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ISO 9001:2008 Audit & Gap Analysis Checklist Version 1

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Audit Date:

Audit Description:

Lead Auditor:

Audit Team Members:

4.1 4.2.1 4.2.2 4.2.3 4.2.4

ISO 9001:2008 Auditable Clauses
5.1 5.2 5.3 5.4.1 5.4.2
(Tick those to be evaluated during this audit)
5.5.1 5.5.2 5.5.3 5.6.1 5.6.2
Each auditor should complete the section of the checklist they have been
assigned by the Quality Manager (Internal audits) or Lead Auditor (external 5.6.3 6.1 6.2.1 6.2.2 6.3
audits) [delete as appropriate]. The auditor may provide additional notes 6.4 7.1 7.2.1 7.2.2 7.2.3
and questions regarding the audit trail for each element in the blank space
on the checklist. 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5

The Quality Manager or Lead Auditor [delete as appropriate] is responsible 7.3.6 7.3.7 7.4.1 7.4.2 7.4.3
for reviewing completed sections of the checklist and to organize all
individual sections into one sequential checklist at the conclusion of the 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5
audit. 7.6 8.1 8.2.1 8.2.2 8.2.3

8.2.4 8.3 8.4 8.5.1 8.5.2

8.5.3
PRODUCT REALIZATION PROCESS EXCLUSIONS
ISO 9001:2008 Permissible Exclusions 7.1 7.2.1 7.2.2 7.2.3 7.3.1
(Tick those applicable, if any) 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6

7.3.7 7.4.1 7.4.2 7.4.3 7.5.1

7.5.2 7.5.3 7.5.4 7.5.5 7.6

Legend

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A = Opportunity for B = Minor Non- C = Major Non-conformance SQ = Supplementary Question

Improvement conformance

Conformance: Adherence with the requirements of the standard. No major or minor non-conformances found

Opportunity for Improvement A situation or condition of a management system that may be weak, cumbersome, redundant, overly complex, or in
(OFI): some other manner, may, in the opinion of the auditor, offer an opportunity for an organization to improve its current
status.

OFIs do not require any action on the part of the organization; however, the organization should give them serious
consideration in view of the auditor’s knowledge and exposure to similar systems.

An OFI may be an improvement to the management system or could prevent future problems.
Minor Non-conformance: A non-conformity that, based on the judgment and experience of the auditor, is not likely to result in the failure of the
management system or reduce its ability to assure controlled processes or products.

It may be either:

A failure in some part of the supplier's management system relative to a specified requirement.

A single observed lapse in following one item of a company's management system.

Major Non-conformance: The absence (omission, not addressed) or total breakdown (commission, failure, not implemented) of a system to meet a
specified requirement.

A number of minor non-conformities against one requirement can represent a total breakdown of the system and thus
be considered a major non-conformity.

Any non-compliance that would result in the probable shipment of a non-conforming product. Conditions that may result
in the failure of or materially reduce the usability of the products or services for their intended purpose.

A non-compliance that, in the judgment and experience of the auditor, is likely to either to result in the failure of the
management system or to materially reduce its ability to assure controlled processes and products.

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4.1 General Requirements

Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Has the organization established, documented, implemented

1 4.1 and maintained a QMS and continually improved its
effectiveness?

Has the organization identified the processes needed for the

2 4.1a
QMS and their application throughout the organization?

Has the organization determined the sequence and interaction

3 4.1b
of QMS processes?

What are the criteria and methods the organization uses to

4 4.1c ensure that the operation and control of QMS processes are
effective?

Has the organization provided resources and information

5 4.1d needed to support the operation and monitoring of QMS
processes?

Does the organization monitor, measure and analyze QMS

6 4.1e
processes?

Has the organization implemented actions necessary to achieve

7 4.1f planned results and continual improvement of processes
needed for the QMS?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are processes needed for the QMS managed by the

8 4.1 organization in accordance with the requirements of ISO
9001:2008?

How does the organization maintain control over outsourced

9 4.1
processes?

Are the necessary controls for outsourced processes that affect

10 4.1 product conformity with requirements identified within the
QMS?

Does organization have adequate control over outsourced

11 4.1
processes to ensure conformity to all customer requirements?

4.2.1 General

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

1 4.2.1a Does the organization have a documented quality policy?

Does the organization have a set of documented quality

2 4.2.1a
objectives?

3 4.2.1b Does the organization have a quality manual?

Does the organization operate a set of documented

4 4.2.1c
procedures?

Are adequate documents in place to ensure the effective

5 4.2.1d
planning, operation and control of organization’s processes?

Does documentation include the records required by ISO

6 4.2.1d
9001:2008?

4.2.2 Quality Manual

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Where in the quality manual is the scope of the QMS identified,

1 4.2.2a
including details of and justification for exclusions?

Where does the quality manual contain or reference the

2 4.2.2b documented procedures established for the QMS?

Where does the quality manual include a description of the

3 4.2.2c
interaction between the processes of the QMS?

4.2.3 Control of Documents

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the organization operate an establish document control

1 4.2.3
procedure? (If yes, proceed with questions 22 to 28)

Does the document control procedure define the controls

2 4.2.3a
needed to approve documents for adequacy prior to issue?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary
Does the document control procedure define the controls
3 4.2.3b needed to review and update as necessary and re-approve
documents?

Does the document control procedure define the controls

4 4.2.3c needed to ensure that changes and the current revision status
of documents are identified?

Does the document control procedure define the controls

5 4.2.3d needed to ensure that relevant versions of applicable
documents are available at points of use?

Does the document control procedure define the controls

6 4.2.3e needed to ensure that documents remain legible and readily
identifiable?

Does the document control procedure define the controls

7 4.2.3f needed to ensure that documents of external origin are
identified and their distribution controlled?

Does the document control procedure define the controls

needed to prevent the unintended use of obsolete documents,
8 4.2.3g
and to apply suitable identification to them if they are retained
for any purpose?

4.2.4 Control of Records

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Do records exist that provide evidence of conformity to

1 4.2.4 requirements and of the effective operation of the QMS?
(Should be reviewed throughout the audit)

Does the organization have a documented procedure defining

2 4.2.4 the controls needed for the identification, storage, protection,
retrieval, retention time and disposition of records?

Are records legible, readily identifiable and retrievable? (Should

3 4.2.4
be reviewed throughout the audit)

Have the record requirements been reviewed to ensure

4 4.2.4
conformance with contractual and customer requirements?

5 Management Responsibility

5.1 Management Commitment

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the organization communicate the importance of meeting

1 5.1a
customer, statutory and regulatory requirements?

2 5.1b Does the organization have an established quality policy?

3 5.1c Are the quality objectives established by top management?

4 5.1d Does top management conduct management reviews?

Does top management ensure the availability of resources to

5 5.1e
support and continually improve the QMS?

5.2 Customer Focus

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does top management ensure that customer requirements are

1 5.2
determined and met?

5.3 Quality Policy

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

1 5.3a Is the quality policy appropriate to the organization?

Does the quality policy include a commitment to continually

2 5.3b
improve the effectiveness of the QMS?

Does the quality policy provide a framework to establish and

3 5.3c
review quality objectives?

Is the quality policy communicated effectively throughout the

4 5.3d
organisation?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

5 5.3e Is the quality policy reviewed to confirm suitability?

5.4 Planning

5.4.1 Quality Objectives

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Has top management established quality objectives at relevant

1 5.4.1
functions and levels within the organization?

2 5.4.1 Are the quality objectives measurable?

3 5.4.1 Are the quality objectives consistent with quality policy?

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5.4.2 Quality Management System Planning

Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is the planning of the QMS consistent with the organisation’s

1 5.4.2a quality objectives and general requirements of ISO 9001:2008
(Clause 4.1)?

Does the organization ensure that the integrity of the QMS is

2 5.4.2b maintained when changes to the QMS are planned and
implemented?

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Has the organization defined and communicated responsibility

1 5.5.1
and authority? (e.g. organizational chart)

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5.5.2 Management Representative

Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

1 5.5.2 Does the organization have a Management Representative?

Does the Management Representative have responsibility and

2 5.5.2a authority to ensure that processes needed for the QMS are
established, implemented and maintained?

Does the Management Representative have responsibility and

3 5.5.2b authority to report to top management on the performance of
the QMS and any need for improvement?

Does the Management Representative have responsibility and

4 5.5.2c authority to ensure the promotion of awareness of customer
requirements throughout the organization?

5.5.3 Internal Communication

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is information regarding the effectiveness of the QMS

1 5.5.3
communicated within the organization?

2 SQ If yes, how is the effectiveness of the QMS communicated?

5.6 Management Review

5.6.1 General
Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

1 5.6.1 Does top management undertake management review?

Are the records of management reviews maintained in

2 5.6.1
accordance with Clause 4.2.4?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

3 SQ What is the frequency of management reviews?

4 SQ What sort of information is reviewed in management reviews?

Please show me what records are available from the most

5 SQ
recent management review?

5.6.2 Review Input

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

1 5.6.2a Does the review process consider the results of audits?

2 5.6.2b Does the review process consider customer feedback?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the review process consider process performance and

3 5.6.2c
product conformity?

Does the review process consider the status of the corrective

4 5.6.2d
and preventive actions?

Does the review process follow up actions from previous

5 5.6.2e
management reviews?

Does the review process consider changes that could affect the
6 5.6.2f
QMS?

Does the review process make recommendations for

7 5.6.2g
improvement?

5.6.3 Review Output

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary
Do the outputs of the review process include decisions and
1 5.6.3a actions concerning the improvement of the effectiveness of the
QMS and its processes?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary
Do the outputs of the review process include decisions and
2 5.6.3b actions concerning the improvement of product related
customer requirements?

Do the outputs of the review process include decisions and

3 5.6.3c
actions concerning the resource requirements?

6 Resource Management

6.1 Provision of Resources

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary
Has the organization provided the necessary resources to
1 6.1.1a implement and maintain the QMS and continually improve its
effectiveness?

Has the organization provided the necessary resources to

2 6.1.1b
ensure that customer requirements are met?

6.2 Human Resources

6.2.1 General
Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the organization ensure that personnel have the

1 6.2.1
necessary competence to ensure product conformity?

6.2.2 Competence, Training & Awareness

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the organization determine the necessary education,

1 6.2.2a training, skills and experience for people performing work
affecting product quality?

Does the organization initiate training or other actions to

2 6.2.2b
achieve the necessary level of competence?

Does the organization evaluate the effectiveness of training or

3 6.2.2c
other actions taken?

Does the organization ensure that personnel are aware of the

4 6.2.2d
relevance and importance of their activities?

Does the organization ensure that personnel are aware of how

5 6.2.2d
they contribute to the achievement of the quality objectives?

Does the organization maintain training records in accordance

7 6.2.2e
with Clause 4.2.4?

6.3 Infrastructure

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Has the organization identified any shortcomings in its

1 6.3
infrastructure and is it taking appropriate action?

Are the buildings, workspace and utilities appropriate for the

2 6.3a
organization product or service?

Is process equipment (including computer software)

3 6.3b
appropriate for the organization’s product or service?

Are support services (e.g. transport, communications, and

4 6.3c waste disposal) appropriate for the organization’s product or
service?

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6.4 Work Environment

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is the work environment appropriate for achieving product or

1 6.4
service requirements?

2 6.4 Is safety and protective equipment provided where necessary?

3 6.4 Are workstations set out ergonomically?

4 6.4 Are kitchen and toilet facilities adequate?

5 6.4 Are heat, humidity, light levels and airflow controllable?

Are factors affecting hygiene, cleanliness, noise, vibration and

6 6.4
pollution controllable?

Has the organization identified any shortcomings and is it

7 6.4
taking appropriate action?

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7 Product Realization
Question No.

Clause Ref.
Finding
Audit Evidence/Comment
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Has the organization excluded itself from the requirements of

1 7
the Product Realization process?

Has the organization justified any permissible exclusion in the

2 7
relevant section of the quality manual?

7.1 Planning & Product Realization

Question No.

Clause Ref.

Finding
Audit Evidence/Comment
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

1 7.1 Have the processes needed for product realization identified?

Is the planning of product realization consistent with the

2 7.1
requirements of the other processes of the QMS?

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Question No.

Clause Ref.
Finding
Audit Evidence/Comment
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Has the organisation determined quality objectives for its

3 7.1a
products?

Has the organisation identified processes, documents and

4 7.1b
resources required by specific products?

Has the organisation identified methods for verification,

5 7.1c validation, monitoring and inspection and test activities to meet
acceptance criteria?

Has the organisation determined what records are needed to

6 7.1d provide evidence that requirements for specific products have
been met?

Is there an identifiable output from the planning process, in an

7 7.1e
appropriate format in accordance with 4.2.4?

7.2 Customer-related Processes

7.2.1 Determination of Requirements Related to the Product

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Has the organisation determined product requirements prior to

1 7..2
commitment to supply?

Customer’s specified requirements, delivery, warranty and

2 7.2.1a
service?

3 7.2.1b Requirements necessary for the product’s intended use?

4 7.2.1c Statutory and regulatory requirements?

5 7.2.1d Any additional requirements determined by the organisation?

7.2.2 Review of Requirements Related to the Product

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary
Does the organization undertake a review to ensure that the
1 7.2.2 organization has the ability to meet requirements before
committing to supply product?

Does the organization ensure that product requirements are

2 7.2.2a
defined and reviewed before committing to supply product?

Does the organization ensure that contract or order

3 7.2.2b requirements differing from those previously expressed are
resolved before committing to supply product?

Does the organization ensure that it has the ability to meet the
4 7.2.2c
defined requirements?

Can you show me records of the product requirement review

5 SQ
results and actions resulting from them?

When customers don’t have documented requirements, how do

6 SQ
you confirm their requirements before accepting orders?

When product requirements are changed, how do you ensure

7 SQ that relevant documents are changed and that relevant
personnel are made aware of the changes?

7.2.3 Customer Satisfaction

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Has the organization implemented effective arrangements for

1 7.2.3a
communicating product information?

Has the organization implemented effective arrangements for

2 7.2.3b
communicating enquiries?

Has the organization implemented effective arrangements for

3 7.2.3b communicating contracts or order handling including
amendments?

Has the organization implemented effective arrangements for

4 7.2.3c
communicating customer feedback?

Has the organization implemented effective arrangements for

5 7.2.3c
communicating customer complaints?

7.3 Design & Development

7.3.1 Design & Development Planning

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Have stages of design and development been determined for

1 7.3.1a
the product?

Are requirements for review, verification and validation defined

2 7.3.1b
for each stage?

Is validation completed prior to delivery or use, where

3 7.3.1b
practical?

4 7.3.1c Are responsibilities for design and development defined?

Is there effective communication between different members or

5 7.3.1
groups in the design team?

Is planning output updated as appropriate as the design and

6 7.3.1
development progresses?

7.3.2 Design & Development Inputs

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are records of design inputs maintained in accordance with

1 7.3.2
Clause 4.2.4?

2 7.3.2a Are requirements defined for function and performance?

3 7.3.2b Are applicable statutory and regulatory requirements defined?

4 7.3.2c Is information to be used from previous designs defined?

Are other requirements essential for design and development

5 7.3.2d
adequately defined?

Are design inputs reviewed for adequacy to confirm that they

6 7.3.2
are complete, unambiguous and not in conflict?

7.3.3 Design & Development Outputs

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Do the outputs meet input requirements for design and

1 7.3.3a
development?

Do the outputs provide information required for purchasing,

2 7.3.3b
production and service provision?

Do the outputs contain or reference product acceptance

3 7.3.3c
criteria?

Do outputs specify characteristics for the product’s safe and

4 7.3.3d
proper use?

7.3.4 Design & Development Review

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Have design and development reviews taken place (involving

1 7.3.4 representatives of all relevant functions) in accordance with the
design and development plan?

Do participants in design reviews include representatives of

2 7.3.4 functions concerned with the design development stage being
reviewed?

Are records of reviews available in accordance with Clause

3 7.3.4
4.2.4?

Can the organization confirm that the results of design and

4 7.3.4a
development have been evaluated?

5 7.3.4b Were problems identified and were actions taken for resolution?

7.3.5 Design & Development Verification

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary
Has verification been completed in accordance with the design
1 7.3.5 and development plan to confirm that design and development
outputs meet requirements of inputs?

Are records maintained of the results of verification and any

2 7.3.5
necessary actions in accordance with Clause 4.2.4?

7.3.6 Design & Development Validation

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary
Has validation been completed in accordance with the design
1 7.3.6 and development plan to confirm that the product is suitable
for its specified application or intended use?

Are records maintained of the results of validation and any

2 7.3.6
necessary actions in accordance with Clause 4.2.4?

7.3.7 Control of Design & Development Changes

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Have changes been reviewed to evaluate their effect on

1 7.3.7
constituent parts and on product already delivered?

2 7.3.7 Have changes been approved prior to implementation?

3 7.3.7 Have changes been appropriately verified and validated?

Are records maintained of the results of change reviews and

4 7.3.7
any necessary actions in accordance with Clause 4.2.4?

7.4 Purchasing

7.4.1 Purchasing Process

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are verification requirements appropriate for the product’s

1 7.4.1
application?

Are suppliers evaluated and selected (in accordance with

2 7.4.1 established criteria) on the basis of their ability to meet
specified requirements?

Are suppliers periodically re-evaluated in accordance with

3 7.4.1
established criteria?

Are records maintained of the results of supplier evaluations in

4 7.4.1
accordance with Clause 4.2.4?

7.4.2 Purchasing Information

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does purchasing information adequately describe the product

1 7.4.2
to be purchased?

Does purchasing information adequately describe the

2 7.4.2a requirements for approval of product, procedures and
equipment?

Does purchasing information adequately describe the

3 7.4.2b
requirements for qualification of personnel?

Does purchasing information adequately describe quality

4 7.4.2c
management system requirements?

Does the organisation ensure that purchasing information is

5 7.4.2
adequate prior to issue to the supplier?

7.4.3 Verification of Purchased Product

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is purchased product verified in accordance with specified

1 7.4.3
requirements?

Does purchasing information contain details of any verification

2 7.4.3
to be performed at the supplier’s premises?

7.5 Product & Service Provision

7.5.1 Control of Production & Service Provision

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is required information available to describe product

1 7.5.1a
characteristics?

2 7.5.1b Are necessary work instructions available?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

3 7.5.1c Is suitable equipment available?

4 7.5.1d Are required monitoring and measuring devices available?

Are required monitoring and measuring devices used in

5 7.5.1e
accordance with work instructions and/or the quality plan?

Are requirements for release, delivery and post delivery

6 7.5.1f
activities implemented?

7.5.2 Validation Processes for Production & Service Provision

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is production or provision of service which cannot be verified by

1 7.5.2a subsequent monitoring or measuring adequately validated to
demonstrate that planned results are being achieved?

2 7.5.2b Are criteria defined for review and approval of the processes?

3 7.5.2c Are personnel qualified and is equipment approved?

Are required records maintained in accordance with Clause

4 7.5.2d
4.2.4?

5 7.5.2e Is the time interval for process re-validation defined?

Does validation demonstrate the ability of the process to

6 7.5.2f
achieve planned results?

7.5.3 Identification & Traceability

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is product identification and traceability required to be

1 7.5.3
maintained throughout production (for any products)?

Is inspection and test status adequately defined maintained

2 7.5.3
throughout production?

If traceability is a requirement are records of unique

3 7.5.3 identification of the product available in accordance with
Clause 4.2.4?

7.5.4 Customer Property

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the organisation adequately identify, verify, protect and

1 7.5.4
safeguard customer property?

2 7.5.4 Is the customer’s intellectual property controlled?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are records maintained of any loss or damage to customer

3 7.5.4
property in accordance with Clause 4.2.4?

7.5.5 Preservation of Product

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are components adequately identified, handled, packaged,

1 7.5.5
stored and protected prior to use?

Are finished products adequately identified, handled, packaged,

2 7.5.5
stored and protected prior to delivery?

7.6 Control of Monitoring & Measuring Equipment

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are monitoring and measuring devices required by the QMS

1 7.6
controlled?

Is each device calibrated or verified at specified intervals (or

2 7.6a prior to use) against measurement standards traceable to
national or international standards?

Where no such standards exist is the basis of calibration or

3 7.6a
verification defined?

Is each device adjusted or re-adjusted as necessary (in

4 7.6b
accordance with manufacturer’s instructions)?

Is each device identified to enable calibration status to be

5 7.6c
determined?

Is each device safeguarded from adjustment, which would

6 7.6d
invalidate the measurement result?

Is each device protected from damage or deterioration during

7 7.6e
handling, maintenance or storage?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is the validity of previous results assessed and appropriate

8 7.6 action taken, when a device is found not to conform to
requirements?

Are records of the results of calibration and verification

9 7.6
maintained in accordance with Clause 4.2.4?

When computer software is used in the monitoring and

10 7.6
measuring equipment is it validated prior to initial use?

When computer software is used in the monitoring and

11 7.6
measuring equipment is it re-confirmed as necessary?

8.0 Measurement, Analysis & Improvement

8.1 General

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Has the organization implemented appropriate measurement,

1 8.1a analysis and improvement processes needed to demonstrate
product conformity?

Has the organization implemented appropriate measurement,

2 8.1b analysis and improvement processes needed to ensure
conformity of the QMS

Has the organization implemented appropriate measurement,

3 8.1c analysis and improvement processes needed to continually
improve the effectiveness of the QMS?

Does the organization apply statistical techniques and

4 8.1
determine the extent of their use?

8.2 Monitoring & Measurement

8.2.1 Customer Satisfaction

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

1 8.2.1 Does the organization monitor customer satisfaction?

Does the organization use this information in accordance with

2 8.2.1
defined methods?

8.2.2 Audit
Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is there a documented procedure which defines responsibility

1 8.2.2
and requirements for planning and conducting audits?

Is there a documented procedure which defines responsibility

2 8.2.2
and requirements for reporting audit results?

Is there an audit programme in place defining audit criteria,

3 8.2.2
scope, frequency and methods?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

4 8.2.2 Are records of audits maintained?

5 8.2.2 Do audit records confirm that audits were conducted?

Do audit records confirm that audits were conducted in

6 8.2.2
accordance with the audit schedule?

Were appropriate follow up actions taken to eliminate non-

7 8.2.2
conformances and their root cause?

8 8.2.2 Were the results of any follow up actions verified?

Are effective methods used to monitor (and measure if

9 8.2.2
applicable) the processes of the QMS and the organisation?

Do the results confirm that they are capable of achieving

10 8.2.2
planned results?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

If planned results are not achieved has appropriate action been

11 8.2.2
taken?

8.2.3 Monitoring & Measurement of Processes

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are effective methods used to monitor and measure the

1 8.2.3
processes of the QMS and the organisation?

Do the results confirm that the processes are capable of

2 8.2.3
achieving planned results?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

If planned results are not achieved has appropriate action been

3 8.2.3
taken?

8.2.4 Monitoring & Measurement of Product

Question No.

Clause Ref.

Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are product characteristics measured to confirm that product

1 8.2.4
requirements are met?

Do monitoring and measuring activities take place at

2 8.2.4
predetermined stages during the product realization process?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are records of evidence of conformity with acceptance criteria

3 8.2.4
maintained in accordance with Clause 4.2.4?

Are records that indicate authorized release of a product to the

4 8.2.4
next stage available?

Do arrangements exist to ensure that a product is not released

5 8.2.4
until the all requirements have been met

Do arrangements exist to ensure that if a product must be

6 8.2.4
released prior satisfying the requirements, is it approved?

8.3 Control on Non-conforming Product

Question No.

Clause Ref.

Finding
Audit Evidence/Comment
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is there a documented procedure which describes how non-

1 8.3
conforming product is dealt with?

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Question No.

Clause Ref.
Finding
Audit Evidence/Comment
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is there a documented procedure which describes the

2 8.3 identification of non-conformities and actions to prevent
unintended use or delivery?

Is there a documented procedure which describes the

3 8.3 necessary responsibility and authority for dealing with non-
conforming product?

Is there a documented procedure which describes methods of

4 8.3
dealing with non-conforming product?

Is there a documented procedure which describes the action to

5 8.3
be taken if non-conformity is detected after delivery?

Are there records of action taken following identification of a

6 8.3
non-conformity maintained in accordance with Clause 4.2.4?

Do the records detail any re-work undertaken to eliminate the

7 8.3
detected non-conformity?

Do the records detail methods and criteria for re-verification to

8 8.3
demonstrate conformity?

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Question No.

Clause Ref.
Finding
Audit Evidence/Comment
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Do the records detail acceptances under concession by a

9 8.3
relevant authority?

Do the records detail if non-conforming products were

10 8.3
withdrawn from intended use?

8.4 Analysis of Data

Question No.

Clause Ref.

Finding
Audit Evidence/Comment
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Are data collected and analyzed to demonstrate the suitability

1 8.4 and effectiveness of the QMS and to evaluate where continual
improvement of its effectiveness can be made?

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Question No.

Clause Ref.
Finding
Audit Evidence/Comment
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the analysis of data include information relating to

2 8.4
customer satisfaction?

Does the analysis of data include information relating to the

3 8.4
conformity to product requirements?

Does the analysis of data include information relating to

4 8.4
characteristics and trends of processes and products?

Does the analysis of data include information relating to

5 8.4
improvement opportunities and preventive action?

Does the analysis of data include information relating to

6 8.4
suppliers?

8.5 Improvement

8.5.1 Continual Improvement

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the organisation continually improve the effectiveness of

1 8.5.1
the QMS through use of the quality policy?

Does the organisation continually improve the effectiveness of

2 8.5.1
the QMS through use of quality objectives?

Does the organisation continually improve the effectiveness of

3 8.5.1
the QMS through use of audit results?

Does the organisation continually improve the effectiveness of

4 8.5.1
the QMS through use of data analysis?

Does the organisation continually improve the effectiveness of

5 8.5.1
the QMS through use of corrective and preventive action?

Does the organisation continually improve the effectiveness of

6 8.5.1
the QMS through use of management reviews?

8.5.2 Corrective Action

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Is there a documented procedure which describes how

1 8.5.2
corrective action is undertaken?

Do corrective actions records identify and address root

2 8.5.2
cause(s)?

3 8.5.2 Are actions taken appropriate to the severity of the problem?

Does the corrective action procedure define the requirements

4 8.5.2a for the review of non-conformities (including customer
complaints)?

Does the corrective action procedure define the requirements

5 8.5.2d
for the review of determining the causes of non-conformities?

Does the corrective action procedure define the requirements

6 8.5.2c for evaluating the need for action to ensure that non-
conformities do not recur?

Does the corrective action procedure define the requirements

7 8.5.2d
for determining and implementing action needed?

Does the corrective action procedure define the requirements

8 8.5.2e
for the records of the results of action taken?

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the corrective action procedure define the requirements

9 8.5.2f
for reviewing the effectiveness of corrective actions taken?

Have corrective actions been implemented in accordance with

10 8.5.2
the documented procedure?

8.5.3 Preventive Action

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Question No.

Clause Ref.
Finding
Audit Evidence
Audit Question NO
YES N.B. Provide references to documentation
A B C
where necessary

Does the preventive action procedure define the requirements

1 8.5.3a
for determining causes of potential non-conformities?

Does the preventive action procedure define the requirements

2 8.5.3b for evaluating whether action needs to be taken to prevent
occurrence?

Does the preventive action procedure define the requirements

3 8.5.3c for determining what action is required and ensuring that it is
implemented?

Does the preventive action procedure define the requirements

4 8.5.3d for maintaining records (in accordance with Clause 4.2.4) of the
results of action taken?

Does the preventive action procedure define the requirements

5 8.5.3e
for reviewing preventive action taken?

Has preventive action been implemented in accordance with

6 8.5.3
the documented procedure?

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