Professional Documents
Culture Documents
Audit Checklist
(ISO 9000:2000, TS 16949:2002)
Supplier: _________________________________________________________________________________________________________________
____________________________________________
____________________________________________
Scope of Audit: ___________________________________________________________________________________________
Potential suppliers may be requested to conduct a self-assessment of their quality system to determine eligibility. The Nova Sourcing Team shall
determine eligibility after analysis of the self-assessment. Results of the Checklist shall be documented and communicated to the supplier by the Nova
Sourcing Team.
4.1q2f The organization shall f) implement actions How has Supplier implemented actions
necessary to achieve planned results and necessary to achieve planned results
continual improvement of these processes. and continual improvement of processes
needed for the QMS?
4.1q3 These processes shall be managed by the Are processes needed for the QMS
organization in accordance with the managed by Supplier in accordance with
requirements of this International Standard. the requirements of ISO 9001:2000?
4.1q4 Where an organization chooses to When Supplier out sources any process
outsource any process that affects product that affects product conformity with
conformity with requirements, the requirements, how is control ensured
organization shall ensure control over such over such processes? (See 7.4)
processes.
4.1q5 Control of such outsourced processes shall Where is the control of outsourced
be identified within the quality management processes that affect product conformity
system. with requirements identified within the
QMS? (See 7.4)
5 Management responsibility
5.1 Management commitment
5.1q1a Top management shall provide evidence of How does top management
its commitment to the development and communicate the importance of meeting
implementation of the quality management customer and legal requirements
system and continually improving its throughout its organization?
effectiveness by
a) communicating to the organization the Has a company quality policy been
importance of meeting customer as well established? (See 5.3)
as statutory and regulatory
requirements, What are the quality objectives
b) establishing the quality policy, established by top management? (See
c) ensuring that quality objectives are 5.4.1)
established,
d) conducting management reviews, and Does top management conduct
e) ensuring the availability of resources. management reviews? (See 5.6)
5.4.1q2 The quality objectives shall be measurable Are the quality objectives consistent with
and consistent with the quality policy. the quality policy? What are the
measurements?
T5.5.1.1q3 Production operations across all shifts shall What personnel on each shift have
be staffed with personnel in charge of, or responsibility for ensuring product
delegated responsibility for, ensuring quality?
product quality.
5.5.2 Management representative
5.5.2q1a Top management shall appoint a member Who is your ISO 9001:2000
of management who, irrespective of other management representative?
responsibilities, shall have responsibility
and authority that includes Does the management representative
a) ensuring that processes needed for the have responsibility and authority to:
quality management system are a) ensure that processes needed for the
established, implemented and QMS are established, implemented and
maintained, maintained?
b) reporting to top management on the b) report to top management on the
performance of the quality performance of the QMS and any need
management system and any need for for improvement?
improvement, and c) ensure the promotion of awareness of
b) c) ensuring the promotion of customer requirements throughout
awareness of customer requirements Supplier?
throughout the organization.
NOTE The responsibility of a management representative can include liaison with external
parties on matters relating to the quality management system.
5.6.1q2 This review shall include assessing What kinds of information are reviewed
opportunities for improvement and the need in management reviews? (must include
for changes to the quality management suitability, adequacy and effectiveness
system, including the quality policy and of QMS; improvement; & changes to the
quality objectives. QMS, quality policy and objectives)
5.6.1q3 Records from management reviews shall Can you show me records from recent
be maintained (see 4.2.4). management reviews?
NOTE 1 This applies to all employees having an effect on quality at all levels of the
organization.
T6.2.2.3q2 Personnel whose work can affect quality How do you inform personnel about the
shall be informed about the consequences consequences to the customer of
to the customer of nonconformity to quality nonconformity to quality requirements?
requirements. (Sample throughout Supplier)
T6.2.2.4q2 The process shall include the promotion of Does the process include the promotion
quality and technological awareness of quality and technological awareness
throughout the whole organization. throughout the entire Supplier?
T6.2.2.4q3 The organization shall have a process to What process has been established
measure the extent to which its personnel to measure the extent to which
are aware of the relevance and importance personnel are aware of the relevance
of their activities and how they contribute to and importance of their activities
the achievement of the quality objectives and how they contribute to the
[see 6.2.2 d)]. achievement of the quality
objectives?
(See 6.2.2d)
T6.3.1q2 Plant layouts shall optimize material travel, Can you show that plant layouts
handling and value-added use of floor optimize material travel, handling and
space, and shall facilitate synchronous floor space use, and facilitate
material flow. synchronous material flow?
T6.3.1q3 Methods shall be developed and What methods are used to evaluate and
implemented to evaluate and monitor the monitor the effectiveness of existing
effectiveness of existing operations. operations?
NOTE These requirements should focus on lean manufacturing principles and the link to the
effectiveness of the quality management system.
7 Product realization
7.1 Planning of product realization
7.1q1 The organization shall plan and develop Where are the processes needed for
the processes needed for product product realization identified?
realization.
7.1q3 In planning product realization, the Where in the product realization process
organization shall determine the following, do you determine the quality objectives
as appropriate: and requirements for products?
a) quality objectives and requirements for
the product; When planning for product realization,
b) the need to establish processes, how do you establish processes,
documents, and provide resources documents, and provide resources
specific to the product; specific to the product
c) required verification, validation,
monitoring, inspection and test activities How do you determine verification,
specific to the product and the criteria for validation, monitoring, inspection and
product acceptance; test activities specific to the product, and
d) records needed to provide evidence that the criteria for product acceptance?
the realization processes and resulting
product meet requirements (see 4.2.4). What records exist showing that both
the realization processes and the
product meet requirements?
7.1q4 The output of this planning shall be in a What are the outputs of product
form suitable for the organization's method realization planning? Are they in a form
of operations. suitable for Supplier?
T7.1.2q2 For attribute data sampling, the acceptance When attribute data sampling, is the
level shall be zero defects (see 8.2.3.1). acceptance level zero defects?
7.1.3 Confidentiality
T7.1.3q1 The organization shall ensure the How does Supplier ensure the
confidentiality of customer-contracted confidentiality of customer-contracted
products and projects under development, products, projects under development,
and related product information. and related product information?
T7.1.4q2 The effects of any change, including those How are the effects of changes
changes caused by any supplier, shall be assessed, including changes caused
assessed, and verification and validation by suppliers? , and verification and
activities shall be defined, to ensure validation activities shall be defined,
compliance with customer requirements. to ensure compliance with customer
requirements.
T7.1.4q4 For proprietary designs, impact on form, fit Is impact on form, fit and function
and function (including performance and/or (including performance and/or
durability) shall be reviewed with the durability) reviewed with the
customer so that all effects can be properly customer for proprietary designs
evaluated. so that all effects can be properly
evaluated?
T7.1.4q5 When required by the customer, additional Do you have evidence that any
verification/identification requirements, such additional verification/identification
as those required for new product requirements required by the
introduction, shall be met. customer are met?
7.3.1q3 The organization shall manage the How does Supplier ensure effective
interfaces between different groups communication and clear assignment of
involved in design and development to responsibility between different groups
ensure effective communication and clear involved in design and development?
assignment of responsibility.
7.3.1q4 Planning output shall be updated, as As product design and development
appropriate, as the design and progresses, how are the planning
development progresses. outputs updated?
7.3.2q2 These inputs shall be reviewed for How & when are the design and
adequacy. development inputs reviewed for
adequacy?
7.4.1q2 The type and extent of control applied to How do you determine the type and
the supplier and the purchased product extent of control applied to the supplier
shall be dependent upon the effect of the and the purchased product?
purchased product on subsequent product
realization or the final product.
7.4.1q3 The organization shall evaluate and select How do you evaluate and select
suppliers based on their ability to supply suppliers? (based on their ability to
product in accordance with the supply product in accordance with
organization's requirements. Suppliers requirements)
7.4.1q4 Criteria for selection, evaluation and re- Can you show me the criteria for
evaluation shall be established. selection, evaluation and re-evaluation
of suppliers?
7.4.1q5 Records of the results of evaluations and Can you show me records of the results
any necessary actions arising from the of supplier evaluations and any
evaluation shall be maintained (see 4.2.4). necessary actions? (verify that criteria
have been met)
NOTE 1 Purchased products above includes all products and services that affect customer
requirements such as sub-assembly, sequencing, sorting, rework and calibration services.
NOTE 2 When there are mergers, acquisitions or affiliations associated with suppliers, the
organization should verify the continuity of the suppliers quality system and its effectiveness.
7.4.1.1 Regulatory conformity
T7.4.1.1q1 All purchased products or materials used in What evidence is there that all
product shall conform to applicable purchased products or materials
regulatory requirements. used in product conform to regulatory
requirements?
7.4.2q2 The organization shall ensure the adequacy How does Supplier ensure the
of specified purchase requirements prior to adequacy of purchasing requirements
their communication to the supplier. before communicating them to the
supplier?
7.4.3q2 Where the organization or its customer Do you ever perform product verification
intends to perform verification at the at the supplier's site?
supplier's premises, the organization shall
state the intended verification arrangements If so, where are the verification
and method of product release in the arrangements and method of product
purchasing information. release identified?
T7.4.3.2q2 The organization shall promote supplier How do you promote supplier
monitoring of the performance of their monitoring of the performance
manufacturing processes. of their manufacturing
processes?
T7.5.1.3q2 Work instructions shall be available for set- What work instructions do you have for
up personnel. job setup personnel?
T7.5.1.3q3 The organization shall use statistical What statistical methods are used to
methods of verification where applicable. verify job setups?
T7.5.1.4q2 As a minimum, this system shall include the (Verify that the PM system includes the
following: following:
- planned maintenance activities; - planned maintenance activities
- packaging and preservation of - packaging and preservation of
equipment, tooling and gauging; equipment, tooling and gauging
- availability of replacement parts for key - availability of replacement parts for key
manufacturing equipment; manufacturing equipment
- documenting, evaluating and improving - documenting, evaluating and improving
maintenance objectives. maintenance objectives)
T7.5.1.5q2 The organization shall establish and Does the production tooling
implement a system for production tooling management system include:
management including: - maintenance and repair facilities and
- maintenance and repair facilities and personnel
personnel; - storage and recovery
- storage and recovery, - set-up
- set-up; - perishable tool change programs
- tool-change program for perishable tools; - tool design modification
- tool design modification documentation, documentation, including engineering
including engineering change level; change level
- tool modification and revision to - tool modification and revision to
documentation; documentation
- tool identification, defining the status, - tool identification, defining the status,
such as production, repair or disposal. such as production, repair or disposal.
T7.5.1.5q3 The organization shall implement a system Are any tooling management activities
to monitor these activities if any work is outsourced?
outsourced.
If so, how are these activities
monitored?
NOTE This requirement also applies to the availability of tools for vehicle service parts.
7.5.1.6 Production scheduling
T7.5.1.6q1 Production shall be scheduled in order to Can you demonstrate that customer
meet customer requirements, such as just- scheduling requirements (such as just-
in-time supported by an information system in-time) are being met?
that permits access to production
information at key stages of the process
and is order driven.
7.5.2q2 Validation shall demonstrate the ability of Can you show me records that
these processes to achieve planned results. demonstrate that the validation done has
met the requirements?
7.5.2q3a The organization shall establish How are these special processes
arrangements for these processes reviewed and approved?
including, as applicable
a) defined criteria for review and approval Can you show me records of personnel
of the processes, and equipment qualification?
b) approval of equipment and qualification
of personnel, Where are specific methods and
c) use of specific methods and procedures procedures defined?
d) requirements for records (see 4.2.4),
and Can you show me records for these
e) revalidation. processes?
7.5.3q3 Where traceability is a requirement, the Can you show me unique identification
organization shall control and record the records for products requiring
unique identification of the product (see traceability?
4.2.4).
NOTE In some industry sectors, configuration management is a means by which identification and
traceability are maintained.
X NOTE Inspection and test status is not indicated by the location of product in the production flow
unless inherently obvious such as material in an automated production transfer process. Alternatives
are permitted, if the status is clearly identified, documented, and achieves the designated purpose.
X 7.5.3.1 Identification and traceability Supplemental
X The words Where appropriate in 7.5.3 Is all product suitably identified?
above, shall not apply.
7.6q3a Where necessary ensure valid results, a) How do you ensure that measuring and
measuring equipment shall test equipment is calibrated or verified
a) be calibrated or verified at specified proper frequencies with NIST traceable
intervals, or prior to use, against standards? If no such standards exist,
measurement standards traceable to where do you record the basis used for
international or national measurement calibration or verification?
standards; where no such standards b) What process is used to adjust or re-
exist, the basis used for calibration or adjust measuring and test equipment
verification shall be recorded; when needed?
b) be adjusted or re-adjusted as necessary; c) How are measuring tools identified to
c) be identified to enable the calibration enable the calibration status to be
status to be determined; determined?
d) be safeguarded from adjustments that d) How do you safeguard measuring
would invalidate the measurement equipment from adjustments that
result; would invalidate the measurement
e) be protected from damage and results?
deterioration during handling, e) How do you ensure that measuring
maintenance and storage. its test equipment is protected from
damage and deterioration during
handling, maintenance and storage?
T7.6.3.1q2 The laboratory shall specify and implement, Where are laboratory technical
as a minimum, technical requirements for requirements specified for
- adequacy of laboratory procedures, - adequacy of laboratory procedures,
- competency of the laboratory personnel, - competency of the laboratory
- testing of the product, personnel,
- capability to perform these services - testing of the product,
correctly, traceable to the relevant - capability to perform these services
process standard (such as ASTM, EN, correctly, traceable to the relevant
etc.), and process standard, and
- review of the related records?
- review of the related records.
Have these requirements been
implemented?
8.1q1b The organization shall plan and implement How do you plan and implement
the monitoring, measurement, analysis and measurement, analysis and
improvement processes needed improvement processes needed to
b) to ensure conformity of the quality ensure conformity of the QMS?
management system, and
8.1q1c The organization shall plan and implement How do you plan and implement
the monitoring, measurement, analysis and measurement, analysis and
improvement processes needed improvement processes needed to
c) to continually improve the effectiveness continually improve the effectiveness of
of the quality management system. the QMS?
8.1q2 This shall include determination of How do you determine what methods to
applicable methods, including statistical use, including statistical techniques?
techniques, and the extent of their use. How do you determine the extent of their
use?
T8.2.1.1q2 The organization shall monitor the How do you monitor manufacturing
performance of manufacturing processes processes to demonstrate compliance
to demonstrate compliance with customer with customer requirements for product
requirements for product quality and quality and process efficiency?
efficiency of the process.
8.2.2 Internal audit
8.2.2q1 The organization shall conduct internal Are internal audits being conducted at
audits at planned intervals to determine planned intervals?
whether the quality management system
a) conforms to the planned arrangements Do they determine whether the QMS
(see 7.1), to the requirements of this conforms to the requirements of ISO
International Standard and to the quality 9001 and to the other requirements
management system requirements established by Supplier? (Review
established by the organization, and records to demonstrate conformance)
b) is effectively implemented and
maintained. Do they determine whether the QMS is
effectively implemented and
maintained? (Review records)
8.2.2q2 An audit programme shall be planned, Can you show me an audit plan that
taking into consideration the status and takes into consideration the importance
importance of the processes and areas to of the processes and areas to be
be audited, as well as the results of audited, and the results of previous
previous audits. audits?
8.2.2q3 The audit criteria, scope, frequency and Where are the audit criteria, scope,
methods shall be defined. frequency and methods defined?
8.2.2q4 Selection of auditors and conduct of audits Can you demonstrate that selection of
shall ensure objectivity and impartiality of auditors and the conduct of audits are
the audit process. Auditors shall not audit objective and impartial, and that auditors
their own work. dont audit their own work?
8.2.2q6 The management responsible for the area Who ensures that actions are taken to
being audited shall ensure that actions are eliminate detected nonconformities and
taken without undue delay to eliminate their causes?
detected nonconformities and their causes.
Are they being taken care of in a timely
manner? (verify with records)
8.2.2q7 Follow-up activities shall include the What activities are done to verify the
verification of the actions taken and the actions taken, and how are the
reporting of verification results (see 8.5.2). verification results reported?
NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
8.2.4q4 Records shall indicate the person(s) Can you show me records that indicate
authorizing release of product (see 4.2.4). who has authorized release of product
to the next stage of the process?
8.2.4q5 Product release and service delivery shall How do you ensure that product is not
not proceed until the planned arrangements released until the all requirements have
(see 7.1) have been satisfactorily been met? If product must be released
completed, unless otherwise approved by a prior to this, how is it approved?
relevant authority and, where applicable, by
the customer.
NOTE When selecting product parameters to monitor compliance to specified internal and external
requirements, the organization determines the types of product characteristics, leading to
- the types of measurement,
- suitable measurement means, and
- the capability and skills required.
8.3q3 The organization shall deal with When you have nonconforming
nonconforming product by one or more of product, what methods do you
the following ways: use to deal with it?
a) by taking action to eliminate the
detected nonconformity;
c) by authorizing its use, release or
acceptance under concession by a
relevant authority and, where
applicable, by the customer;
d) by taking action to preclude its original
intended use or application.
T8.3.4q3 The organization shall also ensure How do you ensure that original
compliance with the original or superseding requirements are met when the
specifications and requirements when the authorization expires?
authorization expires.
T8.3.4q4 Material shipped on an authorization shall How do you identify material shipped on
be properly identified on each shipping an authorization?
container.
8.4q2a The analysis of data shall provide information What information does this analysis
relating to provide relating to:
a) customer satisfaction (see 8.2.1), - customer satisfaction? (See 5.6)
b) conformity to product requirements (see - conformity to product requirements?
7.2.1), (See 5.6)
c) characteristics and trends of - characteristics and trends of
processes and products including processes and products? (See 5.6)
opportunities for preventive action, - suppliers? (See 7.4.1)
and
d) suppliers.
8.5.2q2 Corrective actions shall be appropriate to Are actions taken appropriate to the
the effects of the nonconformities severity of the problem?
encountered.
8.5.2q3 A documented procedure shall be Can you show me a documented
established to define requirements for procedure defining requirements for
a) reviewing nonconformities (including each of the following?
customer complaints), a) reviewing nonconformities (including
b) determining the causes of customer complaints)
nonconformities, b) determining the causes of
c) evaluating the need for action to ensure nonconformities
that nonconformities do not recur, c) evaluating the need for action to ensure
d) determining and implementing action that nonconformities do not recur
needed, d) determining and implementing action
e) records of the results of action taken needed
(see 4.2.4), and e) records of the results of action taken
f) reviewing corrective action taken. f) reviewing corrective action taken
8.5.2.2 Error-proofing
T8.5.2.2q1 The organization shall use error-proofing Can you show that error-proofing
methods in their corrective action process. methods are used in the corrective
action process?
NOTE Cycle time related to rejected product analysis should be consistent with the
determination of root cause, corrective action and monitoring the effectiveness of
implementation.
8.5.3q2 Preventive actions shall be appropriate to Are actions taken appropriate to the
the effects of the potential problems. severity of the problem?
8.5.3q4 d) records of results of action taken (see Can you show me records of preventive
4.2.4) actions taken?