AUDIT CHECKLIST

AUDITEE:
ITEM

AUDIT DATE:

AUDIT REF:
DOC. REFERENCE

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Table of Contents
General Requirements........................................................................................................................................................................................................2
Quality Management System.............................................................................................................................................................................................2
Management Responsibility...............................................................................................................................................................................................4
Resource Management.......................................................................................................................................................................................................6
Product Realization............................................................................................................................................................................................................7
Measurement, analysis and improvement.......................................................................................................................................................................15

Q1 Section 3.1.4 - Control feature

Organizations documented method to perform an activity under controlled conditions to achieve conformity to specified requirements.

259170020.doc

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AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM

AUDIT REF:
DOC. REFERENCE

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

General Requirements
1.

Organization has identified all exclusions that apply to the

QMS (limited to Sections 7.3, 7.5.1, 7.5.2 &
7.5.4)

Q1 Section 1.2

Quality Management System

2.

3.

Organization shall:
a) Determine processes needed for QMS
b) Determine sequence and interaction of processes
c) Determine criteria & methods needed to ensure
operation and control of processes are effective
d) Ensure the availability of resources necessary to
support the operation
e) Monitor, Measure, where applicable, and analyze
processes
f) Implement actions necessary to achieve results and
continual improvement of processes
Organization shall control all processes that are outsourced

259170020.doc

Q1 Section 4.1

Q1 Section 4.1

Page 2 of 21

AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM
4.

5.

AUDIT REF:
DOC. REFERENCE

Documentation includes:
a) Statement of quality policy and quality objectives
b) Quality Manual
c) Documented procedures and records
d) Documents, including records, determined to be
necessary to ensure effective planning, operation
and control of its processes
Quality Manual includes:
a) Scope of QMS and exclusions (with justifications)
b) Documented procedures or reference to them
c) A description of interaction between the processes
of the QMS

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N
Y

Q1 Section 4.2.1

Q1 Section 4.2.2

d) The manner in which the organization addresses

each specific
Specification

requirement

of

the

Technical
Q1 Section 4.2.2.1

259170020.doc

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AUDIT CHECKLIST
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AUDIT DATE:

ITEM
6.

7.

8.

9.

10.

AUDIT REF:
DOC. REFERENCE

Documented Procedures established and maintained for

control of documents
a) Approve documents for adequacy prior to issue
b) Review and update as necessary and re-approve
documents
c) Changes to current revisions are identified
d) Relevant revisions of documents available at points
of use
e) Ensure documents remain legible and readily
identifiable
f) Ensure documents of external origin are identified
and distribution controlled
g) Prevent unintended use of obsolete documents and
apply suitable identification to obsolete documents if
they are retained
Master list or equivalent established to identify current
revisions
Changes to documents reviewed an approved by same
function as original
Documented Procedure for the identification, storage,
protection, retrieval and disposition of
records, and Retention times established and
recorded
Documented Procedure includes the functions responsible
for the collection and maintenance of records.
(Records retained for minimum of 5 years or
as specified in applicable industry standard)

259170020.doc

Q1 Section 4.2.3

Q1 Section 4.2.3.1

Q1 Section 4.2.3.2

Q1 Section 4.2.4

Q1 Section 4.2.4.1

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N
Y

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AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM

AUDIT REF:
DOC. REFERENCE

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Management Responsibility
11.

12.

13.

14.

15.

16.

Top Management commitment to develop and implement

QMS and continually improve effectiveness
Focus on the customer requirements are determined and
met with aim of enhancing customer
satisfaction (7.2.1 and 8.2.1)
Documented Quality Policy by Top management:
a) Is appropriate to the purpose of the organization,
b) Includes commitment to comply and continually
improve QMS
c) Provides a framework for establishing quality
objectives
d) Is communicated and understood within the
organization
e) Is reviewed periodically
Top Management establishes quality objectives that are
measurable and consistent with quality policy
Planning of QMS carried out to meet requirements of quality
objectives
Responsibilities and authorities are defined

259170020.doc

Q1 Section 5.1

Q1 Section 5.2

Q1 Section 5.3 &

5.3.1

Q1 Section 5.4.1

Q1 Section 5.4.2

Q1 Section 5.5.1

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AUDIT DATE:

ITEM
17.

18.

19.

20.

21.

AUDIT REF:
DOC. REFERENCE

Management representative (member of organizations

management):
a) Is identified and has authority to ensure that quality
system is implemented and maintained
b) Promotes awareness of customer requirements
through out organization
Top Management commits to establishing communication
within
the
organization
(internal
communications)
Management Review of QMS Conducted annually with
records of reviews maintained
Management review includes:
a) Results of internal audits
b) Customer feedback
c) Process
performance
(to
include
product
nonconformity)
d) Status of corrective and preventive actions
e) Follow up actions from last management reviews
f) Changes that could affect the QMS (to include oil /
gas industry standards)
g) Recommendations for improvement
Management review output includes:
a) Improvement of effectiveness of QMS
a) Improvement of product to meet customer needs
b) Resource needs

259170020.doc

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Q1 Section 5.5.2

Q1 Section 5.5.3

Q1 Section 5.6.1
& 5.6.1.1
Q1 Section 5.6.2

Q1 Section 5.6.3

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AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM

AUDIT REF:
DOC. REFERENCE

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Resource Management
22.

23.

24.

Human Resources: Personnel shall be competent on the

basis of education, training, skills and/or
experience
Human Resources:
a) Determine necessary competence (requirements)
for personnel performing work affecting product
b) Where applicable, provide training.
c) Evaluate effectiveness of actions taken
d) Ensure personnel are aware of importance of their
work with respect to QMS
e) Maintain records of education, training, skills and
experience
Control Features for Training:

Q1 Section 6.2.1

Q1 Section 6.2.2

Q1 Section 6.2.2.1

Establish control features (see Q1 Section 3.1.4) for

identifying training needs and providing for
training of personnel who perform activities
addressed in the quality management
system.
25.

26.

Provide

and

maintain the infrastructure (equipment,

buildings, etc) needed to achieve conformity
to product requirements

Determine and manage work environment needed to

achieve conformity to product requirements

259170020.doc

Q1 Section 6.3

Q1 Section 6.4

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AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM

AUDIT REF:
DOC. REFERENCE

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Product Realization
27.

28.

29.

30.
31.

32.

33.

34.

35.

The organization shall determine the quality objectives and

requirements for the product
The organization shall determine verification, validation,
monitoring, measurement, inspection and test
activities
Contract review ensures that:
a) Product requirements are defined
b) Requirements differing from those previously
expressed are resolved
c) Organization has ability to meet defined
requirements
Records of the results of reviews shall be maintained
Organization shall ensure amendments are made and
transferred to proper function
Control Features for review of requirements related to
product
Determine and implement effective arrangements for
communication with customers
Organization shall manage the interfaces between different
groups involved in design and development
Design output updated as the design and development
progresses

259170020.doc

Q1 Section 7.1a

Q1 Section 7.1 c

Q1 Section 7.2.2

Section 7.2.2
Section 7.2.2

Q1 Section 7.2.2.1

Section 7.2.3

Section 7.3.1

Section 7.3.1
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AUDITEE:

AUDIT DATE:

ITEM
36.
37.

38.

39.

40.

41.
42.

AUDIT REF:
DOC. REFERENCE

Control features for the design of the product

Design development shall include methods, assumptions,
formulations and calculations
Input includes:
a) Functional and performance requirements
b) Applicable statutory and regulatory requirements
c) Where applicable, information derived from previous
similar designs
d) Other requirements essential for design and
development
Identify,

document and review the product design

requirements including development input
from customer specified requirements

Output shall:
a) Meet the input requirements.
b) Provide information for purchasing, production and
service
c) Contain or reference product acceptance criteria
a) Specify the characteristics of the product that are
essential for the safe and proper use
Design and development outputs are documented
Review shall occur at suitable stages to evaluate design as
it meets requirements

259170020.doc

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Q1 Section 7.3.1.1
Q1 Section 7.3.1.2

Section 7.3.2

Q1 Section 7.3.2.1

Section 7.3.3

Q1 Section 7.3.3.1
Section 7.3.4

Page 9 of 21

AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM
43.

44.
45.

46.

AUDIT REF:
DOC. REFERENCE

Participants of review shall include representatives of

functions concerned with design and
development
Records of review shall be maintained
Final design reviews shall be conducted/documented by
individual(s) other than the person(s) who
developed the design
Verification shall be performed and results shall be recorded

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Section 7.3.4

Section 7.3.4
Q1 Section 7.3.4.1

Section 7.3.5

(Design verification activities includes one or more of the

following: a) confirming the accuracy of
design results through the performance of
alternative calculations; b) review of design
output documents independent of activities of
7.3.4; c) comparing new designs to similar
proven designs.)
47.

Validation shall be performed and results shall be recorded

Section 7.3.6

(Design validation includes one or more of the following: a)

prototype tests; b) functional and/or
operational tests of production products; c)
tests specified by industry standards and/or
regulatory requirements; d) field performance
tests and reviews.)
48.

Changes shall be identified, reviewed, verified, validated

and records maintained. And require the
same controls as the original design and
development, and design documentation.

259170020.doc

Section 7.3.7 &

Q1 Section 7.3.7.1

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AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM
49.

50.

51.

52.
53.
54.

55.

56.

AUDIT REF:
DOC. REFERENCE

Evaluation of design changes on constituent parts and

delivered product
Changes require the same control as the original design and
design documentation
Organization establish the criteria for evaluation/selection of
a supplier ability to supply product in accord
with requirements
Quality records of acceptable suppliers maintained
Control features for the purchasing process
Criteria for the selection, evaluation and re-evaluation of
suppliers shall include one or more of the
following:
a) Inspection at supplier facility;
b) Inspection upon delivery;
c) Surveillance of supplier;
d) Conforms to Minimum QMS
Purchasing documents includes: a) products, procedures,
processes, equipment, personnel and QMS
requirements
Organization shall ensure adequacy of specified purchase
requirements prior to communication to the
supplier

259170020.doc

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Section 7.3.7

Q1 Section 7.3.7.1

Section 7.4.1

Section 7.4.1
Q1 Section 7.4.1.1
Q1 Section 7.4.1.2

Section 7.4.2

Section 7.4.2.

Page 11 of 21

AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM
57.

58.

59.

60.

61.

62.
63.

AUDIT REF:
DOC. REFERENCE

Purchasing information to supplier includes type, class,

grade, specifications, drawings, process
requirements, other data
Organization established & implemented controls to ensure
purchased
product
meets
specified
purchasing requirements
Organization has implemented controls for verification of
product at suppliers premises (by itself or its
customers)
Control features for the verification of purchased products
(receiving inspection)
Controlled conditions include:
a) Information that describes the characteristics of the
product
b) Availability of work instructions
c) Use of suitable equipment
d) Availability and use of monitoring and measuring
equipment
e) Implementation of monitoring and measurement
f) Implementation of release, delivery and postdelivery activities
Control features for production and service activities
Process controls include compliance with control features,
plans, codes, standards, etc.

259170020.doc

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Q1 Section 7.4.2.1

Section 7.4.3

Section 7.4.3

Q1 Section 7.4.3.1

Section 7.5.1

Q1 Section 7.5.1.1
Q1 Section 7.5.1.2

Page 12 of 21

AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM
64.

65.

AUDIT REF:
DOC. REFERENCE

Process controls are documented and include reference to

specified requirements and acceptance
criteria
The organization shall validate any processes for production
and service provision where the resulting
output cannot be verified by subsequent
monitoring or measurement and as a
consequence, deficiencies become apparent
only after the product is in use or the service
has been delivered.

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Q1 Section 7.5.1.2

Section 7.5.2

Validation shall demonstrate the ability of these processes to

achieve planned results.
The organization shall establish arrangements for these
processes including, as applicable
a) Define criteria for review and approval of processes
where resulting output cannot be verified by
subsequent m & m
b) Approval of equipment and qualification of
personnel
c) Use of specified methods and procedures
d) Requirements for records
e) Revalidation
66.
67.

68.

Control features established for special processes

Organization shall identify product by suitable means
throughout product realization
Where traceability is requirement, organization shall control
and maintain records

259170020.doc

Q1 Section 7.5.2.1
Section 7.5.3

Section 7.5.3

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AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM
69.

70.

71.

72.
73.

74.

AUDIT REF:
DOC. REFERENCE

Organization shall identify the product status with respect to

monitoring and measurement requirements
Control features for identification of product as required by
organization, the customer, and applicable
specifications
Controls shall include maintenance or replacement of
identification marks and identification records
Control features for identification of product status
Control of customer property while under organizations
control
Control features for verification, storage, maintenance and
control of customer property

259170020.doc

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Section 7.5.3

Q1 Section 7.5.3.1

Q1 Section 7.5.3.2

Q1 Section 7.5.3.3
Section 7.5.4

Q1 Section 7.5.4.1

Page 14 of 21

AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM
75.

76.

77.

78.

AUDIT REF:
DOC. REFERENCE

Y/N

Section 7.5.5

The organization shall include:

Pre
servation
of product
during
handling

Pre
servation
of product
during
packagin
g

Pre
servation
of product
during
storage

Pre
servation
of product
during
delivery

Control features for describing methods used to preserve

the conformity of product
Assessment of product or constituent parts in stock at
specified intervals
Organization determined the monitoring and measurements
required and obtain the required devices

259170020.doc

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK

Q1 Section 7.5.5.1

Q1 Section 7.5.5.2

Section 7.6

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AUDITEE:

AUDIT DATE:

ITEM

AUDIT REF:
DOC. REFERENCE

79.

The organization shall establish processes to ensure that

monitoring and measurement can be carried
out and are carried out in a manner that is
consistent
with
the
monitoring
and
measurement requirements

Section 7.6

80.

Monitoring and Measuring Equipment shall be:

Section 7.6

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N
Y

a) Calibrated
against
standards
traceable
to
international or national standards
b) Adjusted or re-adjusted as necessary
c) Identified to enable calibration status to be
determined
d) Safeguarded from adjustments that would invalidate
the measurement results
e) Protected from damage and deterioration during
handling, maintenance and storage
81.

Assess and record the validity of previous measuring results

when the equipment is found not to conform
to requirements

Section 7.6

82.

Action taken on monitoring and measurement equipment

when found to be out of calibration

Section 7.6

83.

Calibration records of equipment maintained

84.

Control features to control, calibrate and maintain monitoring

and measuring devices

Q1 Section 7.6.1

85.

Environmental

Q1 Section 7.6.2

259170020.doc

conditions suitable for

measurements performed

Q1 Section 7.6

inspection

and

Page 16 of 21

AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM

AUDIT REF:
DOC. REFERENCE

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Measurement, analysis and improvement

86.

Customer Satisfaction - monitor info relating to customer

perception
whether
organization
met
customer
requirements,
i.e.
customer
satisfaction surveys, customer data on
delivered product quality, user opinion
surveys, lost business analysis, complaints,
warranty claims, etc.

Section 8.2.1

87.

Documented procedure implemented to ensure QMS

effectively implemented and maintained

Section 8.2.2

88.

Internal audits:

Section 8.2.2

a) Consider the results of previous audits

b) The audit criteria, scope, frequency and methods
shall be defined
c) The selection of auditors and conduct of audits shall
ensure objectivity and impartiality of the audit
process.
d) A documented procedure shall be established to
define the responsibilities and requirements for
planning and conducting audits, establishing
records and recording results.
e) Auditors shall not audit their own work
f) Results brought to the attention of the personnel
responsible for area audited for follow-up
g) Corrective action taken, implemented and verified
89.

Internal audits scheduled and conducted at least annually

90.

The

259170020.doc

organization shall identify response times

addressing detected nonconformities.

Q1 Section 8.2.2.1
for

Q1 Section 8.2.2.2

Page 17 of 21

AUDIT CHECKLIST
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AUDIT DATE:

ITEM

AUDIT REF:
DOC. REFERENCE

91.

Apply suitable methods of monitoring and measurement of

QMS conformity

Section 8.2.3

92.

Monitor characteristics of product to verify it meets

requirements

Section 8.2.4

93.

Monitoring carried out at appropriate stages of product

realization process

Section 8.2.4

94.

Evidence of product conformity maintained

Section 8.2.4

95.

Records indicate the person(s) authorizing release of

product

Section 8.2.4

96.

Product release and delivery shall not proceed until planned

arrangements have been completed

Section 8.2.4

97.

Control features for required to monitor and measure the

characteristics of the product

Q1 Section 8.2.4.1

98.

Final

Q1 Section 8.2.4.2

99.

Documented procedure to ensure nonconforming product is

identified
and
controlled
to
prevent
unintended use or delivery

Section 8.3

100.

Review of nonconforming product as repaired/reworked to

meet requirements; accepted with/without
repair by concession; re-graded for
alternative applications; rejected/scrapped

Section 8.3

101.

Responsibility for review and disposition defined

Section 8.3

259170020.doc

(acceptance) inspection/testing
independent personnel

is

controlled

by

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Page 18 of 21

AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM

AUDIT REF:
DOC. REFERENCE

102.

Records of nonconformities and any subsequent actions

maintained

Section 8.3

103.

When nonconformity is corrected, it shall be re-verified to

demonstrate conformity to requirements

Section 8.3

104.

When nonconformity is detected after delivery or use,

organization shall take appropriate action

Section 8.3

105.

Documented procedure for nonconforming product shall

include requirements for identifying, documenting and
reporting incidents of field nonconformities or product
failures.

Q1 Section 8.3.2

106.

Controls

for
evaluation/disposition
of
accepting
nonconforming product that does not meet
original design acceptance

Q1 Section 8.3.2

107.

Notify customers in the event that product which does not

conform to design acceptance criteria has
been delivered, and records of such
notification shall be maintained.

Q1 Section 8.3.3

108.

Determine, collect & analyze data to demonstrate the

suitability & effectiveness of QMS & evaluate
continual improvement

Section 8.4

109.

Data provided relating to customer satisfaction, product

conformity, process/product trends, supplier
information

Section 8.4

110.

Control features for the identification and use of the

techniques for analysis of data

Q1 Section 8.4.1

111.

Continually improve the effectiveness of the QMS

259170020.doc

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Section 8.5.1
Page 19 of 21

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AUDIT DATE:

ITEM

AUDIT REF:
DOC. REFERENCE

112.

Documented procedure required to take action to eliminate

the cause of nonconformities to prevent
recurrence

Section 8.5.2

113.

Corrective action documented procedure established and

includes:

Section 8.5.2

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

a) Reviewing nonconformities (including customer

complaints)
b) Determining the cause of nonconformities
c) Evaluating the need for action to ensure that
nonconformities do not recur
d) Determining and implementing action to eliminate
nonconformity
e) Records of results taken
f) Reviewing the effectiveness of the corrective action
taken
114.

Ensure that any corrective action is effective

Q1 Section 8.5.2.1

115.

Identify response times for addressing corrective action.

Q1 Section 8.5.2.2

116.

Documented procedure required to take action to eliminate

the cause of potential nonconformities to
prevent occurrence

259170020.doc

Section 8.5.3

Page 20 of 21

AUDIT CHECKLIST
AUDITEE:

AUDIT DATE:

ITEM
117.

AUDIT REF:
DOC. REFERENCE

Preventive action document procedure established:

ISO 9001: 2008 and ISO TS 29000: 2008 (Q1)

OK
Y/N

Section 8.5.3

a) To determine potential nonconformities and their

causes
b) Evaluating the need for action to prevent
nonconformities
c) Determining and implementing action needed
d) Records of results taken

e) Reviewing the effectiveness of the preventive action

taken
118.

Ensure that any preventative action is effective

Q1 Section 8.5.3.1
Form Q-002

Prepared By: ___________________________

259170020.doc

Date: ________________________

Page 21 of 21