Internal Quality Management System Audit Checklist (ISO/TS 16949:2009)

Internal Quality Management System Audit Checklist (ISO/TS 16949:2009)
ISO 9001:2008 and/or

Q# Audit Question Audit Evidence
ISO/TS 16949:2009 Clause
4 Quality management system
4.1 General requirements
4.1q1 The organization shall establish, document, Has Organization established, documented,
implement and maintain a quality implemented and maintained a QMS and
management system and continually continually improved its effectiveness in
improve its effectiveness in accordance with accordance with ISO 9001:2008?
the requirements of this International (Questions in section 4.1 are verified
Standard. throughout the audit)
4.1q2a The organization shall a) determine the Where has Organization identified the
processes needed for the quality processes needed for the QMS and their
management system and their application application throughout the organization?
throughout the organization (see 1.2), (See 4.2.2)
4.1q2b The organization shall b) determine the Where has Organization determined the
sequence and interaction of these sequence and interaction of QMS
processes, processes? (See 4.2.2)
4.1q2c The organization shall c) determine criteria What are the criteria and methods
and methods needed to ensure that both Organization uses to ensure that the
the operation and control of these operation and control of QMS processes
processes are effective, are effective?
4.1q2d The organization shall d) ensure the Has Organization provided resources and
availability of resources and information information needed to support the operation
necessary to support the operation and and monitoring of QMS processes? (See
monitoring of these processes, section 6)
4.1q2e The organization shall e) monitor, measure How does Organization monitor, measure
where applicable and analyse these and analyze QMS processes? (See section
processes, and 8)
4.1q2f The organization shall f) implement actions How has Organization implemented actions
necessary to achieve planned results and necessary to achieve planned results and
continual improvement of these processes. 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 the organization in accordance
requirements of this International Standard. with the requirements of ISO 9001:2008?
4.1q4 Where an organization chooses to When Organization outsources any process
outsource any process that affects product that affects product conformity with
conformity to requirements, the organization requirements, how is control ensured over
shall ensure control over such processes. such processes? (See 7.4)
4.1q5 The type and extent of control to be applied Where is the control of outsourced
to these outsourced processes shall be processes that affect product conformity
identified within the quality management with requirements identified within the
system. QMS? (See 7.4)
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NOTE 1 Processes needed for the quality management system referred to above should include
processes for management activities, provision of resources, product realization, measurement,
analysis and improvement. NOTE 2. An ‘outsourced’ process is a process that the organization needs
for its quality management system and which the organization chooses to have performed by an
external party. NOTE 3. Ensuring control over outsourced processes shall not absolve the
organization of the responsibility of conformity to all customer, statutory and regulatory requirements.
The type and extent of control to be applied to the outsourced process can be influenced by factors
such as a) the potential impact of the outsourced process on the organisation’s capability to provide
product that conforms to requirements; b) the degree to which the control for the process is shared; c)
the capability of achieving the necessary control through the application of 7.4.
4.1.1 General requirements — Supplemental
T4.1.1q1 Ensuring control over outsourced processes Does Organization have adequate control
shall not absolve the organization of the over outsourced processes to ensure
responsibility of conformity to all customer conformity to all customer requirements?
requirements. (See 7.4)
NOTE See also 7.4.1 and 7.4.1.3.

4.2 Documentation requirements
4.2.1 General
4.2.1q1a The quality management system Does Organization have documented
documentation shall include statements of a quality policy and quality
a) documented statements of a quality objectives? (See 5.3, 5.4.1)
policy and quality objectives, Does Organization have a quality manual?
b) a quality manual, (See 4.2.2)
c) documented procedures and records Does Organization have the documented
required by this International Standard, procedures required by ISO 9001:2008?
d) documents, including records, (See 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, 8.5.3)
determined by the organization to be Are adequate documents in place to ensure
necessary to ensure the effective planning, the effective planning, operation and
operation and control of its processes. control of Organization’s processes?
Does documentation include the records
required by ISO 9001:2008?
NOTE 1 Where the term “documented procedure” appears within this International
Standard, this means that the procedure is established, documented, implemented and
maintained. A single document may address the requirements for one or more
procedures. A requirement for a documented procedure may be covered by more than
one document.
NOTE 2 The extent of the quality management system documentation can differ from one
organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
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NOTE 3 The documentation can be in any form or type of medium.
4.2.2 Quality manual

4.2.2q1a The organization shall establish and Where in the quality manual is the scope of
maintain a quality manual that includes the QMS identified, including details of and
a) the scope of the quality management justification for exclusions?
system, including details of and justification for Where does the quality manual contain or
any exclusions (see 1.2), reference the documented procedures
b) the documented procedures established established for the QMS?
for the quality management system, or Where does the quality manual include a
reference to them, and description of the interaction between the
c) a description of the interaction between processes of the QMS?
the processes of the quality management
system.
4.2.3 Control of documents
4.2.3q1 Documents required by the quality How are the documents required by the
management system shall be controlled. QMS controlled?
Records are a special type of document and (Documents should be reviewed throughout
shall be controlled according to the the audit)
requirements given in 4.2.4.
4.2.3q2 A documented procedure shall be Can you show me a documented a)
established to define the controls needed procedure that defines the controls needed
a) to approve documents for for each of the following?
adequacy prior to issue, a) approve documents for adequacy
b) to review and update as necessary prior to issue?
and re-approve documents, b) review and update as necessary
c) to ensure that changes and the and re-approve documents?
current revision status of documents c) ensure that changes and the
are identified, current revision status of documents
d) to ensure that relevant versions of are identified?
applicable documents are available at d) ensure that relevant versions of
points of use, applicable documents are available at
e) to ensure that documents remain points of use?
legible and readily identifiable; e) ensure that documents remain
f) to ensure that documents of legible and readily identifiable?
external origin determined by the f) ensure that documents of external
organization to be necessary for the origin are identified and their
planning and operation of the quality distribution controlled?
management system are identified and g) prevent the unintended use of
their distribution controlled, and obsolete documents, and to apply
g) to prevent the unintended use of suitable identification to them if they are
obsolete documents, and to apply retained for any purpose.
suitable identification to them if they are
retained for any purpose.
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4.2.3.1 Engineering specifications
T4.2.3.1q1 The organization shall have a process to What process do you have to assure the
assure the timely review, distribution and timely review, distribution and
implementation of all customer engineering implementation of customer specifications
standards/ specifications and changes and changes?
based on customer-required schedule. Does it meet customer-required
schedule(s)?
T4.2.3.1q2 Timely review should be as soon as Does the review occur in two weeks or
possible, and shall not exceed two working less?
weeks.
T4.2.3.1q3 The organization shall maintain a record of What records do you have showing
the date on which each change is implementation dates of changes? Is there
implemented in production. Implementation evidence showing that documents are
shall include updated documents. updated?
NOTE A change in these standards/ specifications requires an updated record of customer production
part approval when these specifications are referenced on the design record or if they affect
documents of production part approval process, such as control plan, FMEAs, etc.
4.2.4 Control of records
4.2.4q1 Records established to provide evidence of What records exist that provide evidence of
conformity to requirements and of the conformity to requirements and of the
effective operation of the quality effective operation of the QMS? (Should be
management system shall be controlled. reviewed throughout the audit)
4.2.4q2 The organization shall maintain a Does Organization have a documented
documented procedure to define the procedure defining the controls needed for
controls needed for the identification, the identification, storage, protection,
storage, protection, retrieval, retention and retrieval, retention time and disposition of
disposition of records records?
4.2.4q3 Records shall remain legible, readily Are records legible, readily identifiable and
identifiable and retrievable retrievable? (Should be reviewed
throughout the audit)
NOTE 1 “Disposition” includes disposal.
NOTE 2 “Records” also include customer-specified records.
4.2.4.1 Records retention
T4.2.4.1q1 The control of records shall satisfy Have the record requirements been
regulatory and customer requirements. reviewed to ensure conformance with
regulatory and customer requirements?
5 Management responsibility
5.1 Management commitment
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5.1q1a Top management shall provide evidence of How does top management communicate
its commitment to the development and the importance of meeting customer and
implementation of the quality management legal requirements to the organization?
system and continually improving its Has a company quality policy been
effectiveness by established? (See 5.3)
a) communicating to the organization the What are the quality objectives established
importance of meeting customer as well as by top management? (See 5.4.1)
statutory and regulatory requirements, Does top management conduct
b) establishing the quality policy, management reviews? (See 5.6)
c) ensuring that quality objectives are How does top management ensure the
established, availability of resources to support and
d) conducting management reviews, and continually improve the QMS?
e) ensuring the availability of resources.
5.1.1 Process efficiency

T5.1.1q1 Top management shall review the product How does top management review product
realization processes and the support realization and support processes to ensure
processes to assure their effectiveness and effectiveness and efficiency? (5.6?)
efficiency.
5.2 Customer focus
5.2q1 Top management shall ensure that How does top management ensure that
customer requirements are determined and customer requirements are determined and
are met with the aim of enhancing customer met?
satisfaction (see 7.2.1 & 8.2.1).
5.3 Quality policy
5.3q1a Top management shall ensure that the How does top management ensure that the
quality policy quality policy is appropriate to the purpose
a) is appropriate to the purpose of the of the organization?
organization, Does the quality policy include a
b) includes a commitment to comply with commitment to comply with requirements
requirements and continually improve the and continually improve QMS
effectiveness of the quality management effectiveness?
system, Are the contents of the quality policy
c) provides a framework for establishing relevant to Organization, and measurable?
and reviewing quality objectives, Is the quality policy communicated and
d) is communicated and understood within understood within the organization?
the organization, and Is there an established process to review
e) is reviewed for continuing suitability. the quality policy for continuing suitability?
5.4 Planning
5.4.1 Quality objectives
5.4.1q1 Top management shall ensure that quality Has top management established quality
objectives, including those needed to meet objectives (including those needed to meet
requirements for product [see 7.1 a)], are requirements for product) at relevant
established at relevant functions and levels functions and levels within the organization?
within the organization.
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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?
5.4.1.1 Quality objectives – Supplemental
T5.4.1.1q1 Top management shall define quality Are quality objectives and metrics included
objectives and measurements that shall be in the business plan?
included in the business plan and used to
deploy the quality policy.
NOTE Quality objectives should address customer expectations and be achievable within a defined
time period.
5.4.2 Quality management system planning
5.4.2q1a Top management shall ensure that a) the How do you ensure that the planning of the
planning of the quality management QMS is carried out in order to meet the
system is carried out in order to meet the requirements given in ISO 9001:2008
requirements given in 4.1, as well as the section 4.1, as well as the quality
quality objectives, and objectives?
5.4.2q1b Top management shall ensure that b) the How do you ensure that the integrity of the
integrity of the quality management QMS is maintained when changes to the
system is maintained when changes to QMS are planned and implemented?
the quality management system are
planned and implemented.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.1q1 Top management shall ensure that How are responsibilities and authorities
responsibilities and authorities are defined defined and communicated within the
and communicated within the organization. organization? (Verify throughout audit).
5.5.1.1 Responsibility for quality
T5.5.1.1q1 Managers with responsibility and authority How are managers responsible for
for corrective action shall be promptly corrective action informed of
informed of products or processes which do nonconforming products or processes?
not conform to requirements. Are they informed in a timely manner?
T5.5.1.1q2 Personnel responsible for product quality Do personnel responsible for product quality
shall have the authority to stop production have the authority to stop production to
to correct quality problems. correct quality problems?
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 quality?
delegated responsibility for, ensuring
conformity to product requirements.
5.5.2 Management representative
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5.5.2q1a Top management shall appoint a member of Who is your ISO 9001:2008 management
the organisation’s management who, representative?
irrespective of other responsibilities, shall Does the management representative have
have responsibility and authority that responsibility and authority to
includes a) ensure that processes needed for the
a) ensuring that processes needed for the QMS are established, implemented and
quality management system are maintained?
established, implemented and maintained, b) report to top management on the
b) reporting to top management on the performance of the QMS and any need for
performance of the quality management improvement?
system and any need for improvement, and c) ensure the promotion of awareness of
c) ensuring the promotion of awareness of customer requirements throughout the
customer requirements throughout the organization?
organization.
NOTE The responsibility of a management representative can include liaison with external parties on
matters relating to the quality management system.
5.5.2.1 Customer representative

T5.5.2.1q1 Top management shall designate personnel Who has top management designated to
with responsibility and authority to ensure ensure that customer requirements are
that customer requirements are addressed. addressed?
This includes selection of special Does their responsibility and authority
characteristics, setting quality objectives include selection of special characteristics,
and related training, corrective and setting quality objectives and related
preventive actions, product design and training, corrective and preventive actions,
development. product design and development?
5.5.3 Internal communication

5.5.3q1 Top management shall ensure that How is information regarding the
appropriate communication processes are effectiveness of the QMS communicated
established within the organization and that within the organization?
communication takes place regarding the
effectiveness of the quality management
system.
5.6 Management review
5.6.1 General
5.6.1q1 Top management shall review the What is the frequency that top management
organization's quality management system, reviews the organization's QMS?
at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness.
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5.6.1q2 This review shall include assessing What kinds of information are reviewed in
opportunities for improvement and the need management reviews? (must include
for changes to the quality management suitability, adequacy and effectiveness of
system, including the quality policy and QMS; improvement; & changes to the QMS,
quality objectives. quality policy and objectives)
5.6.1q3 Records from management reviews shall be Can you show me records from recent
maintained (see 4.2.4). management reviews?
5.6.1.1 Quality management system performance

T5.6.1.1q1 These reviews shall include all Do management reviews include all
requirements of the quality management requirements of the quality management
system and its performance trends as an system and performance trends? (Verify
essential part of the continual improvement records)
process.
T5.6.1.1q2 Part of the management review shall be the Can you show management review records
monitoring of quality objectives, and the including monitoring of quality objectives,
regular reporting and evaluation of the cost and cost of poor quality metrics? (Verify
of poor quality (see 8.4.1 and 8.5.1). records)
T5.6.1.1q3 These results shall be recorded to provide, Can you show records providing evidence
as a minimum, evidence of the achievement of achievement of the quality objectives
of specified in the business plan, and
- the quality objectives specified in customer satisfaction with product
the business plan, and supplied?
- customer satisfaction with product
supplied.
5.6.2 Review input
5.6.2q1 The input to management review shall Can you show me that each of the following
include information on were included in review(s)?
a) results of audits, a) results of audits,
b) customer feedback, b) customer feedback,
c) process performance and product c) process performance and product
conformity, conformity,
d) status of preventive and corrective d) status of preventive and corrective
actions, actions,
e) follow-up actions from previous e) follow-up actions from previous
management reviews, management reviews,
f) changes that could affect the quality f) changes that could affect the quality
management system, and management system, and
g) recommendations for improvement. g) recommendations for improvement
5.6.2.1 Review input – Supplemental
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T5.6.2.1q1 Input to management review shall include Do records show input to management
an analysis of actual and potential field- review includes analysis of actual and
failures and their impact on quality, safety or potential field-failures and their impact?
the environment. (See also 7.3.4.1)
5.6.3 Review output
5.6.3q1 The output from the management review What decisions or actions have resulted
shall include any decisions and actions from management reviews for each of the
related to following?
a) improvement of the effectiveness of the a) improvement of the effectiveness of the
quality management system and its quality management system and its
processes, processes,
b) improvement of product related to b) improvement of product related to
customer requirements, and customer requirements, and
c) resource needs. c) resource needs.
6 Resource management
6.1 Provision of resources
6.1q1 The organization shall determine and What resources has Organization provided
provide the resources needed to implement and maintain the QMS and
a) to implement and maintain the quality continually improve its effectiveness?
management system and continually What resources has Organization provided
improve its effectiveness, and to ensure that customer requirements are
b) to enhance customer satisfaction by met?
meeting customer requirements. (See 6.2, 6.3, 6.4)
6.2 Human resources

6.2.1 General
6.2.1q1 Personnel performing work affecting (While auditing, select some personnel
conformity to product requirements shall be performing work affecting product quality)
competent on the basis of appropriate What are the education, training, skills and
education, training, skills and experience. experience required by this job/task?
NOTE. Conformity to product requirements How does this person meet those
can be affected directly or indirectly by qualifications?
personnel performing any task within the
quality management system.
6.2.2 Competence, awareness and training
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6.2.2q1 The organization shall How do you determine the necessary
a) determine the necessary competence for education, training, skills and experience
personnel performing work affecting for people performing work affecting
conformity to product requirements, product quality?
b) where applicable, provide training or take What training or other actions do you
other actions to achieve the necessary provide to satisfy the needs of personnel?
competence, (records)
c) evaluate the effectiveness of the actions When you provide training or other actions
taken, to satisfy competence needs, how do you
d) ensure that its personnel are aware of evaluate the effectiveness of those
the relevance and importance of their actions? (records)
activities and how they contribute to the
achievement of the quality objectives, and (Sample throughout organization)
e) maintain appropriate records of How do your activities contribute to the
education, training, skills and experience achievement of quality objectives?
(see 4.2.4). Where do you maintain records of
education, training, skills and experience?
6.2.2.1 Product design skills
T6.2.2.1q1 The organization shall ensure that What tools and techniques has the
personnel with product design responsibility organization identified as necessary for
are competent to achieve design product design personnel?
requirements and are skilled in applicable What records do you have showing that
tools and techniques. product design personnel are competent to
Applicable tools and techniques shall be design and are skilled in the identified tools
identified by the organization. and techniques?
6.2.2.2 Training
T6.2.2.2q1 The organization shall establish and Can you show me documented
maintain documented procedures for procedures for identifying training needs
identifying training needs and achieving and achieving competence of all personnel
competence of all personnel performing performing activities affecting product
activities affecting conformity to product quality?
requirements.
T6.2.2.2q2 Personnel performing specific assigned What records do you have that personnel
tasks shall be qualified, as required, with performing specific assigned tasks are
particular attention to the satisfaction of qualified - especially to meet customer
customer requirements. requirements. (See 6.2.2e)
NOTE 1 This applies to all employees having an effect on quality at all levels of the organization.
NOTE 2 An example of the customer specific requirements is the application of digitized
mathematically based data.
6.2.2.3 Training on the job
T6.2.2.3q1 The organization shall provide on-the-job What kinds of on-the-job training do you
training for personnel in any new or provide for people in new or changed
modified job affecting conformity to product jobs?
requirements, including contract or agency Does this include contract and agency
personnel. personnel?
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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 organization)
6.2.2.4 Employee motivation and empowerment

T6.2.2.4q1 The organization shall have a process to What process has been established to
motivate employees to achieve quality motivate employees to
objectives, to make continual - achieve quality objectives,
improvements, and to create an - to make continual improvements, and
environment to promote innovation. - to create an environment to promote
innovation?
T6.2.2.4q2 The process shall include the promotion of Does the process include the promotion of
quality and technological awareness quality and technological awareness
throughout the whole organization. throughout the whole organization?
T6.2.2.4q3 The organization shall have a process to What process has been established to
measure the extent to which its personnel measure the extent to which personnel are
are aware of the relevance and importance aware of the relevance and importance of
of their activities and how they contribute to their activities and how they contribute to
the achievement of the quality objectives the achievement of the quality objectives?
[see 6.2.2 d)]. (See 6.2.2d)
6.3 Infrastructure
6.3q1 The organization shall determine, provide Are the buildings, workspace, and utilities
and maintain the infrastructure needed to provided appropriate to achieve conformity
achieve conformity to product requirements. to product requirements? How are they
Infrastructure includes, as applicable maintained?
a) buildings, workspace and associated What kind of process equipment (both
utilities, hardware and software) is necessary to
b) process equipment (both hardware and conform to product requirements? How is
software), and the equipment maintained?
c) supporting services (such as transport, What supporting services (such as transport
communication or information systems). or communication) are needed to ensure
that product meets requirements? How are
they maintained?
6.3.1 Plant, facility and equipment planning
T6.3.1q1 The organization shall use a What groups are involved in developing
multidisciplinary approach (see 7.3.1.1) for plant, facility and equipment plans?
developing plant, facility and equipment (Must be multidisciplinary)
plans.
T6.3.1q2 Plant layouts shall optimize material travel, Can you show that plant layouts optimize
handling and value-added use of floor material travel, handling and floor space
space, and shall facilitate synchronous use, and facilitate synchronous material
material flow. flow?
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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.
6.3.2 Contingency plans
T6.3.2q1 The organization shall prepare contingency Can you show me contingency plans for
plans to satisfy customer requirements in each of the following?
the event of an emergency such as utility - Utility interruptions
interruptions, labour shortages, key - Labor shortages
equipment failure and field returns. - Key equipment failure(s)
- Field returns
6.4 Work environment
6.4q1 The organization shall determine and What kind of work environment is required
manage the work environment needed to to achieve conformity to product
achieve conformity to product requirements. requirements? How is this environment
NOTE. The term ‘work environment’ relates to managed and maintained?
those conditions under which work is performed
including physical, environmental and other
factors (such as noise, temperature, humidity,
lighting or weather).
6.4.1 Personnel safety to achieve conformity to product requirements
T6.4.1q1 Product safety and means to minimize How are product safety and potential risks
potential risks to employees shall be to employees addressed by Organization?
addressed by the organization, especially in
the design and development process and in
manufacturing process activities.
6.4.2 Cleanliness of premises
T6.4.2q1 The organization shall maintain its premises Does the organization maintain the state of
in a state of order, cleanliness and repair order, cleanliness and repair needed for
consistent with the product and products and manufacturing processes?
manufacturing process needs. (Verify throughout audit)
7 Product realization
7.1 Planning of product realization
7.1q1 The organization shall plan and develop the Where are the processes needed for
processes needed for product realization. product realization identified?
7.1q2 Planning of product realization shall be Is the planning of product realization
consistent with the requirements of the consistent with the requirements of the
other processes of the quality management other processes of the QMS? (Verify there
system (see 4.1). are no inconsistencies or conflicts between
quality system procedures)
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7.1q3 In planning product realization, the Where in the product realization process do
organization shall determine the following, you determine the quality objectives and
as appropriate: requirements for products?
a) quality objectives and When planning for product realization, how
requirements for the product; do you establish processes, documents,
b) the need to establish processes and provide resources specific to the
and documents, and to provide product
resources specific to the product; How do you determine verification,
c) required verification, validation, validation, monitoring, inspection and test
monitoring, inspection and test activities activities specific to the product, and the
specific to the product and the criteria for criteria for product acceptance?
product acceptance; What records exist showing that both the
d) records needed to provide realization processes and the product
evidence that the realization processes meet requirements?
and resulting product meet requirements
(see 4.2.4).
7.1q4 The output of this planning shall be in a What are the outputs of product realization
form suitable for the organization's method planning? Are they in a form suitable for
of operations. Organization?
NOTE 1 A document specifying the processes of the quality management system (including the
product realization processes) and the resources to be applied to a specific product, project or
contract, can be referred to as a quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product
realization processes.
NOTE Some customers refer to project management or advanced product quality planning as a
means to achieve product realization. Advanced product quality planning embodies the concepts of
error prevention and continual improvement as contrasted with error detection, and is based on a
multidisciplinary approach.
7.1.1 Planning of product realization – Supplemental
T7.1.1q1 Customer requirements and references to Does the quality plan include customer
its technical specifications shall be included requirements and reference to technical
in the planning of product realization as a specifications?
component of the quality plan.
7.1.2 Acceptance Criteria

T7.1.2q1 Acceptance criteria shall be defined by the Where is acceptance criteria defined?
organization and, where required, approved When required, does the customer approve
by the customer. them?
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 the organization ensure the
confidentiality of customer-contracted confidentiality of customer-contracted
products and projects under development, products, projects under development, and
and related product information. related product information?
7.1.4 Change control
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T7.1.4q1 The organization shall have a process to What process is there to control and react
control and react to changes that impact to changes that impact product realization?
product realization.
T7.1.4q2 The effects of any change, including those How are the effects of changes assessed,
changes caused by any supplier, shall be including changes caused by suppliers? ,
assessed, and verification and validation and verification and validation activities
activities shall be defined, to ensure shall be defined, to ensure compliance with
compliance with customer requirements. customer requirements.
T7.1.4q3 Changes shall be validated before Are changes validated before
implementation. implementation?
T7.1.4q4 For proprietary designs, impact on form, fit Is impact on form, fit and function (including
and function (including performance and/or performance and/or durability) reviewed
durability) shall be reviewed with the with the customer for proprietary designs so
customer so that all effects can be properly that all effects can be properly evaluated?
evaluated.
T7.1.4q5 When required by the customer, additional Do you have evidence that any additional
verification/identification requirements, such verification/identification requirements
as those required for new product required by the customer are met?
introduction, shall be met.
NOTE 1 Any product realization change affecting customer requirements requires notification to, and
agreement from, the customer.
NOTE 2 The above requirement applies to product and manufacturing process changes.
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.1q1a The organization shall determine How does Organization determine each of
a) requirements specified by the customer, the following requirements?
including the requirements for delivery and a) requirements specified by the customer,
post-delivery activities, including the requirements for delivery and
b) requirements not stated by the customer post-delivery activities,
but necessary for specified or intended use, b) requirements not stated by the customer
where known, but necessary for specified or intended use,
c) statutory and regulatory requirements where known,
related to the product, and c) statutory and regulatory requirements
d) any additional requirements determined related to the product, and
by the organization. d) any additional requirements determined
by the organization.
NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual
obligations such as maintenance services, and supplementary service such as recycling or final
disposal.
NOTE 1 Post delivery activities include any after-sales product service provided as part of the
customer contract or purchase order.
NOTE 2 This requirement includes recycling, environmental impact and characteristics identified as a
result of the organisation’s knowledge of the product and manufacturing processes (see 7.3.2.3.).
Page 14 of 45
NOTE 3 Compliance to item c) includes all applicable government, safety and environmental
regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.
7.2.1.1 Customer-designated special characteristics
T7.2.1.1q1 The organization shall demonstrate How do you meet customer requirements
conformity to customer requirements for for designation, documentation and control
designation, documentation and control of of special characteristics?
special characteristics.
7.2.2 Review of requirements related to the product
7.2.2q1 The organization shall review the What kind of review is done to ensure that
requirements related to the product. This the organization has the ability to meet
review shall be conducted prior to the requirements before committing to supply
organization's commitment to supply a product?
product to the customer (e.g. submission of How do you ensure that product
tenders, acceptance of contracts or orders, requirements are defined and reviewed
acceptance of changes to contracts or before committing to supply product?
orders) and shall ensure that How do you ensure that contract or order
a) product requirements are defined, requirements differing from those
b) contract or order requirements differing previously expressed are resolved before
from those previously expressed are committing to supply product?
resolved, and
c) the organization has the ability to meet
the defined requirements.
7.2.2q2 Records of the results of the review and Can you show me records of the product
actions arising from the review shall be requirement review results and actions
maintained (see 4.2.4). resulting from them?
7.2.2q3 Where the customer provides no When customers don’t have documented
documented statement of requirement, the requirements, how do you confirm their
customer requirements shall be confirmed requirements before accepting orders?
by the organization before acceptance.
7.2.2q4 Where product requirements are changed, When product requirements are changed,
the organization shall ensure that relevant how do you ensure that relevant documents
documents are amended and that relevant are changed and that relevant personnel
personnel are made aware of the changed are made aware of the changes?
requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for each order.
Instead the review can cover relevant product information such as catalogues or advertising material.
7.2.2.1 Review of requirements related to the product — Supplemental
T7.2.2.1q1 Waiving the requirement stated in 7.2.2 for If you have waived the requirement for a
a formal review (see note) shall require formal review above, have you obtained
customer authorization. customer authorization?
7.2.2.2 Organization manufacturing feasibility
Page 15 of 45
T7.2.2.2q1 The organization shall investigate, confirm What documents do you have that show
and document the manufacturing feasibility investigation and confirmation of
of the proposed products in the contract manufacturing feasibility in the contract
review process, including risk analysis. review process for proposed products,
including risk analysis?
7.2.3 Customer communication

7.2.3q1 The organization shall determine and What method(s) are used to communicate
implement effective arrangements for with customers regarding
communicating with customers in relation to - product information?
a) product information, - enquiries, contracts, or order handling,
b) enquiries, contracts or order handling, including amendments?
including amendments, and - feedback, including customer complaints?
c) customer feedback, including customer
complaints.
7.2.3.1 Customer communication – Supplemental

T7.2.3.1q1 The organization shall have the ability to Do your customers require information to be
communicate necessary information, communicated in specific languages
including data, in a customer-specified and/or formats?
language and format (e.g. computer-aided If so, how do you meet those requirements?
design data, electronic data exchange).
7.3 Design and development

NOTE The requirements of 7.3 include product and manufacturing process design and development,
and focus on error prevention rather than detection.
7.3.1 Design and development planning
7.3.1q1 The organization shall plan and control the Can you explain to me the process used by
design and development of product. Organization to plan and control the design
and development of product?
7.3.1q2 During the design and development What are the stages in the design and
planning, the organization shall determine development process?
a) the design and development stages, How do you determine the review,
b) the review, verification and validation that verification and validation activities
are appropriate to each design and appropriate to each design and
development stage, and development stage?
c) the responsibilities and authorities for How /where are design and development
design and development. responsibilities and authorities defined?
7.3.1q3 The organization shall manage the How does Organization ensure effective
interfaces between different groups involved communication and clear assignment of
in design and development to ensure responsibility between different groups
effective communication and clear involved in design and development?
assignment of responsibility.
Page 16 of 45
7.3.1q4 Planning output shall be updated, as As product design and development
appropriate, as the design and development progresses, how are the planning outputs
progresses. NOTE. Design and updated?
development review, verification and
validation have distinct purposes. They can
be conducted and recorded separately or in
any combination, as suitable for the product
and the organization.
7.3.1.1 Multidisciplinary approach

T7.3.1.1q1 The organization shall use a Do you use a multidisciplinary approach to
multidisciplinary approach to prepare for prepare for product realization? Does it
product realization, including include:
- development/finalization and - development/finalization and monitoring
monitoring of special characteristics of special characteristics
- development and review of - development and review of FMEAs,
FMEAs, including actions to reduce including actions to reduce potential risks,
potential risks, and - development and review of control plans.
- development and review of control
plans.
NOTE A multidisciplinary approach typically includes the organization's design, manufacturing,
engineering, quality, production and other appropriate personnel.
7.3.2 Design and development inputs

7.3.2q1a Inputs relating to product requirements shall What are the design inputs relating to each
be determined and records maintained (see of the following product requirements?
4.2.4). These inputs shall include a) functional and performance
a) functional and requirements,
performance requirements, b) applicable statutory and regulatory
b) applicable statutory and requirements,
regulatory requirements, c) where applicable, information
c) where applicable, derived from previous similar designs,
information derived from previous similar and
designs, and d) other requirements essential for
d) other requirements design and development.
essential for design and development. Where are they recorded?
7.3.2q2 These inputs shall be reviewed for How & when are the design and
adequacy. development inputs reviewed for adequacy?
7.3.2q3 Requirements shall be complete, How does Organization ensure that
unambiguous and not in conflict with each requirements are complete, unambiguous
other. and don’t conflict with each other?
NOTE Special characteristics (see 7.2.1.1) are included in this requirement.
7.3.2.1 Product design input
Page 17 of 45
T7.3.2.1q1 The organization shall identify, document Where are product design input
and review the product design inputs requirements documented?
requirements, including the following: (including the following:
- customer requirements (contract - contract reviews of requirements such as
review) such as special characteristics special characteristics, identification,
(see 7.3.2.3), identification, traceability traceability and packaging;
and packaging; - a process to deploy information gained
- use of information: the from previous design projects, competitor
organization shall have a process to analysis, supplier feedback, internal input,
deploy information gained from previous field data, and other relevant sources, for
design projects, competitor analysis, current and future projects of a similar
supplier feedback, internal input, field nature;
data, and other relevant sources, for - targets for product quality, life, reliability,
current and future projects of a similar durability, maintainability, timing and
nature; cost.)
- targets for conformity to product Can you show me they are reviewed?
requirements, life, reliability, durability,
maintainability, timing and cost.
-
7.3.2.2 Manufacturing process design input

T7.3.2.2q1 The organization shall identify, document Where are manufacturing process design
and review the manufacturing process input requirements documented? (including
design input requirements, including the following:
- product design output data - product design output data
- targets for productivity, process - targets for productivity, process capability
capability and cost, and cost,
- customers requirements, if any, - customers requirements, if any, and
and - experience from previous developments.)
- experience from previous Can you show me they are reviewed?
developments.
NOTE The manufacturing process design includes the use of error-proofing methods to a degree
appropriate to the magnitude of the problems and commensurate with the risks encountered.
7.3.2.3 Special characteristics
Page 18 of 45
T7.3.2.3q1 The organization shall identify special Can you show me that all special
characteristics [see 7.3.3 d)] and characteristics are identified and included
- include all special characteristics in in drawings, FMEAs, control plans, and
the control plan, operator instructions?
- comply with customer-specified Are the customer-specified (or equivalent)
definitions and symbols, and symbols used?
- identify process control documents Do they meet customer-specified
including drawings, FMEAs, control definitions?
plans, and operator instructions with the Do they include process steps that affect
customer’s special characteristic symbol special characteristics?
or the organization’s equivalent symbol or
notation to include those process steps
that affect special characteristics.
-
NOTE Special characteristics can include product characteristics and process parameters.
7.3.3 Design and development outputs
7.3.3q1 The outputs of design and development How can design and development outputs
shall be provided in a form suitable for be verified against the inputs? (see 7.3.5q1)
verification against the design and Are these outputs approved prior to
development input and shall be approved release?
prior to release.
7.3.3q2 Design and development outputs shall Can you show me examples of design and
a) meet the input requirements for design development outputs and how they meet
and development, the input requirements?
b) provide appropriate information for What outputs include information for
purchasing, production and for service purchasing, production and service?
provision, Where is product acceptance criteria
c) contain or reference product acceptance specified?
criteria, and Where are product characteristics needed
d) specify the characteristics of the product for safe and proper use specified?
that are essential for its safe and proper
use.
NOTE. Information for production and
service provision can include details for the
preservation of product.
7.3.3.1 Product design outputs – Supplemental
Page 19 of 45
T7.3.3.1q1 The product design output shall be Can you show that the product design
expressed in terms that can be verified and outputs include
validated against product design input - design FMEA, reliability results
requirements. - product special characteristics,
The product design output shall include specifications,
- design FMEA, reliability results - product error-proofing, as appropriate,
- product special characteristics and - product definition including drawings or
specifications, mathematically based data,
- product error-proofing, as appropriate, - product design reviews results, and
- product definition including drawings or - diagnostic guidelines where applicable
mathematically based data, Are the outputs expressed in terms that can
- product design reviews results, and be verified and validated against product
- diagnostic guidelines where applicable. design input requirements?
7.3.3.2 Manufacturing process design output
T7.3.3.1q1 The manufacturing process design output Can you show that the manufacturing
shall be expressed in terms that can be process design outputs include
verified against manufacturing process - specifications and drawings,
design input requirements and validated. - manufacturing process flow chart/
The manufacturing process design output layout,
shall include - manufacturing process FMEAs,
- specifications and drawings. - control plans,
- manufacturing process flow chart/ - work instructions,
layout, - process approval acceptance
- manufacturing process FMEAs, criteria,
- control plan (see 7.5.1.1), - data for quality, reliability,
- work instructions, maintainability and measurability
- process approval acceptance - results of error-proofing activities,
criteria, as appropriate, and
- data for quality, reliability, - methods of rapid detection and
maintainability and measurability, feedback of product/manufacturing
- results of error-proofing activities, process nonconformities.
as appropriate, and The manufacturing process design output
- methods of rapid detection and shall be expressed in terms that can be
feedback of product/manufacturing verified against manufacturing process
process nonconformities. design input requirements and validated.
7.3.4 Design and development review
7.3.4q1a At suitable stages, systematic reviews of At what stages of design and development
design and development shall be performed do you perform reviews to evaluate if the
in accordance with planned arrangements results meet requirements? (See 7.3.1q2b)
(see 7.3.1)
a) to evaluate the ability of the results Can you show me some problems that have
of design and development to meet been identified and actions proposed at
requirements, and these reviews?
b) to identify any problems and
propose necessary actions.
Page 20 of 45
7.3.4q2 Participants in such reviews shall include What functions are represented at these
representatives of functions concerned with reviews?
the design and development stage(s) being At each stage, are all functions concerned
reviewed with that stage represented?
7.3.4q3 Records of the results of the reviews and Can you show me records of the results of
any necessary actions shall be maintained the reviews and any necessary actions
(see 4.2.4). taken?
NOTE These reviews are normally coordinated with the design phases and include manufacturing
process design and development.
7.3.4.1 Monitoring
T7.3.4.1q1 Measurements at specified stages of design Can you show me reports of analysis of
and development shall be defined, analysed measurements at specified design and
and reported with summary results as an development stages?
input to management review. Are summary results included in
management reviews? (See 5.6.2)
NOTE These measurements include quality risks, costs, lead-times, critical paths and others, as
appropriate.
7.3.5 Design and development verification
7.3.5q1 Verification shall be performed in What verification activities are performed to
accordance with planned arrangements ensure that the design and development
(see 7.3.1) to ensure that the design and outputs have met the input requirements?
development outputs have met the design (See 7.3.3q1)
and development input requirements.
7.3.5q2 Records of the results of the verification and Can you show me records of the results of
any necessary actions shall be maintained the verification activities and resulting
(see 4.2.4). actions?
7.3.6 Design and development validation

7.3.6q1 Design and development validation shall be What design and development validation
performed in accordance with planned activities are performed to ensure that the
arrangements (see 7.3.1) to ensure that the product is capable of meeting the
resulting product is capable of meeting the requirements for the intended use?
requirements for the specified application or
intended use, where known.
7.3.6q2 Wherever practicable, validation shall be Do records show that validation is done
completed prior to the delivery or before product shipment?
implementation of the product. If not, is the justification recorded?
7.3.6q3 Records of the results of validation and any Can you show me records of the validation
necessary actions shall be maintained (see activity results and any follow-up actions?
4.2.4).
NOTE 1 The validation process normally includes an analysis of field reports for similar products.
NOTE 2 The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing
processes.
7.3.6.1 Design and development validation – Supplemental
Page 21 of 45
T7.3.6.1q1 Design and development validation shall be Is design and development validation
performed in accordance with customer performed in accordance with customer
requirements including programme timing. requirements, including program timing?
7.3.6.2 Prototype programme
T7.3.6.2q1 When required by the customer, the Do your customer(s) require a prototype
organization shall have a prototype program and control plan?
programme and control plan. If so, can you describe the program?
Can you show me the control plan(s)?
T7.3.6.2q2 The organization shall use, whenever Does Organization’s prototype program use
possible, the same suppliers, tooling and the same suppliers, tooling and
manufacturing processes as will be used in manufacturing processes as will be used in
production. production? If not, what is the justification?
T7.3.6.2q3 All performance testing activities shall be What records show that performance-
monitored for timely completion and testing activities are monitored for timely
conformance to requirements. completion and conformance to
requirements?
T7.3.6.2q4 While services may be outsourced, the Are any prototyping services outsourced?
organization shall be responsible for the If so, who is responsible for the outsourced
outsourced services, including technical services, including technical leadership?
leadership.
7.3.6.3 Product approval process
T7.3.6.3q1 The organization shall conform to a product What product and/or process approval
and manufacturing process approval procedure(s) do your customer(s) require?
procedure recognized by the customer. Can you show me records of both process
and product approvals?
NOTE Product approval should be subsequent to the verification of the manufacturing process.
T7.3.6.3q2 This product and manufacturing process Do you have evidence that the product and
approval procedure shall also be applied to manufacturing process approval procedures
suppliers. are applied to suppliers? (See 7.4.2)
7.3.7 Control of design and development changes

7.3.7q1 Design and development changes shall be How are design and development changes
identified and records maintained. identified? Where are the records kept?
7.3.7q2 The changes shall be reviewed, verified and Are changes reviewed, verified, validated,
validated, as appropriate, and approved and approved before implementation?
before implementation.
7.3.7q3 The review of design and development Can you show me evidence that the review
changes shall include evaluation of the of design and development changes
effect of the changes on constituent parts includes evaluation of the effect on
and product already delivered. component parts and products in the field?
7.3.7q4 Records of the results of the review of Can you show me records of the results of
changes and any necessary actions shall change reviews and any necessary
be maintained (see 4.2.4). actions?
Page 22 of 45
NOTE 1 Design and development changes include all changes during the product programme life
(see 7.1.4).
7.4 Purchasing
7.4.1 Purchasing process
7.4.1q1 The organization shall ensure that How do you ensure that purchased product
purchased product conforms to specified conforms to specified purchase
purchase requirements. requirements?
7.4.1q2 The type and extent of control applied to the How do you determine the type and extent
supplier and the purchased product shall be of control applied to the supplier and the
dependent upon the effect of the purchased purchased product?
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?
suppliers based on their ability to supply (based on their ability to supply product in
product in accordance with the accordance with Organization’s
organization's requirements. requirements)
7.4.1q4 Criteria for selection, evaluation and re- Can you show me the criteria for selection,
evaluation shall be established. evaluation and re-evaluation of suppliers?
7.4.1q5 Records of the results of evaluations and Can you show me records of the results of
any necessary actions arising from the supplier evaluations and any necessary
evaluation shall be maintained (see 4.2.4). 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 supplier’s 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 purchased
product shall conform to applicable statutory products or materials used in product
and regulatory requirements. conform to regulatory requirements?
7.4.1.2 Supplier quality management system development

T7.4.1.2q1 The organization shall perform supplier What supplier development actions are
quality management system development being taken toward the goal of supplier
with the goal of supplier conformity with this conformity with TS 16949?
Technical Specification. Conformity with ISO Do your suppliers’ quality management
9001:2008 is the first step in achieving this systems conform with ISO 9001:2008?
goal. (see below)
NOTE The prioritization of suppliers for development depends upon, for example, the supplier’s
quality performance and the importance of the product supplied.
Page 23 of 45
T7.4.1.2q2 Unless otherwise specified by the customer, Are all of your suppliers registered to ISO
suppliers to the organization shall be third 9001:2008?
party registered to ISO 9001:2008 by an If not, do you have written waivers from
accredited third-party certification body. applicable customer(s)?
7.4.1.3 Customer-approved sources

T7.4.1.3q1 Where specified by the contract (e.g. Do your customer(s) specify supplier(s) in
customer engineering drawing, contracts/ purchase orders?
specification), the organization shall (This includes products, materials, services,
purchase products, materials or services tooling, & gauges, )
from approved sources. The use of If so, can you show that the customer-
customer-designated sources, including designated sources are being used as
tool/gauge suppliers, does not relieve the required?
organization of the responsibility for
ensuring the quality of purchased products.
7.4.2 Purchasing information

7.4.2q1 Purchasing information shall describe the Do orders/contracts include requirements
product to be purchased, including where for approval of product, procedures,
appropriate processes and equipment?
a) requirements for approval of product, Do require any qualification of supplier
procedures, processes and equipment, personnel? If so, can you show where the
b) requirements for qualification of requirement is documented?
personnel, and Do you have any QMS requirements of your
c) quality management system suppliers? If so, can you show me where
requirements. they are required?
7.4.2q2 The organization shall ensure the adequacy How does Organization ensure the
of specified purchase requirements prior to adequacy of purchasing requirements
their communication to the supplier. before communicating them to the supplier?
7.4.3 Verification of purchased product

7.4.3q1 The organization shall establish and What inspection or other activities are used
implement the inspection or other activities to ensure that purchased product meets
necessary for ensuring that purchased your purchasing requirements?
product meets specified purchase
requirements.
Page 24 of 45
7.4.3q2 Where the organization or its customer Do you ever perform product verification at
intends to perform verification at the the supplier's site?
supplier's premises, the organization shall If so, where are the verification
state the intended verification arrangements arrangements and method of product
and method of product release in the release identified?
purchasing information.
7.4.3.1 Incoming product conformity to requirements

T7.4.3.1q1 The organization shall have a process to What processes are in place to assure the
assure the quality of purchased product quality of purchased product?
(see 7.4.3) utilizing one or more of the
following methods: (Must include one or more of following:
- receipt of, and evaluation of, - evaluation of supplier statistical
statistical data by the organization; data
- receiving inspection and/or testing - receiving inspection and/or testing
such as sampling based on performance; - second- or third-party audits of
- second- or third-party
suppliers, along with records of
assessments or audits of supplier sites,
when coupled with records of acceptable acceptable quality
delivered product quality; - laboratory part evaluation
- part evaluation by a designated - another method agreed with the
laboratory; customer)
- another method agreed with the
customer.
-
7.4.3.2 Supplier monitoring

T7.4.3.2q1 Supplier performance shall be monitored How do you monitor supplier performance?
through the following indicators: (Must include the following indicators):
- delivered product conformity to - delivered product quality
requirements; - customer disruptions including field
- customer disruptions including field returns
returns; - delivery schedule performance
- delivery schedule performance (including incidents of premium freight)
(including incidents of premium freight); - special status customer
- special status customer notifications related to quality or delivery
notifications related to quality or delivery issues
issues.
T7.4.3.2q2 The organization shall promote supplier How do you promote supplier monitoring of
monitoring of the performance of their the performance of their manufacturing
manufacturing processes. processes?
Page 25 of 45
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.1q1a The organization shall plan and carry out When carrying out production (or service)
production and service provision under are all of the following controlled conditions
controlled conditions. Controlled conditions in place?
shall include, as applicable, a) Is information that describes the
a) the availability of information that characteristics of the product available?
describes the characteristics of the b) Are appropriate work instructions
product, available (if needed)? (See 7.5.1.2)
b) the availability of work instructions, c) Is suitable equipment used for
as necessary, carrying out production (or service)?
c) the use of suitable equipment, d) Are appropriate gages, etc. used in
d) the availability and use of production (or service)? (See 7.6)
monitoring and measuring equipment, e) Are appropriate kinds of monitoring
e) the implementation of monitoring and measurement done? (See 8.2.4)
and measurement, and f) Are proper release, delivery and
f) the implementation of product post-delivery activities in place?
release, delivery and post-delivery
activities.
7.5.1.1 Control plan

T7.5.1.1q1 The organization shall Can you show me control plans for system,
- develop control plans (see annex subsystem, and component/ material
A) at the system, subsystem, component levels for product supplied?
and/or material level for the product Can you show me control plans for both
supplied, including those for processes pre-launch and production?
producing bulk materials as well as parts, Can you show how the control plans take
and into consideration design FMEA and
- have a control plan for pre-launch process FMEA information?
and production that takes into account (See annex A)
the design FMEA and manufacturing
process FMEA outputs.
T7.5.1.1q2 The control plan shall (Review control plans to ensure they:
- list the controls used for the - list controls used for manufacturing
manufacturing process control, process control
- include methods for monitoring of - include methods for monitoring of
control exercised over special control of special characteristics
characteristics (see 7.3.2.3) defined both - include customer-required
by the customer and the organization, information, if any)
- include the customer-required Can you show that specified reaction plans
information, if any, and have been carried out when a process
- initiate the specified reaction plan becomes unstable or not statistically
(see 8.2.3.1) when the process becomes capable?
unstable or not statistically capable.
Page 26 of 45
T7.5.1.1q3 Control plans shall be reviewed and What conditions initiate the review and
updated when any change occurs affecting update of control plans?
product, manufacturing process,
measurement, logistics, supply sources or
FMEA (see 7.1.4).
NOTE Customer approval may be required after review or update of the control plan.
7.5.1.2 Work instructions
T7.5.1.2q1 The organization shall prepare documented Do all employees responsible for processes
work instructions for all employees having that impact product quality have
responsibilities for the operation of documented work instructions?
processes that impact product quality. (Verify throughout audit)
These instructions shall be accessible for Are they accessible for use at the
use at the work station. workstation?
T7.5.1.2q2 These instructions shall be derived from How are the work instructions developed?
sources such as the quality plan, the control
plan and the product realization process.
7.5.1.3 Verification of job set-ups
T7.5.1.3q1 Job set-ups shall be verified whenever Can you show me records of job setups that
performed, such as an initial run of a job, are being performed?
material changeover or job change. Do they occur at the initial run of a job,
material changeover, or job change?
T7.5.1.3q2 Work instructions shall be available for set- What work instructions do you have for job
up personnel. setup personnel?
T7.5.1.3q3 The organization shall use statistical What statistical methods are used to verify
methods of verification where applicable. job setups?
NOTE Last-off-part comparisons are recommended.

7.5.1.4 Preventive and predictive maintenance
T7.5.1.4q1 The organization shall identify key process How do you identify key process
equipment and provide resources for equipment?
machine/equipment maintenance and Can you walk me through your total
develop an effective planned total preventive maintenance system?
preventive maintenance system.
Page 27 of 45
T7.5.1.4q2 As a minimum, this system shall include the (Verify that the TPM 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 - availability of replacement parts for
key manufacturing equipment; key manufacturing equipment
- documenting, evaluating and - documenting, evaluating and
improving maintenance objectives. improving maintenance objectives)
T7.5.1.4q3 The organization shall utilize predictive What predictive maintenance methods do
maintenance methods to continually you use?
improve the effectiveness and the efficiency Can you demonstrate that predictive
of production equipment. maintenance has resulted in continual
improvement of the effectiveness and
efficiency of production equipment?
7.5.1.5 Management of production tooling

T7.5.1.5q1 The organization shall provide resources for What resources have Organization provided
tool and gauge design, fabrication and for tool and gage design, fabrication and
verification activities. verification activities?
T7.5.1.5q2 The organization shall establish and Does the production tooling management
implement a system for production tooling system include:
management including: - maintenance and repair facilities
- maintenance and repair facilities and personnel
and personnel; - storage and recovery
- storage and recovery, - set-up
- set-up; - perishable tool change programs
- tool-change programmes for - tool design modification
perishable tools; documentation, including engineering
- tool design modification change level
documentation, including engineering - tool modification and revision to
change level; documentation
- tool modification and revision to - tool identification, defining the
documentation; status, such as production, repair or
- tool identification, defining the disposal.
status, 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? If so, how are these activities
outsourced. monitored?
NOTE This requirement also applies to the availability of tools for vehicle service parts.
7.5.1.6 Production scheduling
Page 28 of 45
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-
in-time supported by an information system time) are being met?
that permits access to production
information at key stages of the process
and is order driven.
7.5.1.7 Feedback of information from service
T7.5.1.7q1 A process for communication of information What is your process to communicate
on service concerns to manufacturing, information on service concerns to
engineering and design activities shall be manufacturing, engineering, and design?
established and maintained.
NOTE The intent of the addition of “service concerns” to this subclause is to ensure that the
organization is aware of nonconformities that occur external to its organization.
7.5.1.8 Service agreement with customer
T7.5.1.8q1 When there is a service agreement with the Do you have any service agreement(s) with
customer, the organization shall verify the customers? If so, how do you verify the
effectiveness of effectiveness of
- any organization service centres, - any organization service centers,
- any special-purpose tools or - any special-purpose tools or
measurement equipment, and measurement equipment, and
- the training of service personnel. - the training of service personnel?
7.5.2 Validation of processes for production and service provision

7.5.2q1 The organization shall validate any Do you have any production or service
processes for production and service processes where the resulting output
provision where the resulting output cannot cannot be verified later? (This applies to all
be verified by subsequent monitoring or processes in TS 16949)
measurement and, as a consequence, If so, how to you validate them?
deficiencies become apparent only after the
product is in use or the service has been
delivered.
7.5.2q2 Validation shall demonstrate the ability of Can you show me records that demonstrate
these processes to achieve planned results. that the validation done has met the
requirements?
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7.5.2q3a The organization shall establish How are these special processes reviewed
arrangements for these processes and approved?
including, as applicable Can you show me records of personnel and
a) defined criteria for review and equipment qualification?
approval of the processes, Where are specific methods and
b) approval of equipment and procedures defined?
qualification of personnel, Can you show me records for these
c) use of specific methods and processes?
procedures When changes are made to processes, how
d) requirements for records (see do you revalidate them?
4.2.4), and
e) revalidation.
7.5.2.1 Validation of processes for production and service provision –
Supplemental
T7.5.2.1q1 The requirements of 7.5.2 shall apply to all Are all production processes validated per
processes for production and service 7.5.2 above?
provision.
7.5.3 Identification and traceability 7.5.3 Identification and traceability

7.5.3q1 Where appropriate, the organization shall How do you identify product throughout
identify the product by suitable means your processes? (Verify in production,
throughout product realization. storage, segregation areas, etc.)
7.5.3q2 The organization shall identify the product How is product inspection status identified?
status with respect to monitoring and (Verify in production, storage, segregation
measurement requirements throughout areas, etc.)
product realization.
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 traceability?
unique identification of the product and
maintain records (see 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.
7.5.4 Customer property

7.5.4q1 The organization shall exercise care with Do you use any customer-owned property?
customer property while it is under the (Product, packaging, drawings, tooling,
organization's control or being used by the gages...)
organization. (If so, ask questions below)
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7.5.4q2 The organization shall identify, verify, How do you ensure that customer-owned
protect and safeguard customer property property is identified, verified, protected,
provided for use or incorporation into the defines the requirement and safeguarded?
product.
7.5.4q3 If any customer property is lost, damaged or If any customer property is lost, damaged
otherwise found to be unsuitable for use, etc., how is it reported to the customer?
the organisation shall report this to the Can you show me records regarding this?
customer and maintain records (see 4.2.4).
NOTE Customer property can include intellectual property and personal data.
NOTE Customer-owned returnable packaging is included in this subclause.
7.5.4.1 Customer-owned production tooling
T7.5.4.1q1 Customer-owned tools, manufacturing, test, How are customer-owned tools and
inspection tooling and equipment shall be equipment identified?
permanently marked so that the ownership
of each item is visible, and can be
determined.
7.5.5 Preservation of product

7.5.5q1 The organization shall preserve the product How do you preserve the conformity of
during internal processing and delivery to product during internal processing and
the intended destination in order to maintain delivery?
conformity to requirements. (Verify product throughout audit)
7.5.5q2 As applicable, preservation shall include How do identification, handling, packaging,

identification, handling, packaging, storage storage and protection address the
and protection. preservation of product?
7.5.5q3 Preservation shall also apply to the Does this also apply to component parts?
constituent parts of a product.
7.5.5.1 Storage and inventory

T7.5.5.1q1 In order to detect deterioration, the How do you assess the condition of product
condition of product in stock shall be in stock to detect deterioration?
assessed at appropriate planned intervals.
T7.5.5.1q2 The organization shall use an inventory Can you walk me through your inventory
management system to optimize inventory management system?
turns over time and assure stock rotation, How does the system optimize inventory
such as "first-in-first-out" (FIFO). turns over time and assure stock rotation?
T7.5.5.1q3 Obsolete product shall be controlled in a How is obsolete product controlled to

similar manner to nonconforming product. prevent its unintended use or delivery?
(See 8.3)
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7.6 Control of monitoring and measuring devices
7.6q1 The organization shall determine the How do you determine the measurements
monitoring and measurement to be to be taken and the measuring equipment
undertaken and the monitoring and needed to demonstrate conformity with
measuring equipment needed to provide requirements?
evidence of conformity of product to
determined requirements.
7.6q2 The organization shall establish processes What process is in place to ensure that
to ensure that monitoring and measurement measurements are taken per the
can be carried out and are carried out in a requirements?
manner that is consistent with the
monitoring and measurement requirements.
7.6q3a Where necessary ensure valid results, a) How do you ensure that measuring and a)
measuring equipment shall test equipment is calibrated or verified
a) be calibrated or verified or both, at proper frequencies with traceable
specified intervals, or prior to use, standards? If no such standards exist,
against measurement standards where do you record the basis used for
traceable to international or national calibration or verification?
measurement standards; where no such b) What process is used to adjust or re-
standards exist, the basis used for adjust measuring and test equipment when
calibration or verification shall be needed?
recorded (see 4.2.4.); c) How are measuring tools identified to
b) be adjusted or re-adjusted as enable the calibration status to be
necessary; determined?
c) have identification in order to d) How do you safeguard measuring
determine its calibration status; equipment from adjustments that would
d) be safeguarded from adjustments invalidate the measurement results?
that would invalidate the measurement e) How do you ensure that measuring its
result; test equipment is protected from damage
e) be protected from damage and and deterioration during handling,
deterioration during handling, maintenance and storage?
maintenance and storage.
7.6q4 In addition, the organization shall assess When equipment is found to be out of
and record the validity of the previous calibration, how do you assess and record
measuring results when the equipment is the validity of the previous measuring
found not to conform to requirements. results?
7.6q5 The organization shall take appropriate What actions do you take on the equipment
action on the equipment and any product and any product affected?
affected.
Page 32 of 45
7.6q6 Records of the results of calibration and Can I see your records of the results of
verification shall be maintained (see 4.2.4). calibration and verification?
7.6q7 When used in the monitoring and Do you use computer software for
measurement of specified requirements, the monitoring and measurement? If so, is its
ability of computer software to satisfy the ability to perform that function confirmed
intended application shall be confirmed. prior to initial use and reconfirmed as
This shall be undertaken prior to initial use necessary?
and reconfirmed as necessary.
NOTE Confirmation of the ability of computer software to satisfy the intended application would
typically include its verification and configuration management to maintain its suitability for use.
NOTE A number or other identifier traceable to the device calibration record meets the intent of
requirement c) above.
7.6.1 Measurement system analysis
T7.6.1q1 Statistical studies shall be conducted to Can you show me R&R studies for each
analyse the variation present in the results type of measuring and test equipment
of each type of measuring and test system referenced in the control plan?
equipment system. This requirement shall (Or other statistical studies analyzing the
apply to measurement systems referenced variation in measurement & test results)
in the control plan. The analytical methods Do the methods and acceptance criteria
and acceptance criteria used shall conform conform to those in customer reference
to those in customer reference manuals on manuals on MSA or does the customer
measurement systems analysis. Other
approve them?
analytical methods and acceptance criteria
may be used if approved by the customer.
7.6.2 Calibration/verification records
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T7.6.2q1 Records of the calibration/verification Can you show that calibration records
activity for all gauges, measuring and test include:
equipment, needed to provide evidence of - equipment identification, including
conformity of product to determined the measurement standard against which
requirements, including employee- and the equipment is calibrated,
customer-owned equipment, shall include - revisions following engineering
- equipment identification, including changes,
the measurement standard against which - any out-of-specification readings
the equipment is calibrated,
as received for calibration/verification,
- revisions following engineering
changes, - an assessment of the impact of
- any out-of-specification readings out-of-specification condition,
as received for calibration/verification, - statements of conformity to
- an assessment of the impact of specification after calibration/ verification,
out-of-specification condition, and
- statements of conformity to - notification to the customer if
specification after calibration/verification, suspect product or material has been
and shipped?
- notification to the customer if
suspect product or material has been
shipped.
7.6.3 Laboratory requirements
7.6.3.1 Internal laboratory
T7.6.3.1q1 An organization’s internal laboratory facility Does Organization have an internal
shall have a defined scope that includes its laboratory?
capability to perform the required If so, can you show me a documented
inspection, test or calibration services. This laboratory scope including its capability to
laboratory scope shall be included in the perform inspection, test, or calibration
quality management system documentation. services?
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 the laboratory - adequacy of laboratory
procedures, procedures,
- competency of the laboratory - competency of the laboratory
personnel, personnel,
- testing of the product, - testing of the product,
- capability to perform these
- capability to perform these
services correctly, traceable to the
services correctly, traceable to the
relevant process standard, and
relevant process standard (such as - review of the related records?
ASTM, EN, etc.), and Have these requirements been
- review of the related records. implemented?
NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory
conformity to this requirement but is not mandatory.
7.6.3.2 External laboratory
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T7.6.3.2q1 External/commercial/independent laboratory Can you show me laboratory scope(s) for
facilities used for inspection, test or external/commercial/independent
calibration services by the organization shall laboratory facilities that include the
have a defined laboratory scope that capability to perform the required
includes the capability to perform the inspection, test or calibration?
required inspection, test or calibration, and Can I see evidence that each laboratory is
either either accredited, or is acceptable to the
- there shall be evidence that the customer(s)?
external laboratory is acceptable to the
customer, or
- the laboratory shall be accredited
to ISO/IEC 17025 or national equivalent.
NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by
customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025
or national equivalent.
NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration
services may be performed by the equipment manufacturer. In such cases, the organization should
ensure that the requirements listed in 7.6.3.1 have been met.
8 Measurement, analysis and improvement
8.1 General
8.1q1a The organization shall plan and implement How do you plan and implement
the monitoring, measurement, analysis and measurement, analysis and improvement
improvement processes needed a) to processes needed to demonstrate products
demonstrate conformity to product conform to requirements?
requirements.
8.1q1b The organization shall plan and implement How do you plan and implement
improvement processes needed b) to processes needed to ensure conformity of
ensure conformity of the quality the QMS?
management system, and
8.1q1c The organization shall plan and implement How do you plan and implement
improvement processes needed c) to processes needed to continually improve
continually improve the effectiveness of the the effectiveness of the QMS?
quality management system.
8.1q2 This shall include determination of How do you determine what methods to
applicable methods, including statistical use, including statistical techniques? How
techniques, and the extent of their use. do you determine the extent of their use?
8.1.1 Identification of statistical tools
Page 35 of 45
T8.1.1q1 Appropriate statistical tools for each Have appropriate statistical tools for each
process shall be determined during process been determined and included in
advance quality planning and included in the control plan? (see 7.5.1.1)
the control plan.
8.1.2 Knowledge of basic statistical concepts

T8.1.2q1 Basic statistical concepts, such as variation, How does Organization ensure that basic
control (stability), process capability and statistical concepts are understood and
over-adjustment shall be understood and utilized throughout the organization? (verify
utilized throughout the organization. throughout audit)
8.2 Monitoring and measurement

8.2.1 Customer satisfaction
8.2.1q1 As one of the measurements of the How do you obtain information about
performance of the quality management customer perception as to whether
system, the organization shall monitor Organization has met customer
information relating to customer perception requirements?
as to whether the organization has met How is this information used?
customer requirements. The methods for
obtaining and using this information shall be
determined. NOTE. Monitoring customer
perception can include obtaining input from
sources such as customer satisfaction surveys,
customer data on delivered product quality, user
opinion surveys, lost business analysis,
compliments, warranty claims and dealer reports.
NOTE Consideration should be given to both internal and external customers.

8.2.1.1 Customer satisfaction — Supplemental
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T8.2.1.1q1 Customer satisfaction with the organization What realization process performance
shall be monitored through continual indicators are used to monitor customer
evaluation of performance of the realization satisfaction?
processes. Performance indicators shall be Do they include at least:
based on objective data and include, but not - delivered part quality performance,
be limited to: - customer disruptions including field
- delivered part quality performance, returns,
- customer disruptions including field - delivery schedule performance
returns, (including incidents of premium freight),
- delivery schedule performance and
(including incidents of premium freight), - customer notifications related to
and quality or delivery issues?
- customer notifications related to
quality or delivery issues.
T8.2.1.1q2 The organization shall monitor the How do you monitor manufacturing
performance of manufacturing processes to processes to demonstrate compliance with
demonstrate compliance with customer customer requirements for product quality
requirements for product quality and 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? Do they determine
whether the quality management system whether the QMS conforms to the
a) conforms to the planned arrangements requirements of ISO 9001 and to the other
(see 7.1), to the requirements of this requirements established by Organization?
International Standard and to the quality (Review records to demonstrate
management system requirements conformance)
established by the organization, and Do they determine whether the QMS is
b) is effectively implemented and effectively implemented and maintained?
maintained. (Review records)
8.2.2q2 An audit programme shall be planned, Can you show me an audit plan that takes
taking into consideration the status and into consideration the importance of the
importance of the processes and areas to processes and areas to be audited, and the
be audited, as well as the results of results of previous audits?
previous audits.
8.2.2q3 The audit criteria, scope, frequency and Where are the audit criteria, scope,
methods shall be defined. frequency and methods defined?
Page 37 of 45
8.2.2q4 The selection of auditors and conduct of Can you demonstrate that selection of
audits shall ensure objectivity and auditors and the conduct of audits are
impartiality of the audit process. Auditors objective and impartial, and that auditors
shall not audit their own work. don’t audit their own work?
8.2.2q5 A documented procedure shall be Can you show me your internal audit
established to define the responsibilities procedure?
and requirements for planning and
conducting audits, establishing records and
reporting results.
8.2.2q6 Records of the audits and their results shall Can you show me the records of internal
be maintained (see 4.2.4.) QMS audits?
8.2.2q7 The management responsible for the area What activities are done to verify the actions
being audited shall ensure that any taken, and how are the verification results
necessary corrections and corrective reported? Who ensures that actions are
actions are taken without undue delay to taken to eliminate detected nonconformities
eliminate detected nonconformities and and their causes? Are they being taken
their causes. Follow-up activities shall care of in a timely manner? (verify with
include the verification of the actions taken records)
and the reporting of verification results (see
8.5.2.).
NOTE See ISO 19011 for guidance.

8.2.2.1 Quality management system audit
T8.2.2.1q1 The organization shall audit its quality Do you have audit records showing that the
management system to verify compliance entire QMS is being audited?
with this Technical Specification and any
additional quality management system
requirements.
8.2.2.2 Manufacturing process audit

T8.2.2.2q1 The organization shall audit each Do you have records showing that each
manufacturing process to determine its manufacturing process is being audited to
effectiveness. determine its effectiveness?
8.2.2.3 Product audit
T8.2.2.3q1 The organization shall audit products at Are there records showing that products are
appropriate stages of production and being audited at appropriate stages of
delivery to verify conformity to all specified production and delivery?
requirements, such as product dimensions, Do the audits verify conformity to all
functionality, packaging and labelling, at a specified requirements?
defined frequency.
8.2.2.4 Internal audit plans
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T8.2.2.4q1 Internal audits shall cover all quality Can you show me an annual audit plan?
management related processes, activities Does it show that audits cover all QMS
and shifts, and shall be scheduled processes, activities and shifts?
according to an annual plan.
T8.2.2.4q2 When internal/external nonconformities or Is there evidence that audit frequency is
customer complaints occur, the audit increased due to nonconformances or
frequency shall be appropriately increased. customer complaints?
NOTE Specific checklists should be used for Are specific checklists used for each audit?
each audit.
8.2.2.5 Internal auditor qualification
T8.2.2.5q1 The organization shall have internal How do you determine competence of
auditors who are qualified to audit the internal auditors to audit the requirements of
requirements of this Technical Specification TS 16949? (See 6.2.2.2 – also customer
(see 6.2.2.2). specific requirements).
8.2.3 Monitoring and measurement of processes
8.2.3q1 The organization shall apply suitable What methods are used to monitor and
methods for monitoring and, where measure the QMS processes?
applicable, measurement of the quality
management system processes.
8.2.3q2 These methods shall demonstrate the ability Can you show that they have achieved the
of the processes to achieve planned results. desired results?
8.2.3q3 When planned results are not achieved, When the desired results are not achieved,
correction and corrective action shall be what actions are taken to ensure that the
taken, as appropriate. NOTE. When product meets requirements?
determining suitable methods, it is
advisable that the organization consider the
type and extent of monitoring or
measurement appropriate to each of its
processes in relation to their impact on the
conformity to product requirements and on
the effectiveness of the quality management
system.
8.2.3.1 Monitoring and measurement of manufacturing processes
T8.2.3.1q1 The organization shall perform process Can you show me process studies that
studies on all new manufacturing (including have been performed on new
assembly or sequencing) processes to manufacturing processes?
verify process capability and to provide
additional input for process control.
T8.2.3.1q2 The results of process studies shall be Can you show examples of results of
documented with specifications, where process studies being documented with
applicable, for means of production, specifications? Are they used for
measurement and test, and maintenance instructions?
instructions.
T8.2.3.1q3 These documents shall include objectives Do the documents include objectives for
for manufacturing process capability, manufacturing process capability, reliability,
reliability, maintainability and availability, as maintainability, availability, and acceptance
well as acceptance criteria. criteria?
Page 39 of 45
T8.2.3.1q4 The organization shall maintain Do records show that manufacturing
manufacturing process capability or process capability or original customer-
performance as specified by the customer approved performance is being maintained?
part approval process requirements.
T8.2.3.1q5 The organization shall ensure that the control May I have a copy of the process flow
plan and process flow diagram are implemented, diagram and control plan for (mfg. process)
including adherence to the specified to review the production line with?
- measurement techniques, (Review for adherence to specified
- sampling plans,
- acceptance criteria, and requirements)
- reaction plans when acceptance
criteria are not met.
T8.2.3.1q6 Significant process events, such as tool Can you show that process events like tool
change or machine repair, shall be changes or machine repairs are being
recorded. recorded (on control charts)?
T8.2.3.1q7 The organization shall initiate a reaction Can you show me that reaction plans have
plan from the control plan for characteristics been followed for characteristics that are
that are either not statistically capable or not statistically capable or are unstable?
are unstable. These reaction plans shall Do the reaction plans include containment
include containment of product and 100 % of product and 100 % inspection as
inspection as appropriate. appropriate?
T8.2.3.1q8 A corrective action plan shall then be Have corrective action plan(s) been
completed by the organization, indicating completed by the organization, with timing
specific timing and assigned responsibilities and responsibilities to assure that
to assure that the process becomes stable processes become stable and capable?
and capable.
T8.2.3.1q9 The plans shall be reviewed with and When required, have CA plans been
approved by the customer when so reviewed and approved by the customer?
required.
T8.2.3.1q1 The organization shall maintain records of Can you show me records of effective dates
effective dates of process changes. of process changes?
8.2.4 Monitoring and measurement of product
8.2.4q1 The organization shall monitor and measure What characteristics are checked to verify
the characteristics of the product to verify that product requirements have been met?
that product requirements have been met.
8.2.4q2 This shall be carried out at appropriate At what stages of the product realization
stages of the product realization process in process do monitoring and measuring
accordance with the planned arrangements activities take place?
(see 7.1).
8.2.4q3 Evidence of conformity with the acceptance How is evidence of conformity with
criteria shall be maintained. acceptance criteria maintained?
8.2.4q4 Records shall indicate the person(s) Can you show me records that indicate
authorizing release of product for delivery to who has authorized release of product to
the customer (see 4.2.4). the next stage of the process?
Page 40 of 45
8.2.4q5 The release of product and delivery of How do you ensure that product is not
service to the customer shall not proceed released until the all requirements have
until the planned arrangements (see 7.1) been met? If product must be released
have been satisfactorily completed, unless prior to this, how is it approved?
otherwise approved by a 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.
8.2.4.1 Layout inspection and functional testing
T8.2.4.1q1 A layout inspection and a functional Can you show me layout inspection and
verification to applicable customer functional verification results?
engineering material and performance Do they address applicable customer
standards shall be performed for each specifications and correlate with the
product as specified in the control plans. control plan requirements?
Results shall be available for customer Are results available for customer review?
review.
NOTE Layout inspection is the complete measurement of all product dimensions shown on the
design records.
8.2.4.2 Appearance items
T8.2.4.2q1 For organizations manufacturing parts Do you provide parts designated by
designated by the customer as “appearance customer(s) as appearance items?
items”, the organization shall provide If so can you show that you have:
- appropriate resources including - appropriate resources including
lighting for evaluation, lighting for evaluation,
- masters for colour, grain, gloss, - masters for colour, grain, gloss,
metallic brilliance, texture, distinctness of metallic brilliance, texture, distinctness
image (DOI), as appropriate, of image (DOI), as appropriate,
- maintenance and control of - maintenance and control of
appearance masters and evaluation appearance masters and evaluation
equipment, and equipment, and
- verification that personnel making - verification that personnel making
appearance evaluations are competent appearance evaluations are competent
and qualified to do so. and qualified to do so
8.3 Control of nonconforming product
8.3q1 The organization shall ensure that product How do you ensure that nonconforming
which does not conform to product products are identified and controlled to
requirements is identified and controlled to prevent unintended use or delivery?
prevent its unintended use or delivery. (Verify product throughout audit)
Page 41 of 45
8.3q2 A documented procedure shall be Can you show me your documented
established to define the controls and procedure defining the controls for dealing
related responsibilities and authorities for with nonconforming product?
dealing with nonconforming product. Does it include related responsibilities and
authorities?
8.3q3 Where applicable, the organization shall When you have nonconforming product,
deal with nonconforming product by one or what methods do you use to deal with it?
more of the following ways:
a) by taking action to eliminate the detected When nonconforming product is detected
nonconformity; after shipment, what actions are taken,
b) by authorizing its use, release or such as containment?
acceptance under concession by a relevant (Verify corrective action records)
authority and, where applicable, by the
customer;
c) by taking action to preclude its original
intended use or application:
d) by taking action appropriate to the
effects, or potential effects, of the
nonconformity when nonconforming product
is detected after delivery or use has started.
8.3q4 When nonconforming product is corrected it When nonconforming product is corrected,
shall be subject to re-verification to can you demonstrate that it is re-verified to
demonstrate conformity to the ensure it conforms to requirements?
requirements.
8.3q5 Records of the nature of nonconformities Can you show me records of
and any subsequent actions taken, nonconforming product and any actions
including concessions obtained, shall be taken?
maintained (see 4.2.4). Are there any records of concessions
obtained?
8.3.1 Control of nonconforming product — Supplemental
T8.3.1q1 Product with unidentified or suspect status How are unidentified or suspect products
shall be classified as nonconforming treated?
product (see 7.5.3).
8.3.2 Control of reworked product

T8.3.2q1 Instructions for rework, including re- Can you show me instructions for rework?
inspection requirements, shall be accessible Do they include re-inspection requirements?
to and utilized by the appropriate personnel. Are they accessible and utilized?
8.3.3 Customer information

T8.3.3q1 Customers shall be informed promptly in the Do you have evidence that customers are
event that nonconforming product has been promptly notified if nonconforming product
shipped. is shipped?
8.3.4 Customer waiver
Page 42 of 45
T8.3.4q1 The organization shall obtain a customer Can you show me records of customer
concession or deviation permit prior to approvals prior to processing, whenever
further processing whenever the product or deviations from approved product or
manufacturing process is different from that manufacturing processes occur?
which is currently approved.
T8.3.4q2 The organization shall maintain a record of Do the records indicate expiration date
the expiration date or quantity authorized. and/or quantity authorized?
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 an
be properly identified on each shipping authorization?
container.
T8.3.4q5 This applies equally to purchased product. Do you have records that this process is
The organization shall agree with any applied to purchased products also?
requests from suppliers before submission Do you review and agree with supplier
to the customer. deviation requests before submitting them
to the customer for approval?
8.4 Analysis of data
8.4q1 The organization shall determine, collect What data is collected and analyzed to
and analyse appropriate data to demonstrate the suitability and
demonstrate the suitability and effectiveness of the QMS and to evaluate
effectiveness of the quality management where continual improvement of its
system and to evaluate where continual effectiveness can be made?
improvement of the effectiveness of the
quality management system can be made.
This shall include data generated as a result
of monitoring and measurement and from
other relevant sources.
8.4q2a The analysis of data shall provide What information does this analysis provide
information relating to relating to:
a) customer satisfaction (see 8.2.1), - customer satisfaction? (See 5.6)
b) conformity to product requirements (see - conformity to product
8.2.4.), requirements? (See 5.6)
c) characteristics and trends of processes - characteristics and trends of
and products including opportunities for processes and products? (See 5.6)
preventive action (see 8.2.3. ands 8.2.4), - suppliers? (See 7.4.1)
and
d) suppliers (see 7.4.).
8.4.1 Analysis and use of data
T8.4.1q1 Trends in quality and operational How do you compare trends in quality and
performance shall be compared with operational performance with progress
progress toward objectives and lead to toward objectives?
action to support the following: Does the comparison lead to action to
- development of priorities for supporting the following?
prompt solutions to customer-related - development of priorities for
problems; prompt solutions to customer-related
- determination of key customer- problems;
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related trends and correlation for status - determination of key customer-
review, decision-making and longer term related trends and correlation for status
planning; review, decision-making and longer term
- an information system for the planning;
timely reporting of product information - an information system for the
arising from usage. timely reporting of product information
arising from usage.
NOTE Data should be compared with those of competitors and/or appropriate benchmarks.
8.5 Improvement
8.5.1 Continual improvement
8.5.1q1 The organization shall continually improve Can you demonstrate that Organization’s
the effectiveness of the quality management QMS effectiveness continually improves?
system through the use of the quality policy, What tools do you use?
quality objectives, audit results, analysis of (See 5.6, 8.2.2, 8.4, 8.5.2, 8.5.3)
data, corrective and preventive actions and
management review.
8.5.1.1 Continual improvement of the organization
T8.5.1.1q1 The organization shall define a process for Where has Organization defined a process
continual improvement. for continual improvement?
8.5.1.2 Manufacturing process improvement
T8.5.1.2q1 Manufacturing process improvement shall Can you show that CI efforts focus on
continually focus upon control and reduction control and reduction of variation in product
of variation in product characteristics and and process characteristics (after capability,
manufacturing process parameters. stability, and conformity)?
NOTE 1 Controlled characteristics are documented in the control plan.
NOTE 2 Continual improvement is implemented once manufacturing processes are capable and
stable, or product characteristics are predictable and meet customer requirements.
8.5.2 Corrective action 8.5.2 Corrective action
8.5.2q1 The organization shall take action to Do corrective actions records identify and
eliminate the cause of nonconformities in address root cause(s)?
order to prevent recurrence. (Do root causes match actions?)
8.5.2q2 Corrective actions shall be appropriate to Are actions taken appropriate to the severity
the effects of the nonconformities of the problem?
encountered.
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8.5.2q3 A documented procedure shall be Can you show me a documented
established to define requirements for procedure defining requirements for each
a) reviewing nonconformities of the following?
(including 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 nonconformities
ensure that nonconformities do not recur, c) evaluating the need for action to ensure
d) determining and implementing that nonconformities do not recur
action needed, d) determining and implementing action
e) records of the results of action needed
taken (see 4.2.4), and e) records of the results of action taken
f) reviewing the effectiveness of the f) reviewing the effectiveness of corrective
corrective action taken. action taken
8.5.2q4 e) records of the results of action taken (see Can you show me records of corrective
4.2.4) actions taken?
8.5.2.1 Problem solving

T8.5.2.1q1 The organization shall have a defined Where is the process for problem solving
process for problem solving leading to root defined?
cause identification and elimination. Does it lead to root cause identification and
elimination? (Review records)
T8.5.2.1q2 If a customer-prescribed problem-solving If one or more customer requires a specific
format exists, the organization shall use the problem-solving format can you show me
prescribed format. records documented as required?
8.5.2.2 Error-proofing
T8.5.2.2q1 The organization shall use error-proofing Can you show that error-proofing methods
methods in their corrective action process. are used in the corrective action process?
8.5.2.3 Corrective action impact

T8.5.2.3q1 The organization shall apply to other similar Can you show that corrective actions are
processes and products the corrective applied to other similar processes and
action, and controls implemented, to products?
eliminate the cause of a nonconformity.
8.5.2.4 Rejected product test/analysis
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T8.5.2.4q1 The organization shall analyse parts Can you show me records of analysis of
rejected by the customer's manufacturing parts rejected by customer manufacturing
plants, engineering facilities and plants, engineering facilities and
dealerships. The organization shall dealerships?
minimize the cycle time of this process. How long does the analysis take?
Records of these analyses shall be kept Are records made available (to customers)
and made available upon request. The upon request?
organization shall perform analysis and Is the time consistent with the determination
initiate corrective action to prevent of root cause, corrective action and
recurrence. monitoring the effectiveness of
implementation?
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.
8.5.3 Preventive action 8.5.3 Preventive action
8.5.3q1 The organization shall determine action to How do you determine potential
eliminate the causes of potential nonconformities to take action on?
nonconformities in order to prevent their Do preventive action records identify and
occurrence. address root cause(s)?
8.5.3q2 Preventive actions shall be appropriate to Are actions taken appropriate to the severity
the effects of the potential problems. of the problem?
8.5.3q3 A documented procedure shall be Can you show me a documented

established to define requirements for procedure defining requirements for each
a) determining potential nonconformities of the following?
and their causes, a) determining potential nonconformities
b) evaluating the need for action to prevent and their causes,
occurrence of nonconformities, b) evaluating the need for action to prevent
c) determining and implementing action occurrence of nonconformities,
needed, c) determining and implementing action
d) records of results of action taken (see needed,
4.2.4), and d) records of results of action taken (see
e) reviewing the effectiveness of the 4.2.4), and
preventive action taken. e) reviewing preventive action taken.
8.5.3q4 d) records of results of action taken (see Can you show me records of preventive
4.2.4) actions taken?
Annex A – Control plan

A.1 Phases of the control plan
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TAXA.1q1 The control plan shall cover three distinct Can you show me control plans that cover
phases as appropriate. prototype, pre-launch, and production?
a) Prototype: a description of the If all three types are not used, does
dimensional measurements, material and Organization’s scope of certification justify
performance tests that will occur during
building of the prototype. The their absence?
organization shall have a prototype
control plan if required by the customer.
b) Pre-launch: a description of the
dimensional measurements, material and
performance tests that occur after
prototype and before full production. Pre-
launch is defined as a production phase
in the process of product realization
which may be required after prototype
build.
c) Production: documentation of
product/process characteristics, process
controls, tests and measurement systems
that occur during mass production.
TAXA.1q2 Each part shall have a control plan but, in Can you show me the control plan for (part x)?
many cases, family control plans may cover Do you have family control plans?
a number of similar parts produced using a (If so, are the only differences in the parts
common process. dimensional – not form, application or
function?)
TAXA.1q3 Control plans are an output of the quality plan. Are control plans outputs of the quality plan?
A.2 Elements of the control plan
TAXA.1q1 The organization shall develop a control Do the control plans include the following
plan that includes, as a minimum, the minimum contents:
following contents. a) General data
a) General data - control plan number,
- control plan number, - issue date, and revision date, if
- issue date, and revision date, if any,
any, - customer information (see
- customer information (see customer requirements),
customer requirements), - organization's name/site
- organization's name/site designation,
designation, - part number(s),
- part number(s), - part name/description,
- part name/description, - engineering change level,
- engineering change level, - phase covered (prototype, pre-
- phase covered (prototype, pre- launch, production),
launch, production), - key contact,
- key contact, - part/process step number,
- part/process step number, - process name/operation
- process name/operation description.
description.
b) Product control b) Product control
- product-related special - product-related special
characteristics, characteristics,
- other characteristics for control - other characteristics for control
(number, product or process), (number, product or process),
- specification/tolerance. - specification/tolerance.
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c) Process control c) Process control
- process parameters, - process parameters,
- process-related special - process-related special
characteristics, characteristics,
- machines, jigs, fixtures, tools for - machines, jigs, fixtures, tools for
manufacturing. manufacturing.
d) Methods d) Methods
- evaluation measurement - evaluation measurement
technique, technique,
- error-proofing, - error-proofing,
- sample size and frequency, - sample size and frequency,
- control method. - control method.
e) Reaction plan and corrective e) Reaction plan and corrective
actions actions
- reaction plan (include or - reaction plan (include or
reference), reference),
- corrective action. - corrective action.
Document Audit conducted by Steve Markham, 9th July 2013.
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ISO 9001:2008 and/or

NOTE See also 7.4.1 and 7.4.1.3.

4.2.2 Quality manual

5.1.1 Process efficiency

5.5.2 Management representative

5.5.2.1 Customer representative

5.5.3 Internal communication

5.6.1.1 Quality management system performance

5.6.2.1 Review input – Supplemental

6.2 Human resources

6.2.2.4 Employee motivation and empowerment

7.1.2 Acceptance Criteria

7.2.2.2 Organization manufacturing feasibility

7.2.3 Customer communication

7.2.3.1 Customer communication – Supplemental

7.3 Design and development

7.3.1.1 Multidisciplinary approach

7.3.2 Design and development inputs

7.3.2.2 Manufacturing process design input

7.3.3.1 Product design outputs – Supplemental

7.3.6 Design and development validation

7.3.7 Control of design and development changes

7.4.1.2 Supplier quality management system development

7.4.1.3 Customer-approved sources

7.4.2 Purchasing information

7.4.3 Verification of purchased product

7.4.3.1 Incoming product conformity to requirements

7.4.3.2 Supplier monitoring

7.5.1.1 Control plan

NOTE Last-off-part comparisons are recommended.

7.5.1.5 Management of production tooling

7.5.2 Validation of processes for production and service provision

7.5.3 Identification and traceability 7.5.3 Identification and traceability

7.5.4 Customer property

7.5.5 Preservation of product

7.5.5q2 As applicable, preservation shall include How do identification, handling, packaging,

7.5.5.1 Storage and inventory

T7.5.5.1q3 Obsolete product shall be controlled in a How is obsolete product controlled to

8.1.2 Knowledge of basic statistical concepts

8.2 Monitoring and measurement

NOTE Consideration should be given to both internal and external customers.

8.2.2 Internal audit

NOTE See ISO 19011 for guidance.

8.2.2.2 Manufacturing process audit

8.3.2 Control of reworked product

8.3.3 Customer information

8.3.4 Customer waiver

8.5.2.1 Problem solving

8.5.2.3 Corrective action impact

8.5.2.4 Rejected product test/analysis

8.5.3q3 A documented procedure shall be Can you show me a documented

Annex A – Control plan

Document Audit conducted by Steve Markham, 9th July 2013.

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