TS16949

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TS16949 Checklist.doc
Requirements What to Look For Assessor Notes/Objective Results
Evidence
ELEMENT 4 – Quality Management System
4.1 General Requirements
4.1.1 Has the organization established and • Quality manual according to
documented a quality management ISO/TS 16949:2002 or one with a
system in accordance with the conversion matrix.
requirements of ISO/TS16949:2002?
(4.1)
4.1.2 Has the organization implemented and • Key personnel interview
maintained its established quality • Examples of effective
management system in accordance with implementation.
the requirements of ISO/TS 16949:2002?
(4.1)
4.1.3 Is the organization continually improving • Examples and status of quality
the effectiveness of its quality management system continuous
management system in accordance with improvement projects, not
the requirements of ISO/TS 16949:2002? corrective actions.
(4.1.1.1) • Management review results.
4.1.4 Does the organization’s quality • Quality manual according to
management system: ISO/TS 16949:2002 or one with a
a) Identify the processes need for the conversion matrix.
quality management system and their
application throughout the
organization?
b) Determine the sequence and
interaction of these processes?
c) Determine criteria and methods
needed to ensure that both the
operation and control of these
processes are effective?
(4.1.a,b,c)
4.1.5 Does the organization’s quality • Review of all the elements of the
management system: quality management system to
a) Ensure the availability of resources insure its continuing suitability
and information necessary to support and effectiveness.
the operation and monitoring of the • Review of quality cost indicators.
processes needed for its quality • Management review meeting
management system? minutes, attendance and adequate
b) Monitor, measure and analyze the frequency.
processes needed for its quality • Action plans and follow-up.
management system?
c) Implement actions necessary to
achieve planned results and continual
improvement of the processes needed
for its quality system?
(4.1.d, e, f)
4.1.6 Does the organization manage the
processes needed for its quality
management system in accordance with
the requirements of ISO/TS 16949:2002?
(4.1)
4.1.7 Does the organization ensure control over
outsourced processes that affects product
conformity with requirements? (4.1)
All “Italics” are Automotive Requirements. 1

ISO/TS 16 949 CHECKLIST
Evidence
4.1.8 Is the control of the organization’s • Quality manual according to
outsourced processes that affects product ISO/TS 16949:2002 or one with a
conformity with requirements identified conversion matrix.
within the quality management system?
(4.1)
4.2 Documentation Requirements
4.2.1 General
4.2.1 Does the quality management system • Quality manual according to
documentation include the following: ISO/TS 16949:2002 or one with
a) Documented statements of a quality a conversion matrix.
policy and quality objectives? • Adequacy of the procedures to
b) A quality manual? the complexity of the
c) Documented procedures required by organization.
ISO/TS 16949:2002? • Quality management system
d) Documents needed by the procedures.
organization to ensure the effective • Quality records.
planning, operation and control of its
processes?
e) Records required by ISO/TS
16949:2002 (see element 4.2.4)?
(4.2.4)
4.2.2 Quality Manual
maintained a quality manual that includes: ISO/TS 16949:2002 or one with
a) The scope of the quality management a conversion matrix.
system, including details of and
justification for any exclusions (see
section 1.2 of ISO/TS 16949:2002)?
b) The documented procedures
established for the quality
management system, or reference to
them?
c) A description of the interaction
between the processes of the quality
management system?
(4.2.2)
4.2.3 Control of documents
4.2.3 Does the organization control the • Quality manual according to
documents required by the quality ISO/TS 16949:2002 or one with
management system? a conversion matrix.
(4.2.3) • Document control master list or
equivalent.

Evidence
.2.4 Has the organization established a • Document approval authority.
documented procedure to define controls • Document approval records.
needed: • Availability of documents in
a) To approve documents for adequacy various locations.
prior to issue? • Knowledge of document
b) To review and update as necessary location.
and re-approve documents? • Document accessibility.
c) To ensure that changes and the current • Storage and disposal of obsolete
revision status of documents are documents.
identified?
• Process for
d) To ensure that relevant versions of
notification/distribution of
applicable documents are available at
documents from internal and
points of use?
external origins.
e) To ensure that documents remain
• Review and approval of revised
legible and readily identifiable?
documents.
f) To ensure that documents of external
origin are identified and their
distribution controlled?
g) To prevent the unintended use of
obsolete documents, and to apply
suitable identification to them if they
are retained for any purpose?
(4.2.3)
4.2.3.1 Engineering specifications
4.2.5 Does the organization have a process to • Process for
assure the timely review, distribution and notification/distribution of
implementation of all customer customer engineering standards
engineering standards/specifications and changes.
changes (including the updating of • Process for implementation of
appropriate documents) based on customer initiated changes.
customer required schedule? • Document changes triggered by
(4.2.3.1) engineering changes.
4.2.6 Does the organization maintain a record • Records of engineering changes
of the date on which each change is implemented.
implemented in production?
(4.2.3.1)
4.2.4 Control of records
4.2.7 Has the organization established and • Quality management system
maintained records to provide evidence of records.
conformity to requirements and of the • Records maintenance system,
effective operation of the quality including disposal of records.
management system?
(4.2.4)
4.2.8 Are records legible, readily identifiable • Quality management system
and retrievable? records legibility.
(4.2.4) • Identification of quality
management system records.
• Environment and storage
conditions must be compatible
with the file storage medium (ex:
hard copy, floppy disk, etc.)

Evidence
4.2.9 Has the organization established a • Quality manual according to
documented procedure to define the ISO/TS 16949:2002.
controls needed for the identification, • Defined record retention time
storage, protection, retrieval, retention time compared to customer/
and disposition of records? regulatory requirements.
(4.2.4) • Record disposal after retention
period expires.
• Including identification of
obsolescence documents.
• Identification of invalid/obsolete
documents.
4.2.10 Does the organization treat quality records • Evidence of quality records
as a special type of document and control being maintained and controlled
them according to the requirements given per quality manual.
in questions 4.2.7 and 4.2.8?
(4.2.4)


Evidence
ELEMENT 5 – Management Responsibility
5.1 Management commitment
5.1.1 Does top management have evidence of • Documented policy statement
providing commitment to the with clearly defined and
development and implementation of its measurable quality objectives
quality management system? approved by CEO.
(5.1)
5.1.2 Does the organization’s top management • Customer defined objectives
have evidence of providing commitment (Customer specifications) and
to continually improving its quality company goals stated in the
management system effectiveness by business plan and their alignment
a) Communicating to the organization with the quality policy statement.
the importance of meeting customer • Quality manual according to
as well as statutory and regulatory ISO/TS 16949:2002.
requirements? • Management reviews meeting
b) Establishing the quality policy? minutes, attendance and adequate
c) Ensuring that quality objectives are frequency.
established? • Action plans and follow up.
d) Conducting management reviews?
e) Ensuring the availability of
resources?
(5.1)
5.1.1 Process Efficiency
5.1.3 Does organization’s top management • Review of product realization and
monitor the product realization processes support processes by top
and the support processes to assure their management.
effectiveness and efficiency? • Indicators and records
(5.1.1) • Reporting process.
5.2 Customer Focus
5.2.1 Does top management ensure that • Description of an objective
customer requirements are determined process.
and fulfilled with the aim of enhancing • Methodology used for surveys.
customer satisfaction? • Original Customer data and scope
(5.2) such as customer satisfaction
feedback (surveys, scorecards,
awards, etc.)
5.3 Quality policy
5.3.1 Does top management ensure that the • Documented policy statement
quality policy: with clearly defined and
a) Is appropriate to the purpose of the measurable quality objectives
organization? approved by CEO.
b) Includes a commitment to comply • Records of improvement.
with requirements and continually • Quality objectives included/
improve the effectiveness of the linked to the business plan.
quality management system? • Scope of the Quality objectives.
c) Provides a framework for • Direct interviews with randomly
establishing and reviewing quality selected people of the
objectives? organization.
d) Is communicated and understood • Evidence of periodic review of
within the organization? the quality policy.
e) Is reviewed for continuing
• Review of all the elements of the
suitability?
quality system to insure its
(5.3)
continuing suitability and
effectiveness.

Evidence
5.4 Quality objectives
5.4.1 Does the organization’s top management
ensure that quality objectives, including
those needed to meet requirements for
product (see section 7.1 of the ISO/TS
16949:2002 technical specification) are
established at relevant functions and
levels within the organization?
(5.4.1)
5.4.2 Are the organization’s quality objectives • Quality cost indicators and
measurable and consistent with the quality indices.
quality policy? • Quality objectives included/
(5.4.1) linked to the business plan.
5.4.3 Did top management define any quality • Quality objectives included/
objectives and measurements? linked to the business plan.
(5.4.1.1) • Scope of the Quality objectives.
5.4.4 Are the organization’s quality objectives • Quality objectives included/
and measurements included in the linked to the business plan.
business plan and used by top • Management review meeting
management to deploy the organization’s minutes, attendance and adequate
quality policy? frequency.
(5.4.1.1)
5.4.2 Quality management system planning
5.4.5 Does top management of the organization • Internal audit results
ensure that
a) The planning of the quality
management system is carried out in
order to meet the general quality
management system requirements
stated in section 4.1 of ISO/TS
16949:2002, as well as the quality
objectives?
b) The integrity of the quality
management system is maintained
when changes to the quality
management system are planned and
implemented.
(5.4.2)
5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority
5.5.1 Does the organization’s top management • Responsibilities and authority as
ensure that the responsibilities and defined in job descriptions,
authorities are defined and communicated responsibilities matrices,
within the organization? procedures, and accountabilities
(5.5.1) documents.
5.5.1.1 Quality responsibility
5.5.2 Is management with responsibility and • Select examples of non-
authority for corrective action promptly compliance from suitable sources
informed of products or process that do such as internal or external
not conform to requirements? concerns/complaints, etc.
(5.5.1.1) • Communication channels and
timeliness

Evidence
5.5.3 Does the organization’s personnel • Who is responsible for quality in
responsible for quality have the authority the production process?
to stop production to correct quality • How the authority is defined.
problems? • Recent examples.
(5.5.1.1)
5.5.4 Are the organization’s production • Quality Assurance responsible
operations staffed with personnel that personnel in all shifts.
ensure product quality across all shifts?
(5.5.1.1)
5.5.2 Management representative
5.5.5 Did the organization’s top management • Who is the person in charge of
appoint a member of management who, this responsibility?
irrespective of other responsibilities, shall • Evidence of activities performed
have responsibility and authority that including empowerment for all
includes applicable system elements
a) Ensuring that processes needed for including design, sales,
the quality management system are manufacturing, delivery, etc.
established implemented and • Management review minutes.
maintained?
b) Reporting to top management on the
performance of the quality
management system and any need for
improvement?
c) Ensuring the promotion of awareness
of customer requirements throughout
the organization?
(5.5.2)
5.5.2.1 Customer representative
5.5.6 Did he organization’s top management • Quality function representative in
designate individual(s) to represent the project teams.
needs of the customer to address quality • Quality function participation in
requirements, such as selection of special milestones decision points
charac6eristics, setting quality objectives (Production release, Engineering
and related training, corrective and release, …..).
preventive actions, product design and • Responsibilities and job
development? description of the customer
(5.5.2.1) representative (ex Quality
function).
5.5.3 Internal communication
5.57 Does top management ensure that • Communication channels and
appropriate communication processes are timeliness.
established within the organization?
(5.5.3)
5.5.8 Does top management ensure that • Communication channels and
communication takes place within the timeliness.
organization regarding the effectiveness
of the quality management system?
(5.5.3)
5.6 Management review
5.6.1 General
5.6.1 Does the organization’s top management • Review of all the elements of the
review its quality management system, at quality system to insure its
planned intervals, to ensure its continuing continuing suitability and
suitability, adequacy and effectiveness? effectiveness.
(5.6.1) • Review of quality cost indicators.

Evidence
• Management review meeting
minutes, attendance and adequate
frequency.
• Action plans and follow-ups.
5.6.2 Do the organization’s management • Evidence of continuous
reviews include assessing opportunities improvement projects initiated
for improvement and the need for from management reviews.
changes to the quality management
system, including the quality policy and
quality objectives?
(5.6.1)
5.6.3 Are the organization’s records from • Retention of management reviews
management reviews maintained? meeting minutes.
(5.6.1)
5.6.1.1 Quality management system performance
5.6.4 Do the management reviews include all • Review of all the elements of the
elements of the quality management quality system to insure its
system and its performance trends as an continuing suitability and
essential part of the continual effectiveness.
improvement process? • Trends in metrics (business and
(5.6.1.1) customer satisfaction).
• Basis for continuous
improvement projects.
5.6.5 Do the management reviews include • Policy, business plan and
monitoring of quality objectives, and the customer satisfaction metrics
regular reporting and evaluation of the reports.
cost of poor quality (see elements 8.4.1 • Product results (quality, cost,
and 8.5.1 of ISO/TS 16949:2002(E))? time) against quality policy goals
(5.6.1.1) and customer specified targets.
5.6.6 Are the results of the management • Trends in metrics (business and
reviews recorded to provide, as a customer satisfaction).
minimum, evidence of the achievement of: • Basis for continuous
- Objectives specified in the quality improvement projects.
policy? • Management review meeting
- Objectives specified in the business minutes.
plan? • Action plans and follow-up.
- Customer satisfaction with product
supplied?
(5.6.1.1)
5.6.2 Review input
5.6.7 Does the organization’s input to its • Reports prepared for management
management review include information reviews.
on: • Management review meeting
a) Results of audits? minutes.
b) Customer feedback? • Action plans and follow-up.
c) Process performance and product • Content of management review
conformity? meeting agenda.
d) Status of preventive and corrective
actions?
e) Follow-up actions from previous
management reviews?
f) Planned changes that could affect the
quality management system?
g) Recommendations for improvement?
(5.6.2)

Evidence
5.6.2.1 Review input – Supplemental
5.6.8 Do management reviews include an • Content of management review
analysis of actual and potential field- meeting agenda.
failures and their impact on quality,
safety, or the environment?
(5.6.2.1)
5.6.3 Review output
5.6.9 Does the output from the organization’s • Examples of continuous
management review include any improvement projects initiated
decisions and actions related to: from management reviews.
a) Improvement of the effectiveness of • Examples of product
the quality management system and improvement initiated from
its processes? management reviews.
b) Improvement of product related to
customer requirements?
c) Resources needs?
(5.6.3)


Evidence
ELEMENT 6 – Resource Management
6.1 Provisions of resources
6.1.1 Does the organization determine and • Job descriptions.
provide the resources needed • Training records.
a) To implement and maintain the • Quality plans.
quality management system and • Shift staffing/supervision.
continually improve its • Personnel workload
effectiveness?
b) To enhance customer satisfaction by
meeting customer requirements?
(6.1)
6.2 Human Resources
6.2.1 General
6.2.2 Are the personnel performing work • Training records
affecting product quality competent on complementing the type of
the basis of appropriate education, work that the personnel
training, skills and experience? perform on the product.
(6.2.1) • Personnel records
• Interviews with design
personnel.
6.2.2 Competence, awareness and training
6.2.3 Does the organization • Job description.
a) Determine the necessary competence • Qualification for each
for personnel performing work position.
affecting product quality? • Training plan.
b) Provide training or take other actions • Training records.
to satisfy these needs?
c) Evaluate the effectiveness of the
actions taken?
d) Ensure that its personnel are aware of
the relevance and importance of their
activities and how they contribute to
the achievement of the quality
objectives?
e) Maintain appropriate records of
education, training, skills and
experience?
(6.2.2)
6.2.2.1 Product design skills
6.2.4 Does the organization ensure that • Training records
personnel with product design complementing the type
responsibility are qualified to achieve design activity.
design requirements and are skilled in • Personnel records.
applicable tools and techniques? • Interviews with design
(6.2.2.1) personnel.
6.2.5 Has the organization identified • Listing of tools needed for
applicable tools and techniques needed product design.
for product design? • Personnel training on product
(6.2.2.1) design techniques needed.
• PO(s) on tools needed.

Evidence
6.2.2.2 Training
maintained documented procedures for ISO/TS 16949:2002
identifying training needs and achieving
competence of all personnel performing
activities affecting product quality.
(6.2.2.2)
6.2.7 Are the personnel performing specific • Training records
assigned tasks qualified on the basis of complementing the type of
education, training, skills and/or tasks assigned to personnel.
experience, as required? • Personnel records.
(6.2.2.2) • Interviews with personnel.
6.2.8 Has the organization given attention to • Evidence of personnel training
training that satisfies customer specific that satisfies customer specific
requirements? requirements.
(6.2.2.2)
6.2.2.3 Training on the job
6.2.9 Does the organization provide on the job • Training records for personnel
training for personnel in any new or in new assignments.
modified job affecting product quality • Training records for contract
including contract or agency personnel? personnel.
(6.2.2.3)
6.2.10 Are the personnel affecting quality, • Training contents.
informed about the consequences to the
customer of nonconformity to quality
requirements?
(6.2.2.3)
6.2.2.4 Employee motivation and empowerment
6.2.11 Does the organization have a process for • Incentive systems used.
motivation of employees to achieve
quality objectives, to make continual
improvements, and create an environment
to promote innovation?
(6.2.2.4)
6.2.12 Does the organization’s employee • Scope of employee
motivation process include promotion of motivation.
quality and technological awareness
through the whole organization?
(6.2.2.4)
6.2.13 Does the organization have a process for • Measurement of employee
measurement to ensure that its personnel satisfaction.
are aware of the relevance and
importance of their activities and how
they contribute to the achievement of the
quality objectives?
(6.2.2.4)
6.3 Infrastructure
6.3.1 Does the organization determine, provide • Quality manual according to
and maintain the infrastructure needed to ISO/TS 16949:2002.
achieve conformity to product • Product results – internal and
requirements? external product failure rate.
(6.3)

Evidence
6.3.1 Plant, facility and equipment planning
6.3.2 Does the organization use a • Team composition has to be
multidisciplinary approach for cross-functional.
developing plant, facility and equipment
plans? (6.3.1)
6.3.3 Is the organization’s plant layouts • Process flow analysis.
optimized for material travel, handling • Plant layout (current and
and value-added use of floor space and planned).
shall facilitate synchronous material
flow?
(6.3.1)
6.3.4 Has the organization developed and • Metrics for ergonomics,
implemented methods to evaluate and automation, line balance,
monitor the effectiveness of existing inventory levels.
operations?
(6.3.1)
6.3.2 Contingency plans
6.3.5 Has the organization prepared • Contingency plans
contingency plans to satisfy the customer • Identification of Key
requirements in the event of an Equipment.
emergency such as utility interruptions,
labor shortages, key equipment failure,
and field returns?
(6.3.2)
6.4 Work environment
6.4.1 Does the organization determine and • Quality manual according to
manage the work environment needed to ISO/TS 16949:2002
achieve conformity to product
requirements?
(6.4)
6.4.1 Personnel safety
6.4.2 Does the organization’s quality policy • Preventive activities in design
and practices address product safety and and process control.
means to minimize potential risks to • Knowledge and application of
employees, especially in design and legislation.
development process and in the • Risk analysis such as FMEA.
manufacturing process activities? • Results of internal/external
(6.4.1) audits including:
- System certifications
- Corrective actions
• Records of accidents
• Safety related customer
complaints.
6.4.2. Cleanliness of premises
6.4.3 Does the organization maintain its • Tour of plant
premises in a state of order cleanliness
and repair consistent with the product?
(6.4.2)


Evidence
ELEMENT 7 – Product Realization
7.1 Planning of product realization
7.1.1 Has the organization planned and • Quality Planning process.
developed the processes need for product • Project Planning process.
realization? • Quality plans for new
(7.1) products.
7.1.2 Is the organization’s planning of product • Development of Quality
realization consistent with the plan(s).
requirements of the other processes of the
quality management system?
(7.1)
7.1.3 In planning product realization, does the • Quality plan and Design
organization determine the following, as Record, Control Plan,
appropriate: Operator Instructions, Product
a) Quality objectives and requirements Approval records,
for the product? resources/facilities and any
b) The need to establish processes, plans to enhance them.
documents, and provide resources • Design validation at the
specific to the product? various stages of the design.
c) Required verification, validation, • Link between process changes
monitoring, inspection and test and updates in the quality
activities specific to the product and plan(s).
the criteria for product acceptance?
d) Records needed to provide evidence
that the realization processes and
resulting product meet requirements?
(7.1)
7.1.4 Is the organization’s planning of product • Product realization output
realization output in a form suitable for format & content.
the organization’s method of operation?
(7.1)
7.1.1. Planning of product realization – supplemental
7.1.5 Are the customer requirements and • Quality plans.
references to its technical specifications • Customer specifications.
included in the planning of product • Technical specifications.
realization as a quality plan?
(7.1.1)
7.1.2 Acceptance criteria
7.1.6 Did the organization define acceptance • Test specification
criteria for the product being developed • Product validation test plan
and where required, approved by the with defined acceptance
customer? criteria.
(7.1.2)
7.1.7 Is the organization’s acceptance criteria • Acceptance criteria in test plan
for attribute data sampling zero defects? and test specifications.
(7.1.2)
7.1.3 Confidentiality
7.1.8 Does the organization ensure the • Information access security
confidentiality of customer contracted • Security for product
products and projects under development, development.
and related product information?
(7.1.3)

Evidence
7.1.4 Change control
7.1.9 Does the organization have a process to • Engineering change request
control and react to changes that impact process.
product realization including those • Change records.
initiated by the supplier?
(7.1.4)
7.1.10 Does organization assess the effects of • Impact study including
changes? proprietary design.
(7.1.4) • Change management process.
7.1.11 Has the organization defined the • Test specification.
verification and validation activities for • Product validation test plan
changes, to ensure compliance with with defined acceptance
customer requirements? criteria.
(7.1.4)
7.1.12 Does the organization validate changes • Evidence of design and
before implementation? production validation tests
(7.1.4) conducted for product
changes.
7.1.13 Does the organization review proprietary • Impact study including
designs, impact on form, fit, function, proprietary design.
(including performance, and/or • Change management process.
durability) with the customer so that all
effects can be properly evaluated?
(7.1.4)
7.1.14 Does the organization meet additional • Design and production
verification/identification requirements validation test report.
such as those required for new product
introduction when required by the
customer?
(7.1.4)
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.1 Does the organization determine: • Process for government, safety
a) Requirements specified by the and environmental regulations
customer, including the requirements compliance.
for delivery and post-delivery • Organization’s internal
activities? product specification.
b) Requirements not stated by the
customer but necessary for specified
or intended use, where known?
c) Statutory and regulatory
requirements related to the product?
d) Any additional requirements
determined by the organization?
(7.2.1)
7.2.1.1 Customer designated special characteristics
7.2.2 Can the organization demonstrate • Designation and control of
conformity to customer requirements for special characteristics.
designation, documentation and control • Quality documents: control
of special characteristics? plan, specifications, drawings,
(7.2.1.1) etc. shall report the special
characteristics designation.

Evidence
7.2.2 Review of requirements related to the product
7.2.3 Does the organization review the • Feasibility studies
requirements related to a product prior to
the organization’s commitment to supply
to the customer?
(7.2.2)
7.2.4 Does the organization ensure that • Customer contract review.
a) Product requirements are defined? • Product specification review.
b) Contract or order requirements • Resolution of differences.
differing from those previously • Feasibility assessments.
expressed are resolved?
c) The organization has the ability to
meet the defined requirements?
(7.2.2)
7.2.5 Does the organization maintain records of • Records of contract review.
the results of the review and actions
arising from the review?
(7.2.2)
7.2.6 Where the customer provides no • Sign off design validation and
documented statement of requirement, production validation test plan
does the organization confirm the with acceptance criteria.
customer requirements before
acceptance?
(7.2.2)
7.2.2.1 Organization manufacturing feasibility
7.2.7 Does the organization investigate, • Feasibility studies.
confirm and document the manufacturing • Risk analysis.
feasibility of the proposed products in the
contract review process including risk
analysis?
(7.2.2.1)
7.2.3 Customer communication
7.2.8 Has the organization determined and • Common language at the
implemented effective arrangements for interface level.
communicating with customers in relation
to:
a) Product information?
b) Enquiries, contracts or order
handling, including amendments?
c) Customer feedback, including
customer complaints?
(7.2.3)
7.2.3.1 Customer communication – supplemental
7.2.9 Does the organization have the ability to • Common language at the
communicate necessary information interface level.
including data in a customer-specified • Common language for
language and format? technical specifications and
(7.2.3.1) important documents.
• Customer/supplier EDI system
requirements and supplier
capabilities.

Evidence
7.3 Design and development
7.3.1 Design and development planning
7.3.1 Does the organization plan and control • The organization taking lead
the design and development of product? in product design and
(7.3.1) development activities.
• The organization managing
the product design and
development processes.
• Project records such as
milestones decision points are
controlled and approved by
the organization.
7.3.2 During the design and development • Product design and
planning, does the organization development process.
determine: • Product design review;
a) The design and development stages? verification and validation
b) The review, verification and process.
validation that is appropriate to each • Job description for product
design and development stage? design and development
c) The responsibilities and authorities personnel.
for design and development?
(7.3.1)
7.3.3 Does the organization manage the • Internal audit results
interfaces between different groups • Review of organizational
involved in design and development to interfaces with roles and
ensure effective communication and clear communication processes.
assignment of responsibility?
(7.3.1)
7.3.4 Is the organization’s product design and • Evidence of product design
development planning output updated, as and development planning
appropriate, as the design and output updated as design and
development progresses? development progresses.
(7.3.1)
7.3.1.1 Multidisciplinary approach
7.3.5 Does the organization use a • Functions represented in
multidisciplinary approach to prepare for product development teams.
product realization, including: • Personnel involved in
- Development/finalization and definition of special
monitoring of special characteristics, FMEA, and
characteristics? Control Plan.
- Development, and review of FMEAs
including actions to reduce potential
risks?
- Development, and review of control
plans?
(7.3.1.1)
7.3.2 Design and development inputs
7.3.6 Does the organization determine inputs • Design input records &
relating to product requirements and documents
maintain the related records?
(7.3.2)

Evidence
7.3.7 Does the organization’s inputs relating to • Customer specification.
product requirements include: • Statutory and regulatory
a) Functional and performance requirements.
requirements? • Previous/existing product
b) Applicable statutory and regulatory design information.
requirements? • Product benchmarking.
c) Where applicable, information
derived from previous similar
designs?
d) Other requirements essential for
design and development?
(7.3.2)
7.3.8 Does organization review its inputs • Customer specification
relating to product requirements for analysis.
adequacy? • Feasibility contract review.
(7.3.2)
7.3.9 Are the inputs relating to product • Customer specification
requirements complete, unambiguous and analysis.
not in conflict with each other? • Feasibility contract review
(7.3.2) minutes.
7.3.2.1 Product design input
7.3.10 Does the organization identify, document • Customer specification
and review the product design inputs analysis
requirements including: • Feasibility contract review
- Customer requirements (contract minutes.
review)?
- Use of information (the organization
shall have a process to deploy
information gained)?
- Targets for product quality, life,
reliability, durability,
maintainability, timing, and cost?
(7.3.2.1)
7.3.2.2 Manufacturing process design input
7.3.11 Does the organization identify, document • Design FMEA.
and review the manufacturing process • Productivity, process
design input requirements, including: capability, costs targets.
- Product design output data? • Regulations.
- Targets for productivity process • Customer requirements, if any.
capability and costs? • Experience from previous
- Customers requirements, if any? development.
- Experience from previous
developments?
(7.3.2.2)

Evidence
7.3.2.3 Special characteristics
7.3.12 Does the organization identify specials • Process to establish special
characteristics and: characteristics.
- Include all special characteristics in • Design Record
the control plan? • Review customer
- Comply with customer-specified requirements for special
definitions and symbols? characteristics, definitions and
- Identify process control documents symbol identification.
including drawings, FMEAs, control • Control plans.
plans, and operator instructions with • Product drawings.
the customer’s special characteristic • Operator instructions.
symbol or the organization’s
equivalent symbol or notation to
include those process steps that
affect special characteristics?
(7.3.2.3)
7.3.3 Design and development outputs
7.3.13 Does the organization provide outputs of • Design output records
design and development in a form that matching criteria established
enables verification against the design in design input requirements.
and development input and approved
prior to release?
(7.3.3)
7.3.14 Do the organization’s design and • DV test reports that show test
development outputs results; acceptance criteria.
a) Meet the input requirements for • Engineering drawings.
design and development?
b) Provide appropriate information for
purchasing, production and for
service provision?
c) Contain or reference product
acceptance criteria?
d) Specify the characteristics of the
product that are essential for its safe
and proper use?
(7.3.3)
7.3.3.1 Product design outputs – Supplemental
7.3.15 Is the organization’s product design • Design output records
output expressed in terms that can be matching criteria established
verified and validated against product in design input requirements.
design input requirements?
(7.3.3.1)
7.3.16 Does the organization’s product design • Availability of all applicable
output include: product design output
- Design FMEA, reliability results? documents.
- Product special characteristics,
specifications?
- Product error-proofing, as
appropriate?
- Product definition including
drawings?
- Product design review results?
- Diagnostic guidelines where
applicable?
(7.3.3.1)
7.3.3.2 Manufacturing process design output

Evidence
7.3.17 Is the organization’s manufacturing • Process specifications and
process design output expressed in terms drawings.
that can be verified against • Process FMEAs.
manufacturing process design input • Job instructions.
requirements and validated? • Process approval acceptance
(7.3.3.2) criteria.
• Quality, reliability,
maintainability data.
• Mistake-proofing activities
results.
• Nonconformity detection
methods.
• Product/Process verification
plans.
7.3.18 Does the organization’s manufacturing • Availability of all applicable
process design output include: process design output
- Specifications and drawings? documents.
- Manufacturing process flow chart /
layout?
- Manufacturing process FMEAs?
- Control plan?
- Work instructions?
- Process approval acceptance
criteria?
- Data for quality, reliability,
maintainability and measurability?
- Results of error-proofing activities,
as appropriate?
- Methods of rapid detection and
feedback of product/manufacturing
process non-conformities?
(7.3.3.2)
7.3.4 Design and development review
7.3.19 Does the organization perform systematic • Design review planning and
reviews of design and development at records.
suitable stages in accordance with • Design review extended to all
planned arrangements: functions affected by it.
a) To evaluate the ability of the results • Product design and
of design and development to fulfill development status reviews.
requirements? • Link of corrective action to
b) To identify any problems and status reviews.
propose necessary actions?
(7.3.4)
7.3.20 Do the participants in the systematic • Link of corrective action to
reviews of design and development status/design reviews.
identify any problems and propose
necessary actions?
(7.3.4)
7.3.21 Are the records of the results of the • Design review planning and
reviews and any necessary actions records maintained.
maintained by the organization?
(7.3.4)

Evidence
7.3.4.1 Monitoring
7.3.22 Does the organization define and analyze • Project reviews at different
measurements at specified stages of phases of product realization
design and development and reported process for all active projects.
with summary results as an input to • Policy deployment summary
management review? results.
(7.3.4.1)
7.3.5 Design and development verification
7.3.23 Does the organization perform design and • Design verification done in
development verification in accordance according to the planning.
with planned arrangements to ensure that • Comparison between outputs
the design and development outputs have and design requirements.
satisfied the design and development • Corrective actions based on
input requirements? results.
(7.3.5)
7.3.24 Does the organization maintain records of • Design verification reports.
the results of the verification and any
necessary actions?
(7.3.5)
7.3.6 Design and development validation
7.3.25 Does the organization perform design and • Design validation against user
development validation, accordance with requirements/needs.
planned arrangements (see element 7.3.1 • Comparison between customer
of ISO/TS 16949:2002) to ensure that the plan and internal development
resulting product is capable of meeting plans.
the requirements for the specified • Design validation records.
application or intended use, where • Documented failure.
known?
(7.3.6)
7.3.26 Wherever practicable, does the • Completion of product
organization complete design and validation testing prior to start
development validation prior to the of production.
delivery or implementation of the
product?
(7.3.6)
7.3.27 Does the organization maintain records of • Product validation test report.
the results of validation and any • Corrective action process for
necessary actions? the design activity.
(7.3.6) • Corrective Action Records.
7.3.6.1 Design and development validation – Supplemental
7.3.28 Does the organization perform design • Design validation against user
and development validation in requirements/needs.
accordance with customer requirements • Comparison between customer
including program timing? plan and internal development
(7.3.6.1) plans.
• Design validation records.
• Documented failure.
7.3.6.2 Prototype program
7.3.29 When required by the customer, does the • Prototype facilities.
organization have a prototype program • Prototype records.
and control plan? • Prototype control plan.
(7.3.6.2)

Evidence
7.3.30 Wherever possible, does the organization • Design/prototype/production
use the same suppliers, tooling and tooling.
manufacturing processes as will be used • Prototype realization and test
in production? conditions must be known and
(7.3.6.2) controlled.
7.3.31 Does the organization monitor all • Test records.
performance testing activities for timely
completion and conformance to
requirements?
(7.3.6.2)
7.3.32 Is the organization responsible for the • Sub-contractor management as
subcontracted services, including appropriate.
technical leadership?
(7.3.6.2)
7.3.6.3 Product approval process
7.3.33 Does the organization conform to a • Compliance with customer
product and process approval procedure requirements regarding
recognized by the customer? product approval process.
(7.3.6.3)
7.3.34 Does the organization apply a product • Product approval process
and process approval procedure documentation and records for
recognized by the customer to its suppliers.
suppliers?
(7.3.6.3)
7.3.7 Control of design and development changes
7.3.35 Does the organization identify design and • Change records.
development changes and maintain
records relevant to those changes?
(7.3.7)
7.3.36 Does the organization review, verify and • Design change approval
validate design and development changes, process.
as appropriate, and approved before
implementation?
(7.3.7)
7.3.37 Does the organization’s review of design • Impact study including
and development changes include proprietary design.
evaluation of the effect of the changes on • Change management process.
constituent parts and already delivered
product?
(7.3.7)
7.3.38 Does the organization maintain records of • Change records.
the results for the review of design and
development changes and any necessary
actions?
(7.3.7)
7.4 Purchasing
7.4.1 Purchasing Process
7.4.1 Does the organization ensure that • Organization’s incoming
purchased product conforms to specified inspection.
purchase requirements? • Source inspection.
(7.4.1) • Process audit at supplier’s site.

Evidence
7.4.2 Does the organization’s type and extent • Control methods determined
of control applied to the supplier and the by effect of the purchased
purchased product depend upon the effect product on subsequent product
of the purchased product on subsequent realization or final product.
product realization or the final product?
(7.4.1)
7.4.3 Does the organization evaluate and select • Selection system.
suppliers based on their ability to supply • Performance rating system.
products in accordance with the • Organization’s supplier
origination’s requirements. manual.
(7.4.1)
7.4.4 Has the organization established criteria • Selection system.
for selection, evaluation, and re- • Performance rating system.
evaluation of its suppliers?
(7.4.1)
7.4.5 Does the organization maintain records of • Suppliers’ 2nd party audit
the results of supplier evaluations and any results conducted by the
necessary actions arising from the organization.
supplier evaluation? • Approved supplier records.
7.4.1.1 Regulatory compliance
7.4.6 Do all purchased products or materials •
Audit results from government
used in the organization’s product satisfy and environment
applicable regulatory requirements? organizations.
(7.4.1.1) • Supplier Internal Audits
• Warrants or certificates of
compliance.
• Audits of suppliers.
7.4.1.2 Supplier quality management system development
7.4.7 Are the organization’s suppliers • Copies of suppliers’ ISO
registered to ISO 9001:2000 by a third 9001:2000 certificates.
party?
(7.4.1.2)
7.4.8 Does the organization perform quality • Supplier development process.
management system development with the • Evidence of subcontractor
goal of supplier compliance to ISO/TS development.
16949:2002 (E)?
(7.4.1.2)
7.4.1.3 Customer-approved sources
7.4.9 Where specified by the contract, does the • Approved suppliers list, if
organization purchase products, applicable.
materials or services from approved • How are these lists used?
sources?
(7.4.1.3)
7.4.10 Is the organization responsible for • Scope of organization’s
ensuring the quality of purchased incoming inspection includes
products supplied by customer-designed purchased products supplied
sources, including tool/gage suppliers? by customer-designated
(7.4.1.3) sources.
• Scope of organization’s
supplier management process
includes customer-designated
sources.

Evidence
7.4.2 Purchasing information
7.4.11 Does the organization’s purchasing • Purchase order/release.
information describe the product to be • Commercial contract.
purchased, including where appropriate:
a) Requirements for approval of
product, procedures, processes and
equipment?
b) Requirements for qualification of
personnel?
c) Quality management system
requirements?
(7.4.2)
7.4.12 Does the organization ensure the • Review of contract/purchase
adequacy of specified purchase order extends to suppliers.
requirements prior to their
communication to the supplier?
(7.4.2)
7.4.3 Verification of purchased product
7.4.13 Does the organization establish and • Incoming inspection plans.
implement the inspection or other
activities necessary for ensuring that
purchased product meets specified
purchase requirements?
(7.4.3)
7.4.14 Where the organization or its customer • Supplier and subcontractors.
intends to perform verification at the • Purchase order and contract.
supplier’s premises, does the organization
state the intended verification
arrangements and method of product
release in the purchasing information?
(7.4.3)
7.4.3.1 Incoming product quality
7.4.15 Does the organization have a process to • Incoming inspection.
ensure the quality of purchased product • Source inspection.
utilizing one or more of the following • 2nd or 3rd party audits of
methods: supplier sites.
- Receipt of, and evaluation of, • Independent evaluation of
statistical data by the organization? acceptability of product by a
- Receiving inspection and/or testing designated 3rd party.
such as sampling based on
performance?
- Second or third party assessments or
audits of supplier sites, when coupled
with records of acceptable quality
performance?
- Part evaluation by a designated
laboratory?
- Another method agreed with the
customer?
(7.4.3.1)

Evidence
7.4.3.2 Supplier monitoring
7.4.16 Does the organization monitor supplier • Subcontractor performance
performance through the following records.
indicators: • Subcontractor corrective
- Delivered part quality performance? action.
- Customer disruptions including field
returns?
- Delivery schedule performance
(including incidents of premium
freight)?
(7.4.3.2)
7.4.17 Does the organization promote supplier • Evidence of continuous
monitoring of their manufacturing improvements implemented
processes’ performance? by the suppliers through
(7.4.3.2) review of their own
monitoring of manufacturing
processes’ performance.
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.1 Does the organization plan and carry out • Tour of plant and facilities
production and service provision under • Master part or correct level
the following controlled conditions, as assembly drawings.
applicable: • Work instructions at work
a) The availability of information that stations.
describes the characteristics of the
product?
b) The availability of work instructions,
as necessary?
c) The use of suitable equipment?
d) The availability and use of
monitoring and measuring devices?
e) The implementation of monitoring
and measurement?
f) The implementation of release,
delivery and post-delivery activities?
(7.5.1)
7.5.1.1 Control plan
7.5.2 Does the organization: • Control plan for different
- Develop control plans at the system, product levels.
subsystem, component and/or • DFMEA and PFMEA were
material level, for the product used as inputs to the control
supplied, including those for bulk plan.
materials produced by the
organization and all purchased
products and materials?
- Have a control plan for pre-launch
and production that take into account
the design FMEA and manufacturing
process FMEA outputs?
(7.5.1.1)

Evidence
7.5.3 Does the organization’s control plan: • Review of control plans.
- List the controls used for the • Control plans for applicable
manufacturing process control? stages.
- Includes methods for monitoring and • Control plan framework with
recording results of control exercised data.
over special characteristics (see
7.3.2.3 of ISO/TS 16949:2002(E))
defined by both the customer and the
organization?
- Include the customer-required
information if any?
- Initiate the specified reaction plan
(see 8.2.3.1 of ISO/TS
16949:2002(E)) when the process
becomes unstable or noncapable?
(7.5.1.1)
7.5.4 Does the organization review and update • Matching between
control plans when any change occurs product/process changes,
affecting product, manufacturing process, instability/non-capability
measurement, logistics, supply sources or process results, and control
FMEA (see 7.1.4 of ISO/TS 16949:2002 plans updating.
(E))?
(7.5.1.1)
7.5.1.2 Work instructions
7.5.5 Has the organization prepared • Availability of job instructions
documented work instructions for all at the work station.
employees having responsibilities for the
operation of processes?
(7.5.1.2)
7.5.6 Are the organization’s work instructions • Availability of job instructions
accessible for use at the workstation? at the work station.
(7.5.1.2)
7.5.7 Are the organization’s work instructions • Link between job instructions
derived from sources such as the quality and source documents, e.g.
plan, the control plan and the product Control Plan, Design Record,
realization process? FMEA.
(7.5.1.2)
7.5.1.3 Verification of job set-ups
7.5.8 Does the organization verify job set-ups • Job set-up records and
whenever performed? approval.
(7.5.1.3)
7.5.9 Are the organization work instructions • Set-up instructions.
available for set-up personnel?
(7.5.1.3)
7.5.10 Does the organization use statistical • Job set-up records.
methods of verification of job set-ups
where applicable?
(7.5.1.3)
7.5.1.4 Preventive and predictive maintenance
7.5.11 Does the organization identify key • Existence of preventive
process equipment and provide resources maintenance.
for machine/equipment maintenance and
develop an effective planned total
preventive maintenance system?
(7.5.1.4)

Evidence
7.5.12 Does the organization’s preventive • System effectiveness
maintenance system minimally include demonstrated by specific
the following: measurement indicator.
- Planned maintenance activities? • Key equipment list.
- Packaging and preservation of • Maintenance records.
equipment, tooling and gauging? • Predictive maintenance
- Availability of replacement parts for examples.
key manufacturing equipment? • Plant tour.
- Documenting, evaluating and
improving maintenance objectives?
(7.5.1.4)
7.5.13 Does the organization utilize predictive • Predictive maintenance
maintenance methods to continually examples.
improve the effectiveness of its preventive
system?
(7.5.1.4)
7.5.1.5 Tooling management
7.5.14 Does the organization provide resources • Tool/gage design staffing and
for tool and gauge design, fabrication qualification.
and verification activities?
(7.5.1.5)
7.5.15 Does the organization establish and • Tool management process.
implement a system for tooling
management including:
- Maintenance and repair facilities
and personnel?
- Storage and recovery?
- Set-up?
- Tool-change programs for perishable
tools?
- Tool design modification
documentation, including
engineering change level?
- Tool modification and revision to
documentation?
- Tooling identification defining the
status?
(7.5.1.5)
7.5.16 Has the organization implemented a • Sub-contractor management
system to monitor its tooling management system (choice, evaluation and
activities if any work is outsourced? control).
(7.5.1.5)
7.5.1.6 Production scheduling
7.5.17 Is the organization’s production • Process for production
scheduled in order to meet customer scheduling.
requirements? • The scheduling system should
(7.5.1.6) be based on a “pull” and not
on a “push” system.
7.5.1.7 Feedback of information from service
7.5.18 Has the organization established and • Meeting reports, follow up and
maintained a process for communication corrective actions/
of information on service concerns to responsibility/dates.
manufacturing, engineering and design • Product service data.
activities?
(7.5.1.7)

Evidence
7.5.1.8 Servicing agreement with customer
7.5.19 When there is a servicing agreement with • Planning of periodical audits.
the customer, does the organization verify • Reports and follow up.
the effectiveness of:
- Any organization service centers?
- Special purpose tools or
measurement equipment?
- Training of servicing personnel?
(7.5.1.8)
7.5.2 Validation of processes for production and service provision
7.5.20 Does the organization validate any • Process validation/capability
processes for all its production and studies results.
service provision where the resulting • Process parameters monitoring
output cannot be verified by subsequent and control evidence.
monitoring or measurement?
(7.5.2)
7.5.21 Does the organization’s validation of • Process validation/capability
processes for all its production and studies results.
service provision demonstrate the ability
of these processes to achieve planned
results?
(7.5.2)
7.5.22 Has the organization established • Requirement specification for
arrangements for all its processes for operations, equipment and
production and service provisions personnel.
including, as applicable: • Related records of
a) Defined criteria for review and qualification.
approval of the processes? • Frequency and conditions of
b) Approval of equipment and revalidation.
qualification of personnel?
c) Use of specific methods and
procedures?
d) Requirements for records?
e) Revalidation?
(7.5.2)
7.5.3 Identification and traceability
7.5.23 Does the organization identify the product • Check for positive recall.
by suitable means throughout product • Suitable product identification
realization? throughout the facility.
(7.5.3) • Traceability from raw
materials to delivered product.
7.5.24 Does the organization identify the product • Clear identification of work
status with respect to monitoring and inprocess; finished goods and
measurement requirements? rejected goods and/or
(7.5.3) components.
• Inspection records.
7.5.25 Where traceabilaity is a requirement, does • Traceabilty system.
the organization control and record the
unique identification of the product (see
element 4.2.4 of ISO/TS 16949:2002?
(7.5.3)

Evidence
7.5.4 Customer property
7.5.26 Does the organization exercise care with • Handling procedure of
customer property while it is under the customer property.
organization’s control or being used by
the organization?
(7.5.4)
7.5.27 Does the organization identify, verify, • Product identification
protect and safeguard customer property • Storage environment.
provided for use or incorporation into the
product.
(7.5.4)
7.5.28 Does the organization report to the • Damage to customer supplied
customer and maintain records for product reports.
customer property that is lost, damaged or • What happened to customer
otherwise found to be unsuitable for use? owned returnable packaging?
(7.5.4) How was it accounted for?
7.5.4.1 Customer owned tooling
7.5.29 Are the customer-owned tools, • Permanent identification of
manufacturing, test, inspection tooling tooling and equipment
and equipment permanently marked so ownership.
that the ownership of each item is visible,
and can be determined?
(7.5.4.1)
7.5.5 Preservation of product
7.5.30 Does the organization preserve the • Procedure development and
conformity of product during internal documentation.
processing and delivery to the intended • Plant tour.
destination?
(7.5.5)
7.5.31 Does the organization’s preservation of • Product preservation
product include identification, handling, procedures.
packaging, storage and protection? • Plant tour.
(7.5.5)
7.5.32 Does the organization’s preservation of • Scope product preservation
production apply to the constituent parts procedures.
of a product? • Plant tour.
(7.5.5)
7.5.5.1 Storage and inventory
7.5.33 Does the organization assess the • Storage product specifications.
condition of product in stock at • Inspection records.
appropriate planned intervals to detect • Plant tour.
deterioration?
(7.5.5.1)
7.5.34 Does the organization use an inventory • Inventory management
management system to optimize inventory system.
turn over times and assure stock • Evidence of FIFO.
rotation? • Control of obsolete product.
(7.5.5.1)
7.5.35 Does the organization control obsolete • Obsolete products stored in
product in a similar manner to quarantine area.
nonconforming product?
(7.5.5.1)

Evidence
7.6 Control of monitoring and measuring devices
7.6.1 Has the organization determined the • Test equipment accuracy and
monitoring and measurement to be precision capability related to
undertaken and the monitoring and the required measurement.
measuring devices needed to provide
evidence of conformity of product to
determined requirements?
(7.6)
7.6.2 Has the organization established • Monitoring and measurement
processes to ensure that monitoring and trials during prototype builds.
measurement can be carried out and are • Procedure address in
carried out in a manner that is consistent organization’s quality manual
with the monitoring and measurement in accordance to ISO/TS
requirements? 16949:2002(E).
(7.6)
7.6.3 Where necessary to ensure valid results, • Test equipment inventory.
are the organization’s measuring • Certifications for calibration
equipment: masters and their Traceabilty
a) Calibrated or verified at specified to international national
intervals, or prior to use, against recognized standard.
measurement standards traceable to • Calibration results recorded.
international or national • Method of control of
measurement standards? calibration settings.
b) Adjusted or re-adjusted as necessary? • Calibration status
c) Identified to enable the calibration identification.
status to be determined?
d) Safeguarded from adjustments that
would invalidate the measurement
result?
e) Protected from damage and
deterioration during handling,
maintenance and storage?
(7.6)
7.6.4 Does the organization assess and record • Records of re-inspected
the validity of the previous measuring product.
results when the equipment is found not
to conform to requirements?
(7.6)
7.6.5 Does the organization take appropriate • Actions taken on the
action on the equipment that is found not equipment that are found not
conforming to requirements and any conforming to requirements
product affected? and any product that was
(7.6) affected by it.
7.6.6 Does the organization maintain records of • Gage studies records.
the results of calibration and verification
(see element 4.2.4 of ISO/TS
16949:2002)?
(7.6)
7.6.7 When equipment is used in the • Product labeling system.
monitoring and measurement of specified • Customer requirements.
requirements has the organization • Labeling audit.
confirmed the ability of computer
software to satisfy the intended
application?
(7.6)

Evidence
7.6.8 Has the organization undertaken the • Test software / comparative
confirmation of computer software references verification.
satisfying an intended application prior to
initial use and reconfirmed as necessary?
(7.6)
7.6.1 Measurement system analysis
7.6.9 Does organization conduct statistical • Measurement system analysis
studies to analyze the variation present in studies including Gage
the results of each type of measuring and Repeatability &
test equipment system? Reproducibility.
(7.6.1)
7.6.10 Does the organization conduct • Measurement system analysis
measurement system analysis for results.
measurement systems referenced in the
control plan?
(7.6.1)
7.6.11 Does the organization use measurement • Check methods against
system analytical methods and customer measurement system
acceptance criteria that conform to those analysis requirements.
in customer reference manuals on • Customer approval records,
measurement system analysis? for other analytical methods
(7.6.1) used.
7.6.2 Calibration Records
7.6.12 Does the organization’s records of the • Measurement equipment
calibration activity for all gauges, records.
measuring and test equipment, including • Original specification of
employee-and customer-owned gauges measurement equipment.
include:
a) Equipment identification including
the measurement standard against
which the equipment is calibrated?
b) Revisions following engineering
changes?
c) Any out of specification readings as
received for calibration/verification?
d) An assessment of the impact of out of
specification condition?
e) Statements of conformance to
specification after calibration/
verification?
f) Notification to the customer if
suspect product or material has been
shipped?
(7.6.2)
7.6.3 Laboratory requirements
7.6.3.1 Internal laboratory
7.6.13 Does the organization’s internal • Laboratory Scope.
laboratory facility have a defined scope
that includes capability to perform the
required inspection, test or calibration
services?
(7.6.3.1)

Evidence
7.6.14 Is the organization’s lab scope included • Organization’s quality manual
in the quality management system and per ISO/TS 16949:2002(E).
comply with technical requirements
including;
- Adequacy of the laboratory
procedures?
- Qualifications of the laboratory
personnel conducting tests?
- Testing of the commodity?
- Performing these tests correctly,
traceable to the relevant process
standard?
- Review of the related quality
records?
(7.6.3.1)
7.6.3.2 External laboratory
7.6.15 Do the external/commercial /independent • Commercial Laboratory
laboratory facilities used for inspection, accreditation records.
t4est or calibration services by the
organization have a defined laboratory
scope that includes capability to perform
the required inspection, test or
calibration, and:
- Be accredited to ISO/IEC 17025 or
national equivalent?
- Have evidence that the external
laboratory is acceptable to the
customer?
(7.6.3.2)


Evidence
ELEMENT 8 Measurement, analysis and improvement
8.1 General
8.1.1 Has the organization planned and • Internal audit results
implemented the monitoring, • Product conformance data.
measurement, analysis and improvement
processes needed
a) To demonstrate conformity of the
product?
b) To ensure conformity of the quality
management system?
c) To continually improve the
effectiveness of the quality
management system?
(8.1)
8.1.2 Has the organization determined the • Methods for organization’s
applicable methods and the extent of their monitoring, measurement,
use for its monitoring, measurement, analysis and improvement
analysis and improvement processes? processes.
(8.1)
8.1.1 Identification of statistical tools
8.1.3 Does the organization determine the • Review of control plan.
appropriate statistical tools for each • Review of quality plan.
process during advance quality planning • Plant tour.
and included in the control plan?
(8.1.1)
8.1.2 Knowledge of basic statistical concepts
8.1.4 Does the organization understand basic • Interview with personnel
statistical concepts, such as variation, including management
control (stability), process capability and demonstrating the knowledge
over-adjustment? of major statistical concepts
(8.1.2) like variation and distribution,
process control, cause and
effect relationship, common
and special causes.
• Statistical techniques training
records.
8.1.15 Does the organization utilize basic • Basic statistical study reports.
statistical concepts throughout its
establishment?
(8.1.2)
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.1 Does the organization monitor • Review of information relating
information relating to customer to customer satisfaction
perception as to whether the organization routinely/set interval.
has met customer requirements as one of • Customer satisfaction
the performance of the quality performance indicators.
management system?
(8.2.1)

Evidence
8.2.2 Has the organization determined the • Methods for obtaining
methods for obtaining information information relating to
relating to customer perception as to customer perception as to
whether the organization has met whether the organization has
customer requirements? met customer requirements.
(8.2.1)
8.2.1.1 Customer satisfaction – Supplemental
8.2.3 Does the organization monitor customer • Continual evaluation of
satisfaction through continual evaluation performance of realization
of performance of the realization processes.
processes?
(8.2.1.1)
8.2.4 Are the organization’s performance • Review of performance
indicators for customer satisfaction based indicators for customer
on objective data and include, but not be satisfaction.
limited to:
- Delivered part quality performance?
- Customer disruptions including field
returns?
- Delivery schedule performance
(including incidents of premium
freight)?
- Customer notifications related to
quality or delivery issues?
(8.2.1.1)
8.2.5 Does the organization monitor • Measurement of
manufacturing processes performance to manufacturing processes
demonstrate compliance with customer against compliance to
requirements for product quality and customer requirements.
efficiency of the process?
(8.2.1.1)
8.2.2 Internal audit
8.2.6 Does the organization conduct internal • Audit schedule
audits at planned intervals to determine • Records of performed audits.
whether the quality management system:
a) Conforms to the planned
arrangements (see 7.1), to the
requirements ISO/TS 16949:2002
and to the quality management
system requirements established by
the organization?
b) Is effectively implemented and
maintained?
(8.2.2)
8.2.7 Has the organization planned for an audit • Appropriate prioritization.
program that takes into consideration the
status and importance of the processes
and areas to be audited, as well as the
results of the previous audits?
(8.2.2)
8.2.8 Has the organization defined the internal • Audit schedule.
audit criteria, scope, frequency and • Internal audit procedure stated
methods? in quality manual.
(8.2.2)

Evidence
8.2.9 Does the organization ensure objectivity • Organization charts.
and impartiality of the audit process in the • Audits only conduct audits in
selection of auditors and conduct of areas that are independent of
internal audits? their job functions.
(8.2.2)
8.2.10 Has the organization defined the • Department or individual
responsibilities and requirements for responsible for internal audit
planning and conducting audits, and for activities and also the
reporting results and maintaining records reporting of audit results to
in a documented procedure? upper management.
(8.2.2)
8.2.11 Does the management responsible for the • Closure time for audit
area being audited ensure that actions are findings.
taken without undue delay to eliminate
detected non-conformities and their
causes?
(8.2.2)
8.2.12 Does the organization’s internal audit • Records of verification.
follow-up activities include the
verification of the actions taken and the
reporting of verification results (see
element 8.5.2 of ISO/TS 16949:2002)?
(8.2.2)
8.2.2.1 Quality management system audit
8.2.13 Does the organization audit its quality • Audit plans and schedule
management system to verify compliance • Interview with the different
with ISO/TS 16949:2002 and any area managers.
additional quality management system • Audit reports.
requirements?
(8.2.2.1)
8.2.2.2 Manufacturing process audit
8.2.14 Does the organization audit each • Audit plans
manufacturing process to determine its • Audit reports
effectiveness?
(8.2.2.2)
8.2.2.3 Product audit
8.2.15 Does the organization audit products at • Audit plan, process flow chart
appropriate states of production and and schedule.
delivery to verify conformance to all • Product audit procedure and
specified requirements at a defined reports.
frequency?
(8.2.2.3)
8.2.2.4 Internal audit plans
8.2.16 Does the organization’s internal audits • Audit plan
cover all quality management related • Audit schedule.
processes, activities and shifts, and
scheduled according to an annual plan?
(8.2.2.4)
8.2.17 Does the organization increase its audit • Audit schedule
frequency appropriately when internal/ • Appropriate prioritization.
external non-conformities or customer
complaints occur?
(8.2.2.4)

Evidence
8.2.2.5 Internal auditor qualification
8.2.18 Are the organization’s internal auditors • Compliance to customer
qualified to audit the requirements of requirements.
ISO/TS 16949:2002 (see element
6.2.2.2)?
(8.2.2.5)
8.2.3 Monitoring and measurement processes
8.2.19 Does the organization apply suitable • Methods of monitoring/
methods for monitoring and, where measuring quality
applicable, measurement of the quality management system
management system processes? processes.
(8.2.3)
8.2.20 Does the organization’s methods for • Monitoring and measurement
monitoring and measurement of processes results.
demonstrate the ability of the processes to
achieve planned results?
(8.2.3)
8.2.21 When planned results are not achieved by • Planned/executed corrective
the organization’s processes, does the actions.
organization take correction and
corrective action to ensure conformity to
the product?
(8.2.3)
8.2.3.1 Monitoring and measurement of manufacturing processes
8.2.22 Does the organization perform process • Preliminary process capability
studies on all new manufacturing results.
processes to verify process capability and • Production control plan.
to provide additional input for process
control?
(8.2.3.1)
8.2.23 Does the organization document the • Process study reports.
results of process studies with • Plan/executed actions from
specifications where applicable for means process study results.
of production, measurement and test, and
maintenance instructions?
(8.2.3.1)
8.2.24 Does the organization’s documents for • Monitoring & measurement of
monitoring and measurement of manufacturing process
manufacturing processes include documents.
objectives for manufacturing process
capability, reliability, maintainability and
availability, as well as acceptance
criteria?
(8.2.3.1)
8.2.25 Does the organization maintain • Current Cpk/Ppk versus
manufacturing process capability or customer approved Cpk/Ppk.
performance as specified by the customer • Existing reaction plan.
part approval process requirements? • Verifying the accuracy of
(8.2.3.1) Cpk/Ppk calculations.

Evidence
8.2.26 Does the organization ensure that the • Review of production line to
control plan and process flow diagram process flow diagram and
are implemented, including adherence to control plan.
the specified:
- Measurement techniques?
- Sampling plans?
- Acceptance criteria?
- Reaction plans when acceptance
criteria are not met?
(8.2.3.1)
8.2.27 Does the organization note significant • Review of control charts.
process events on the control charts?
(8.2.3.1)
8.2.28 Does the organization initiate the • Records of reaction taken.
appropriate reaction plan from the
control plan for characteristics that are
either unstable or non-capable?
(8.2.3.1)
8.2.29 Does the organization’s reaction plans • Contents of reaction plan for
for characteristics that are either unstable and non-capable
unstable or non-capable include processes.
containment of product and 100% • Records
inspection as appropriate?
(8.2.3.1)
8.2.30 Does the organization establish a • Corrective action reports.
corrective action following the initiation
of reaction plans, indicating specific
timing and assigned responsibilities to
assure that the process becomes stable
and capable?
(8.2.3.1)
8.2.31 Are the organization’s corrective action • Corrective action approval
plans reviewed with and approved by the process.
customer when so required? • Corrective action reports.
(8.2.3.1)
8.2.32 Does the organization maintain records • Records of process change
of effective dates of process changes? dates.
(8.2.3.1)
8.2.4 Monitoring and measurement of product
8.2.33 Does the organization monitor and • Control plans.
measure the characteristics of the product • Inspection instructions.
to verify that product requirements have • Records.
been met?
(8.2.4)
8.2.34 Does the organization monitor and • Control plans.
measure the characteristics of the product • Inspection instructions.
at appropriate stages of the product • Records.
realization process in accordance with the
planned arrangements (see element 7.1 of
ISO/TS 16949:2002)?
(8.2.4)
8.2.35 Does the organization maintain evidence • Inspection records that include
of product conformity with the acceptance criteria, inspector
acceptance criteria? performing the tests, test status
(8.2.4) and, testing date.

Evidence
8.2.36 Does the organization’s records on • Inspection records that
monitoring and measurement of product indicate the person(s)
indicate the person(s) authorizing release authorizing release of product.
of product (see element 4.2.4 of ISO/TS
16949:2002 (E))?
(8.2.4)
8.2.37 Are the organization’s product release • Release of product and service
and service delivery proceed only after all delivery after all planned
the planned arrangements (see element arrangements is satisfactorily
7.1 of ISO/TS 16949:2002) have been completed.
satisfactorily completed, unless otherwise
approved by a relevant authority, and
where applicable by the customer?
(8.2.4)
8.2.4.1 Layout inspection and functional testing
8.2.38 Does the organization perform a layout • Layout inspection reports.
inspection and a functional verification to • Control plan.
applicable customers engineering
material and performance standards for
all products at a sufficient frequency as
specified in the control plan?
(8.2.4.1)
8.2.39 Does the organization have layout • Inspection records that include
inspection and functional testing results acceptance criteria, inspector
available for customer review? performing the test, test status
(8.2.4.1) and, testing date.
8.2.4.2 Appearance items
8.2.40 For organization manufacturing parts • Maintenance/Control and
designated by the customer as storage conditions of masters.
“appearance items”, does the • Visual aids.
organization provide: • Personnel qualifications/
- Appropriate resources including training records.
lighting for evaluation? • Tour of facility.
- Masters for color, grain, gloss,
metallic brilliance, texture,
distinctness of image (DOI) as
appropriate?
- Maintenance and control of
appearance masters and evaluations
equipment?
- Verification that personnel making
appearance evaluations are qualified
to do so?
(8.2.4.2)
8.3 Control of nonconforming product
8.3.1 Does the organization ensure that product • Follow one or more
which does not conform to product nonconforming case and
requirements is identified and controlled verify the flow (identification,
to prevent its unintended use or delivery? segregation, etc.).
(8.3) • Obsolete products.
8.3.2 Does the organization define the controls • Procedure address in quality
and related responsibilities and authorities manual.
for dealing with nonconforming product a
documented procedure?
(8.3)

Evidence
8.3.3 Does the organization deal with • Follow one or more non-
nonconforming product by one or more of conforming case and verify
the following ways: the visual identification and
a) By taking action to eliminate the segregation area.
detected nonconformity? • Records of concession.
b) By authorizing its use, release or
acceptance under concession by a
relevant authority and, where
applicable, by the customer?
c) By taking action to preclude its
original intended use or application?
(8.2.3)
8.3.4 Does the organization maintain records of • Records.
the nature of nonconformities and any
subsequent actions taken, including
concessions obtained (see element 4.2.4
of ISO/TS 169494:2002(E))?
(8.2.3)
8.3.5 When nonconforming product is • Instruction for re-qualifying
corrected, does the organization re-verify corrected nonconforming
to demonstrate conformity to the product.
requirements?
(8.2.3)
8.3.6 When nonconforming product is detected • Follow one or, more
after delivery or use has started, does the nonconforming case and
organization take action appropriate to the verify the flow (identification,
effects, or potential effects, of the segregation, etc.).
nonconformity?
(8.2.3)
8.3.1 Control of nonconforming product – supplemental
8.3.7 Does the organization classify • Follow one or more
unidentified or suspect status product as nonconforming case and
nonconforming product (see element verify the flow (identification,
7.5.3 of ISO/TS 16949:2002)? segregation, etc.)
(8.3.1)
8.3.2 Control of reworked product
8.3.8 Are the organization’s instructions for • Rework instructions.
rework, including re-inspection
requirements accessible and utilized by
the appropriate personnel?
(8.3.2)
8.3.3 Customer information
8.3.9 Does the organization inform the • Follow one or more
customers promptly in the even that nonconforming case and
nonconforming product has been verify the flow (identification,
shipped? segregation, etc.).
(8.3.3) • Procedure stated in quality
manual.
8.3.4 Customer waiver
8.3.10 Does the organization obtain customer • Follow one or more
concession or deviation permit prior to nonconforming case and
further processing whenever the product verify the flow (identification,
or manufacturing process is different segregation, etc.).
from that which is currently approved?
(8.3.4)

Evidence
8.3.11 Does the organization maintain a record • Record of concession with
of the expiration date or quantity expiration date.
authorized by customer concession or
deviation permit?
(8.3.4)
8.3.12 Does the organization ensure compliance • Inspection results.
with the original or superseding
specifications and requirements when the
authorization for deviation expires?
(8.3.4)
8.3.13 Does the organization properly identify • Proper label/identification for
on each shipping container material material shipped on
shipped on an authorization? authorization.
(8.3.4)
8.3.14 Does the organization apply the customer • Process define in quality
waiver requirements for production manual.
product to purchased product as well?
(8.3.4)
8.3.15 Does the organization agree with any • Process define in quality
product concession requests from manual.
suppliers before submission to the
customer?
(8.3.4)
8.4 Analysis of data
8.4.1 Does the organization determine, collect • Internal performance data such
and analyze appropriate data to as:
demonstrate the suitability and Poor quality cost
effectiveness of the quality management indicators,
system and to evaluate where continual Effectiveness and
improvement of the effectiveness of the efficiency of production
quality management system can be made? processes,
(8.4) Test results,
Process capability data,
Quality audits,
Results of product
inspections,
Internal and external
quality data,
Subcontractors rating,
Customer reports
Employee’s information.
8.4.2 Does the organization’s data analysis • Data analysis report.
include data generated as a result of
monitoring and measurement and from
other relevant sources?
(8.4.)

Evidence
8.4.3 Does the organization’s analysis of data • Data analysis report
provide information relating to:
a) Customer satisfaction (see element
8.2.1 of ISO/TS 16949:2002)?
b) Conformance to product
requirements (see element 7.2.1 of
ISO/TS 16949:2002)?
c) Characteristics and trends of
processes and products including
opportunities for preventive action?
d) Suppliers?
(8.4)
8.4.1 Analysis and Use of data
8.4.4 Does the organization compare trends in • Customer problem resolution.
quality and operational performance • Comparison of trends to
compared with progress toward objectives (goals).
objectives and lead to action to support • Specific actions to trend
the following: analysis.
- Development of priorities for prompt • Prioritization of action.
solutions to customer related
problems?
- Determination of key customer
related trends and correlation to
support status review, decision
making and longer term panning?
- An information system for the timely
reporting of product information
arising from usage?
(8.4.1)
8.5 Improvement
8.5.1 Continual improvement
8.5.1 Does the organization continually • Examples of continuous
improve the effectiveness of the quality projects initiated from quality
management system through the use of policy, quality objectives,
the quality policy, quality objectives, audit results, analysis of data,
audit results, analysis of data, corrective corrective and preventive
and preventive actions and management actions and management
review? review.
(8.5.1)
8.5.1.1 Organization continual improvement
8.5.2 Has the organization defined a process • Procedure as stated in quality
for continual improvement? manual.
(8.5.1.1)
8.5.1.2 Manufacturing process improvement
8.5.3 Does the organization’s continual • Records showing
improvement focus upon control and improvements in special
reduction of variation in products of characteristics.
characteristics and manufacturing • Reduction in process
process parameters? parameter variation.
(8.5.1.2)
8.5.2 Corrective action
8.5.4 Does the organization take action to • Examples
eliminate the cause of non-conformities in
order to prevent recurrence?
(8.5.2)

Evidence
8.5.5 Are the organization’s corrective actions • Review examples.
appropriate to the effects of the non-
conformities encountered?
(8.5.2)
8.5.6 Has the organization established a • List of customer complaints.
documented procedure to define • Root Cause Analysis and
requirements for: records.
a) Reviewing non-conformities • Determination of corrective
(including customer complaints)? action needed.
b) Evaluating the need for action to • Corrective action taken.
ensure that non-conformities do not • Corrective action
recur? effectiveness.
c) Determining and implementing
action needed?
d) Records of the results of action taken
16949:2002)?
e) Reviewing corrective action taken?
(8.5.2)
8.5.2.1 Problem solving
8.5.7 Does the organization have a defined • Problem solving process used
process for problem solving leading to by organization.
root cause identification and elimination?
(8.5.2.1)
8.5.8 If a customer-prescribed problem-solving • Responses to customer
format exists, does the organization use complaints.
the prescribed format? • Customer formats.
(8.5.2.1)
8.5.2.2 Error-proofing
8.5.9 Does the organization use error-proofing • Examples.
methods in their corrective action
process?
(8.5.2.2)
8.5.2.3 Corrective action impact
8.5.10 Does the organization apply the • Review of documents related
corrective action, and controls to similar products and
implemented, to eliminate the cause of processes.
nonconformity to other similar processes
and products?
(8.5.2.3)
8.5.2.4 Rejected product test/analysis
8.5.11 Does the organization analyze parts • List of returned parts
rejected by the customer’s manufacturing • Records of analysis.
plants, engineering facilities, and • Minimalization of cycle times.
dealerships?
(8.5.2.4)
8.5.12 Does the organization minimize the cycle • Review product test/analysis
time of its rejected product test/analysis process.
process?
(8.5.2.4)
8.5.13 Does the organization keep records of its • Records
rejected product test/analyses and make
available upon request?
(8.5.2.4)

Evidence
8.5.14 Does the organization perform analysis • Examples
and, initiate corrective action to prevent
recurrence?
(8.5.2.4)
8.5.3 Preventive action
8.5.15 Does the organization determine action to • Examples.
eliminate the causes of potential non-
conformities in order to prevent their
occurrence?
(8.5.3)
8.5.16 Are the organization’s preventive actions • Examples
appropriate to the effects of the potential
problems?
(8.5.3)
8.5.17 Has the organization established a • Sources of information used
documented procedure to define for preventive action.
requirements for: • Root cause determination
a) Determining potential non- (FMEA, FTA, etc.).
conformities and their causes? • Records and result analysis.
b) Evaluating the need for action to
prevent occurrence of non-
conformities?
c) Determining and implementing
action needed?
d) Records of results of action taken
16949:2002)?
e) Reviewing preventive action taken?
(8.5.3)

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Requirements What to Look For Assessor Notes/Objective Results

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Requirements What to Look For Assessor Notes/Objective Results

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Requirements What to Look For Assessor Notes/Objective Results

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