from adjustments that would invalidate the calibration;
are protected from damage and deterioration during handling, maintenance, and storage;
calibration results are recorded;
have the validity of previous results re-assessed if measuring and monitoring devices are
subsequently found to be out of calibration, and corrective action taken.
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All printed copies, and all electronic copies and versions except the one accessible on the
Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.
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Mythical True Value Metrology ensures that service provided which does not meet requirements
is identified, controlled where possible to prevent unintended use or delivery to the customer,
and corrected if it has been delivered. This policy is implemented in QP 8300. This procedure
includes provisions for:
identification, documentation, evaluation, segregation (where practical), disposition of
nonconforming service, and for notification of the functions concerned;
assigning responsibility for the review and the authority for disposition of nonconforming
service;
correction of nonconforming service and re-verification/calibration of the affected
equipment after correction to demonstrate conformity (if necessary);
handling of nonconforming service when it is detected after delivery to the customer.
8.5 Improvement
8.5.1 Continual Improvement
Mythical True Value Metrology plans and manages the processes necessary for the continual
improvement of the QMS.
Mythical True Value Metrology facilitates the continual improvement of the QMS through the
use of the quality policy, objectives, audit results, analysis of data, corrective and preventive
action and management review.
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- - - [END] - - -
Graeme C. Payne
ASQ Senior Member, CQA, CCT, CQE, CQT
GK Systems, Inc.
4440 Weston Drive SW, Suite B
Lilburn GA 30047-3181
USA
http://www.gksystems.biz
This EXAMPLE manual is a representative item for use
as a training aid only. Any resemblance to any real
corporation, organization, policies or procedures is not
All printed copies,
and all electronic
copies
and versions except the one accessible on the
intentional
and is purely
coincidental.
Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.