INTERNAL AUDIT CHECKLIST

Audit Reference Date

Location Audit Department/Activity

Core Operating Procedure Issue

Production Shift Pattern 6 am – 2 pm 2 pm – 10 10 pm – 6 am
Audited pm
6 am – 6 pm 6 pm – 6 am 8 am – 4:30 pm
Auditor Signature
Report Agreed By Signature
Corrective Action Required Not Required
Note – Corrective Actions to be detailed on form GB965

ISO9001:2000 CLAUSE TITLE AND REF

ISO9001:2000 Sub-Clause Title and Ref

Question Question based on ISO9001:2000 requirement. N/C
Number ISO9001:2000 Clause Ref/(QS9000 Clause Ref) Ref,
Statement of objective evidence viewed and findings (min sample of 3 items). Obs

Question Additional question based on QS9000 Third Edition requirement. N/C

Number (QS9000 Clause Ref) Ref,
Statement of objective evidence viewed and findings (min sample of 3 items). Obs

QUALITY MANAGEMENT SYSTEM

ELEMENT 4.0

4.1 General Requirements

1 Has the organisation:-

a) identified the processes needed for the quality management system and applied them
throughout the organisation ?
b) determined the sequence and interaction of these processes ?
c) determined criteria and methods needed to ensure that both the operation and control
of these processes are effective ?
d) ensured the availability of resources and information necessary to support the
operation and monitoring of these processes ?
e) monitored, measured and analysed these processes ?
f) implemented actions necessary to achieve planned results and continual improvement
of these processes ?

4.1

2 Are any outsourced processes that affect product conformity with requirements controlled
and identified within the quality management system ?
 4.1

4.2 Documentation Requirements

3 Does the quality management system documentation include:-

a) documented statements of a quality policy and quality objectives ?

b) a quality manual ?
c) documented procedures required by ISO9001:2000 and QS9000 Third Edition ?
d) documents needed by the organisation to ensure effective planning, operation and
control of its processes ?
e) records required by ISO9001:2000 and QS9000 Third Edition?

4.2.1/(4.1.1, 4.2.1, 4.2.2)

4 Does the quality manual include:-

a) the scope of the quality management system, including details of and justification for
any exclusions ?
b) the documented procedures established for the quality management system, or
reference to them ?
c) a description of the interaction between the processes of the quality management
system ?

4.2.2/(4.2.1)

5 Are all documents required by the quality management system controlled ?

4.2.3/(4.5.1)

6 Have documented procedures been established to define the controls needed:-

a) to approve documents for adequacy prior to issue ?

b) to review and update as necessary and re-approve documents ?
c) to ensure that changes and the current revision status of documents are identified ?
d) to ensure that relevant versions of applicable documents are available at points of
use ?
e) to ensure that documents remain legible and readily identifiable ?
f) to ensure that documents of external origin are identified and their distribution
controlled ?
g) to prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose ?

4.2.3/(4.5)

7 Do the designated functions or organisations have access to pertinent background

information upon which to base the review and approval?
(4.5.3)
8 Is the business plan under document control?
(4.1.4)

9 Is there a master list (or equivalent) identifying document revision status readily
available?
(4.5.2)

10 Is there timely review, distribution and implementation of customer engineering

standards/specifications and changes?
(4.5.2.1)

11 Does the supplier maintain a record of the date on which engineering changes are
implemented in production?
(4.5.2.1;4.16)

12 Does implementation of changes include updates to all appropriate documents?

(4.5.2.1)

13 Are records established and maintained to provide evidence of conformity to requirements

and of the effective operation of the quality management system ?

4.2.4/(4.16)

14 Have records remained legible, readily identifiable and retrievable ?

4.2.4/(4.16)

15 Has a documented procedure been established to define the controls needed for the
identification, storage, protection, retrieval, retention time and disposition of records ?

4.2.4/(4.16)
16 Does the control of quality records include pertinent subcontractor quality records?
(4.16)

17 Where agreed contractually are quality records available to the customer for evaluation
for an agreed period?
(4.16)

18 Are the following retained at a minimum for:

 Production parts approvals, tooling records, purchase orders and amendments for the
time the part is active for production and service plus one calendar year?
 Quality performance records for one calendar year after the year in which they were
created?
 Internal quality audits and management review records for three years?
(4.16.1)

19 Is there evidence of records disposal as established in the record retention?

(4.16.1)

MANAGEMENT RESPONSIBILITY
ELEMENT 5.0

5.1 Management Commitment

20 Does top management provide evidence of its commitment to the development and
implementation of the quality management system and continually improving its
effectiveness by:-

a) communicating to the organisation the importance of meeting customer as well as

statutory and legal requirements ?
b) establishing the quality policy ?
c) ensuring that quality objectives are established ?
d) conducting management reviews ?
e) ensuring the availability of resources ?

5.1

5.2 Customer Focus

21 Have top management ensured that customer requirements are determined and are met
with the aim of enhancing customer satisfaction ?

5.2

5.3 Quality Policy

22 Have top management ensured that the quality policy:-

a) is appropriate to the purpose of the organisation ?

b) includes a commitment to comply with requirements and continually improve the
effectiveness of the quality management system ?
c) provides a framework for establishing and reviewing quality objectives ?
d) is communicated and understood within the organisation ?
e) is reviewed for continuing suitability ?

5.3/(4.1.1)

5.4 Planning
23 Have top management ensured that quality objectives, including those needed to meet
requirements for product, are established at relevant functions and levels within the
organisation ?

5.4.1/(4.1.1)

24 Are the quality objectives measurable and consistent with the quality policy ?

5.4.1/(4.1.1)

25 Does the supplier utilise a formal, documented, comprehensive business plan that includes
short-term and longer-term goals and plan(s)?
(4.1.4)

26 Are there documented methods to track, update, revise and review the business plan to
ensure it is communicated and followed throughout the organisation, as appropriate?
(4.1.4)

27 Have top management ensured that:-

a) the planning of the quality management system is carried out in order to meet the
requirements given in ISO9001:2000 paragraph 4.1, as well as the quality objectives ?
b) the integrity of the quality management system is maintained when changes to the
quality management system are planned and implemented ?
 5.4.2

5.5 Responsibility, Authority and Communication

28 Have top management ensured that responsibilities and authorities are defined and
communicated within the organisation ?

5.5.1/(4.1.2.1)

29 Is management with responsibility and authority for corrective action promptly informed
of products or processes that become non-compliant with specified requirements?
(4.1.2.5)

30 Have top management appointed a member of management who, irrespective of other

responsibilities, has responsibility and authority that includes:-

a) ensuring that processes needed for the quality management system are established,
implemented and maintained ?
b) reporting to top management on the performance of the quality management system
and any need for improvement ?
c) ensuring the promotion of awareness of customer requirements throughout the
organisation ?

5.5.2/(4.1.2.3)

31 Have top management ensured that appropriate communication processes are established
within the organisation and that communication takes place regarding the effectiveness of
the quality management system ?

5.5.3

5.6 Management Review

32 Have top management reviewed the organisations quality management system, at planned
intervals, to ensure its continuing suitability, adequacy and effectiveness ?

5.6.1/(4.1.3)

33 Does the management review include assessing opportunities for improvement and the
need for changes to the quality management system, including the quality policy and
quality objectives ?

5.6.1
34 Are records from management reviews maintained ?

5.6.1/(4.1.3)

35 Does input to management review include information on:-

a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.

5.6.2

36 Does the output from the management review include any decisions and actions related
to:-

a) improvement of the effectiveness of the quality management system and its

processes,
b) improvement of product related to customer requirements, and
c) resource needs.

5.6.3

RESOURCE MANAGEMENT
ELEMENT 6.0

6.1 Provision of Resources

37 Has the organisation determined and provided the resources needed:-

a) to implement and maintain the quality management system and continually improve
its effectiveness ?
b) to enhance customer satisfaction by meeting customer requirements ?

6.1/(4.1.2.2)

6.2 Human Resources

38 Are personnel performing work affecting product quality competent on the basis of
appropriate education, training, skills and experience ?

6.2.1/(4.18)
39 Has the organisation:-

a) determined the necessary competence for personnel performing work affecting

product quality ?
b) provided training or taken other actions to satisfy competency needs ?
c) evaluated the effectiveness of the actions taken to satisfy competency needs ?
d) ensured that its personnel are aware of the relevance and importance of their activities
and how they contribute to the achievement of the quality objectives ?
e) maintained appropriate records of education, training, skills and experience ?

6.2.2/(4.18)

40 Are responsible personnel qualified in the “Required Skills” and equipped with adequate
resources as appropriate?
(4.4.2.1;4.18)

6.3 Infrastructure
41 Has the organisation determined, provided and maintained the infrastructure needed to
achieve conformity to product requirements, including as applicable:-

a) buildings, workspace and associated utilities,

b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication) ?

6.3

42 Is there an effective planned preventive maintenance system that identifies key process
equipment, provides appropriate resources, and includes at a minimum:
- A procedure describing planned maintenance activities?
- Scheduled maintenance activities?
- Predictive maintenance methods?
- A procedure providing for packaging and preservation of equipment, tooling and
gauging?
- Availability of replacement parts for key manufacturing equipment?
- Documenting, evaluating and improving maintenance objectives?
(4.9.g.1)

43 Is a multi-disciplinary approach used for developing facilities, equipment, and process

planning in conjunction with the advanced quality planning process?
(4.2.6.1;4.2.3.7)
44 Does the plant layout minimise material travel and handling, facilitate synchronous
material flow, and maximise value-added use of floor space?
(4.2.6.1)

45 Are methods developed for evaluating the effectiveness of existing operations and
processes which consider the overall work plan, appropriate automation, ergonomics and
human factors, operator and line balance, storage and buffer inventory levels, and value
added labour content?
(4.2.6.1)

46 Does the supplier have contingency plans to reasonably protect the customer’s supply of
product in the event of emergency?
(4.9.b.2)

6.4 Work Environment

47 Has the organisation determined and managed the work environment needed to achieve
conformity to product requirements ?

6.4/(4.9.b)

PRODUCT REALIZATION
ELEMENT 7.0

7.1 Planning of Product Realisation

48 In planning product realisation has the organisation determined the following, as
appropriate:-

a) quality objectives and requirements for the product,

b) the need to establish processes, documents, and provision of resources specific to the
product,
c) required verification, validation, monitoring, inspection and test activities specific to
the product and the criteria for product acceptance,
d) records needed to provide evidence that the realisation processes and resulting
product meet requirements ?

7.1
49 Is the output of product realisation planning in a form suitable for the organisations
method of operations ?

7.1

50 Does the supplier have a system in place to ensure management of appropriate activities
during concept development, prototype and production, (see APQP manual)?
(4.1.2.4)

51 Is the quality planning process consistent with all other requirements of the quality
system, documented in a suitable format, and does it consider as appropriate the elements
of the quality system that address:
 Identification and acquisition of all inspection & production/service resources?
 Conducting design and process feasibility studies?
 Updating and maintenance of all quality control and inspection methodology?
 Identification of suitable verification at appropriate stages?
 Production, installation and servicing processes which directly affect quality
 Preparation of control plans and FMEAs?
 Review of standards and specifications?
(4.2.3)

52 Is there evidence of an implemented advanced product quality planning process?

(4.2.3.1;4.2.3.2)

53 Does the supplier convene multi-disciplinary teams for the production of new or changed
products, that use appropriate techniques as listed in the Advanced Product Quality
Planning and Control Plan reference manual?
(4.2.3.1)

54 When required by the customer, are the process steps that affect Special Characteristics in
process control guidelines and similar documents marked with the customer’s special
characteristic symbol?
(4.2.3.2)

55 Is manufacturing feasibility investigated, confirmed, and documented, (Team Feasibility

Commitment form) prior to contracting proposed products?
(4.2.3.3)
56 Do the supplier’s design control and process control policies and practices consider as
appropriate due care and product safety?
(4.2.3.4)

57 Does the supplier promote internal awareness of safety considerations?

(4.2.3.4)

58 Do process FMEAs consider all Special Characteristics?

(4.2.3.5)

59 Is there evidence of efforts to achieve defect prevention versus detection, using PFMEA
information?
(4.2.3.5)

60 Are mistake proofing techniques utilised where appropriate, which include but are not
limited to planning of process, facilities, equipment and tooling, and in problem
resolution?
(4.2.3.6;4.10.3;4.14.1.2)

61 Are control plans developed by multi-disciplinary approach to the system, subsystem,

component, and/or material level, and list all controls used for process control?
(4.2.3.7)

62 Does the control plan include the information required in the Control Plan form in QS-
9000 Appendix J?
(4.2.3.7)

63 Do control plans cover three phases: prototype, pre-launch, and production, as required by
the customer?
(4.2.3.7)

64 Are control plans reviewed and updated as appropriate when any of the following occurs:
 product or process changes
 processes are found to be unstable or non-capable
  inspection method, frequency, etc. is revised?
(4.2.3.7)

65 Does the supplier fully comply with all requirements set forth in the PPAP manual?
(4.2.4.1)

66 Does the supplier utilise a part approval process for subcontractors?

(4.2.4.2)

67 Is there evidence that product changes are properly validated?

(4.2.4.3)

68 Does the supplier ensure confidentiality of customer contracted product under

development and related product information?
(4.4.11)

69 For attribute data with acceptance criteria other than zero defects, does the supplier
document acceptance criteria and have customer approval?
(4.10.1.1)

7.2 Customer-Related processes

70 Has the organisation determined:-

a) requirements specified by the customer, including the requirements for delivery and
post delivery activities ?
b) requirements not stated by the customer but necessary for specified or intended use,
where known ?
c) statutory and regulatory requirements related to the product ?
d) any additional requirements determined by the organisation ?

7.2.1

71 Does the organisation review the requirements related to the product prior to the
organisations commitment to supply (e.g. submission of tenders, acceptance of contracts
or orders, acceptance of changes to contracts or orders) ensuring that:-

a) product requirements are defined ?

b) contract or order requirements differing from those previously expressed are
resolved ?
c) the organisation has the ability to meet the defined requirements ?
 7.2.2/(4.3.2)

72 Are records of the result of the review and actions arising from the review maintained ?

7.2.2/(4.3.4)

73 Where the customer provides no documented statement of requirement, are the customer
requirements confirmed by the organisation before acceptance ?

7.2.2

74 Where product requirements are changed does the organisation ensure that relevant
documents are amended and that relevant personnel are made aware of the changed
requirements ?

7.2.2/(4.3.3)

75 Are customer specific contract requirements, including those in QS9000, Section II

deployed to the functions concerned and fully met?
(4.3.2;4.12.1)

76 Has the organisation determined and implemented effective arrangements for

communicating with customers in relation to:-

a) product information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints ?

7.2.3

77 Does the supplier have the ability to communicate necessary information and data in the
customer prescribed format?
(4.1.2.4)
7.3 Design and development
78 Does the organisation plan and control the design and development of product ?

7.3.1/(4.4.2)

79 During design and development planning has the organisation determined:-

a) the design and development stages,

b) the review, verification and validation that are appropriate to each design and
development stage, and
c) the responsibilities and authorities for design and development ?

7.3.1/(4.4.2.1)

80 Does the organisation manage the interfaces between different groups involved in design
and development to ensure effective communication and clear assignment of
responsibility ?

7.3.1/(4.4.3)

81 Is the planning output updated, as appropriate, as the design and development progresses ?

7.3.1/(4.4.2)

82 Does the supplier use a multi-disciplinary approach for decision making?

(4.1.2.4)

83 Are inputs relating to product requirements determined and records maintained ?

7.3.2/(4.4.4)

84 Do design inputs include:-

a) functional and performance requirements,

b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development ?

7.3.2/(4.4.1)
85 Are design inputs reviewed for adequacy, and are they complete, unambiguous and not in
conflict with each other ?

7.3.2/(4.4.4)

86 Is there a process to deploy information gained from previous design projects to current
and future ones of similar nature?
(4.4.1.1)

87 Do the following exist, if not waived by the customer:

- Appropriate resources and facilities available to use computer aided design,
engineering and analysis?
- If CAD/CAE is subcontracted, has the supplier provided technical leadership?
- Are CAD/CAE systems capable of two way interface with customer systems?
(4.4.4.1)

88 Are the outputs of design and development provided in a form that enables verification
against the design and development input ?

7.3.3/(4.4.7)

89 Are the outputs of design and development approved prior to release ?

7.3.3

90 Do design and development outputs:-

a) meet the input requirements for design and development,

b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use ?

7.3.3/(4.4.5)

91 Was the design output a result of a process that included:

- efforts to simplify, optimise, innovate and reduce waste?
- GDT (as applicable)?
- Analysis of cost/performance/risk trade offs?
- Feedback from testing, production and the field?
- Analysis of design failure mode and effects (DFMEA)?
(4.4.5.1)
92 At suitable stages are systematic reviews of design and development performed in
accordance with planned arrangements:-

a) to review evaluate the ability of the results of design and development to meet
requirements ?
b) to identify any problems and propose necessary actions ?

7.3.4/(4.4.6)

93 Do participants in design and development reviews include representatives of functions

concerned with the design and development stages being reviewed ?

7.3.4/(4.4.6)

94 Are records of the results of design and development reviews and any necessary actions
maintained ?

7.3.4/(4.4.6)

95 Is design and development verification performed in accordance with planned

arrangements to ensure that the design and development outputs have met the design and
development input requirements ?

7.3.5/(4.4.7)

96 Are records of the results of the design and development verification and any necessary
actions maintained ?

7.3.5/(4.4.7)

97 Has design and development validation been performed in accordance with planned
arrangements to ensure that the resulting product is capable of meeting the requirements
for the specified application or intended use, where known ?

7.3.6/(4.4.8)

98 Where practicable has design and development validation been completed prior to the
delivery or implementation of the product ?

7.3.6
99 Are records of results of design and development validation and any necessary actions
maintained ?

7.3.6/(4.4.8.1)

100 Is design validation performed in conjunction with the customer timing requirements?
(4.4.8.1)

101 Are design failures addressed through the designated corrective and preventive action
procedures?
(4.4.8.1)

102 When required by the customer, does the supplier have a comprehensive prototype
program?
(4.4.10)

103 Wherever possible, are the subcontractor’s tooling and process for the prototype the same
as the ones that will be used in production?
(4.4.10)

104 Is the performance testing (that considers and includes as appropriate life, durability,
reliability) tracked for timely completion and conformance?
(4.4.10)

105 If design verification services have been subcontracted has the supplier provided technical
leadership?
(4.4.10)

106 Are design and development changes identified and records maintained ?

7.3.7/(4.4.9)

107 Are design and development changes reviewed, verified and validated, as appropriate, and
approved before implementation ?

7.3.7/(4.4.9)

108 Does the review of design and development changes include evaluation of the effect of the
changes on constituent parts and product already delivered ?
 7.3.7

109 Are records of the results of the review of design and development changes and any
necessary actions maintained ?

7.3.7/(4.4.9)

110 Has written customer approval or waiver been obtained prior to a design change being
implemented into production?
(4.4.9.1)

111 For proprietary designs, does the supplier evaluate with the customer the impact of the
design change on form, fit, function, performance and/or durability?
(4.4.9.1)

112 Does the supplier consider the impact of design changes on the system in which the
product is used?
(4.4.9.2)

7.4 Purchasing
113 Does the organisation ensure that purchased product conforms to specified purchase
requirements ?

7.4.1

114 Does the type and extent of control applied to the supplier and the purchased product
depend upon the effect of the purchased product on subsequent product realisation or the
final product ?

7.4.1/(4.6.2.b)

115 Does the organisation evaluate and select suppliers based on their ability to supply product
in accordance with the organisation’s requirements ?

7.4.1/(4.6.2.a)

116 Is the criteria for selection, evaluation and re-evaluation established ?

7.4.1
117 Are records of the results of evaluations and any necessary actions arising from the
evaluation maintained ?

7.4.1/(4.6.2.c)

118 Where there is a customer-approved subcontractor list, is it used by the supplier as

required?
(4.6.1.1)

119 Do all purchased materials used in part manufacture conform to all applicable
governmental, safety and environmental regulations as they apply to the country of
manufacture and sale?
(4.6.1.2)

120 Is subcontractor quality system development being conducted using the QS-9000, Section
I as the fundamental quality system requirement with the goal of subcontractor
compliance to QS-9000?
(4.6.2.1)

121 Does purchasing information describe the product to be purchased, including where
appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements ?

7.4.2/(4.6.3)

122 Does the organisation ensure the adequacy of specified purchase requirements prior to
their communication to the supplier ?

7.4.2/(4.6.3)
123 Does the organisation establish and implement the inspection or other activities necessary
for ensuring that purchased product meets specified purchase requirements ?

7.4.3

124 Where the organisation or its customer intends to perform verification at the supplier’s
premises, does the organisation state the intended verification arrangements and method
of product release in the purchasing information ?

7.4.3/(4.6.4.1)

125 Does the supplier ensure that incoming product is not used or processed (except for urgent
production purposes), until it has been inspected or otherwise verified as conforming to
specified requirements in accordance with the quality plan and/or documented
procedures?
(4.10.2.1)

126 Is the amount and nature of receiving inspection based on the control exercised at the
subcontractor’s premises and records of conformance?
(4.10.2.2)

127 Is positive identification provided and recorded for material used in production but not
verified?
(4.10.2.3;4.16)

128 Does the supplier incoming quality system use one or more of the following methods:
- Receipt and evaluation of statistical data by supplier
- Receiving inspection and/or testing?
- Second or third party assessments or audits of subcontractor sites when coupled with
records of acceptable performance?
- Evaluations by accredited laboratories

(4.10.2.4)
129 Is 100% on time delivery a requirement of the subcontractors?
(4.6.2.2)

130 Is there appropriate planning information and purchasing commitments, provided by the
supplier, to enable the subcontractors to meet the required 100% on-time delivery?
(4.6.2.2)

131 Is there evidence of a system to monitor the delivery performance of subcontractors

including all premium freight and evidence of appropriate corrective action?
(4.6.2.2)

7.5 Production and Service Provision

132 Does the organisation plan and carry out production and service provision under
controlled conditions which include, as applicable ?

a) the availability of information that describes the characteristics of the product,

b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement,
f) the implementation of release, delivery and post-delivery activities ?
7.5.1/(4.9)

133 Do controlled conditions include compliance with reference standards/codes, quality plans
and/or documented procedures?
(4.9.c)

134 Has the supplier established and implemented a system for tool management that includes
maintenance and repair facilities and personnel, storage and recovery, set-up, and tool
change programs for perishable tools, tool modification including tool design
modification?
(4.2.6.2)
135 Are appropriate technical resources available for tool and gage design, fabrication and full
dimensional inspection?
(4.2.6.2)

136 If tooling activities are subcontracted, is there a system to track and follow-up these
activities ?
(4.2.6.2)

137 Have documented process monitoring and operator instructions derived from the sources
listed in the Advanced Product Quality Planning and Control Plan reference manual, or
equivalent sources, been prepared for all employees having responsibilities for operation
of processes and are they accessible at the workstation?
(4.9.1)

138 Do process monitoring and operator instructions include or reference, as appropriate:

- Operation name and number keyed to process flow diagram?
- Part name and part number?
- Current engineering level/date?
- Required tools, gages and other equipment?
- Material identification and disposition instructions?
- Customer and supplier designated Special Characteristic?
- SPC requirements?
- Relevant engineering and manufacturing standards?
- Inspections and test instructions?
- Reaction plan
- Revision date and approvals?
- Visual aids/
- Tool change intervals and set-up instructions?
(4.9.1;4.9.4)

139 Are control plans annotated accordingly when the customer requires different capability or
performance?
(4.9.3)
140 Does the supplier verify job set-ups, using statistical methods where applicable?
(4.9.4)

141 Are process activities directed towards defect prevention methods, such as statistical
process control, mistake proofing, visual controls, rather than defect detection?
(4.10.3.c)

142 Is there documented evidence that servicing meets the specified requirements?
(4.19)

143 Have reporting and verification systems been established to communicate information on
service concerns to supplier manufacturing, engineering and design activities?
(4.19.1)

144 Does the organisation validate any processes for production and service provision where
the resulting output cannot be verified by subsequent monitoring or measurement ?
This includes any processes where deficiencies become apparent only after the product is
in use or the service has been delivered.

7.5.2/(4.9)

145 Does validation demonstrate the ability of these processes to achieve planned results ?

7.5.2

146 Does the organisation establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific measures and procedures,
d) requirements for records, and
e) revalidation ?
7.5.2/(4.9)

147 Where appropriate, Does the organisation identify the product by suitable means
throughout product realisation ?

7.5.3/(4.8)
148 Does the organisation identify the product status with respect to monitoring and measuring
requirements ?

7.5.3/(4.12)

149 Where tractability is required, Does the organisation control and record the unique
identification of the product ?

7.5.3/(4.8)

150 Is identification of inspection and test status maintained as defined in the quality plan
(Control Plan) and/or documented procedures throughout production, installation and
services of product?
(4.12)

151 When required by the customer, are additional verification/identification requirements

met?
(4.12.1)

152 Does the organisation exercise care with customer property while it is under the
organisation’s control or being used by the organisation ?

7.5.4/(4.7)

153 Does the organisation identify, verify, protect and safeguard customer property provided
for use or incorporation into the product ?

7.5.4/(4.7)

154 If any customer property is lost, damaged or otherwise found to be unsuitable for use, Is
this reported to the customer and records maintained ?

7.5.4/(4.7)

155 Are customer owned tools and equipment permanently marked so that ownership of each
item is visually apparent?
(4.7.1)
156 Does the organisation preserve the conformity of product during internal processing and
delivery to intended destination ?

7.5.5/(4.15.5)

157 Does this preservation include identification, handling, packaging, storage and
protection ?

7.5.5

158 Does preservation also apply to the constituent parts of a product ?

7.5.5/(4.15.5)

159 Are designated storage areas or stock rooms used to prevent damage or deterioration of
the product pending use or delivery?
(4.15.3)

160 Have appropriate methods for authorising receipt to and dispatch from designated storage
areas or stock rooms been stipulated?
(4.15.3)

161 Is the condition of product in stock assessed at appropriate intervals to detect

deterioration?
(4.15.3)

162 Does the supplier use an inventory management system to optimise inventory turns, assure
stock rotation and minimise inventory levels?
(4.15.3.1)

163 Does the supplier control the packing, packaging and marking processes so as to ensure
product conformance to specifications?
(4.15.4)

164 Are applicable customer packaging standards/guidelines (including service part packaging
standards) complied with?
(4.15.4.1)

165 Has a system been developed to ensure that all materials shipped are labelled according to
customer requirements?
(4.15.4.2)
166 Does the supplier arrange for the protection of the quality of product after final inspection
and test, and when contractually specified does it extend to include delivery to
destination?
(4.15.6)

167 Has the supplier established a system to support 100% on-time shipments to meet
customer production and service requirements?
(4.15.6.1)

168 If the supplier’s delivery performance is not 100% to schedule, is there evidence of
implemented corrective actions, and of communication regarding delivery problem
information to the customer?
(4.15.6.1)

169 Does the supplier have a systematic approach to develop, evaluate and monitor adherence
to established lead time requirements?
(4.15.6.1)

170 Has the supplier implemented a system to track performance to customer delivery
requirements and premium freight?
(4.15.6.1)

171 Are materials shipped in conformance with the customer requirements, adhering to up-to-
date customer specified transportation mode, routings and containers?
(4.15.6.1)

172 Is supplier’s production scheduling activity order driven?

(4.15.6.2)

173 Does the supplier have a computerised system for receiving customer planning
information and ship schedules, unless waived by the customer?
(4.15.6.3)

174 Does the supplier have a computerised system for transmitting advanced ship notices to
the customer, unless waived by the customer?
(4.15.6.4)

175 Does the supplier have a back-up method in the event the on-line system fails?
(4.15.6.4)
176 Has the supplier verified that all ASNs match shipping documents and labels?
(4.15.6.4)

7.6 Control of Monitoring and Measuring Devices

177 Does the organisation determine the monitoring and measurement to be undertaken and
the monitoring and measuring devices needed to provide evidence of conformity of
product to determine requirements?

7.6/(4.11.2.a)

178 Does the organisation 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?

7.6/(4.11.1)

179 Where necessary to ensure valid results, is measuring equipment calibrated or verified at
specified intervals, or prior to use, against measurements standards traceable to
international or national measurement standards ?

Where no such standards exist, is the basis used for calibration or verification recorded ?

7.6.a/(4.11.2.b)

180 Where necessary to ensure valid results, is measuring equipment adjusted or re-adjusted as
necessary ?

7.6.b

181 Where necessary to ensure valid results, is measuring equipment identified to enable the
calibration status to be determined ?

7.6.c/(4.11.2.d)

182 Where necessary to ensure valid results, is measuring equipment safeguarded from
adjustment that would invalidate the measurements results ?

7.6.d/(4.11.2.i)
183 Where necessary to ensure valid results, is measuring equipment protected from damage
and deterioration during handling, maintenance and storage ?

7.6.e/(4.11.2.h)

184 In addition, Does the organisation assess and record the validity of the previous measuring
results when the equipment is found not to conform to requirements ?

7.6/(4.11.2.f)

185 Does the organisation take appropriate action on the equipment and any product affected ?

7.6

186 Are records of the results of calibration and verification maintained ?

7.6/(4.11.2.e)

187 When used in the monitoring and measurement of specified requirements, Is the ability of
computer software to satisfy the intended application confirmed ?

7.6

188 Is this undertaken prior to initial use and reconfirmed as necessary ?

7.6

189 Does the laboratory have a scope and document its policies, systems, programs,
procedures, instructions and findings to assure the quality of calibration and tests
performed?
(4.10.6.1;4.10.6.3)

190 Do lab personnel have appropriate background and experience?

(4.10.6.2)
191 Are items retained until final data is complete to enable traceability to raw data?
(4.10.6.3)

192 Does the laboratory use test and/or calibration methods which meet the needs of the
customer and are appropriate for the intended use?
(4.10.6.5)

193 Is test capability verified prior to performing the testing work?

(4.10.6.5)

194 When the supplier uses independent/commercial laboratories are they accredited to
ISO/IEC Guide 25 (or national equivalent), or have evidence, e.g. assessment by an OEM
customer or an OEM customer –approved second party, that they meet the intent of
ISO/IEC Guide 25 or national equivalent, or where a qualified laboratory doesn’t exist is
the calibration service performed by the original equipment manufacturer ?
(4.10.7, 4.11.2.b1)

195 Is technical data pertaining to the inspection, measuring and test equipment available for
review by the customer, if they so require, for verification that the inspection, measuring
and test equipment is functionally adequate?
(4.11.1)

196 Does the process for calibration of inspection, measuring and test equipment include the
following:
- Type of equipment?
- Unique identification?
- Location?
- Frequency of checks?
- Check method?
-Acceptance criteria?
- Corrective actions
(4.11.2.c)
197 Has the supplier ensured that the environmental conditions are controlled, recorded and
suitable for inspections, measurements and tests being carried out?
(4.10.6.4;4.11.2.g;4.16)

198 Do records of the calibration/verification activity for all gages, measuring and test
equipment, including employee owned gages, include:
- Revisions following engineering changes (if appropriate)?
- Gage conditions and actual readings as received for calibration/verification?
- Notification to customer if suspect material or product may have been shipped?
(4.11.3)

199 For measurement systems referenced in the Control Plan is there evidence that appropriate
statistical studies have been conducted to analyse the variation present in the results of
each type of measuring and test equipment system?
(4.11.4)

MEASURING, ANALYSIS AND IMPROVEMENT

ELEMENT 8

8.1 General
200 Does the organisation plan implement the monitoring, measurement, analysis and
improvement process needed
a) to demonstrate conformity of the product,
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system ?

8.1

201 Does this include determination of applicable methods, including statistical techniques,
and the extent of their use ?

8.1/(4.20.1)
202 Are there documented procedures established and maintained to implement and control
the application of statistical techniques?
(4.20.2)

203 Are appropriate statistical tools for each process determined during advanced quality
planning and included in the control plan?
(4.20.3)

204 Are the concepts of variation, control (stability), capability, and overadjustment
understood throughout the organisation as appropriate?
(4.20.4)

8.2 Monitoring and Measurement

205 As one of the measurements of the performance of the quality management system, Does
the organisation monitor information relating to customer perception as to whether the
organisation has met customer requirements ?

8.2.1/(4.1.6)

206 Are the methods for obtaining and using this information determined ?

8.2.1/(4.1.6)

207 Are there methods in place to determine current and future customer expectations?
(4.1.4)

208 Does the supplier have an objective process that defines the scope and collection of
information (customer expectations and customer satisfaction), frequency and methods of
collection?
(4.1.4; 4.1.6)
209 Is there evidence the supplier notifies within 5 working days the certification
body/registrar when a customer places the site in any status listed in
QS-9000?
(4.1.6.1)

210 Does the organisation conduct internal audits at planned intervals to determine whether
the quality management system
a) conforms to the planned arrangements, to the requirements of this international
standard and to the quality management system requirements established by the
organisation, and
b) is effectively implement and maintained.

8.2.2/(4.17)

211 Is an audit programme planned, taking into consideration the status and importance of the
processes and areas to be audited, as well as the results of previous audits ?

8.2.2/(4.17)

212 Is the audit criteria, scope, frequency and methods defined ?

8.2.2

213 Does selection of auditors and conduct of audits ensure objectivity and impartiality of the
audit process ?

8.2.2/(4.17)

214 Do auditors audit their own work ?

8.2.2/(4.17)

215 Are the responsibilities and requirements for planning and conducting audits, and for
reporting results and maintaining records defined in a documented procedure ?

8.2.2/(4.17)
216 Does the management responsible for the area being audited ensure that actions are taken
without undue delay to eliminate detected nonconformities and their causes?

8.2.2/(4.17)

217 Do follow-up activities include the verification of the actions taken and the reporting of
verification results ?

8.2.2/(4.17)

218 Does internal auditing cover all shifts?

(4.17.1)

219 Is the internal auditing audit schedule updated annually?

(4.17.1)

220 Does the organisation apply suitable methods for monitoring and, where applicable,
measurement of the quality management system processes ?

8.2.3

221 Do these methods demonstrate the ability of the processes to achieve planned results ?

8.2.3

222 When planned results are not achieved, is corrective action taken, as appropriate, to
ensure conformity of the product ?

8.2.3

223 Does the supplier maintain or exceed the process capability or performance as approved
by PPAP through the implementation and adherence to the Control Plan, Process Flow
Diagram, measurement technique, sampling plans and reaction plans when acceptance
criteria is not met?
(4.9.2;4.10.1)
224 Are significant process events recorded, (on the control charts)?
(4.9.2)

225 Does the supplier initiate the appropriate reaction plan for unstable or non-capable
characteristics (identified on the Control Plan), and is it supported by appropriate records?
(4.9.2)

226 Does the reaction plan include as appropriate:

- containment and 100% inspection?
- specific corrective action timing?
- responsibility assignment?
- customer approval
(4.9.2)

227 Does the supplier maintain record(s) of process change effective dates?
(4.9.5;4.5.3)

228 Does the organisation monitor and measure the characteristics of the product to verify that
product requirements have been met ?

8.2.4/(4.9.d)

229 Is this carried out at appropriate stages of the product realisation process in accordance
with the planned arrangements ?

8.2.4/(4.10.3.a)

230 Is evidence of conformity with the acceptance criteria maintained ?

8.2.4/(4.10.5)

231 Do records indicate the person(s) authorising release of the product ?

8.2.4/(4.10.5)
232 Does product release and service delivery not proceed until the planned arrangements
have been satisfactorily completed, unless otherwise approved by a relevant authority and,
where applicable, by the customer ?

8.2.4/(4.10.4)

233 For customer designated appearance items:

- Is there appropriate lighting for the evaluation area(s)?
-Are all appropriate masters available?
- Are the masters and evaluation equipment adequately maintained and controlled?
- Is there verification that personnel making appearance evaluation are qualified
(4.9.6;4.1.2.2)

234 Does the supplier carry out final inspection and testing in accordance with the quality plan
(Control Plan) and/or documented procedures?
(4.10.4)

235 Does the quality plan (Control Plan) mandate that all specified inspections and tests,
incoming, in process, and final, must be performed and that they meet specified
requirements?
(4.10.4)

236 Are layout inspection and functional verification performed for all products at frequencies
established by the customer (see QS-9000 Section II)? Are results from layout inspection
and functional testing available for customer review?
(4.10.4.1)

237 Does the suppler conduct scheduled audits of the packaged final product to verify
conformance to all specified requirements?
(4.10.4.2)

8.3 Control of Non-Conforming Product

238 Does the organisation ensure that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or delivery ?

8.3/(4.13.1)

239 Are the controls and related responsibilities and authorities for dealing with non-
conforming product defined in a documented procedure ?

8.3/(4.13.1)

240 Does the organisation deal with non-conforming product by one or more of the following
ways:
a) By taking action to eliminate the detected non-conformity;
b) By authorising its use, release or acceptance under concession by a relevant authority
and, where applicable, by the customer;
c) By taking action to preclude its original intended use or application.

8.3/(4.13.2)

241 Are records of the nature of non-conformities and any subsequent actions taken, including
concessions maintained ?

8.3/(4.13.2)

242 When non-conforming product is corrected, Is it subject to re-verification to demonstrate

conformity to the requirements ?

8.3/(4.13.2)

243 When non-conforming product is detected after delivery or use has started, Does the
organisation take action appropriate to the effects, of the non-conformity ?

8.3/(4.14.2)

244 Does the supplier quantify and analyse nonconforming product, establish a prioritised
reduction plan and track progress?
(4.13.2.1)

245 Are the rework instructions accessible and utilised by the appropriate personnel in their
work areas?
(4.13.3)
246 Are service application products with visible exterior rework approved by the customer
service parts organisation?
(4.13.3)

247 Does the supplier obtain customer authorisation prior to shipment whenever product or
process is different from the current PPAP approval?
(4.13.4)

248 Does the supplier maintain records of the expiration dates for Engineering Approved
Product Authorisations (EAPs) and quantities authorised?
(4.13.4)

249 Is compliance with the original or superseding specification and requirements ensured
when authorisation expires?
(4.13.4)

250 Is material shipped on an authorisation properly identified on each shipping container?

(4.13.4)

8.4 Analysis of Data

251 Does the organisation determine, collate and analyse appropriate data to demonstrate the
suitability and effectiveness of the quality management system and evaluate the continual
improvement of the effectiveness of the quality management system can be made ?
8.4/(4.1.5)

252 Does this include data generated as a result of monitoring and measurement and from
other relevant sources ?

8.4
253 Does the analysis of data provide information relating to
a) customer satisfaction,
b) conformity to product requirements,
c) characteristics and trends of processes and product including opportunities for
preventative action, and
d) suppliers ?

8.4/(4.1.5, 4.1.6)

254 Are goals and plans based on analysis of competitive products and benchmarking inside
and outside the automotive industry?
(4.1.4)

8.5 Improvement

255 Does the organisation continually improve the effectiveness of the quality management
system through the use of the quality policy, quality objectives, audit results, analysis of
data, corrective and preventative actions and management review ?

8.5.1

256 Is there evidence of continuous improvement in quality (extending to product

characteristics), service (timing and delivery) and price, that benefit all customers?
(4.2.5.1;4.1.6)

257 Does continuous improvement extend to product characteristics with the highest priority
on special characteristics?
(4.2.5.1)

258 Does the supplier have a prioritized action plan for continuous improvement in processes
that have demonstrated stability, acceptable capability and performance?
(4.2.5.1)

259 Has the supplier identified opportunities and implemented appropriate projects for quality
and productivity improvement?
(4.2.5.2)
260 Has the supplier demonstrated knowledge and used appropriate continuous improvement
measures and methodologies?
(4.2.5.3)

261 Does the organisation take action to eliminate the cause of non-conformities in order to
prevent recurrence ?

8.5.2/(4.14.2.c)

262 Are corrective actions appropriate to the effects of the non-conformities encountered ?

8.5.2/(4.14.1)

263 Is there a documented procedure established to define requirements for

a) reviewing nonconformities (including customer complaints),
b) determining the cause of non-conformities,
c) evaluating the need for action to ensure that non-conformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken, and
f) Reviewing corrective action taken.

8.5.2/(4.14.2)

264 Are changes to the documented procedures resulting from corrective or preventive action
implemented and recorded?
(4.14.1)

265 Does the supplier use a disciplined problem solving method to address internal or external
nonconformances?
(4.14.1.1)

266 Does the supplier respond to external nonconformances in the customer prescribed
manner?
(4.14.1.1)

267 Does the supplier use mistake proofing methodology, as appropriate, in their corrective
and preventive action process?
(4.14.1.2)
268 Are returned parts from customer manufacturing plants, engineering facilities, and
dealerships analysed, and are records of this analysis kept and made available upon
request?
(4.14.2.1)

269 Where appropriate, does the supplier initiate corrective action and process changes to
prevent recurrence?
(4.14.2.1)

270 Where applicable, does the supplier consider the impact of corrective actions on other
products?
(4.14.2.2)

271 Does the organisation determine action to eliminate the causes of potential non-
conformities in order to prevent their occurrence ?

8.5.3/(4.14.1)

272 Are preventative actions appropriate to the effects to the potential problems ?

8.5.3/(4.14.1)

273 Is a documented procedure shall be established to define requirements for

a) determining potential non-conformities and their causes,
b) evaluating the need for action to prevent occurrence of non-conformities,
c) determining and implementing action needed,
d) records of resulting of action taken, and
e) reviewing preventive action taken ?

8.5.3/(4.14.3)

274 Do procedures for preventive action include the use of appropriate sources of information,
e.g., product quality, deviation, audit result, quality records, etc., to develop preventive
actions?
(4.14.3.a)
275 Do procedures for preventive action include the determination of steps needed to deal
with problems requiring preventive action?
(4.14.3.b)

276 Do procedures for preventive action include initiation of preventive action and application
of controls to ensure that it is effective?
(4.14.3.c)

277 Do procedures for preventive action include provisions that the relevant information on
actions taken is submitted for management review?
(4.14.3.d;4.1.3)