All in 1 Procedure 01.07.17

SREE KRISHNA STRAPPING & QUALITY SYSTEM
DOC.REF:QSP/01
LABELS PRIVATE LIMITED PROCEDURES
ISO 9001:2015 Date: 01.07.2017 Rev: 00
INDEX
Sl.No. Name of the Procedure Rev No. Date Page no.

1 Context of the Organization 00 01.07.2017 1
2 Risk & Opportunity Management 00 01.07.2017 4
3 Change Management 00 01.07.2017 7
4 Calibration 00 01.07.2017 10
5 Training 00 01.07.2017 12
6 Control of Documents 00 01.07.2017 14
7 Control of Records 00 01.07.2017 17
8 Quoting and Orders 00 01.07.2017 21
9 Shipping 00 01.07.2017 22
10 Purchasing 00 01.07.2017 23
11 Receiving 00 01.07.2017 27
12 Equipment Validation 00 01.07.2017 30
13 Identification and Traceability 00 01.07.2017 31
14 Preventive Maintenance 00 01.07.2017 35
15 Special Processes 00 01.07.2017 37
16 Control of customer property 00 01.07.2017 38
17 Preservation 00 01.07.2017 39
18 Control of NC Product 00 01.07.2017 42
19 Internal Auditing 00 01.07.2017 44
20 Management Review 00 01.07.2017 48
21 Corrective & Preventive Action 00 01.07.2017 49
Prepared by (MR): Approved by: MD
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Procedure: 1. Context of the Organization

1. SUMMARY
1.1. The purpose of this procedure is to define how the company’s Strategic Direction is developed
by senior management through the identification of interested parties, issues of concerns, risks
and opportunities.
1.2. The MD is responsible for implementation and management of this procedure.
2. REVISION AND APPROVAL
Rev. Date Nature of Changes Approved By

00 01.07.2017 Original issue. MD
3. SCOPE OF PRODUCTS AND SERVICES
3.1. SKL provides the following [Products or Services ]:

 Self adhesive labels
3.2. SKL limits the offering of its products and services as follows:
 Polyester
 Maplitho
 Chromo
 Synthetic
4. INTERESTED PARTIES
4.1. “Interested parties” are those stakeholders who receive our Products or Services, who may be
impacted by them, or those parties who may otherwise have a significant interest in our
company. The interested parties applicable to SES are listed in the COTO Log, along with the
reason for their inclusion. This includes both internal and external parties.
4.2. The identification of an interested party does not necessarily bring that party into the scope of
the QMS; for example, labor union leadership may be identified as an interested party, but that
does not mean QMS documents and policies must be developed related to them.
5. ISSUES OF CONCERN
5.1. For each interest party, the related issues of concern shall be identified in the COTO Log.
These issues may reflect direct concerns of the party (for example, customers are concerned
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about quality of products or services they purchase) or they may be indirect concerns. Such
concerns may impact on the interested party, or may be concerns derived from the party that
impact on the company.
5.2. Issues may be either internal or external, depending on whether the interested party is internal
or external. In addition, a certain type of party may have both internal and external concerns.
5.3. When attempting to identify internal concerns, it may be useful to consider technological
concerns, employee concerns, etc.
5.4. When attempting to identify external concerns, it may be useful to consider concerns arising
from competition, society and culture, labor relations, statutory and regulatory issues, supply
chain, economic issues, etc.
6. RISKS AND OPPORTUNITIES
6.1. Management will then identify risks and opportunities related to the issues of concern within the
COTO Log.
6.2. Within the COTO Log, each risk and opportunity will be noted, along with the primary process
involved, priority, and a bias. The “bias” identifies if the issue is a risk, an opportunity, or some
blending of the two.
6.3. Management will then determine a treatment method for each risk or opportunity. Risks are
managed to reduce their likelihood and consequence, while opportunities are managed to
increase their likelihood and consequence. Blended issues may require more complex
treatment.
6.4. Where a risk is determined to be treated via a Failure Mode Effects Analysis (FMEA) style
treatment, these must then be entered into the Risk Register tag within the COTO Log.
6.5. Opportunities are managed via the Opportunity Register tab within the COTO Log.
6.6. For more on the management of risks and opportunities, see “Risk Management Procedure”.
7. STRATEGIC DIRECTION
7.1. From the information above, the [MR] devises a “strategic direction” which is documented in
the records of management review. See the procedure Management Review Procedure.
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Procedure: 2. Risk Management

1. SUMMARY
1.1. The company has established, implemented and maintained this procedure for managing
risks and opportunities throughout the [SES].
1.2. Responsibility and authority for this procedure are spread across various functions, and
defined within this procedure.
1.3. Note: this procedure has adopted definitions for key terms developed specifically by [Short
Client Name] and determined appropriate for its use within the unique requirements of its
management system. It does not adopt current ISO definitions, which [Short Client Name] has
determined are not sufficient for its use.
1.4. Note: the QMS documentation occasionally uses the term “opportunity for improvement” when
discussing internal audit findings or management review actions; that term does not have the
same context as the term “opportunity” used herein.

3. DEFINITIONS
3.1. Risk: A negative effect of uncertainty.

3.2. Opportunity: A positive effective of uncertainty.
3.3. Uncertainty deficiency of information related to understanding or knowledge of an event, its
consequence, or likelihood. (Not to be confused with measurement uncertainty.)
3.4. Risk Assessment: a systematic investigation and analysis of potential risks, combined with
the assignment of severities of probabilities and consequences. These are used to rate risks
in order to prioritize the mitigation of high risks.
3.5. Risk Mitigation: a plan developed with the intent of addressing all known or possible risks
and preventing their occurrence.
3.6. FMEA (Failure Mode Effects Analysis): a specific risk treatment method which ranks risks
by probability and consequence.
4. PROCEDURE: GENERAL
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4.1. SES considers and manages risks and opportunities differently.

4.2. Risks are managed with a focus on decreasing their likelihood, and minimizing their impact if
they should occur.
4.3. Opportunities are managed to increase their likelihood, and to maximize their benefits if they
should occur.
4.4. Where risks and opportunities overlap, the best appropriate method for managing them shall
be ascertained, given the situation at hand. Elements of such “blended” uncertainties may
require methods which both address the negative risk and positive opportunity.
5. PROCEDURE: MANAGEMENT OF RISKS
5.1. Risks are identified as part of the “Context of the Organization Exercise” described in Context
of the Org Procedure.
5.2. Additional risks may be identified by any employee at any time.
5.3. Each process is defined in detail through a Process Definition Doc. This document includes
the identification and mitigation plans for key risks associated with the defined process. [Short
Client Name] management reviews these risks and takes action to minimize them.
5.4. Risks identified as part of the Context of the Organization exercise defined in the procedure
Context of the Org Procedure and logged within the COTO Log. This indicates a rough
priority, as well as a selected risk treatment method.
5.5. The methods for risk assessments vary, but should always include a means of identifying the
risk under examination, and a description of the result of the risk assessment.
5.6. Detailed methods may include FMEA (failure mode effects analysis), SWOT (strength,
weakness, opportunity and threat) or other tools. No single method is used for all risk
assessments; the tool selected should be the best tool applicable to that particular risk
analysis.
5.7. ISO 31010 provides guidance on the selection of risk tools.
5.8. Where FMEA style risk treatment is deemed optimal, an entry shall be made in the Risk
Register tab of the COTO Log. When using the Risk Register, the following steps are to be
followed:
5.8.1. Identifying the risk.
5.8.2. Identifying the process for which the risk most likely dominates.
5.8.3. Assigning a probability rating to the identified risk; this probability is comprised of two
elements: likelihood and previous occurrences. Each element is given a score from 1
(lowest risk) to 5 (highest risk). The final probability rating is the average of the
elements.
5.8.4. Assigning a consequence rating if the risk were to be encountered; this consequence
is comprised of five elements: eventual loss of contract; negative impact on existing
customers; inability to meet contract terms; any violation of statutory regulations or
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law; impact on [Short Client Name]’s reputation; and estimated cost of correction.
Again, each element is given a score from 1 (lowest risk) to 5 (highest risk). The final
consequence rating is the average of the elements.
5.8.5. Calculating a final Risk Factor based on the equation:
PROBABILITY RATING x CONSEQUENCE RATING = RISK FACTOR
5.8.6. For risks with a final Risk Factor rating equal to or greater than the threshold set in
the Risk Register, management will decide whether to reject the subject due to the
risk, or accept the risks after the development of a risk mitigation plan. The mitigation
plan must be documented, either in the Risk Register or in another document which
must be referenced on the form.
5.8.7. Risks with a factor less than the risk threshold may be accepted without a mitigation
plan, unless otherwise directed by management.
5.8.8. The Risk Register also allows for setting a “warning” threshold range, where risks
that have a Risk Factor within that range are flagged as suggesting the need for a
mitigation plan, but such a plan is not mandatory.
5.8.9. The final column allows for entry of an estimated risk factor after mitigation, which is
an estimate on what the risk should be reduced to if the risk treatment is successful.
5.9. If a risk includes a potential positive aspect, management may elect to conduct an opportunity
pursuit assessment on the positive aspect, as defined below.
6. PROCEDURE: MANAGEMENT OF OPPORTUNITIES
6.1. SES actively seek out opportunities which could enhance its financial viability and market
position. For example:
 obtaining new contracts
 obtaining access to new markets
 identification of new industries which may be served by [SES]
 development of new offerings that are within the scope of capabilities of [SES]
 streaSKLining existing processes to improve efficiency and reduce costs
6.2. Opportunities are identified as part of the “Context of the Organization Exercise” described in
Context of the Org Procedure and as part of the corrective and preventive action program
described in Corrective Preventive Action Procedure.
6.3. Discussing and analyzing opportunities shall be done by top management. If made part of the
management review activities, these shall be recorded in the management review records.
6.4. To help determine which opportunities should be pursued, the Opportunity Register within the
COTO Log may be used to conduct an “opportunity pursuit assessment.” This register is
similar to the Risk Register, but ranks potential positive opportunities by their likelihood of
success and potential benefit.
6.5. The opportunity pursuit assessment is conducted by:
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6.5.1. Identifying the opportunity.

6.5.2. Identifying the process for which the opportunity most likely falls under.
6.5.3. Assigning a probability rating to the identified opportunity; this probability that the
organization can achieve the opportunity. It is comprised of two elements: likelihood
and previous occurrences. Each element is given a score from 1 (lowest probability)
to 5 (highest probability). The final probability rating is the average of the elements.
6.5.4. Assigning a benefit rating to assess potential benefits if the opportunity is won. This is
comprised of six elements: potential for new business; potential expansion of current
business; potential improvements in the organization’s ability to satisfy regulatory or
statutory requirements; potential improvements to the quality management system;
potential enhancements of [Short Client Name]’s reputation; and estimated cost of
implementation. Again, each element is given a score from 1 (lowest benefit) to 5
(highest benefit). The final benefit rating is the average of the elements.
6.5.5. Calculating a final Opportunity Factor based on the equation:
PROBABILITY RATING x BENEFIT RATING = OPPORTUNITY FACTOR
6.5.6. For opportunities with a final Opportunity Factor rating equal to or greater than the
threshold set in the Opportunity Register, management will decide whether to pursue
the opportunity through an “opportunity pursuit plan” or to abandon the opportunity
altogether. The opportunity pursuit plan must be documented, either in the
Opportunity Register or in another document which must be referenced on the form.
6.5.7. Opportunities with a factor less than the opportunity target rating may be abandoned
outright, unless otherwise directed by management.
6.5.8. The final column allows for entry of success result, once the opportunity has been
closed; this includes entries for abandoning the opportunity, failing to win the
opportunity, and three grades of success.
6.6. Analysis of any opportunity will generally result in one of the following possible determinations:
 Pursue the opportunity
 Explore the opportunity in greater detail before proceeding
 Accept the opportunity, but under limited and controlled conditions
 Decline the opportunity, typically based on a high expected cost or low anticipated
benefit
If an opportunity includes a negative aspect, management may elect to conduct a risk
assessment on the negative aspect, as defined above.
Procedure: 3. Change Management

1. SUMMARY
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1.1. The purpose of this procedure is to define the methods for managing changes to processes and
other aspects of the management system in a controlled manner.
1.2. Where this document discusses changes to processes, this shall be understood to mean the top-
level processes identified in the [Quality Manual].
1.3. The MD is responsible for implementation and management of this procedure.

3. DEFINITIONS
3.1. “Process Output” – the result of any process; these are typically defined inthe Process Definition
Doc for each top-level process.
4. CHANGES TO PROCESSES
4.1. Management system processes will undergo changes, typically when:

4.1.1. Improvement opportunities have been identified, typically to improve process effectiveness
4.1.2. Nonconformities within a process are identified and require corrective action
4.1.3. Conditions in the industry or company change, requiring a process to be updated
4.1.4. New processes are added which impact on existing processes, requiring changes
4.1.5. Customer requirements result in a need to change processes
4.1.6. Any other reason determined by management
4.2. In such cases, the process must be changed in a controlled manner to ensure proper
authorization and implementation of the changes.
4.3. At a minimum, process changes shall include the steps herein:
4.3.1. The request for a process change shall be documented, typically in a [CAR Form Name]
per the procedure [Corrective Preventive Action Procedure]. The justification for the
change shall be recorded.
4.3.2. The change shall be reviewed by appropriate management, including the senior most
managers responsible for the process. Changes must be approved prior to implementation.
4.3.3. The appropriate [Process control chart / standard mold parameter] will be updated to
reflect the change. This document will undergo review and approval per the procedure
[Control of Documents Procedure]. The revision indicator of the [Process control
chart / standard mold parameter] will be incremented, and the nature of the change
recorded.
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4.3.4. The follow-up verification step of the CAR process shall seek to ensure the change has had
the intended effect, and/or has improved the process. If not, the change may be rolled back
or a new change made to correct any new issues that arise as a result of the change.
5. CHANGES TO PROCESS OUTPUTS
5.1. The methods for changing process outputs are typically defined in the Process control chart /
standard mold parameter]. Where a process output is a document, the rules for changing
documents above shall apply.
5.2. Formal changes to process outputs will be used when the change is significant. Minor changes
may be made without formal control, however the decision on what constitutes a significant vs
minor change must be agreed upon by those involved in the change. If a customer indicates a
change is significant, this will trump any internal decision.
6. CHANGES TO DOCUMENTATION
6.1. Management system documents undergo changes when there is a need to revise them.
6.2. Changes to documentation are done in accordance with the procedure [Control of Documents
Procedure].
7. CHANGES TO ORDERS OR CONTRACTS
7.1. Changes to active orders or contracts may occur when the customer changes the requirements
after the work has begun, or may be initiated by [SES] when unforeseen circumstances are
encountered.
7.2. When changes are initiated by the customer, the new requirements will undergo the same review
and acceptance per the procedure [Quoting and Orders Doc Title]. If the changes cannot be
accepted by [Short Client Name], a satisfactory solution will be negotiated with the customer.
7.3. When changes are initiated by SES, the MD will notify the customer and negotiate a resolution.
7.4. In all cases, when changes are agreed upon, they shall be initiated as follows:
Procedure: 4.Calibration Procedure

1. SUMMARY
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1.1. The purpose of this procedure is to define the requirements for calibration or verification of
equipment used to determine the acceptability of product.
1.2. Typically, this is limited to inspection or test equipment used to “buy off” product prior to
movement to a subsequent process or prior to final delivery. However, at the discretion of
management, calibration or verification may also be applied to critical process equipment.
1.3. The MR is responsible for implementation and management of this procedure.

00 01.07.2017 Original issue. MR
3. PROCEDURE: CALIBRATION
3.1. Devices subject to calibration shall be calibrated by an approved outside service provider, or by
trained [SES] employees.
3.2. Third party calibration laboratories should be accredited to ISO 17025 whenever possible, as this
provides the best control of calibration activities, and traceability to national standards.
3.3. When employees perform in-house calibration, this shall be performed in accordance with
documented procedures for each type of calibration performed.
3.4. Traceability to the national standards will be maintained for all devices where such traceability is
possible by the current state of the art.
3.5. Approved calibration service providers must maintain suitable environmental conditions for
calibration, and report temperature and relative humidity on any calibration test certificates or
other calibration documentation. For in-house calibration, the MR will ensure suitable
environmental conditions for calibration.
3.6. The Calibration plan will be maintained by the MR. This document will list all devices, their serial
number, date of last calibration, and next scheduled calibration date. The frequency of calibration
for each device shall be adjusted based on the history of the device and its impact on product
quality. NOTE: third party calibration providers may not establish calibration frequencies;
this must be determined by [SES].
3.7. For tools calibrated by third party laboratories, these shall be returned with a certificate of
calibration showing the status of the calibration, as well as the condition the equipment was found
in (e.g., “defective,” “out of tolerance”, “in tolerance”, etc.) Such certificates must have the
identification of any standards used by the calibration house, and their serial numbers, allowing
for traceability to NIST.
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3.8. For tools calibrated in-house by [SES] staff, the results and standards used shall be recorded on
the Calibration Record and shall include any standards and/or procedures uses.
3.9. Calibrated devices will be identified with a calibration sticker that includes the current calibration
status, calibration due date, and device identification number. Where the device cannot
accommodate a calibration sticker due to size or frequency of use, the device shall be numbered
and the [MR] shall keep a log of those devices and their status. Employees may only use devices
for acceptance testing that are current on calibration.
3.10. Employees shall submit expired tools to [MR] for recalibration, and/or the [MR] shall positively
recall such expired tools for recalibration.
3.11. An “amnesty window” of 2 weeks is allowed beyond the due date marked on the device, to
accommodate arrangement of calibration or verification, or for production capacity purposes.
[Oxbridge recommends against this practice, and recommends deleting this paragraph entirely.]
3.12. Devices in use for noncritical measurements are to be marked REFERENCE ONLY.
3.13. Any device failing to meet calibration standards will immediately be taken out of service. The
device may then be destroyed or sent out for repair. Repaired devices must be calibrated before
being returned to service.
3.14. When a measuring device is found to be out of tolerance, and/or reported on the calibration
certificate of having been found as “defective” or “out of tolerance” by the third party provider, the
[MR] shall be notified immediately. The [MR]or designate shall oversee a study to determine the
impact of the out-of-tolerance device on product shipped; if deemed necessary, a recall may be
initiated. The customer possessing the material in question is immediately notified of the problem.
This study and the results shall be recorded and placed in the calibration file.
3.15. Measuring & monitoring devices must be stored and handled in a manner that does not invalidate
their calibration or ability to function without error.
4. VERFICATION
4.1. Where a device cannot be calibrated against traceable standards, it must be verified against
some known-good object or method. This may be done by comparing the part against another
part or tool which has been evaluated and validated and proven as acceptable.
Known-good objects must be protected so their status is not altered, either by physical damage
or deterioration. Known-good methods must be documented in procedures, with a rationale for
their acceptability being documented.
Procedure: 5. Training Procedure
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1. SUMMARY
1.1. The purpose of this procedure is to define the requirements for positions in the company
affecting quality, for hiring and training employees to ensure these requirements are met, and
for evaluating the effectiveness of training provided.
1.2. The [MR] is responsible for implementation and management of this procedure.

3. OVERVIEW
3.1. [SES] employees are selected, trained and evaluated to ensure that those personnel performing
work affecting product quality are competent on the basis of four primary criteria:
 education
 training
 skills
 experience
3.2. Job requirements have been developed for each position in the company affecting quality and
documented in an applicable [Position Description]. These define the desired minimum
requirements for each position, including the four criteria listed above.
3.3. [Position Description] s shall include applicable statutory or regulatory requirements for the
position defined.
4. CANDIDATE SCREENING
4.1. All [SES] personnel are hired on the basis of their ability to perform acceptable work. This is
done by comparing the candidate’s resume, experience, application, etc. against the job
description requirements.
4.2. It is not mandatory that candidates meet all requirements, if the company can provide
subsequent training or other actions to bring the candidate up to the requirements eventually.
5. NEW HIRES
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5.1. New employees for the [SES] undergo employee orientation, which includes ISO 9001 training,
and training on the Quality Policy. Orientation training to shall be completed within 10 days of
the employee’s start date.
5.2. Orientation shall include discussing with the employee the relevance and importance of that
person meeting customer and company QMS requirements, and how their work will affect
quality objectives.
5.3. A record of the completion of the orientation shall be maintained in the employee’s training file.
6. SUBSEQUENT TRAINING / OJT
6.1. Subsequent training, including on-the-job training (“OJT”) is performed to ensure each
employee is knowledgeable in their job function and their role within the company.
6.2. The Employee Skill Matrix lists applicable task-specific requirements for some positions; for
employees hired in these positions, the [MR] will update this matrix as training is conducted for
these tasks.
6.3. On the Employee Skill Matrix, an employee is considered qualified is the task is marked off as
completed; the employee may train others if this is indicated.
6.4. Prior to qualification, an employee’s supervisors or managers are responsible for that
employee’s work.
6.5. Other training is recorded on individual employee training records. Such records should
indicate the following:
 Type of training
 Method of training
 Duration of training
 Date of completion
 Location of training
 The name of the instructor or individual who conducted the training
6.6. Personnel undergoing third party training and receiving a certificate of training by the training
provider may retain this certificate as a training record in lieu of an employee training record.
6.7. All training records are to be maintained in the employee training file. Copies may be given to
the employee for their personal retention or posting in their work areas.
7. TRAINING EVALUATION
7.1. Management periodically reviews and re-certifies employees for operations where recertification
is required or beneficial. Annual personnel evaluations are performed to assess effectiveness of
training. Employee evaluations shall include goals for continual improvement of the employee’s
competency and abilities, as well as their growth within the company, as applicable.
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7.2. Where appropriate, some training programs will include a test or other means of verifying the
effectiveness of training. In such cases, work instructions will define the minimum passing
grade, and actions to be taken when an employee does not pass.
7.3. If problems, weaknesses or concerns are discovered during an evaluation or otherwise reported
for any other reason (including customer complaints), a [CAR Form Name] form shall be
completed to identify the weaknesses and develop a plan of improvement for that employee;
see the procedure [Corrective Preventive Action Procedure].
7.4. For some tasks, tests may be developed and given to assess training effectiveness. In such
cases, procedures shall define the method for giving the test and the passing grades / criteria
required. The procedures shall also define the actions to take when an employee fails such a
test.
7.5. The Internal Auditing process (see [Internal Auditing Procedure]) shall evaluate the
effectiveness of training and its effects on product and service quality; in addition, the review of
training effectiveness shall be a permanent feature of Management Review (see [Management
Review Procedure].)
Procedure: 6. Control of Documents Procedure

1. SUMMARY
1.1. This procedure defines the requirements for the creation, review, approval, distribution, use and
revision of [SES] quality management system documents.
1.2. This procedure applies only to documents which instruct [SES] staff on how to carry out activities
and tasks; this includes manuals, procedures, forms and instructional sheets or posters.
Documents outside of this scope do not require control.
This procedure is released and approved as follows.

3. PROCEDURE
3.1. Creation of Documents
3.1.1. Documents are created by an appropriate subject matter expert.

3.1.2. All internal documents are created as soft files / hard copies; it is recommended that files of
a similar type follow the format of other documents in that type.
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3.1.3. Draft versions must then be sent to the appropriate approver(s) for review and approval.
3.1.4. Original releases of documents are given a revision indicator of “00”.)
3.2. Review and Approval
3.2.1. The [Quality Manual] may only be approved by the [MD]. Other documents are to be
approved by the original author/MR/ an appropriate area supervisor or a company
executive.
3.2.2. Draft files may be sent to the approver(s) via hardcopy or e-mail.
3.2.3. The reviewer will resolve any issues with the original author to achieve a satisfactory
document.
3.2.4. The reviewer will indicate approval of the document by [Signing method.]
3.2.5. The approved document shall then be forwarded to the [original author/MR].
3.2.6. [If hardcopy binder will be used] The [original author/MR] will maintain a binder of most
current hardcopy versions of documents. Any previous hardcopies in this binder are to be
discarded or filed in an obsolete document file.
3.2.7. The [original author/MR] will maintain a computer folder, on the company server, for the
latest soft copy versions of document. This file set must be on a server subject to data
backup. The [Original author/MR] will place new or revised documents into that folder,
setting each file’s permission to READ ONLY, or converting the released versions to a non-
editable file format.
3.2.8. Any previous soft versions are then moved to a separate folder identified for obsolete
documents which are kept for historical purposes.
3.2.9. The directory of official released documents shall act as a “master list” of documents,
indicating the current versions of all documents. No other master list is required.
3.3. Distribution of Documents
3.3.1. [If intranet is used]Controlled documents will be available via the intranet for all employees.
Employees receive training on the file and folder locations for most current documents.
3.3.2. [If hardcopy document distribution is used]The [Original author/MR] will maintain a list of
where controlled hardcopy documents are to be distributed. The [Original author/MR] will
be responsible for distributing updated copies of such controlled hardcopies to proper
locations. Controlled hardcopies shall be stamped CONTROLLED in red ink on the first
page, to distinguish them from uncontrolled documents or photocopies.
3.3.3. Controlled hardcopies may not be altered or modified by users, and must remain legible
and readily identifiable. This includes hand mark-ups by unauthorized personnel. The only
exception to this rule is for Forms (see below.)
3.3.4. Controlled hardcopies may not be photocopied, unless for the purposes of sending to a
recipient who is authorized to receive uncontrolled versions of [SES] documents (i.e., a
vendor or customer). The only exception to this rule is for Forms (see below.)
3.4. Re-Evaluation
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3.4.1. Documents must be reviewed by the original author or another subject matter expert or top
manager every three years.
3.4.2. The [Original author/MR] will ensure re-evaluation is conducted and that documents are
updated if required. The [Original author/MR] will maintain a record of document re-
evaluations, to identify when documents are due for re-evaluation.
3.4.3. If a document is determined to require updating, the changes shall be made and a new
version issued per the rules below.
3.4.4. If a document is determined not to require updating, no action on the document is
necessary.
3.5. Revising Documents
3.5.1. Changes to documents go through the same steps as original issue, except that their
revision level is advanced upon approval.
3.5.2. Only authorized personnel may change documents, although any employee can request a
change to their Manager, or by filing a [CAR Form Name] [or other document change
request form.]Wherever possible, the document shall include a change history table within
its text.[Other methods for identifying changes might be use of Track Changes feature in
document, highlighting revisions in yellow. If so, edit this as required.] Forms do not require
a revision history table.
3.5.3. Any changes to documents that require customer or regulatory authority review and
approval shall be submitted accordingly, and not implemented until such approval is
obtained.
3.5.4. If document changes require customer or regulatory approval prior to implementation, this
will be obtained in writing. When processes are changed, the appropriate documentation
shall be updated, with a change history updated to reflect the reason for the change.
3.5.5. Re-evaluation, inspection (where applicable) and internal auditing will confirm the
effectiveness of changes.
3.6. Controlling Documents of External Origin
3.6.1. For external documents such as standards or third party specifications which are
referenced in a customer purchase order or contract, these documents may be maintained
without control, provided that the revision of the document on file matches the revision
indicated by the customer. Where the customer provides no revision number, the latest
(most recent) revision shall be assumed.
3.6.2. For external documents such as standards or third party specifications which are not
referenced in a customer purchase order or contract, these must be controlled. Such
control requires that the [Original author/MR] or responsible manager obtain the latest
version of the document, and maintain it on the company server (for electronic versions) or
in a binder of controlled external documents (for hardcopies). Like other controlled
documents, these may not be edited or copied.
3.6.3. Third party specifications and prints, including those of the customer, are controlled per the
configuration management requirements set forth in the [Short Client Name][Quality
Manual].
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3.6.4. External documents for non-critical use, such as user manuals, reference books, marketing
materials, and supplier directories are not controlled.
3.7. Forms
3.7.1. Forms are a special kind of document that may be photocopied as needed. Furthermore,
forms do not require an approval signature; department managers are responsible for
creating and using forms in their areas.
3.7.2. A softcopy of each approved form must be sent to the [Original author/MR] for inclusion in
the document control area on the intranet, and for inclusion in the [Master list of
Documents].
Procedure: 7. Control of Records Procedure

1. SUMMARY
1.1. This procedure defines the requirements for the identification, storage, protection, retrieval,
retention time and disposition of controlled quality records.
1.2. “Quality records” are those records which provide evidence of [SES] having met – or not met –
requirements. This may include requirements related to inspection requirements, purchasing
requirements, contractual requirements, etc. The full listing of records affected by this procedure
is given in the table at the end of this procedure.
1.3. Records outside of this scope do not require control, but may be controlled at the discretion of
management.

3. PROCEDURE
3.1. Identification
3.1.1. [SES] maintains records that are needed to provide evidence of conformity to requirements
and of the effective operation of the quality management system. The records are
identified in the table below, along with the controls for each record type.
3.2. Storage
3.2.1. Storage methods are indicated in the table below, for each record type.
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3.2.2. Softcopy records and data are stored on the company server or computers; in all cases,
computers are subject to backup.
3.2.3. Hardcopy records are stored in suitable cabinets that prevent damage or deterioration.
3.3. Retention, Retrieval & Disposition
3.3.1. Records shall be maintained a minimum of 3 years [should not be less than 3 years due to
ISO audit cycle requirements]unless otherwise indicated below or as defined by customer,
statutory or regulatory requirements.
3.3.2. Training records and other records pertaining to employees must be retained at least one
year beyond that employee’s end of employment.
3.3.3. Records that are discarded after retention shall be permanently destroyed.
3.3.4. When archived records are stored offsite or in another location, these shall be stored in a
controlled environment that also protects them from damage or deterioration.
3.3.5. As required by customer contract or regulatory requirements, quality records shall be made
readily available for review by the requesting authority. Such review is limited to those
records applicable to the customer or regulatory authority, and shall not allow for the
accidental or intentional release of confidential information to an unauthorized party.
3.4. Protection
3.4.1. The listed “controller” shown in the table below must ensure their assigned records remain
legible, readily identifiable and retrievable.
3.4.2. In order to ensure protection of records, electronic records are subject to periodic backups,
with the backup stored on a separate server. The MR is responsible for backup of data.
3.4.3. Quality records data stored on individuals’ computers must either be backed up through the
server (as above), or backed up manually onto the server. The individual users of such
data are responsible when data is not backed up by the server
3.4.4. Entries made by hand on hardcopy forms shall be made in ink.
3.4.5. White-out or correction tape is not to be used on any quality records. The correct
procedure for making corrections is to cross the error out, make the correction and initial it.
Optionally, date-sensitive corrections should be dated as well.
Example:
126
# parts accepted = 124S.P . 12/12/2015
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QUALITY RECORDS MATRIX

Required Record or Responsible Type of
[SES] Record Storage Location Discard Method
Document Type Controller Record
Management Review Softcopy /
MD / MR Computer Secure delete
Meeting Minutes Hardcopy
Management Review Customer Satisfaction Softcopy /
MD / MR MD’s Office Shred and discard
Records records Hardcopy
Employee Opinion Softcopy /
Surveys Hardcopy
Softcopy /
Training Matrix MD / MR MD’s Office Shred and discard
Hardcopy
Employee Training Softcopy /
Records Hardcopy
Softcopy /
Training Records Statements of Training MD / MR MD’s Office Shred and discard
Hardcopy
Softcopy /
Applications, resumes MD / MR MD’s Office Shred and discard
Hardcopy
Softcopy /
Authority Roster MD / MR MD’s Office Shred and discard
Hardcopy
Preventive Maintenance MR / Dept. Softcopy /
Dept. / MR Office Shred and discard
Records Supervisor Hardcopy
Stamp & Signature MR / Dept. Softcopy /
Control Log Supervisor Hardcopy
MR / Dept. Softcopy /
Work Orders Dept. / MR Office Shred and discard
Supervisor Hardcopy
Travelers Dept. / MR Office Shred and discard
Supervisor Hardcopy
Records of realization
process meeting Purchase Orders Dept. / MR Office Shred and discard
Supervisor Hardcopy
requirements
Packing Lists / Packing MR / Dept. Softcopy /
Slips Supervisor Hardcopy
Process control records MR / Dept. Softcopy /
(incl. temp charts) Supervisor Hardcopy
Design verification MR / Dept. Softcopy /
records Supervisor Hardcopy
Design validation records Dept. / MR Office Shred and discard
Supervisor Hardcopy
Contract Review MR / Dept. Softcopy /
Customer RFQs MD’s Office Shred and discard
Records Supervisor Hardcopy
Quotes MD’s Office Shred and discard
Supervisor Hardcopy
Customer POs MD’s Office Shred and discard
Supervisor Hardcopy
Customer drawings MR / Dept. Softcopy / MD’s Office Shred and discard
Supervisor Hardcopy
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Customer specifications MD’s Office Shred and discard
Supervisor Hardcopy
AVL Dept. / MR Office Shred and discard
Supervisor Hardcopy
Vendor Evaluation Vendor survey reports Dept. / MR Office Shred and discard
Supervisor Hardcopy
Suppler evaluation MR / Dept. Softcopy /
records Supervisor Hardcopy
Calibration Master List Dept. / MR Office Shred and discard
Supervisor Hardcopy
Calibration Records Calibration Records Dept. / MR Office Shred and discard
Supervisor Hardcopy
Certificates of Calibration Dept. / MR Office Shred and discard
Supervisor Hardcopy
Traceability records Travelers Dept. / MR Office Shred and discard
Supervisor Hardcopy
First Article Inspection MR / Dept. Softcopy /
Reports Supervisor Hardcopy
Receiving Inspection MR / Dept. Softcopy /
Forms Supervisor Hardcopy
Record of release of MR / Dept. Softcopy /
Final Inspection Sheets Dept. / MR Office Shred and discard
product Supervisor Hardcopy
Nonconforming Product MR / Dept. Softcopy /
Dispositions Supervisor Hardcopy
Nonconformance Log Dept. / MR Office Shred and discard
Supervisor Hardcopy
Record of
Nonconforming Product MR / Dept. Softcopy /
nonconformingcustom MD’s Office Shred and discard
Dispositions Supervisor Hardcopy
er property
CARs MD’s Office Shred and discard
Corrective & Supervisor Hardcopy
Preventive Actions MR / Dept. Softcopy /
CAR Log MD’s Office Shred and discard
Supervisor Hardcopy
Internal audit Reports MD’s Office Shred and discard
Supervisor Hardcopy
Internal Audit records
Internal Audit Schedule MD’s Office Shred and discard
Supervisor Hardcopy
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Procedure: 8. Quoting and Orders

1. SUMMARY
1.1. The purpose of this procedure is to define the methods for capturing customer requirements, and
then reviewing those requirements to ensure [SES] has the capability to meet those requirements
before committing to providing [Products or Services.].
1.2. The [MD] is responsible for implementation and management of this procedure.

3. CAPTURE OF REQUIREMENTS
3.1. During the marketing process, customer requirements are captured and recorded work order
register.
3.2. Details here on how such requirements are captured, typically by sales or other business
development staff. Include a reference to whatever records are used to record this information.
3.3. [MD] will also ensure that [SES] has suitable access to all applicable statutory and regulatory
requirements which may apply to the work.
3.4. [MD] will also document any requirements not specified by the customer, but for which [SES]
knows will apply to the work.
4. REVIEW OF REQUIREMENTS
4.1. [MD] will oversee the review of incoming requirements, to ensure [SES] has the capability to meet
those requirements. This must occur before any commitment to provide the [Products or Services
Plur.] to the customer.
4.2. Details here on how the review is conducted, and CONTRACT REVIEW records are kept of the
review and approval.
4.3. The review of requirements may require a formal risk assessment, at the discretion of
management. If so, the risk assessment shall define the expected risks associated with the work,
as well as a mitigation plan for each identified risk. If useful, risks may be ranked by likelihood of
occurrence and severity of the impact of the risk, if it does occur. Management may elect to
accept certain risks as a function of doing business, but if so, this must also be indicated. When a
risk assessment is conducted, this will be filed with the appropriate requirements information
COTO Log.
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4.4. If a formal quotation is to be prepared for the customer, this shall be developed by the [MR] with
input from all proper departments and staff, and released to the customer after reviewed and
approved by [MD].
4.5. When a contract or purchase agreement is subsequently received, it shall be reviewed by [MD] to
ensure there are no differences between it and any previously submitted quotations. If there are
differences, the [MD] shall resolve these with the customer before the contract is accepted.
4.6. Acceptance of a contract or purchase agreement is to be done by [MD] and recorded.
5. CHANGES TO REQUIREMENTS
5.1. Where the customer requests changes to active work, the changes must also be captured,
reviewed and approved prior to committing to the change.
5.2. The change will consider the impact on work already delivered, work underway, and planned
work. Problems or concerns over implementing the change will be communicated by [MD] with the
customer. Such changes may require renegotiation of contracts.
5.3. If changes are agreed upon, the [MD] will work with the affected departments to implement the
change. The disposition of existing work shall be determined by management, along with input
from the customer.
5.4. Where changes are required by [SES], these will be negotiated with the customer before
implementation, and a record of the customer’s acceptance maintained.
Procedure: 9. Shipping Procedure

1. SUMMARY
1.1. This procedure defines the requirements for packaging and shipping of product
1.2. The Quality in charge is responsible for implementation and management of this procedure

3. PACKAGING
3.1. All handling requirements as defined [Preservation Procedure] in shall be followed.

3.2. Packaging of items prior to shipment must be done in a way best suited to protect the items
from damage or deterioration throughout delivery.
3.3. ASTM D 3951 shall be used as a guideline for packaging. [ONLY INCLUDE THIS IF TRUE]
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3.4. Commercial best practices for packaging shall be used to preserve the product through to final
delivery. [INCLUDE THIS IF 3.2 ABOVE IS NOT USED]
3.5. During packaging, the employee will perform a visual inspection on parts and report any
problems found to [QC or QA Preferred Term]. This inspection specifically will ensure:
a) All parts are accounted for (proper ship quantity)
b) Condition of parts appears adequate
c) There are no foreign objects in/on the parts
d) All appropriate paperwork is present for inclusion in or attachment to the package
3.6. Customer-mandated packaging and shipping requirements will be defined on the order
documentation.
4. LABELING
4.1. Labeling of special handling requirements (such as hazard warnings) will be utilized as required.
4.2. The shipping clerk will label the packages as prescribed by the carrier and/or order
documentation.
5. SHIPPING
5.1. The delivery method and carrier are defined on the delivery Chelan/ invoice Chelan
5.2. The cusromer will arrange pickup of the products awaiting shipment
5.3. The shipping clerk will stage items for shipment in an appropriate area.
5.4. The shipping clerk will ensure all items intended for the day’s delivery are loaded safely on the
carrier’s delivery vehicle.
5.5. The shipping clerk will process any necessary carrier paperwork in accordance with the carrier’s
requirements.
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Procedure: 10. Purchasing Procedure

1. SUMMARY
1.1. This procedure defines the requirements for evaluation and selection of critical suppliers,
purchasing critical materials and services, and monitoring supplier performance.
1.2. The receipt and receiving inspection of incoming purchased items is defined in the procedure
[Receiving Procedure].
1.3. “Critical materials or services” are those materials or services which are incorporated into final
product, or which have a direct impact on the company’s product or quality system, or which are
otherwise deemed as critical by management.
1.4. Office supplies, administrative consumables, furniture, etc. are not critical materials, and
therefore not subject to this procedure.
1.5. [SES] understands it is responsible for the conformity of all products purchased from suppliers,
including product from sources defined by the customer.

3. SUPPLIER EVALUATION, SELECTION AND CONTROL
3.1. The MD evaluates new suppliers. This person/these individualshas/have both the responsibility
and authority to approve and disapprove suppliers.
3.2. New suppliers are evaluated in accordance with the following criteria:
 Pricing
 Availability
 Reputation / references
 Location
 Shipping terms and capabilities
 Quality system certification status (ISO 9001 or AS9100 certification preferred)
 Quality of samples received (incl. testing results)
 On-site audit results
 Telephone interview results
 Written survey results
 Customer mandate
 Sole source / OEM status
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3.3. Where a customer mandates a special process source, both [SES] and any suppliers must use
the required supplier; this usage may override [SES]’s approval status rules.
3.4. In some cases a formal risk assessment may be conducted as part of the evaluation and
selection of a potential supplier, or in order to determine if a problematic supplier should be
retained; see [Risk Management Procedure].
The MR will maintain an Approved Supplier which lists all evaluated and approved suppliers, their
approval status, and the scope of their approval (commodities for which they are approved.)
Suppliers who meet any of the evaluation criteria, in the judgment of the person conducting the
evaluation, may then be entered into the purchasing system and items may be purchased. However,
the supplier is entered into the Approved Supplier List (ASL) on a CONDITIONAL basis, pending
inspection or review of products or services rendered.
3.5. Upon successful receipt or review of products or services, the manager may then advance the
supplier’s status to APPROVED.
3.6. If the results of review of product or service received are insufficient or otherwise lacking, the
buyer may then elect to change the supplier’s status to DISAPPROVED, or to leave it at
CONDITIONAL until further orders are received and reviewed.
3.7. A supplier may also be listed as RESTRICTED, where certain purchasing restrictions are placed
on the supplier. This may be useful to limit what products may be purchased from a supplier, or
to place other conditions.
3.8. The Approved Supplier List indicates the supplier, location, approval status (Approved,
Conditional, Disapproved, Restricted), and the scope of approval (typically commodity type or
product family). Re-approval of suppliers is continual and ongoing based on the suppliers ability
to meet the criteria of paragraph 3.2.2. For Restricted status, a note of the restriction must also
be included.
3.9. Suppliers used for at least six months prior to [01.07.2017], have been grandfathered into the
system as Approved, provided they have no outstanding quality issues on record, and only upon
the decision by MR to do so.
3.10. For parts entered into the ERP system, this system will list approved suppliers for the individual
part, along with secondary choices of approved suppliers, if applicable.
3.11. In such cases, Purchasing will use this information to select the appropriate supplier.
3.12. Add details on specific ERP system here; for example, how the system lists suppliers,
commodities, ratings, etc.
3.13. Purchasing from suppliers is then carried out in accordance with section 4 below.
3.14. Verification of purchased product is carried out in accordance with the [Receiving Procedure]
procedure.
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3.15. Supplier performance is monitored on the basis of the quality of items received. Enter details on
how this is logged, trended and reported. For active suppliers, this activity acts as a continuous
re-evaluation of the supplier, with the receipt of every purchased item or service.
3.16. During periodic Management Review meetings, supplier performance is reported to top
management, in accordance with the procedure [Management Review Procedure]. This
periodic activity also consists of secondary re-evaluation of suppliers.
4. PURCHASING
4.1. In order to purchase critical materials or items, an employee will submit a Requisition Form to
Purchasing. This form must be approved by an appropriate manager, in accordance with the
following approval authorities, based on dollar value of the purchase:
PURCHASING AUTHORITY TABLE HERE.
Position Authorization Value (Rs)
MD Above 1000
MR Below 1000
Dept.Supervisors Below 500
4.2. If the requestor has indicated a preferred supplier, Purchasing will ensure the supplier has been
approved in accordance with the section above; if the proposed supplier is not approved,
Purchasing will either use an approved supplier, or contact the requestor and resolve the issue.
4.3. Purchasing may purchase items directly, without a Requisition Form.
4.4. For some purchases, Purchasing may elect to submit competitive requests for quotes from
potential suppliers before making a purchase.
4.5. Purchases may only be made using APPROVED suppliers. Purchases from RESTRICTED
suppliers must be made in accordance with the restrictions noted in the ASL/ERP.
4.6. If a new supplier is to be used, a CONDITIONAL supplier may be used, in accordance with the
conditions noted in the ASL/ERP.
4.7. Purchasing shall then generate a Purchase Order (PO) to the supplier / PURCHASE
REGISTER maintained.
4.8. Each PO must contain the following information at a minimum:
 Items to be ordered, identified clearly (typically to include catalog number, part number,etc.)
 Date of delivery desired
 Quantity
 Pricing
4.9. In addition, the following information shall be included on the PO if applicable:
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 requirements for approval of product, procedures, processes and equipment

 requirements for qualification of personnel
 quality management system requirements
 the identification and revision status of specifications, drawings, process requirements,
inspection/verification instructions and other relevant technical data
 requirements for design, test, inspection, verification (including production process
verification), use of statistical techniques for product acceptance, and related instructions
for acceptance by the organization, and as applicable critical items including key
characteristics
 requirements for test specimens (e.g., production method, number, storage conditions) for
design approval, inspection/verification, investigation or auditing
 requirements regarding the need for the supplier to:
o notify the organization of nonconforming product
o obtain organization approval for nonconforming product disposition
o notify the organization of changes in product and/or process, changes of suppliers,
changes of manufacturing facility location and, where required, obtain organization
approval
o flow down to the supply chain the applicable requirements including customer
requirements
 records retention requirements
 right of access by the organization, their customer and regulatory authorities to the
applicable areas of all facilities, at any level of the supply chain, involved in the order and to
all applicable records
4.10. The PO shall be reviewed and approved before release to the supplier; this is indicated by the
inclusion of MD`s name entered onto the PO.
4.11. A copy of the PO shall then be sent to Receiving to await receipt of the items.
5. PROCEDURE: SUPPLIER CORRECTIVE ACTION REQUESTS
5.1. The [MR] maintains a system of Supplier Corrective Action Requests, or SCARs. This allows
for the flow down of corrective action requirements to a supplier when a supplier is found to be
responsible for a particular nonconformity.
5.2. Any purchasing agent or manager may submit a SCAR Form to a supplier that has shown quality
problems or the potential for nonconformity.
5.3. SCARs are routed to the supplier’s representative for root cause analysis and action planning.
5.4. Failure of a supplier to respond to a SCAR, or to respond with an insufficient action plan, may
mean adjustment in that supplier’s evaluation standing.
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Procedure: 11. Receiving Procedure

1. SUMMARY
1.1. This procedure defines the process and methods receiving incoming purchased product, and for
verifying incoming purchased product to ensure it meets requirements.
1.2. The MR is responsible for implementation and management of receiving activities.

3. PROCEDURE: RECEIVING
3.1. Incoming items are received from various shipping carriers and staged for receiving.
3.2. The Receiving Clerk will conduct an immediate visual examination of the packaging of each
received item, looking for obvious damage. If such damage is found, the Receiving Clerk will
hold the driver, and notify Purchasing if an immediate refusal should be conducted.
3.3. Once items are accepted without any visual damage, the driver may leave.
3.4. The Receiving Clerk will then conduct an incoming receiving inspection for each package,
checking the following against the Purchase Order:
 Correct quantity received
 Correct items received
 Items received on time or late
 Obvious damage to items inside the packaging.
 Items on backorder
3.5. Any problems will be noted on the SCAR form and Purchasing alerted. Purchasing will advise
the Receiving Clerk as to what actions to take. In the interim, the questionable received items
must be segregated away from accepted items, and marked or tagged as “AWAITING
DISPOSITION” or similar language.
3.6. Depending on the severity of the problem, Purchase may alert the supplier and attempt to
resolve the issue over the phone, or may submit a full Supplier Corrective Action Request
(SCAR) per the procedure [Corrective Preventive Action Proc. Title].
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3.7. The form shall be used to track the quality of products received by suppliers; this form is then
summarized or sent to Purchasing for evaluation and consideration of any changes to the
supplier’s current approval status in the Approved supplier List.
3.8. Once items are deemed acceptable, Receiving will determine if the items require additional
precision inspection by QC. If so, these items shall be sent to QC for dimensional or precision
inspection. QC will notify the Receiving Clerk of the results of the inspection, and allow release if
they are acceptable. If the items are unacceptable, the controls set forth in the procedure
[Control of NCP Procedure] are to be followed.
3.9. QC will maintain records of inspections of incoming items.
3.10. For accepted items, the PO will be stamped RECEIVED with the date received; any backorder
or other notes may be indicated on this PO. This PO is then returned to Purchasing for review
and filing.
3.11. Accepted items may then be staged for routing to the appropriate location, either to inventory or
to the buyer.
3.12. Items entered into inventory shall be marked with the company PO # and material or item
number or description, if the packaging does not already include this information.
3.13. Any received certificates of conformity, test reports, certificates of analysis, etc. will be
forwarded to QC for review. QC will review these reports for adequacy and to ensure they
reflect the actual lot received. If there are any problems, QC or Purchasing will notify the
supplier to submit a corrected certificate. If the certificate is acceptable, QC or Purchasing will
stamp or initial the report, and file it accordingly.
3.14. All items are to be handled carefully, in a manner that will not introduce damage, foreign
objects, or deterioration.
3.15. As required, broken down packages shall be relabeled so that split items are readily identifiable
if aster packaging labels are destroyed.
3.16. Only authorized persons may enter or remove items from inventory; this authorization is
recorded within employee training records.
3.17. Materials handlers must abide by all company safety rules and training while working in the
areas.
3.18. No product may be released to production prior to receiving inspection.
3.19. Items with a shelf life (expiration date) are to be labeled with an expiration sticker, based on the
manufacturer’s product guidelines, unless such a label has been affixed by the manufacturer.
[Short Client Name] management may override manufacturer guidelines for expiration if they
document the basis for doing so and maintain this on file in Purchasing.
3.20. Tools received with calibration certificates, or those tools which are known to need calibration,
must be submitted to QC for inclusion in the calibration records prior to delivery to the buyer.
See the section on calibration in the [Quality Manual] for more details on calibration activities.
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3.21. Management will use information provided by Receiving and Purchasing on supplier incoming
inspection results to re-evaluate suppliers and adjust supplier ratings accordingly.
Procedure: 12. Equipment Validation Procedure

1. SUMMARY
1.1. The purpose of this procedure is to define how the company validates critical equipment tools
and software programs prior to use.
1.2. The [Production supervisor] is responsible for implementation and management of this
procedure.

3. APPLICATION AND EXEMPTIONS
3.1. Application
3.1.1. This procedure applies to all departments and facilities which develop and design
production equipment, test equipment, tooling and CNC software programs.
3.2. Exemptions
3.2.1. Equipment solely used for supporting the facilities is exempt from this procedure; this
includes compressors, vehicles, air handling systems, lighting, etc.
3.2.2. All production equipment, tooling and software in use for at least six months prior to the
release of the first version of this procedure in [Date of Issue]is to be considered validated
by way of previous use and history, and therefore is exempted from this procedure, unless
otherwise marked as nonconforming (see rules below). However, if any significant change
is made to legacy equipment, tooling or software, this may trigger a new validation
requirement if the change could affect product quality.
3.2.3. CNC software programs used solely for the machining of tooling or anything other than
product are exempted from validation.
4. VALIDATION PROCEDURES
4.1. Equipment and Tooling

4.1.1. In order to validate production equipment and tooling, the items shall be built or installed
and put through at least one trial operation; this usually means producing a part using the
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item or software, and then sending the resulting part to [QC or QA Preferred Term] for an
inspection of the dimensions created or impacted by the hardware or software in question;
this is typically through a first piece inspection, but could also be a full First Article. In some
cases, multiple parts may be manufactured and inspected to ensure validation, or multiple
production runs may be required at various settings or over a range of criteria.
4.1.2. If the results of [QC or QA Preferred Term] inspection show the item is not acceptable, the
information shall be provided to the appropriate area manager and adjustments to the
device made. Another round of production and [QC or QA Preferred Term] inspection is
then conducted.
4.1.3. Where appropriate, it may become necessary to work with a device’s manufacturer to
assist in making the appropriate adjustment or repairs to get the equipment validated.
4.1.4. Equipment failing validation may not be used, and must be marked visibly with appropriate
signage indicating “DO NOT USE” or “AWAITING VALIDATION” or similar language.
4.1.5. Equipment and tooling may be considered to have been validated unless otherwise
marked. And validation reports are maintained.
4.2. CNC Manufacturing Software
4.2.1. For CNC programs used in the manufacture of flight or development hardware, a first piece
inspection will be made of either one or more parts produced under the CNC program. If
the results are within the tolerances indicated on the print, the CNC program is considered
validated and may be used for production runs.
4.2.2. If the inspection results show the part fails, the CNC program will be modified, and
additional parts run and inspected, until the CNC program produces parts that are within
tolerance.
5. MAINTENANCE AND ONGOING VERIFICATION
5.1. Ongoing assessments of the validity of validated equipment, tooling and programs are done
during internal auditing (see procedure [Internal Auditing Procedure]), as well as ongoing
inspection of parts during normal production.
5.2. Preventive maintenance programs are in place for critical equipment, to ensure proper
functioning of such equipment, per the procedure [Preventive Maintenance Procedure].
Procedure: 13. Identification & Traceability Procedure

1. SUMMARY
1.1. This procedure defines the methods used to identify and (where applicable) provide unique
traceability for [SES] products. This procedure includes methods:
1.1.1. To define the methods for identifying products (what they are)
1.1.2. To define the methods for identifying products as to their current inspection or test
status
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1.1.3. To define the methods for segregating and discriminating between product and tooling
when their appearance is similar
1.1.4. To define the methods for providing traceability, including unique serialization, or
product as applicable

3. APPLICATION
3.1. This procedure applies to all departments which use, handle, transport, store, inspect or
manufacture product, raw materials and tooling, at all [SES] facilities.
3.2. This procedure not only applies to typical product, but also deliverables from services, such as
reports, schedules, etc.
3.3. Non-critical materials or supplies, which are not incorporated into final product or which serve only
to support facilities or operations, are not subject to this procedure.
4. DEFINITIONS
4.1. Product
4.1.1. “Product” includes any of the following:
 Any part, assembly or item ordered by the customer
 Deliverable reports or documents
 Product may refer to finished product, or work in process (WIP)
4.2. Raw Materials
4.2.1. “Raw materials” include any of the following:
 Any materials or items (metals, plastics, components, pre-built assemblies, small parts)
which become part of the finished product’s physical construction; some of these items
may sometimes be referred to as “consumables”.
 Coatings, paint, plating, adhesives, chemicals or materials which will be incorporated
into (or onto) the final product.
4.3. Tooling
4.3.1. “Tooling” can include any of the following:
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 Devices used by manufacturing for setup or production, including fixtures and jigs.
 Devices used by inspection for determining acceptance of product, including test
fixtures.
 Shop aids, which are simple devices (blocks, spacers, shapes) used to assist in
production or development, but which are not precision tools and which can be used for
a variety of applications.
4.3.2. Tooling does not include:
 Cutting tools, drill bits, etc.
 Hand tools
 Machining equipment
5. PRODUCT
5.1. There are many ways to identify product; this procedure presents the most typical, acceptable
methods. Additional product identification methods may be called out in the design or production
documentation.
5.2. Identification typically includes the part number, revision, Work Order # and unique serial number
(if applicable).
5.3. Identification is done through any of the following methods:
5.3.1. Part marking, by way of ink marking, etching or some other method.
5.3.2. Bag-and-tag methods, especially for small parts.
5.3.3. Placement of parts on shelves orin containers that are properly marked, with signage
or other methods.
5.3.4. Placement of parts near associated paperwork, for the purpose of identification and
traceability, may be used if the paperwork can clearly be identified as relating to the
parts in question, typically by way of the inclusion of a drawing which can be compared
to the product.
5.3.5. Segregating entire areas of the production floor with belt stanchions and attached
signage, indicating what type of items are allowed, or disallowed, within the enclosed
area.
5.4. Where unique serialization is required for traceability, the parts shall be identified with a serial
number in accordance with customer requirements, or in a manner developed to ensure that no
two parts are given the same number. Serial number logs may be used to control this; work orders
shall reference the serial numbers under which the unique parts were built.
5.5. All products may be assumed to be inspected and/or tested and found to be acceptable for use if
identified in accordance with the rules above, unless it is marked as nonconforming product. For
the methods of identifying nonconforming product, see procedure [Control of NCP Proc. Title].
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6. RAW MATERIALS
6.1. Raw materials requiring traceability back to heat lot numbers, manufacturer lot or batch numbers,
certificates of conformity or analysis, etc., must be marked in a way that provides this traceability.
This is typically done by marking the raw materials with the [Short Client Name] purchase order
number under which the items were purchased, and the supplier’s lot number.
6.2. When raw materials are used, any remaining material that will be returned to stock and used in
the future must be re-identified before re-entry into inventory.
6.3. Raw materials which are determined to require identification and traceability, but which lack such
identification, may not be used for flight hardware. These may be used for tooling stock or other
non-product purposes.
6.4. All raw materials may be assumed to be inspected and/or tested and found to be acceptable for
use if identified in accordance with the rules above, unless it is marked as nonconforming. For the
methods of identifying nonconforming raw materials, see procedure [Control of NCP Procedure].
7. PRODUCTION TOOLING
7.1. Tooling used for production (fixtures, molds, jigs, setup devices, product supports or stands, etc.)
shall be designed and built according to engineering data, and then validated to ensure the tool
performs the intended function without risk or harm to product. Validation of tooling is typically
done by using the tooling and inspecting the resulting parts to ensure the tooling results in parts
that meet dimensional or other requirements.
7.2. Once validated and approved for use, the tool will be marked with a tooling ID number, which is
typically the part number for which the tool is to be used.
7.3. Tools that produce production hardware or are used to accept hardware must undergo inspection
before release. [QC or QA Preferred Term] must stamp or mark the tool as accepted before it can
be used.
7.4. Shop aids for setup of production operations, supporting a part temporarily, or other simple or
temporary use, may not require identification with a unique identifier. Instead, these must be
identified as tooling by either marking the item itself as “TOOLING” (or similar language) or
placement in an area, shelf, cabinet or other container that is properly marked as “TOOLING” or
“SHOP AIDS”(or similar language). The marking must allow tooling to clearly be distinguished
from raw material or product (whether flight or development).
7.5. Tooling used for lifting shall be proof load tested and include an upper load lift limit, as required by
regulations.
7.6. Tooling found to be nonconforming shall be tagged to prevent use until fixed, repaired or deemed
acceptable. Segregation of nonfonconforming tooling from the production area should be
performed when possible.
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7.7. When approved tooling undergoes modification, the identification must be updated to reflect the
change; this is typically done by editing or re-marking the item with the latest revision of the
engineering part number.
8. SERVICE DELIVERABLES ( delete if not applicable)
8.1. Service deliverables, such as reports and schedules, shall be identified with a title and, if
applicable, reference to the project or contract under which they are developed.
8.2. Customer contracts may indicate additional methods for identification of service deliverables.
8.3. In all cases, the deliverable will be identified in a way that makes it clearly understood for which
contract or project the deliverable is subject to.
8.4. As required, service deliverables may be subject to date and revision control, to distinguish
earlier versions or submittals.
9. STAMP CONTROL ( delete this section if QC stamps are not used)
9.1. Quality stamps or employee initials are used to indicate product acceptance or for other quality-
related notations. Individual authorities for signing off for inspection, testing and operations are
defined on the Stamp & Signature Control Log; this log is maintained to identify the owner of
each stamp.
9.2. The [QC] shall maintain the Stamp and Signature Control Log.
9.3. Stamps are numbered, and taken out of service for six months after an employee leaves the
company; after the six-month period, the stamp may be reissued to a different employee.
9.4. No employee may use any stamp except that which was issued to them.
Procedure: 14. Preventive Maintenance Procedure

1. SUMMARY
1.1. The purpose of this procedure is to define the methods to maintain critical equipment to ensure
such equipment does not impact product quality or delivery schedules.
1.2. Preventive maintenance only applies to “key process equipment”; these are defined as those
devices or tooling that are critical for maintaining continuing process capability (i.e., uninterrupted
manufacturing flow), and those machines and systems that the breakdown of which could
adversely impact product quality.
1.3. Emphasis shall be put on preventive maintenance (P/M), designed to ensure equipment operates
without unexpected down time or error. Correcting a fault in a machine after it breaks is
considered repair, and not maintenance. The purpose of a robust P/M program is to eliminate
the need for unscheduled repairs and down time.
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1.4. The [Maintenance supervisor] is responsible for implementation and management of this
procedure.

3. PROCEDURE: PREVENTIVE MAINTENANCE
3.1. Maintenance supervisor are responsible for identifying key process equipment, machines, and
systems to be included in the preventive maintenance program.
3.2. Maintenance supervisor will preventive maintenance records for each unique piece of key process
equipment. This record will contain, at a minimum, the following information:
 Type of device
 Manufacturer
 Model number
 Serial number / company asset number
 Location
 P/M tasks required
 Frequency of each P/M task (monthly, weekly, annually, before use, etc.)
3.3. P/M tasks shall be based on manufacturer’s guidelines, but may be overridden or altered to suit
the company’s specific needs, based on equipment usage, criticality to quality, etc.
3.4. The resulting records may take the form of logs, procedure(s), databases, spreadsheets or
other methods as deemed appropriate by the area manager.
3.5. Records of completed P/M tasks must be maintained. P/M records must show:
 the completion of the required P/M step
 the operator responsible for completing the step
 the date of completion
 any notes or problems encountered
3.6. For P/M tasks that are done daily, hourly, “before use” or at a more frequent basis, the need for
a record is not required. Records must be maintained for any task performed at a frequency of
weekly or greater.
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3.7. Maintenance work may be performed by employees or approved third party maintenance
service providers, as needed. If third party providers are used, the provider’s maintenance
records may be maintained in lieu of any company internal records.
In order to identify equipment problems at an early stage and to prevent breakdowns, process
equipment operators are instructed to monitor tool wear, process performance, vibrations, etc.,
and report any abnormal functioning to their supervisors.
Procedure: 15. Special Process

1. SUMMARY
1.1. The purpose of this procedure is to define the controls for special processes.
1.2. “Special processes” are those processes where the output cannot be verified through traditional
inspection, testing or other means. Special process outputs typically can only be verified by
destroying the product (destructive testing) or through a method outside of the capability of the
company. In some cases, the special process output cannot be verified at all.
1.3. The production in charge is responsible for implementation and management of this procedure.

3. SPECIAL PROCESSES
3.1. The following special processes have been identified as being used by [SES]. The table below
provides the controls over these special processes.
Additional
Personnel Equipment Parameter
Special Process Specifications Verification
Requirements Requirements Controls
Methods
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Procedure: 16. Customer Property Procedure

1. SUMMARY
1.1. The purpose of this procedure is to define the requirements for controlling, using and protecting
property owned by customers, suppliers or subcontractors.
1.2. Such property includes materials, product, equipment and tooling, as well as intellectual
property.

3. PROCEDURE
3.1. [SES] regularly works with items provided by customers, suppliers or subcontractors. These
may include:
 List types of third party property here; typically include:
 Product drawings
 Tooling / dies
 Measurement equipment
 Intellectual property, such as specifications
 Sample component
3.2. For “hard” property (physical items) these are identified with the customer name and any
applicable identifiers. Where deemed appropriate, such property may be physically secured in
locked, limited-access areas.
3.3. If the property requires calibration and/or preventive maintenance, the responsibilities and
methods for such will be negotiated with the customer and documented.
3.4. If the amount of third party property stored in-house becomes significant, the stores in charge
will develop and maintain a log of customer property to maintain an accurate inventory.
3.5. Such third party property shall be preserved as if the items were owned by [Short Client Name],
in accordance with the procedure [Preservation Procedure].
3.6. For “soft” property (intellectual property, documentation, software, etc.) these are maintained to
ensure ongoing legibility and good condition.
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3.7. Such intellectual property is stored on the server and identified by the customer name and
protected from accidental deletion or alteration, as well as protected from unauthorized access.
3.8. Electronic versions of customer-provided intellectual property are maintained on secure,
backed-up company servers.
3.9. In all cases, damage or loss of customer property will be promptly reported to the customer for
disposition or instructions.
Procedure: 17. Preservation Procedure

4. SUMMARY
4.1. This procedure defines the requirements for preserving and protecting product, raw materials, or
other key process outputs.
4.2. The store in charge is responsible for implementation and management of this procedure.

6. HANDLING & LABELING
6.1. Proper handling of all parts and raw materials is performed.

6.2. Specific handling requirements for operations will be defined in the appropriate work
instructions, where applicable.
6.3. Customer-mandated handling requirements will be defined on the order documentation.
6.4. Labeling of special handling requirements (such as hazard warnings) will be utilized as required.
7. STORAGE & PROTECTION
7.1. All raw materials and work in process are stored in a manner that prevents nonconformance.
7.2. [SES] utilizes stock rooms, storage areas, shelving, and other means to segregate and store
materials. Access to stockrooms is limited to authorized personnel, with this authorization
recorded in the employee's training file.
7.3. Issuance and removal of parts from the stock room is controlled using the following methods:
7.3.1. Parts are removed or replaced [describe inventory methods here, both in and out.]
7.3.2. The store in charge exercises control over the stock room.
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7.3.3. All parts removed from the stock room are recorded on the stock register that requested
their removal.
7.3.4. Raw material is issued only in conjunction with a released document. The Purchase Order
number is recorded on the [document?].
7.3.5. Parts with a suspected nonconformance are tagged and stored per the procedure [Control
of NCP Procedure].
7.3.6. No part or material under investigation for suspected nonconformances is placed in the
stock room unless steps are taken to prevent their issuance, including proper identification.
7.4. The store in charge reviews any recurrent part damage linked to currently approved protection
methods to ensure changes are made to properly protect materials and parts.
7.5. Any material handling equipment utilized in [SES] operations is used in accordance with the
manufacturer’s operating instructions. A copy of those instructions is maintained by the store in
charge and made available to required personnel. Any person using material handling
equipment for the first time is given training on the use of the equipment by a qualified person.
7.6. Parts are stacked to prevent damage from contact with other parts or crushing. If required,
material is used to separate sensitive parts to prevent damage.
7.7. Best industry practices are used by [SES] when tying, wrapping or supporting parts to preclude
shifting and falling.
7.8. Special care is taken to prevent damage to critical machined surfaces, highly polished surfaces
or plated parts. The methods include protective containers, wrapping, protective material or
special racks
7.9. Special care is taken by wearing protective gloves anywhere fingerprints could cause
deterioration of the part or cause inadequate adhesion during fastening operations.
7.10. Raw materials, parts, assemblies and finished parts are protected from damage or
contamination during transit using the following methods:
 Parts and material are bagged, boxed or tied to prevent intermixing.
 Parts are retained in their original containers for as long as possible.
 Parts susceptible to vibration and shock damage are packed with foam, pads or other special
packaging.
 Any parts that could be knocked or blown from carts, trucks are covered, tied or banded.
7.11. All parts and materials are protected from weather conditions that could adversely affect them.
This includes coating or special containers for raw materials to prevent corrosion or rust.
7.12. Environmentally sensitive materials are protected using the following special procedures:
7.12.1. Materials are stored in original containers or, if removed for inspection, are appropriately
resealed.
7.12.2. Stock areas are checked to ensure compliance with any written procedures for
environmentally sensitive materials.
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7.12.3. When temperature and humidity must be controlled, calibrated recording devices are used
to track temperature and humidity and monitored.
7.12.4. The store department inspects the general housekeeping of the storage areas and the in
charge department maintains their cleanliness.
7.12.5. Stock room personnel are trained in the special procedures required for environmentally
sensitive materials.
7.13. Internal auditing will ensure the ongoing suitability of all materials and equipment stored at
[SES], including constituent parts of assemblies. Appropriate reports of product nonconformity
and corrective action are completed when material is found to be stored improperly or is at risk
of nonconformance.
8. PACKAGING
8.1. Good accepted packaging practices that maintain product conformance and integrity through
delivery are utilized. Customer-mandated packaging requirements are captured and utilized
when required.
8.2. Only parts that have been manufactured and that meet established acceptance criteria are
packaged for shipment. Industry standard preservation, packing and shipping methods are
used for completed parts. All subcomponents are identified prior to packaging.
8.3. See also shipping procedure
9. PRESERVATION
9.1. Product is suitably maintained during manufacture, inspection and delivery to prevent
nonconformance. Preservation efforts include segregation and/or the use of controlled
environments or conditions. Such requirements are incorporated into job instructions as
required.
9.2. The store in charge is responsible for control of shelf life material. Age sensitive (perishable)
materials are identified and controlled as follows:
9.2.1. When material is received into the system, a receiving inspector determines if shelf life is
applicable. In most cases, the manufacturer will indicate the shelf life. In other cases, the
date of manufacture is given and the inspector must determine the life based on a
acceptable data. Shelf life items are marked as described below.
9.2.2. For some materials, the shelf life is determined after it is opened for use. In those cases,
the person who opens the material must place a label on the container as noted below.
9.2.3. Any extension of shelf life must be covered by special instructions for retest determined by
the appropriate authority. The permissible amount of time that shelf life can be extended
must be established and recorded.
9.2.4. Bins containing shelf life items are clearly marked as such.
9.2.5. The stock room is checked every month for shelf life items. Any items found to be out of
date are removed and segregated in a controlled area until re-inspection, retesting and
dispositioning can be accomplished.
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9.2.6. Incoming items subject to shelf life controlled are labeled with a special label during
receiving inspection; this label identifies the expiration date.
10. CLEANING
10.1. Parts are cleaned to remove any residue, foreign objects, burrs, etc. at steps throughout the
production process.
10.2. Any cleaners, solvents or other fluids used in the production area are marked as appropriate
and stored in containers designed for solvent storage. They are stored in a segregated area
along with other fluids and chemicals.
11. DELIVERY
11.1. Preservation related to delivery methods are defined in the documented procedure [Shipping
Procedure].
Procedure: 18. Control of NCP Procedure [Non-conforming Product]

1. SUMMARY
1.1. This procedure defines the requirements for identifying, processing and dispositioning non-
conforming product (“NCP”).
1.2. The following definitions are important for a clear understanding of this procedure:
1.2.1. “Nonconforming product” is any product, at any point along its life cycle, which is found
to not conform to requirements. These requirements may be customer requirements,
design requirements, statutory/regulatory requirements, or any other requirement deemed
by [Short Client Name]. “Nonconforming Product” is referred to herein as “NCP”.
1.2.2. “Rework”. Parts may be “reworked” when additional machining or processing is conducted
without affecting the design of the part. Typically this means simply doing more of the
already-approved processes or activities listed on the traveler (additional machining, etc.)
1.2.3. “Repair”. Any work done on NCP which affects the original design is considered “repair”
and is subject to the special controls defined in section 3.3 below. Such work includes but
is not limited to the adding welds to correct a problem, adding or removing material beyond
design specifications, adding plating or metal finishing not originally included in the design
specs, or adding any other materials (epoxy, patches, etc.) not provided for in the original
design.
1.3. While nonconforming product is typically found during an inspection or test, it can be discovered
at any time, by any person or organization, including the customer, regulatory authorities, etc.

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3. CONTROLLING NCP
3.1. Discovery and Reporting of NCP

3.1.1. When NCP is discovered, the operator must report this immediately to the QC
3.1.2. The QC in charge shall confirm if a nonconformity exists, and if so document it on the NC
Register.
3.1.3. The NCP shall then be identified clearly to distinguish it from acceptable product, or product
awaiting inspection or test
3.1.4. The NCP shall then be disposition. Disposition authority is granted to the following
personnel:
 QC in charge
 MR and
 The MD
3.1.5. The selection of these staff members has been made by top management, and is based on
their role in the company, previous experience, and knowledge of [SES] processes and
products.
3.1.6. Possible dispositions are:
 Accept as is
 Repair (see special rules for repair below)
 Rework
 Scrap
 Return to Vendor
3.1.7. All repair or reworked product must be re-inspected, with the results recorded re-work
register
3.1.8. If “accept as is” will require the acceptance of the part which deviates from a customer’s
design, the customer’s approval must be obtained and documented on the NCR form. In
addition, when applicable, regulatory authority approval(s) may also be required to be
obtained and recorded.
3.1.9. The disposition, dispositioning authority and any subsequent work and re-inspection are to
be recorded on the NCR
3.1.10. The processing of NCP must take into consideration any actions necessary to contain the
effect of the nonconformity on other processes or products.
4. SPECIAL RULES FOR REPAIRS
4.1. “Repair” is defined in section 1 above.

4.2. Any repair affecting a customer designed part must be approved by the customer in advance.
4.3. Repairs without customer approval are disallowed in all circumstances!
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4.4. All approvals must be documented and the records maintained with the part records.
5. NONCONFORMANCE DATA ANALYSIS &TRENDING
5.1. The MR will present product quality trend data regularly to top management as part of periodic
Management Review Meetings.
Procedure: 19. Internal Auditing Procedure

1. SUMMARY
1.1. This procedure defines the process and methods for conducting internal quality management
system (QMS) audits.
1.2. The MR is responsible for implementation and management of all internal audits.

3. TERMS AND DEFINITIONS
 Audit – systematic and formal comparison of documentation and practice against

requirements, performed for the purpose of finding areas of nonconformity or opportunities for
improvement.
 Evidence – data or examples which can be proven true and verified for the purposes of
proving an audit finding.
 Finding – any summary of audit evidence; findings may be positive (reports of compliance) or
negative (reports of nonconformity)
 Major Nonconformity – a nonconformity that shows an AS9100 clause or other requirement
has not been implemented at all, or has been implemented in such a way that the
requirements are not met at all.
 Minor Nonconformity – A single instance or small set of single instances that show a
requirement has not been met. At the Lead Auditor’s discretion, a large number of related
Minor Nonconformities may instead be filed as a single Major Nonconformity.
 Nonconformity / noncompliance – any instance where practice or evidence does not
comply with requirements.
4. PROCEDURE: CONDUCTING INTERNAL QMS AUDITS
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4.1. Internal quality audits are conducted to ensure ongoing compliance with requirements of the QMS
standards, company’s policies and procedures. This is accomplished by auditing against all
important processes and areas, and by applying all applicable sections of the standard. Audit
requirements include those of ISO 9001,the company’s quality system documentation, as well as
requirements of customers or regulatory authorities, as applicable.
4.2. Audits are conducted by process, and each process must be audited at least once 6 months using
Internal Audit Check List.
4.3. The applicable ISO 9001 standard clauses pertaining to each process are defined in Table 1
below. These are the minimum clauses which must be audited for each process; an auditor may
audit any clause of the applicable standard, and writing findings against them, depending on how
the audit unfolds
4.4. Additional processes of other activities or facilities, outside of the process model, may also be
scheduled. For example, this may include safety audits, configuration management audits, etc. In
such cases, unique audit forms may be developed for such non-process related audits.
4.5. The MR plans audits according to need, management decision, or customer requirements, and
assigns a Lead Auditor for each, as well as any supporting auditor team members. Scheduling is
recorded in the Internal Audit Schedule portion of the Internal Audit Log.
4.6. Auditors are independent of the area being audited; [SES] may therefore use approved third-party
contract auditors for its internal audit program; the requirements for third party auditors are
defined in the [Quality Manual]. Employees selected as internal auditors will have attended at a
minimum a 4 hour internal auditor training program and at least 8 hours of shadow auditing with a
previously qualified internal auditor, or third party auditor.
4.7. Using the Internal Audit Report as a basic checklist, the Lead Auditor will plan the scheduled
audit with the appropriate departments and with any other audit team members. The audit team
will determine additional checklist items or requirements to verify, and add these to the checklist
portion of the Internal Audit Report.
4.8. Auditors will then conduct the audit by following the steps defined on the Internal Audit Report.
These are:
4.8.1. Step One: Audit Planning – definition of the scope of the audit, dates of audit, auditors,
applicable clauses of affected standards, and documents to review.
4.8.2. Step Two: Document Review – a comparison of the quality system documentation
against the requirements of the applicable standard.
4.8.3. Step Three: Auditing – comparison of actual practice vs. the requirements of both the
company QMS documentation and the applicable standards.
4.8.4. Step Four: Verifying Effectiveness of the Process – general questions aimed at
verifying that the process being audited is effective and not prone to generating
nonconformities.
4.8.5. Step Five: Summarize Findings – a detailed list of the negative findings to be entered into
the [CAR Form Name] system.
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4.8.6. Step Six: Review of Report – a review by the Lead Auditor of all findings and evidence to
ensure the audit report is complete, clear, objective, and provides traceable objective
evidence.
4.9. Auditing shall be performed by obtaining objective evidence to support each requirement, or
indicate where non conformances are found. All findings are recorded on the Internal Audit
Report. The internal auditor submits [CAR Form] as necessary to address the non
conformances recorded on the report.
4.10. When recording nonconformities, each negative finding must include three elements:
4.10.1. Indication of the Requirement – the document or clause of the applicable standard which
is thought to have been violated.
4.10.2. Objective Evidence – traceable indication of the evidence found which supports the claim
of a nonconformity (e.g.: documents, products examined, interview results). In all cases,
objective evidence must be recorded in sufficient detail to ensure a third party can find the
exact evidence at a later date.
4.10.3. Details of the Disconnect – a brief statement on why the objective evidence shows a non-
conformity against the requirement.
4.11. The nonconformities shall be rated as either “Major” or “Minor” per the requirements of
customers and some regulatory bodies. See definitions of Major and Minor Nonconformities in
section 3 above
4.12. Findings shall be rated by Type, whether Corrective, Preventive or Opportunity for Improvement
(OFI) for when [CAR Form] s are filed.
4.13. Once [CAR Form]s are filed, the responsible managers or parties shall ensure timely corrective
action is taken to remedy any non-conformances found. During the [CAR Form] effectiveness
review, the results of actions taken to address audit findings are evaluated.
4.14. The [MR] shall update the audit schedule within the Internal Audit Log to reflect to closure of
the audit, and enter a summary of audit findings. Based on the results of the audits, and previous
audits, the MR will then schedule the next audit of the particular process. Processes for which
internal audits discover a high number of findings, or critical findings of any number, should be
audited more frequently until the process is proven effective again.
4.15. The completed Internal Audit Report is then published on the company’s server and/or sent to
the appropriate supervisors of the areas audited, in order to report the findings and results. In
this way, and in conjunction with the submission o [CAR Form]s, all necessary managers are
notified of the audit results and may make informed decisions for their departments based on
those results.
4.16. The results of internal audits are also gathered and summarized on the Audit Trend Analysis
Chart, generated by the Internal Audit Log, for review by top management during management
review and by all employees, through a general posting of the chart.
4.17. In all cases, auditee is expected to cooperate fully with the audit team.
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ISO 9001:2015 Date: 01.07.2017 Rev: 00
Table 1: Processes vs. ISO 9001:2015 Clauses
Process Applicable ISO 9001:2015 Clause(s)

Top management 4.1, 4,2, 4.3, 4.4, 5.1, 5,2, 5.3. 5.4, 6.1, 6.2, 6.3,
7.1, 7.5
Marketing 7.5, 8.2.1,
Purchasing 7.5, 8.4
Quality 7.5
Stores 7.5, 8.5.3, 5.5.4
Production 7.5, 8.2, 8.5, 8.5.2
HR and Admin 7.2, 7.3, 7.4, 7.5
MR / MR 7.5, 9.1, 9.2, 9.3, 10.1, 10.2, 10.3
Procedure: 20. Management Review Procedure

1. SUMMARY
1.1. This procedure defines the process and methods for conducting both formal and informal
management reviews of the quality management system.
1.2. The [MR] is responsible for implementation of this procedure.
1.3. Top management is responsible for attending formal management review meetings.

3. PROCEDURE: CONDUCTING MANAGEMENT REVIEWS
3.1. Top Management reviews the suitability, adequacy and effectiveness of the Quality
Management System through two primary methods: a formal “Management Review Meeting”
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ISO 9001:2015 Date: 01.07.2017 Rev: 00
held periodically, and ongoing management activities conducted throughout the rest of the
year.
3.2. The formal “Management Review Meeting” is held at a minimum of once in 6 months
3.3. The minimum attendance for Management Review Meeting shall be the [list the titles of those
who must attend the MR at a minimum; this must include top management]; other employees
shall attend as needed to meet the requirements of the agenda indicated below.
3.4. If any attendee is absent, draft minutes will be sent to him/her, for review and so that the
person may amend the minutes with any additional data, notes, opinions or opportunities for
improvement they may wish to add.
3.5. This review shall include assessing opportunities for improvement and the need for changes to
the quality management system, including the quality policy and quality objectives.
3.6. Minutes of the meetings are taken and maintained. The form Management Review Meeting
Minutes may be used as a template for the records, or may be completed and filed as the
finished record.
3.7. The Management Review Meeting shall include analysis of the following inputs:
• review and updating of the COTO Log, including Issues, Risks and Opportunities
• review and updating of the Strategic Plan
• review and updating of process objectives, metrics and KPIs
• review of customer feedback
• review of the CAR system and related trends
• review of internal and external audit results
• review of the performance of external providers;
• review of the adequacy of resources;
• review of the effectiveness of actions taken to address risks and opportunities;
• review of opportunities for improvement.
• review of the Quality Policy for adequacy and to ensure it remains consistent with the needs
of customers and the industry;
• recommendations for improvement of the quality management system
• follow-up activities from previous Management Reviews
3.8. The Management Review Meeting shall generate Corrective and/or Preventive Action
Requests (see procedure [Corrective Preventive Action Procedure]), or take other recorded
action, as a result of review topics in an effort to improve the management system, products,
processes and services, and to address resource needs.
3.9. This includes any decisions and actions related to the improvement of the effectiveness of the
quality management system and its processes, improvement of product related to customer
requirements, and resource needs.
3.10. Additional informal management review activities are also conducted, and include:
UPDATE THE FOLLOWING AS APPLICABLE
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ISO 9001:2015 Date: 01.07.2017 Rev: 00
3.10.1. Updating of some objectives data and trending in real time, and making such data available
on the company server for constant review. This includes product nonconformity data, CAR
data, internal audit data, and customer complaints.
3.10.2. Weekly meetings are held with the [who?] to discuss issues and problems encountered,
and to ensure ongoing compliance with established quality objectives.
3.10.3. Daily, informal meetings between the management team [who?] to ensure ongoing
compliance with established quality objectives, as well as to manage daily processing of
orders and manufacturing efficiency.
Procedure: 21. Corrective Preventive Action Procedure

1. SUMMARY
1.1. In an effort to ensure continual improvement, [Short Client Name] engages in corrective and
preventive action to discover, investigate, and correct nonconformance related to [SES] products,
its processes, and the company’s quality system.
1.2. For internal issues, the company refers to this as the [CAR Form Name] ([CAR Form
Abbreviation]) system.
1.3. For issues which are found to be the fault of suppliers, the Supplier Corrective Action Request
(SCAR) system is used; this is defined in the procedure [Purchasing Procedure].

3. PROCEDURE
3.1. The [CAR Form Name] system shall be used to address all of the following:
 Customer complaints
 Employee reports of problems with equipment, procedures, processes, buildings,
infrastructure
 Employee suggestions for improvement
 Resolving trends associated with product nonconformities
 Process nonconformities
 Audit findings (internal or external)
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DOC.REF:QSP/01
ISO 9001:2015 Date: 01.07.2017 Rev: 00
 Management review action items

 Any other reported problem or suggestion, no matter the source
3.2. All employees are empowered to submit a corrective or preventive action request when they
discover an existing or potential nonconformity against ISO 9001requirements, company
procedures, customer requirements, or statutory/regulatory requirements.
3.3. In addition, customer complaints, returns, and/or reports of nonconformances shall be handled
through corrective action procedures.
3.4. In addition, employees may submit suggestions for improvement to the company through the
[CAR Form Name] system.
3.5. Individual product issues (scrap parts, nonconforming parts, etc.) should be first written up per
the procedure [Control of NCP Proc. Title]. When trends are noticed within nonconforming
products, then a [CAR Form Name] may be issued to investigate the cause of the trend.
3.6. This system provides for the reporting and resolution of both corrective action requests
(existing problems) and preventive action requests (potential problems.)
3.7. The [CAR Form Name] system is comprised of two forms:
 The [CAR Form Name]– this is used by employees to request corrective or preventive
action, or to submit suggestions for improvement.
 The [CAR Form Name] Log – this is used to track [CAR Form Abbreviation]s and to
provide trend data on the [CAR Form Abbreviation]system for later management
review.
3.8. To request corrective or preventive action, or to submit a suggestion for improvement, the
employee obtains the [CAR Form Abbreviation]form; this may be filled out by hand, or by filling
in the electronic form in MS Excel ®.
3.9. The employee requesting action fills out the top portion, completing the following:
 [CAR Form Abbreviation]number: leave blank (this will be filled in later)
 Type of action requested: select corrective when reporting existing problems,
“preventive” when reporting potential problems, or “opportunity for improvement /
suggestion” when the report is a pure improvement action, unrelated to any particular
problem.
 Source: indicate where the report originates from. In most cases, this will be from
employees, but if an employee is filling the [CAR Form Abbreviation]on behalf of
someone else, indicate the original source (i.e., customer, supplier, external auditor,
etc.)
 Process: indicate the process for which the issue being reported is mostly likely
covered by. The employee may guess here, as the [CAR System Manager Title] may
revise this later, as needed.
 Priority: indicate a priority based on the following criteria:
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DOC.REF:QSP/01
ISO 9001:2015 Date: 01.07.2017 Rev: 00
o LOW: Respond as availability allows; may extend deadline with permission of

[CAR System Manager Title].
o MEDIUM: Respond as soon as feasible; deadline established, but may be
interrupted by higher priority activities.
o HIGH: Respond by established deadline, which may interrupt other staff working
low or medium priority activities.
o URGENT / CRITICAL: Respond immediately with sustained effort using all
available resources until resolved. Company at legal or other compliance risk.
 The Issue: describe the problem being reported or the suggestion offered; be as
detailed as possible. Internal audit findings must comply with the requirements put forth
in the procedure [Internal Auditing Proc. Title].
3.10. The employee will then send the [CAR Form Abbreviation] form to the [CAR System Manager
Title].
3.11. The [CAR System Manager Title] will then begin an entry for the [CAR Form Abbreviation]form
in the [CAR Form Name] Log by entering the information in the next available line in the log.
The information entered should match that indicated on the [CAR Form Abbreviation]form (i.e.,
the process, priority, etc.) Under “Brief Description, only a short sentence describing the issue
need be entered, not the entire text of the issue; this is only to help remember the nature of the
[CAR Form Name] later.
3.12. The [CAR System Manager Title] will assign the [CAR Form Abbreviation]to one or more
employees who are best able to research and resolve the issue, and enter this in both the log
and the [CAR Form Abbreviation]form under “Assigned To.” This person is hereinafter referred
to as the “Assignee.”
3.13. The [CAR System Manager Title] will assign a response date for the [CAR Form Abbreviation];
this can be whatever time frame the [CAR System Manager Title] thinks is suitable for the issue
being investigated. The consideration of this time frame will take into consideration the level of
effort expected, costs, risks, etc.; for example, some actions may take months to correct and
resolve, while others may take days or less. If necessary, the [CAR System Manager Title] will
determine this time frame with the help of the assignee.
3.14. The [CAR System Manager Title] will then send the [CAR Form Abbreviation]to the assignee.
3.15. The log will highlight when [CAR Form Abbreviation]s are overdue, based on the assigned
date. In the event of an overdue [CAR Form Abbreviation], the [CAR System Manager Title]
will either negotiate a revised date with the Assignee, or escalate the [CAR Form
Abbreviation]to the Assignee’s manager for attention.
3.16. The Assignee shall conduct a root cause analysis to determine the cause(s) of the problem.
This exercise should be thoughtful and detailed, so as to ensure the actual root causes are
identified. Failure to properly conduct root cause analysis may result in the wrong cause being
acted upon, and thus the problem not being permanently resolved.
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DOC.REF:QSP/01
ISO 9001:2015 Date: 01.07.2017 Rev: 00
3.17. Root cause analysis is mandatory for corrective or preventive actions; it is not required for
opportunities for improvement or suggestions since these may not be attached to any known
problem; in such cases root cause analysis is optional.
3.18. The Assignee will then develop an action plan to address the root cause and eliminate it. By
eliminating the root cause, the problem should never occur or recur.
3.19. For some preventive and corrective action issues, management may elect to perform a risk
assessment as part of the action plan determination; see [Risk Management Proc. Title].
3.20. The Assignee will then implement the plan, updating the text of the [CAR Form Abbreviation]as
the plan progresses. During this time the plan may change, or expand, etc., so the text must be
updated to reflect the actions assigned and taken.
3.21. Once the action is complete, and the Assignee feels the issue is resolved, he/she will sign the
[CAR Form Abbreviation]and indicate a completion date. They shall then return the [CAR Form
Abbreviation]to the [CAR System Manager Title].
3.22. The [CAR System Manager Title] will update the log entry for the [CAR Form Abbreviation],
indicating the action complete date.
3.23. The [CAR System Manager Title] will perform independent verification of the actions taken to
ensure the actions are effective in resolving the root cause(s). This verification should examine
evidence and take into consideration the following:
 Has the action plan removed the root cause(s)?
 Does the action appear to eliminate the original issue reported?
 Were any related documents updated, as needed?
 Was training conducted, if required?
 Does the action require an update to the internal audit schedule?
 Were all interested parties properly notified of the actions taken?
3.24. The [CAR System Manager Title] will record the results of the verification activity in the log.
3.25. If the issue is satisfactorily addressed, the [CAR System Manager Title] may close the [CAR
Form Abbreviation]by indicating this in the final column on the log. The [CAR Form
Abbreviation] form is then filed.
3.26. If the [CAR System Manager Title] determines the issue is not properly addressed, the [CAR
Form Name] may be re-assigned for further action, or a new [CAR Form Abbreviation] filed.
This is indicated in the log.
3.27. The [CAR Form Name] Log generates trend reports for both corrective and preventive actions
over time; these are reported during management review.
Page 52 of 52

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SREE KRISHNA STRAPPING & QUALITY SYSTEM

Sl.No. Name of the Procedure Rev No. Date Page no.

Prepared by (MR): Approved by: MD

Procedure: 1. Context of the Organization

Rev. Date Nature of Changes Approved By

3. SCOPE OF PRODUCTS AND SERVICES

3.1. SKL provides the following [Products or Services ]:

6. RISKS AND OPPORTUNITIES

Procedure: 2. Risk Management

Rev. Date Nature of Changes Approved By

3.1. Risk: A negative effect of uncertainty.

4.1. SES considers and manages risks and opportunities differently.

6.5.1. Identifying the opportunity.

Procedure: 3. Change Management

Rev. Date Nature of Changes Approved By

4.1. Management system processes will undergo changes, typically when:

Procedure: 4.Calibration Procedure

Rev. Date Nature of Changes Approved By

Procedure: 5. Training Procedure

Rev. Date Nature of Changes Approved By

Procedure: 6. Control of Documents Procedure

2. REVISION AND APPROVAL

This procedure is released and approved as follows.

3.1. Creation of Documents

3.1.1. Documents are created by an appropriate subject matter expert.

Procedure: 7. Control of Records Procedure

2. REVISION AND APPROVAL

Rev. Date Nature of Changes Approved By

QUALITY RECORDS MATRIX

Procedure: 8. Quoting and Orders

Rev. Date Nature of Changes Approved By

Procedure: 9. Shipping Procedure

Rev. Date Nature of Changes Approved By

3.1. All handling requirements as defined [Preservation Procedure] in shall be followed.

Procedure: 10. Purchasing Procedure

Rev. Date Nature of Changes Approved By

3. SUPPLIER EVALUATION, SELECTION AND CONTROL

 requirements for approval of product, procedures, processes and equipment

Procedure: 11. Receiving Procedure

Rev. Date Nature of Changes Approved By

Procedure: 12. Equipment Validation Procedure

Rev. Date Nature of Changes Approved By

3. APPLICATION AND EXEMPTIONS

4.1. Equipment and Tooling

Procedure: 13. Identification & Traceability Procedure

2. REVISION AND APPROVAL

Rev. Date Nature of Changes Approved By

Procedure: 14. Preventive Maintenance Procedure

2. REVISION AND APPROVAL

Rev. Date Nature of Changes Approved By

3. PROCEDURE: PREVENTIVE MAINTENANCE

Procedure: 15. Special Process

Rev. Date Nature of Changes Approved By

Procedure: 16. Customer Property Procedure

Rev. Date Nature of Changes Approved By

Procedure: 17. Preservation Procedure

Rev. Date Nature of Changes Approved By

6. HANDLING & LABELING

6.1. Proper handling of all parts and raw materials is performed.

Procedure: 18. Control of NCP Procedure [Non-conforming Product]

Rev. Date Nature of Changes Approved By

3.1. Discovery and Reporting of NCP