Iatf 16949 Quality Management System Requirements

IATF 16949 QUALITY MANAGEMENT SYSTEM
REQUIREMENTS _______________________________________________________
ISO 9001:2015-based requirements are in plain text.
IATF 16949 requirements are in italics.
4 – Context of the Organization
4.1 Understanding the organization and its context requires the organization to determine
external and internal issues that are relevant to its purpose and its strategic direction and that
affect its ability to achieve the intended result(s) of its quality management system. It also
requires the organization to monitor and review information about these external and
internal issues. Issues are understood to include positive and negative factors or conditions
for consideration. Understanding of external context can be facilitated by considering issues
arising from legal, technological, competitive, market, cultural, social and economic
environments, whether international, national, regional or local. Understanding of internal
context can be facilitated by considering issues related to values, culture, knowledge and
performance of the organization.
4.2 Understanding the needs and expectations of interested parties requires an organization
to determine the interested parties and requirements therein that are relevant to the quality
management system. The organization is also required to monitor and review information
about these interested parties and their relevant requirements.
4.3 Determining the scope of the quality management system requires the organization to
determine the boundaries and applicability of the quality management system to establish its
scope. When doing so, the organization should consider the external and internal issues
referred to in 4.1, the requirements of relevant interested parties referred to in 4.2, and what
their products and services are. Organizations are required to apply all the requirements of
ISO 9001:2015 if they are applicable within the determined scope of the quality
management system. The scope of the organization’s quality management system has to be
available and maintained as documented information. The scope must stipulate the types of
products and services covered, and provide justification for any requirement of ISO
9001:2015 that the organization has determined as not applicable to the scope of its quality
management system. Conformity to ISO 9001:2015 may only be claimed if the requirements
determined as not being applicable do not affect the organization’s ability or responsibility
to ensure the conformity of its products and services and the enhancement of customer
satisfaction.
IATF 16949 Executive Overview - PJC Page 15 12/16

4.3.1 Determining the scope of the quality management system – supplemental requires
organizations to ensure that supporting function, whether on-site or remote (such as
design centers, corporate headquarters, and distribution centers) are included in the
scope of the Quality Management System (QMS.) The only permitted exclusion for
the Automotive QMS Standard relates to the product design and development
requirements within ISO 9001, Section 8.3. The exclusion must be justified and
maintained as documented information (see ISO 9001, Section 7.5.) Permitted
exclusions do not include manufacturing process design.
4.3.2 Customer Specific Requirements requires that customer specific requirements be

evaluated and included in the scope of the organization’s quality management
system.
4.4 Quality management system and its processes establishes two different sets of
requirements:
4.4.1 Requires the organization to establish, implement, maintain and continually improve
a quality management system, including the processes needed and their interactions,
in accordance with the requirements of ISO 9001:2015. It requires the organization
to determine the processes needed for the quality management system and their
application throughout the organization. It requires the organization to determine the
inputs required and the outputs expected from these processes, determine the
sequence and interaction of these processes, to determine and apply the criteria and
methods (including monitoring, measurements and related performance indicators)
needed to ensure the effective operation and control of these processes, to determine
the resources needed for these processes and ensure their availability, to assign the
responsibilities and authorities for these processes, to address the risks and
opportunities as determined in accordance with the requirements of 6.1, to evaluate
these processes and implement any changes needed to ensure that these processes
achieve their intended results, and to improve the processes and the quality
management system.
4.4.1.1 Conformance of products and processes requires the organization to

ensure conformance of all products and processes, including service parts
and those that are outsourced, to all applicable customer, statutory, and
regulatory requirements (see Section 8.4.2.2.)
4.4.1.2 Product Safety requires the organization to have documented processes for
the management of product-safety related products and manufacturing
processes, which must include but not be limited to the following, (where
applicable) identification by the organization of statutory and regulatory
product-safety requirements, customer notification of requirements, special
approvals for design FMEA, identification of product-safety related
characteristics, identification and controls of safety-related characterizes of
product and at the point of manufacture, special approval of control plans
and process FMEAs, reaction plans (see Section 9.1.1.1), defined

responsibilities, definition of escalation process and flow of information,
including top management, customer notification, and training identified by
the organization or customer for personnel involved in product-safety
related products and associated manufacturing processes, changes of
product or process shall be approved prior to implementation, including
evaluation of potential effects on product safety from process and product
changes (see ISO 9001, Section 8.3.6), transfer of requirements with regard
to product safety throughout the supply chain, including customer-
designated sources (see Section 8.4.3.1), product traceability by
manufactured lot (at a minimum) throughout the supply chain (See Section
8.5.2.1); and lessons learned for new product information.
A supplemental note defines special approval as an additional approval by

the function (typically the customer) that is responsible to approve such
documents with safety related content.
4.4.2 Requires the organization to maintain documented information to support the

operation of its processes, and to retain documented information to have confidence
that the processes are being carried out as planned.
5 – Leadership
5.1 Leadership and Commitment
5.1.1 General requires top management to demonstrate leadership and commitment with
respect to the quality management system by taking accountability for the
effectiveness of the quality management system, ensuring that the quality policy and
quality objectives are established for the quality management system and are
compatible with the context and strategic direction of the organization, ensuring the
integration of the quality management system requirements into the organization’s
business processes, promoting the use of the process approach and risk-based
thinking, ensuring that the resources needed for the quality management system are
available, communicating the importance of effective quality management and of
conforming to the quality management system requirements, ensuring that the quality
management system achieves its intended results, engaging, directing and supporting
persons to contribute to the effectiveness of the quality management system,
promoting improvement, and supporting other relevant management roles to
demonstrate their leadership as it applies to their areas of responsibility.
5.1.1.1 Corporate responsibility requires the organization to define and implement

corporate responsibility policies, including at a minimum an anti-bribery
policy, an employee code of conduct, and an ethics escalation policy
(“whistle-blowing policy”).

5.1.1.2 Process effectiveness and efficiency requires top management to review the
product realization processes and support processes to evaluate and
improve their effectiveness and efficiency. The results of the process review
activities must be included as input to the management review.
5.1.1.3 Process owners requires top management to identify process owners who
are responsible for managing the organization’s processes and related
outputs. Process owners must understand their roles and be competent to
perform these roles. (See ISO 9001, Section 7.2.)
5.1.2 Customer focus requires top management to demonstrate leadership and

commitment with respect to customer focus by ensuring that customer and applicable
statutory and regulatory requirements are determined, understood and consistently
met, the risks and opportunities that can affect conformity of products and services
and the ability to enhance customer satisfaction are determined and addressed, and
that the focus on enhancing customer satisfaction is maintained.
5.2 Policy
5.2.1 Establishing the quality policy requires top management to establish, implement and
maintain a quality policy that is appropriate to the purpose and context of the
organization and supports its strategic direction, provides a framework for setting
quality objectives, includes a commitment to satisfy applicable requirements, and
includes a commitment to continual improvement of the quality management system.
5.2.2 Communicating the quality policy requires the quality policy to be available and be
maintained as documented information, be communicated, understood and applied
within the organization, and be available to relevant interested parties, as appropriate.
5.3 Organizational roles, responsibilities and authorities requires top management to ensure
that the responsibilities and authorities for relevant roles are assigned, communicated and
understood within the organization. It further requires top management to assign the
responsibility and authority for ensuring that the quality management system conforms to
the requirements of ISO 9001:2015, ensuring that the processes are delivering their intended
outputs, reporting on the performance of the quality management system and on
opportunities for improvement (see 10.1), in particular to top management, ensuring the
promotion of customer focus throughout the organization, and ensuring that the integrity of
the quality management system is maintained when changes to the quality management
system are planned and implemented.
5.3.1 Organizational roles, responsibilities, and authorities – supplemental requires top

management to assign personnel with the responsibility and authority to ensure that
customer requirements are met. These assignments must be documented. This
includes but is not limited to the selection of special characteristics, setting quality
objective and related training, corrective and preventive action, product design and
development, capacity analysis, logistics information, customer scorecards, and
customer portals.

5.3.2 Responsibility and authority for product requirements and corrective actions
requires top management to ensure that personnel responsible for conformity to
product requirements have the authority to stop shipment and stop production to
correct quality problems. It is noted that due to the process design in some
industries, it might not always be possible to stop production immediately. In this
case, the affected batch must be contained and shipment to the customer prevented.
This requirement goes on to require that personnel with authority and responsibility
for corrective action be promptly informed of products or processes that do not
conform to requirements to ensure that nonconforming product is not shipped to the
customer and that all potential nonconforming product is identified and contained.
Finally it requires that production operations across all shifts be staffed with
personnel in charge of, or delegated responsibility for, ensuring conformity to
product requirements.
6 – Planning
6.1 Actions to Address Risks and Opportunities
6.1.1 Requires the organization to consider the issues referred to in 4.1 and the
requirements referred to in 4.2 and then to determine the risks and opportunities that
need to be addressed to give assurance that the quality management system can
achieve its intended result(s), to enhance desirable effects, to prevent, or reduce,
undesired effects, and to achieve improvement.
6.1.2 Requires the organization to plan actions to address these risks and opportunities, to
determine how to integrate and implement the actions into its quality management
system processes and to evaluate the effectiveness of these actions. Actions taken to
address risks and opportunities must be proportionate to the potential impact on the
conformity of products and services.
6.1.2.1 Risk analysis requires the organization to include in its risk analysis, at a
minimum, lessons learned from product recalls, product audits, field returns
and repairs, complaints, scrap, and rework. It also requires the
organization to retain documented information as evidence of the results of
risk analysis.
6.1.2.2 Preventive action requires the organization to determine and implement

actions to eliminate the causes of potential nonconformities in order to
prevent their occurrence. It further requires preventive actions be
appropriate to the severity of the potential issues. It goes on to mandate
that the organization establish a process to lessen the impact of negative
effectives of risk including determining potential nonconformities and their
causes, evaluating the need for action to prevent occurrence of
nonconformities, determining and implementing action needed, documented
information of action taken, reviewing the effectiveness of the preventive
action taken, and utilizing lessons learned to prevent recurrence in similar
processes (See ISO 9001, Section 7.1.6.)

6.1.2.3 Contingency plans requires the organization to identify and evaluate
internal and external risks to all manufacturing processes and infrastructure
equipment essential to maintain production output and to ensure that
customer requirements are met, define contingency plans according to risk
and impact to the customer, prepare contingency plans for continuity of
supply in the event of any of the following: key equipment failures (also see
Section 8.5.6.1.1), interruption from externally provided products, process,
and services, recurring natural disasters, fire, utility interruptions, labor
shortages, or infrastructure disruptions.
It further requires the organization to include, as a supplement to the

contingency plans, a notification process to the customer and other
interested parties for the extent and duration of any situation impacting
customer operations, to periodically test the contingency plans for
effectiveness (e.g. simulations as appropriate), to conduct contingency plan
reviews (at a minimum annually) using a multi-disciplinary team including
top management, and update as required, and to document the contingency
plans and retain documented information describing any revision(s)
including the person(s) who authorized the change(s.)
This requirement also mandates that the contingency plans must include
provisions to validate that the manufactured product continues to meet
customer specifications after the re-start of production following an
emergency in which production was stopped and if the regular shutdown
processes were not followed.
6.2 Quality Objectives and Planning to Achieve Them
6.2.1 Requires the organization to establish quality objectives at relevant functions, levels
and processes needed for the quality management system. It further requires that
quality objectives be consistent with the quality policy, be measurable, take into
account applicable requirements, be relevant to conformity of products and services
and to enhancement of customer satisfaction, be monitored, be communicated, and be
updated as appropriate. Lastly, it requires the organization to maintain documented
information on the quality objectives.
6.2.2 Requires the organization (with regards to Quality Objectives) to determine what will
be done, what resources will be required, who will be responsible, when it will be
completed, and how the results will be evaluated.
6.2.2.1 Quality objectives and planning to achieve them – supplemental requires

top management to ensure that quality objectives to meet customer
requirements are defined, established, and maintained for relevant
functions, processes, and levels throughout the organization. It further
requires that the results of the organization’s review regarding interested
parties and their relevant requirements be considered when the organization
establishes its annual (at minimum) quality objectives and related
performance targets (internal and external.)

6.3 Planning of changes requires (when an organization determines that there is a need for
changes to the quality management system,) that those changes be carried out in a planned
manner (per 4.4.) Furthermore, it requires the origination to consider the purpose of the
changes and their potential consequences, the integrity of the quality management system,
the availability of resources, and the allocation or reallocation of responsibilities and
authorities.
7 – Support
7.1 Resources
7.1.1 General requires the organization to determine and provide the resources needed for
the establishment, implementation, maintenance and continual improvement of the
quality management system. It further requires the organization to consider the
capabilities of, and constraints on, existing internal resources, and what needs to be
obtained from external providers.
7.1.2 People requires the organization to determine and provide the persons necessary for
the effective implementation of its quality management system and for the operation
and control of its processes.
7.1.3 Infrastructure requires the organization to determine, provide and maintain the
infrastructure necessary for the operation of its processes and to achieve conformity
of products and services. Infrastructure is understood to include buildings and
associated utilities, equipment, including hardware and software, transportation
resources, and information and communication technology.
7.1.3.1 Plant, facility, and equipment planning requires the organization to use a
multidisciplinary approach including risk identification and risk mitigation
methods for developing and improving plant, facility, and equipment plans.
In designing plant layouts, the organization must optimize material flow,
material handling, and value added use of floor space including control of
nonconforming product; and must also facilitate synchronous material flow,
as applicable. The requirement goes on to stipulate that methods be
developed and implemented to evaluate manufacturing feasibility for new
product or new operations. Manufacturing feasibility assessment must
include capacity planning. These methods must also be applicable for
evaluating proposed changes to existing operations. This requirement also
stipulates that the organization maintain process effectiveness, including
periodic reevaluation relative to risk, to incorporate any changes made
during process approval, control plan maintenance (See Section 8.5.1.1),
and verification of job set-ups (see Section 8.5.1.3.) Finally, this
requirements mandates that assessments of manufacturing feasibility and
evaluation of capacity planning be used as inputs to management reviews
(see ISO 9001, Section 9.1.3.) Two notes are also provided indicating that
these requirements should include the application of lean manufacturing
principles, and should apply to onsite supplier activities, as applicable.

7.1.4 Environment for the operation of processes requires the organization to determine,
provide and maintain the environment necessary for the operation of its processes and
to achieve conformity of products and services. Environment is understood to
include a combination of human and physical factors, such as social (e.g. non-
discriminatory, calm, non-confrontational), psychological (e.g. stress-reducing,
burnout prevention, emotionally protective), and physical (e.g. temperature, heat,
humidity, light, airflow, hygiene, noise). These factors can differ substantially
depending on the products and services provided.
IATF 16949 adds a note indicating that where third-party certification to ISO 45001
(or equivalent) is recognized, it may be used to demonstrate the organization’s
conformity to personnel safety aspects of this requirement.
7.1.4.1 Environment for the operation of processes – supplemental requires the

organization to maintain its premises in a state of order, cleanliness, and
repair consistent with the product and manufacturing process needs.
7.1.5 Monitoring and measuring resources
7.1.5.1 General requires the organization to determine and provide the resources
needed to ensure valid and reliable results when monitoring or measuring is
used to verify the conformity of products and services to requirements. It
further requires the organization to ensure that the resources provided are
suitable for the specific type of monitoring and measurement activities being
undertaken, and are maintained to ensure their continuing fitness for their
purpose. Finally, it requires the organization to retain appropriate
documented information as evidence of fitness for purpose of the monitoring
and measurement resources.
7.1.5.1.1 Measurement systems analysis requires statistical studies be

conducted to analyze the variation present in the results of each
type of inspection, measurement, and test equipment system
identified in the control plan. The analytical methods and
acceptance criteria used must conform to those in reference
manuals on measurements systems analysis. It allows for other
analytical methods and acceptance criteria to be used if approved
by the customer, but stipulates that records of customer
acceptance of alternative methods be retained along with results
from alternative measurement systems analysis (see Section
9.1.1.1.) A note is provided indicating that prioritization of MSA
studies should focus on critical or special product or process
characteristics.

7.1.5.2 Measurement traceability requires that when measurement traceability is a
requirement, or is considered by the organization to be an essential part of
providing confidence in the validity of measurement results, measuring
equipment be calibrated or verified, or both, at specified intervals, or prior to
use, against measurement standards traceable to international or national
measurement standards; when no such standards exist, the basis used for
calibration or verification to be retained as documented information. It also
requires that measuring equipment be identified in order to determine their
status, and safeguarded from adjustments, damage or deterioration that
would invalidate the calibration status and subsequent measurement results.
Finally, it requires the organization to determine if the validity of previous
measurement results has been adversely affected when measuring equipment
is found to be unfit for its intended purpose, and to take appropriate action as
necessary.
IATF 16949 provides a note indicating that a number or another identifier

traceable to the device calibration record meets the intent of the
requirements in ISO 9001:2015.
7.1.5.2.1 Calibration/verification records requires the organization to

have a documented process for managing calibration/verification
records. Records of the calibration/verification activity for all
gages and measuring and test equipment (including employee
owned equipment relevant for measuring, customer owned
equipment, or on-site supplier owned equipment) needed to
provide evidence of conformity to internal requirements,
legislative and regulatory requirements, and customer defined
requirements must all be retained. This requirement also
stipulates that the organization must ensure that
calibration/verification activities and records include revisions
following engineering changes that impact measurement systems,
any out of specification readings as received for
calibration/verification, and an assessment of the risk of the
intended use of the product caused by the out-of-specification
condition.
It further requires that when a piece of inspection, measurement,

and test equipment is found to be out of calibration or defective
during its planned verification or calibration or during its use,
documented information on the validity of previous measurement
results obtained with this piece of inspection, measurement, and
test equipment be retained, including the associated standard’s
last calibration date and the next due date on the calibration
report. It also requires notification to the customer if suspect
product or material has been shipped, statements of conformity to
specification after calibration/verification, verification that the

software version used for product and process control is as
specified, records of the calibration and maintenance activities
for all gauging (including employee owned equipment, customer
owned equipment, or on-site supplier owned equipment); and
production related software verification used for product and
process control (including software installed on employee owned
equipment, customer owned equipment, or onsite supplier owned
equipment.)
7.1.5.3 Laboratory requirements is split into two pieces.
7.1.5.3.1 Internal laboratory requires that an organization’s internal

laboratory facility have a defined scope that includes its
capability to perform the required inspection, test, or calibration
services. It further requires the laboratory scope be included in
the quality management system documentation. The laboratory
must specify and implement, as a minimum, requirements for
adequacy of the laboratory technical procedures, competency of
the laboratory personnel, testing of the product, capability to
perform these services correctly, traceable to the relevant process
standard (such as ASTM, EN, etc.) When no national or
international standards are available, the organization must
define and implement a methodology to verify measurement
system capability. Furthermore, the laboratory must specify and
implement customer requirements, if any; and review of the
related records. A note is provided indicating that third party
accreditation to ISO/IEC 17025 (or equivalent) may be used to
demonstrate the organization’s in-house laboratory’s conformity
to this requirement.
7.1.5.3.2 External laboratory requires any external/commercial/

independent laboratory facilities used for inspection, test, or
calibration services by the organization to have a defined
laboratory scope that includes the capability to perform the
required inspection, test, or calibration, and either the laboratory
must be accredited to ISO/IEC 17025 or a national equivalent
and include the relevant inspection, test, or calibration service in
the scope of the accreditation (certificate.) Certificate of
calibration or test report must include the mark of a national
accreditation body; or there must be evidence that the external
laboratory is acceptable to the customer. A note is provided
indicating that 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. The second party assessment may be
performed by the organization assessing the laboratory using a

customer approved method of assessment. The requirement goes
on to state that calibration services may be performed by the
equipment manufacturer when a quality laboratory is not
available for a given piece of equipment. In such cases, the
organization must ensure that the requirements listed in Section
7.1.5.3.1 have been met. Finally, it stipulates that use of
calibration services other than by qualified (or customer
accepted) laboratory, may be subject to government regulatory
confirmation, if required.
7.1.6 Organizational knowledge requires the organization to determine the knowledge

necessary for the operation of its processes and to achieve conformity of products and
services. It also requires that knowledge be maintained and made available to the
extent necessary. When addressing changing needs and trends, the organization must
consider its current knowledge and determine how to acquire or access any necessary
additional knowledge and required updates.
7.2 Competence requires the organization to determine the necessary competence of person(s)
doing work under its control that affects the performance and effectiveness of the quality
management system, to ensure that these persons are competent on the basis of appropriate
education, training, or experience, to take actions (where applicable) to acquire the
necessary competence, to evaluate the effectiveness of the actions taken; and to retain
appropriate documented information as evidence of competence.
7.2.1 Competence – supplemental requires the organization to establish and maintain a

documented process for identifying training needs including awareness (see Section
7.3.1) and achieving competence for all personnel performing activities affecting
conformity to product and process requirements. Personnel performing specific
assigned tasks must be qualified, as required, with particular attention to the
satisfaction of customer requirements.
7.2.2 Competence – on-the-job training requires the organization to provide on-the-job

training (which must include customer requirements training) for personnel in any
new or modified responsibilities affecting conformity to quality requirements,
internal requirements, regulatory or legislative requirements. This must include
contract or agency personnel. The level of detail required for on-the-job training
must be commensurate with the level of education the personnel possess and the
complexity of the tasks they are required to perform for their daily work. Persons
whose work can affect quality must be informed about the consequences of
nonconformity to customer requirements.

7.2.3 Internal auditor competency requires the organization to have a documented
process to verify that internal auditors are competent, taking into account any
customer specific requirements. For additional guidance on auditor competencies,
refer to ISO 19011. The organization must maintain a list of qualified internal
auditors. This requirement goes on to mandate that quality management system
auditors, manufacturing process auditors, and product auditors must all be able to
demonstrate the following as minimum competencies. Understanding of the
automotive process approach for auditing, including risk-based thinking,
Understanding of applicable customer specific requirements, understanding of
applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit,
understanding of applicable core tool requirements related to the scope of the audit;
and understanding how to plan, conduct, report, and close out audit findings.
Additionally, it requires that manufacturing process auditors demonstrate technical

understanding of the relevant manufacturing processes to be audited, including
process risk analysis (such as PFMEA) and control plan. Product auditors must
demonstrate competence in understanding product requirements and use of relevant
measuring and test equipment to verify product conformity.
Where training is provided to achieve competency, documented information must be

retained to demonstrate the trainer’s competency with the above requirements.
Maintenance of and improvement in internal auditor competence must be
demonstrated through executing a minimum number of audits per year, as defined by
the organization; and maintaining knowledge of relevant requirements based on
internal changes (e.g., process technology, product technology) and external changes
(e.g., ISO 9001, IATF 16949, core tools, and customer specific requirements.)
7.2.4 Second party auditor competency requires the organization to demonstrate the
competence of the auditors undertaking the second party audits. Second party
auditors must meet customer specific requirements for auditor qualification and
demonstrate the minimum following core competencies, including understanding of
the automotive process approach to auditing, including risk based thinking,
applicable customer and organization specific requirements, applicable ISO 9001
and IATF 16949 requirements related to the scope of the audit, applicable
manufacturing processes to be audited, including PFMEA and control plan,
applicable core tools requirements related to the scope of the audit; and how to plan,
conduct, report, and close out audit findings.

7.3 Awareness requires the organization to ensure that persons doing work under the
organization’s control are aware of the quality policy, relevant quality objectives, their
contribution to the effectiveness of the quality management system, including the benefits of
improved performance, and the implications of not conforming with the quality
management system requirements.
7.3.1 Awareness – supplemental requires the organization to maintain documented

information that demonstrates that all employees are aware of their impact on
product quality and the importance of their activities in achieving, maintaining, and
improving quality, including customer requirements and the risks involved for the
customer with nonconforming product.
7.3.2 Employee motivation and empowerment requires the organization to maintain a

documented process to motive employees to achieve quality objectives, to make
continual improvements, and to create an environment that promotes innovation.
The process must include the promotion of quality and technological awareness
throughout the whole organization.
7.4 Communication requires the organization to determine the internal and external
communications relevant to the quality management system, including on what it will
communicate, when to communicate, with whom to communicate, how to communicate,
and who communicates.
7.5 Documented Information
7.5.1 General requires the organization’s quality management system to include

documented information required by ISO 9001:2015, documented information, as
well as documented information determined by the organization as being necessary
for the effectiveness of the quality management system.
7.5.1.1 Quality management system documentation requires the organization’s

quality management system to be documented and to include a quality
manual, which can be a series of documents (electric or hard copy.) The
format and structure of the quality manual is at the discretion of the
organization and will depend on the organization’s size, culture, and
complexity. If a series of documents is used, then a list must be retained of
the documents that comprise the quality manual for the organization. The
quality manual must include, at a minimum, the scope of the quality
management system, including details of justification for any exclusions,
documented processes established for the quality management system, or
reference to them, the organization’s processes and their sequence and
interactions (inputs and outputs), including type and extent of control of any
outsourced processes; and a document (i.e. matrix) indicating where within
the organization’s quality management system their customer-specific
requirements are addressed. A note is given that indicates a matrix of how
the requirements of IATF 16949 are addressed by the organization’s
processes may be used to assist with linkages of the organization’s
processes and IATF 16949.
7.5.2 Creating and updating requires that when creating and updating documented
information, the organization ensures appropriate identification and description (e.g.
a title, date, author, or reference number), format (e.g. language, software version,
graphics) media (e.g. paper, electronic) and review and approval for suitability and
adequacy.
7.5.3 Control of documented information
7.5.3.1 Requires documented information required by the quality management

system and by ISO 9001:2015 to be controlled to ensure it is available and
suitable for use, where and when it is needed. It further requires that
documented information be adequately protected (e.g. from loss of
confidentiality, improper use, or loss of integrity).
7.5.3.2 Requires the organization (as it pertains to control of documented

information) to address the following activities, as applicable. Distribution,
access, retrieval and use, storage and preservation, including preservation of
legibility, control of changes (e.g. version control), and retention and
disposition. It further required that documented information of external
origin determined by the organization to be necessary for the planning and
operation of the quality management system be identified as appropriate, and
be controlled. Finally it requires documented information retained as
evidence of conformity be protected from unintended alterations.
7.5.3.2.1 Record retention requires the organization to define, document,

and implement a record retention policy. It further requires that
control of records must satisfy statutory, regulatory,
organizational, and customer requirements. It goes on to require
that production part approvals, tooling records (including
maintenance and ownership), product and process design
records, purchase orders (if applicable), or contracts and
amendments be retained for the length of time that the product is
active for production and service requirements, plus one calendar
year, unless otherwise specified by the customer or regulatory
agency. A note is given indicating that production part approval
documented information may include approved product,
applicable test equipment records, or approved test data.
7.5.3.2.2 Engineering specifications requires the organization to have a

documented process describing the review, distribution, and
implementation of all customer engineering standards/
specifications and related revisions based on customer schedules,
as required. It goes on to require that when an engineering
standard/specification change results in a product design change,
refer to the requirements in ISO 9001, Section 8.3.6. When an

engineering standard/specification change results in a product
realization change, refer to the requirements in Section 8.5.6.1.
The organization shall retain a record of the date on which each
change is implemented in production. Implementation shall
include updated documents. The requirement goes to state that
review should be completed within 10 working days of receipt of
notification of engineering standards/specification changes. A
note is provided indicating that a change in these
standards/specifications may require an updated records of
customer production part approval when these specifications are
referenced on the design record or if they affect documents of the
production part approval process, such as control plan, risk
analysis (such as FMEA), etc.
8 – Operation
8.1 Operational planning and control requires the organization to plan, implement and
control the processes (see 4.4) needed to meet the requirements for the provision of products
and services, and to implement the actions determined in Clause 6. This is to be
accomplished by determining the requirements for the products and services, establishing
criteria for the processes and the acceptance of products and services, determining the
resources needed to achieve conformity to the product and service requirements,
implementing control of the processes in accordance with the criteria, determining,
maintaining and retaining documented information to the extent necessary to have
confidence that the processes have been carried out as planned and to demonstrate the
conformity of products and services to their requirements. Furthermore it requires that the
output of this planning be suitable for the organization’s operations. The organization must
control planned changes and review the consequences of unintended changes, taking action
to mitigate any adverse effects, as necessary. Finally, it requires that the organization
ensures control of the outsourced processes (per 8.4).
8.1.1 Operational planning and control – supplemental requires that planning for
product realization include customer product realization and technical
specifications, logistics requirements, manufacturing feasibility, product planning
(refer to ISO 9001, Section 8.3.2); and acceptance criteria. It goes on to state that
the resources identified in ISO 9001, Section 8.1c refer to the required verification,
validation, monitoring, measurement, inspection, and test activities specific to the
product and the criteria for product acceptance.
8.1.2 Confidentiality requires the organization shall ensure the confidentiality of customer
contracted products and projects under development, including related product
information.
8.2 Requirements for Products and Services

8.2.1 Customer communication requires that communication with customers includes
providing information relating to products and services, handling enquiries, contracts
or orders, including changes, obtaining customer feedback relating to products and
services, including customer complaints, handling or controlling customer property,
and establishing specific requirements for contingency actions, when relevant.
8.2.1.1 Customer communication – supplemental requires written or verbal

communication be in the language agreed with the customer. The
organization must have the ability to communicate necessary information,
including data in a customer specified computer language and form (e.g.
computer aided design data, electronic data interchange.)
8.2.2 Determining the requirements for products and services requires that when
determining the requirements for the products and services to be offered to
customers, the organization must ensure that the requirements for the products and
services are defined, including any applicable statutory and regulatory requirements,
as well as those considered necessary by the organization. Furthermore, the
organization must determine that it can meet the claims for the products and services
it offers.
8.2.2.1 Determining the requirements for products and services – supplemental

indicates that the items defined in section 8.2.2 must include recycling,
environmental impact, and characteristics identified as a result of the
organization’s knowledge of the product and manufacturing processes. It
goes on to state that compliance to ISO 9001, Section 8.2.2a1 must include
but should not be limited to the following: all applicable government,
safety, and environmental regulations related to acquisition, storage,
handling, recycling, elimination, or disposal of material.
8.2.3 Review of the Requirements for Products and Services
8.2.3.1 Requires the organization to ensure that it has the ability to meet the
requirements for products and services to be offered to customers. The
organization must conduct a review before committing to supply products
and services to a customer. This review must include requirements specified
by the customer, including the requirements for delivery and post-delivery
activities, requirements not stated by the customer, but necessary for the
specified or intended use, when known, requirements specified by the
organization, statutory and regulatory requirements applicable to the
products and services and contract or order requirements differing from
those previously expressed. Furthermore it mandates that the customer’s
requirements must be confirmed by the organization before acceptance when
the customer does not provide a documented statement of their
requirements.

8.2.3.1.1 Review of the requirements for products and services –
supplemental requires the organization to retain documented
evidence of a customer authorized waiver for the requirements
stated in ISO 9001, Section 8.2.3.1, for a formal review.
8.2.3.1.2 Customer designated special characteristics requires the

organization to conform to customer requirements for
designation, approval documentation, and control of special
characteristics.
8.2.3.1.3 Organization manufacturing feasibility requires the

organization to utilize a multidisciplinary approach to conduct an
analysis to determine if it is feasible that the organization’s
manufacturing processes are capable of consistently producing
product that meets all of the engineering and capacity
requirements specified by the customer. The organization must
conduct this feasibility analysis for any manufacturing or product
technology new to the organization and for any changed
manufacturing process or product design. It goes on to require
that the organization should validate through production runs,
benchmarking studies, or other appropriate methods, their ability
to make product to specification at the required rate.
8.2.3.2 Requires the organization to retain (as applicable) documented information

on the results of the review, and on any new requirements for the products
and services.
8.2.4 Changes to requirements for products and services requires the organization to
ensure that relevant documented information is amended, and that relevant persons
are made aware of the changed requirements, when the requirements for products and
services are changed.
8.3 Design and Development of Products and Services
8.3.1 General requires the organization to establish, implement and maintain a design and
development process that is appropriate to ensure the subsequent provision of
products and services.
8.3.1.1 Design and development of products and services – supplemental requires

that the requirements of ISO 9001, Section 8.3.1 apply to product and
manufacturing process design and development and must focus on error
prevention rather than detection. It also requires that the organization
document the design and development process.

8.3.2 Design and development planning requires the organization (when they determine
the stages and controls for design and development) to consider the nature, duration
and complexity of the design and development activities, the required process stages,
including applicable design and development reviews, the required design and
development verification and validation activities, the responsibilities and authorities
involved in the design and development process, the internal and external resource
needs for the design and development of products and services, the need to control
interfaces between persons involved in the design and development process, the need
for involvement of customers and users in the design and development process, the
requirements for subsequent provision of products and services, the level of control
expected for the design and development process by customers and other relevant
interested parties, and the documented information needed to demonstrate that design
and development requirements have been met.
8.3.2.1 Design and development planning – supplemental requires that the

organization ensure that design and development planning includes all
affected stakeholders within the organization and, as appropriate, its supply
chain. Examples of areas for using such a multidisciplinary approach
include but are not limited to project management (for example APQP or
VDA-RGA), product and manufacturing process design activities (for
example DFM and DFA), such as consideration of the use of alternative
designs and manufacturing processes, development and review of product
design risk analysis (FMEAs) including actions to reduce potential risks,
and development and review of manufacturing process risk analysis (for
example, FMEAs, process flows, control plan, and standard work
instruction.) A note is provided indicating that a multi-disciplinary
approach typically includes the organization’s design, manufacturing,
engineering, quality, production, purchasing, supplier, maintenance, and
other appropriate functions.
8.3.2.2 Product design skills requires the organization to ensure that personnel
with product design responsibility are competent to achieve design
requirements and are skilled in applicable product design tools and
techniques. Applicable tools and techniques must be identified by the
organization. A note is provided indicating that an example of product
design skills is the application of digitized mathematically based data.
8.3.2.3 Development of products with embedded software requires the

organization to use a process for quality assurance for their products with
internally developed embedded software. A software development
assessment methodology must be utilized to assess the organization’s
software development process. Using prioritization based on risk and
potential impact to the customer, the organization must retain documented
information of a software development capability self-assessment. It further
requires the organization to include software development within the scope
of their internal audit program (See 9.2.2.1.)

8.3.3 Design and development inputs requires the organization to determine the
requirements essential for the specific types of products and services to be designed
and developed. It further requires the organization to consider functional and
performance requirements, statutory and regulatory requirements, standards or codes
of practice that the organization has committed to implement, and potential
consequences of failure due to the nature of the products and services. It further
requires that inputs be adequate for design and development purposes, as well as
complete and unambiguous. Finally, it requires that conflicting design and
development inputs be resolved and that the organization retain documented
information on design and development inputs.
8.3.3.1 Product design input requires the organization to identify, document, and
review product design input requirements as a result of contract review.
Product design input requirements include but are not limited to product
specification including but not limited to special characteristics (see Section
8.3.3.3), boundary and interface requirements, identification, traceability,
and packaging, consideration of design alternatives, assessment of risks
with the input requirements and the organization’s ability to
mitigate/manage the risks, including from the feasibility analysis, targets for
conformity to product requirements including preservation, reliability,
durability, serviceability, health, safety, environmental, development timing,
and cost, applicable statutory and regulatory requirements of the customer
identified country of destination, if provided, and embedded software
requirements.
This requirement also mandates that the organization will have a process to
deploy information gained from previous design projects, competitive
product analysis (benchmarking), supplier feedback, internal input, field
data, and other relevant sources for current and future projects of a similar
nature. A note is given indicating that one approach for considering design
alternatives is the use of trade-off curves.
8.3.3.2 Manufacturing process design input requires the organization to identify,

document, and review manufacturing process design input requirements
including but not limited to product design output data including special
characteristics, targets for productivity, process capability, timing, and cost,
manufacturing technology alternatives, customer requirements, if any,
experience from previous developments, new materials, product handling
and ergonomic requirements, and design for manufacturing and design for
assembly. It further requires the manufacturing process design to include
the use of error-proofing methods to a degree appropriate to the magnitude
of the problem(s) and commensurate with the risks encountered.

8.3.3.3 Special Characteristics requires the organization to use a multi-disciplinary
approach to establish, document, and implement its processes to identify
special characteristics, including those determined by the customer and the
risk analysis performed by the organization, and in so doing to ensure
documentation of all special characteristics in the drawings (as required),
risk analysis (such as FMEA), control plans, and standard work/operator
instructions, special characteristics are identified with specific markings
and are cascaded through each of these documents, development of control
and monitoring strategies for special characteristics of products and
production processes, customer specified approvals, when required. It
further requires compliance with customer specified definitions and symbols
or the organization’s equivalent symbols or notations, as defined in a
symbol conversion table. If used, the symbol conversion table must be
submitted to the customer.
8.3.4 Design and development controls requires the organization to apply controls to the
design and development process to ensure that the results to be achieved are defined,
that reviews are conducted to evaluate the ability of the results of design and
development to meet requirements, that verification activities are conducted to ensure
that the design and development outputs meet the input requirements, that validation
activities are conducted to ensure that the resulting products and services meet the
requirements for the specified application or intended use, that any necessary actions
are taken on problems determined during the reviews, or verification and validation
activities, and that documented information of these activities is retained.
8.3.4.1 Monitoring requires measurements at specified stages during the design

and development of products and processes be defined, analyzed, and
reported with summary results as an input to management review (see
Section 9.3.2.1.) It further requires that when required by the customer,
measurements of the product and process development activity be reported
to the customer at stages specified, or agreed to, by the customer. A note is
provided indicating that when appropriate, these measurements may include
quality risks, costs, lead times, critical paths, and other measurements.
8.3.4.2 Design and development validation requires design and development

validation be performed in accordance with customer requirements,
including any applicable industry and governmental agency-issued
regulatory standards. The timing of design and development validation
must be planned in alignment with customer specified timing, as applicable.
This requirement goes on to mandate that where contractually agreed with
the customer, this must include evaluation of the interaction of the
organization’s product, including embedded software, within the system of
the final customer’s product.

8.3.4.3 Prototype program requires that when required by the customer, the
organization must have a prototype program and control plan. The
organization must use, whenever possible, the same suppliers, tooling, and
manufacturing processes as will be used in production. This requirements
goes on to stipulate that all performance testing activities be monitored for
timely completion and conformity to requirements, and that when services
are outsourced, the organization include the type and extent of control in the
scope of its quality management system to ensure that outsourced services
conform to requirements (see ISO 9001, Section 8.4.)
8.3.4.4 Product approval process requires the organization to establish, implement,

and maintain a product and manufacturing approval process conforming to
requirements defined by the customer. It also requires the organization to
approve externally provided products and services per ISO 9001, Section
8.4.3, prior to submission of their part approval to the customer. Finally, it
requires the organization to obtain documented product approval prior to
shipment, if required by the customer. Records of such approval are to be
retained. A note is provided indicating that product approval should be
subsequent to the verification of the manufacturing process.
8.3.5 Design and development outputs requires the organization to ensure that design and
development outputs meet the input requirements, are adequate for the subsequent
processes for the provision of products and services, include or reference monitoring
and measuring requirements, as appropriate, and acceptance criteria, and specify the
characteristics of the products and services that are essential for their intended
purpose and their safe and proper provision. Furthermore, it requires the
organization to retain documented information on design and development outputs.
8.3.5.1 Design and development outputs – supplemental requires the product

design output to be expressed in terms that can be verified and validated
against product design input requirements. The product design output must
include but is not limited to design risk analysis (FMEA), reliability study
results, product special characteristics, results of product design error
proofing, such as DFSS, DFMA, and FTA, product definition including 3D
models, technical data packages, product manufacturing information, and
geometric dimensioning and tolerances (GD&T), product design review
results, service diagnostic guidelines and repair and serviceability
instructions, service part requirements, and packaging and labeling
requirements for shipping. A note is provided indicating that interim design
outputs should include any engineering problems being resolved through a
trade-off process.

8.3.5.2 Manufacturing process design output requires the organization to
document the manufacturing process design output in a manner that enables
verification against the process design inputs. It further requires the
organization to verify the outputs against manufacturing process design
requirements. Finally, it requires the manufacturing process design output
include specifications and drawings, special characteristics for product and
manufacturing processes, identification of process input variables that
impact characteristics, tooling and equipment for production and control,
including capability studies of equipment and processes, manufacturing
process flow charts/layout, including linkages of product, process, and
tooling, capacity analysis, manufacturing process FMEA, maintenance
plans and instructions, control plan (See Annex A), standard work and work
instructions, process approval acceptance criteria, data for quality,
reliability, maintainability, and measurability, results of error-proofing
identification and verification, as appropriate, methods of rapid detection,
feedback, and correction of product/manufacturing process
nonconformities.
8.3.6 Design and development changes requires the organization to identify, review and
control changes made during, or subsequent to, the design and development of
products and services, to the extent necessary to ensure that there is no adverse
impact on conformity to requirements. It further requires the organization to retain
documented information on design and development changes, the results of reviews,
the authorization of the changes, and the actions taken to prevent adverse impacts.
8.3.6.1 Design and development changes-supplemental requires the organization

to evaluate all design changes after initial product approval, including those
proposed by the organization or its suppliers, for potential impact on fit,
form, function, performance, and/or durability. These changes have to be
validated against customer requirements and approved internally, prior to
production implementation. If further indicates that if required by the
customer, the organization must obtain documented approval, or a
documented waiver, from the customer prior to production implementation.
Finally, it stipulates that for products with embedded software, the
organization must document the revision level of software and hardware as
part of the change record.
8.4 Control of Externally Provided Processes, Products and Services
8.4.1 General requires the organization to ensure that externally provided processes,
products and services conform to requirements. It further requires the organization to
determine the controls to be applied to externally provided processes, products and
services when products and services from external providers are intended for
incorporation into the organization’s own products and services, when products and
services are provided directly to the customer(s) by external providers on behalf of
the organization, or when a process, or part of a process, is provided by an external

provider as a result of a decision by the organization. This requirement further
stipulates that the organization must determine and apply criteria for the evaluation,
selection, monitoring of performance, and re-evaluation of external providers, based
on their ability to provide processes or products and services in accordance with
requirements. Lastly the organization is required to retain documented information
of these activities and any necessary actions arising from the evaluations.
8.4.1.1 General – supplemental requires the organization to include all products

and services that affect customer requirements such as sub-assembly,
sequencing, sorting, rework, and calibration services in the scope of their
definition of externally provided products, processes, and services.
8.4.1.2 Supplier selection process requires the organization to have a documented

supplier selection process. The selection process must include an assessment
of the selected supplier’s risk to product conformity and uninterrupted
supply of the organization’s product to their customers, relevant quality and
delivery performance, an evaluation of the supplier’s quality management
system, multi-disciplinary decision making; and an assessment of software
development capabilities, if applicable. The requirement goes on to indicate
that other supplier selection criteria that should be considered include
volume of automotive business (absolute and as a percentage of total
business), financial stability, purchased product, material, or service
complexity, required technology (product or process), adequacy of available
resources (e.g., people, infrastructure), design and development capabilities
(including project management), manufacturing capability, change
management process, business continuity planning (e.g. disaster
preparedness, contingency planning), logistics process, and customer
service.
8.4.1.3 Customer-directed sources (also known as “Directed-Buy”) requires that

when specified by the customer, the organization purchase products,
materials, or services from customer-directed sources. It goes on to require
that all requirements of Section 8.4 (except the requirements in IATF 16949,
Section 8.4.1.2) are applicable to the organization’s control of customer-
directed sources unless specific agreements are otherwise defined by the
contract between the organization and the customer.
8.4.2 Type and extent of control requires the organization to ensure that externally
provided processes, products and services do not adversely affect the organization’s
ability to consistently deliver conforming products and services to its customers.
Furthermore, it requires the organization to ensure that externally provided processes
remain within the control of its quality management system, to define both the
controls that it intends to apply to an external provider and those it intends to apply to
the resulting output, to take into consideration the potential impact of the externally
provided processes, products and services on the organization’s ability to consistently
meet customer and applicable statutory and regulatory requirements, as well as the

effectiveness of the controls applied by the external provider. This requirement also
stipulates that the organization must determine the verification, or other activities,
necessary to ensure that the externally provided processes, products and services
meet requirements.
8.4.2.1 Type and extent of control – supplemental requires the organization to

have a documented process to identify outsourced processes and to select
the types and extent of controls used to verify conformity of externally
provided products, processes, and services to internal (organizational) and
external customer requirements. It goes on to require that the process must
include the criteria and actions to escalate or reduce the types and extent of
controls and development activities based on supplier performance and
assessment of product, material, or service risks.
8.4.2.2 Statutory and regulatory requirements requires the organization to

document their process to ensure that purchased products, processes, and
services conform to the current applicable statutory and regulatory
requirements in the country of receipt, the country of shipment, and
customer identified country of destination, if provided. It goes on to require
that if the customer defines special controls for certain products with
statutory and regulatory requirements, the organization will ensure they are
implemented and maintained as defined, including at suppliers.
8.4.2.3 Supplier quality management system development stipulates that the

organization is to require their suppliers of automotive products and
services to develop, implement, and improve a quality management system
certified to ISO 9001, unless otherwise authorized by the customer (e.g. Item
a) below), with the ultimate objective of becoming certified to this
Automotive QMS Standard. Unless otherwise specified by the customer, the
sequence followed should be as follows. First compliance to ISO 9001
through second-party audits, second certification to ISO 9001 through third-
party audits, unless otherwise specified by the customer, suppliers to the
organization shall demonstrate conformity to ISO 9001 by maintaining a
third-party certification issued by a certification body bearing the
accreditation mark of a recognized IAF MLA (International Accreditation
Forum Multilateral Recognition Arrangement) member and where the
accreditation bodies main scope includes management system certification
to ISO/IEC 17021, third certification to ISO 9001 with compliance to other
customer defined QMS requirements (such as Minimum Automotive Quality
Management System Requirements for Sub-Tier Suppliers (MAQMSR) or
equivalent) through second party audits, fourth certification to ISO 9001
with compliance to IATF 16949 through second party audits, and fifth
certification to 16949 through third-party audits (valid third party
certification of the supplier to IATF 16949 by an IATF recognized
certification body.)

8.4.2.3.1 Automotive product-related software or automotive products
with embedded software requires that the organization require
their suppliers of automotive product related software, or
automotive products with embedded software, to implement and
maintain a process for software quality assurance for their
products. It also requires a software development assessment
methodology be utilized to assess the supplier’s software
development process. Using prioritization based on risk and
potential impact to the customer, the organization will require the
supplier to retain documented information of a software
development capability self-assessment.
8.4.2.4 Supplier monitoring requires the organization to have a documented

process and criteria to evaluate supplier performance in order to ensure
conformity of externally provided products, processes, and services to
internal and external customer requirements. At a minimum, supplier
performance indicators must include delivered product conformity to
requirements, customer disruptions at the receiving plant, including yard
holds and stop ships, delivery schedule performance, and number of
occurrences of premium freight. This requirement also stipulates that if
provided by the customer, the organization will also include the following
additional supplier performance monitoring: Special status customer
notifications related to quality and delivery issues; and dealer returns,
warranty, field actions, and recalls.
8.4.2.4.1 Second party audits requires the organization to include a

second party audit process in their supplier management
approach. Second party audits may be used for supplier risk
assessment, supplier monitoring, supplier QMS development,
product audits, and process audits. It goes on to require that
based on a risk analysis, including product safety/regulatory
requirements, performance of the supplier, and QMS certification
level, at a minimum, the organization will document the criteria
for determining the need, frequency, and scope of second party
audits. Finally, it requires the organization to retain records of
the second party audit reports. If the scope of the second party
audit is to assess the supplier’s quality management system, then
the approach must be consistent with the automotive process
approach. A note is provided indicating that guidance may be
found in the IATF Auditor Guide and ISO 19011.
8.4.2.5 Supplier development requires the organization to determine the priority,

type, extent, and timing of required supplier development actions for its
active suppliers. Determination inputs must include but are not limited to
performance issues identified through supplier monitoring (see Section
8.4.2.4), second party audit findings (see Section 8.4.2.4.1), third party
quality management system certification status; and risk analysis.

This requirements also mandates that the organization implement actions
necessary to resolve necessary to resolve open (unsatisfactory) performance
issues and pursue opportunities for continual improvement.
8.4.3 Information for external providers requires the organization to ensure the
adequacy of requirements prior to their communication to the external provider. It
further requires the organization to communicate to external providers its
requirements for the processes, products and services to be provided, including
specific products and services, methods, processes, equipment; and requirements
pertaining the release of products and services. This requirements further requires
that the organization communicate additional information to external providers
including required competence, including any required qualification of persons, the
external providers’ interactions with the organization, control and monitoring of the
external providers’ performance to be applied by the organization, and verification or
validation activities that the organization, or its customer, intends to perform at the
external providers’ premises.
8.4.3.1 Information for external providers – supplemental requires the

organization to pass down all applicable statutory and regulatory
requirements and special product and process characteristics to their
suppliers and require the suppliers to cascade all applicable requirements
down the supply chain to the point of manufacture.
8.5 Production and Service Provision
8.5.1 Control of production and service provision requires the organization to

implement production and service under controlled conditions. Controlled conditions
are understood to include (as applicable) the availability of documented information
that defines the characteristics of the products to be produced, the services to be
provided, or the activities to be performed, as well as the results to be achieved.
Controlled conditions is also taken to include the availability and use of suitable
monitoring and measuring resources, the implementation of monitoring and
measurement activities at appropriate stages to verify that criteria for control of
processes or outputs, and acceptance criteria for products and services, the use of
suitable infrastructure and environment for the operation of processes, the
appointment of competent persons, including any required qualification, the
validation, and periodic revalidation, of the ability to achieve planned results of the
processes for production and service provision, where the resulting output cannot be
verified by subsequent monitoring or measurement, the implementation of actions to
prevent human error, and the implementation of release, delivery and post-delivery
activities. A note is provided that indicating that suitable infrastructure includes
appropriate manufacturing equipment required to ensure product compliance.
Monitoring and measuring resources include appropriate monitoring and measuring
equipment required to ensure effective control of manufacturing processes.

8.5.1.1 Control plan requires the organization to develop control plans (in
accordance with Annex A) at the system, subsystem, component, and/or
material levels for the relevant manufacturing site and all product suppliers,
including those for processes producing bulk materials as well as parts.
Family control plans are acceptable for bulk material and similar parts
using a common manufacturing process. It goes on to require the
organization to have a control plan for pre-launch and product that shows
linkage and incorporates information from the design risk analysis (if
provided by the customer), process flow diagram, and manufacturing
process risk analysis outputs (such as FMEA.) It also requires the
organization to, if required by the customer, to provide measurement and
conformity data collected during execution of either the pre-launch or
production control plans. Control plans must include controls used for the
manufacturing process control, including verification of job set-ups, first-
off/last-off part validation, as applicable, methods for monitoring of control
exercised over special characteristics (See Annex A) defined by both the
customer and the organization, the customer required information, if any,
and specified reaction plan (see Annex A) when nonconforming product is
detected, the process becomes statistically unstable or not statistically
capable. Finally, the organization has to review control plans, and update
them for events such as when the organization determines it has shipped
nonconforming product to the customer, when any change occurs affecting
product, manufacturing process, measurement, logistics, supply sources,
production volume changes, or risk analysis (FMEA) (see Annex A), after a
customer complaint and implementation of the associated corrective action,
when applicable, and at a set frequency based on a risk analysis. If
required by the customer, the organization has to obtain customer approval
after review or revision of the control plan.
8.5.1.2 Standardized work – operator instructions and visual standards requires

The organization shall ensure that standardized work documents are
communicated to and understood by the employees who are responsible for
performing the work, legible, presented in the language(s) understood by the
personnel responsible to follow them; and accessible for use at the
designated work area. Standardized work documents must also include
rules for operator safety.
8.5.1.3 Verification of job set-ups requires the organization to verify job set-ups
when performed, such as an initial run of a job, material changeover, or job
change that requires a new set-up, maintain documented information for
set-up personnel, use statistical methods of verification, where applicable,
perform first-off/last-off part validation, as applicable; where applicable,
first-off parts should be retained for comparison with the last-off parts;
where applicable, last-off parts should be retained for comparison with
first-off parts in subsequent runs; and retain records of process and product
approval following set-up and first-off/last off part validations.

8.5.1.4 Verification after shutdown requires the organization to define and
implement the necessary actions to ensure product compliance with
requirements after a planned or unplanned shutdown period.
8.5.1.5 Total predictive maintenance requires the organization to develop,

implement, and maintain a documented total productive maintenance
system. At minimum, the system must include identification of process
equipment necessary to product conforming product at the required volume,
availability of replacement parts for the equipment, provision of resources
for machine, equipment, and facility maintenance, packaging and
preservation of equipment, tooling, and gauging, applicable customer
specific requirements, documented maintenance objectives, for example:
OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between
Failure), and MTTR (Mean Time To Repair), and Preventive Maintenance
compliance metrics. Performance to the maintenance objectives shall form
an input into management review (See ISO 9001, Section 9.3), regular
review of maintenance plan and objectives and a documented action plan to
address corrective actions where objectives are not achieved, use of
preventive maintenance methods, use of predictive maintenance methods, as
applicable; and periodic overhaul.
8.5.1.6 Management of production tooling and manufacturing, test, inspection

tooling, and equipment requires the organization to provide resources for
tool and gauge design, fabrication, and verification activities for production
and service materials and for bulk materials, as applicable. It also requires
the organization to establish and implement a system for production tooling
management, whether owned by the organization or the customer, 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 of the product, tool
modification and revision to documentation, and tool identification, such as
serial or asset number; the status, such as production, repair, or disposal;
ownership; and location. It further requires that the organization to verify
that customer-owned tools, manufacturing equipment, and test/inspection
equipment are permanently marked in a visible location so that the
ownership and application of each item can be determined. Finally, it
requires that the organization must implement a system to monitor these
activities if any work is outsourced.
8.5.1.7 Production scheduling requires the organization to ensure that production

is scheduled in order to meet customer orders/demands such as Just-In-Time
(JIT), and is supported by an information system that permits access to
production information at key stages of the process and is order driven. It
further requires the organization to include relevant planning information
during production scheduling, e.g. customer orders, supplier on-time
delivery performance, capacity, shared loading (multi-part station), lead
time, inventory level, preventive maintenance, and calibration.

8.5.2 Identification and traceability requires the organization to use suitable means to
identify outputs when it is necessary to ensure the conformity of products and
services. It further requires the organization to identify the status of outputs with
respect to monitoring and measurement requirements throughout production and
service provision. Lastly, it requires the organization to control the unique
identification of the outputs when traceability is a requirement, and to retain the
documented information necessary to enable traceability. A note is provided
indicating that 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.
8.5.2.1 Identification and traceability – supplemental indicates that the purpose of

traceability is to support identification of clear start and stop points for
product received by the customer or in the field that may contain quality
and/or safety-related nonconformities. It goes on to mandate the following
approach.
The organization must conduct an analysis of internal, customer, and

regulatory traceability requirements for all automotive products, including
developing and documenting traceability plans, based on the levels of risk
or failure severity for employees, customer, and consumers. The plan must
define the appropriate traceability systems, processes, and methods by
product, process, and manufacturing location that enable the organization
to identify nonconforming and/or suspect product, enable the organization
to segregate nonconforming and/or suspect product, ensure the ability to
meet the customer and/or regulatory response time requirements, ensure
documented information is retained in the format (electronic, hardcopy,
archive) that enables the organization to meet the response time
requirements, ensure serialized identification of individual products, if
specified by the customer or regulatory standards, and ensure the
identification and traceability requirements are extended to externally
provided products with safety/regulatory characteristics.
8.5.3 Property belonging to customers or external providers requires the organization

to exercise care with property belonging to customers or external providers while it is
under the organization’s control or being used by the organization. It further requires
the organization to identify, verify, protect and safeguard customers’ or external
providers’ property provided for use or incorporation into the products and services.
Lastly, it requires that when the property of a customer or external provider is lost,
damaged or otherwise found to be unsuitable for use, the organization must report
this to the customer or external provider and retain documented information on what
has occurred.
8.5.4 Preservation requires the organization to preserve the outputs during production and
service provision, to the extent necessary to ensure conformity to requirements.

8.5.4.1 Preservation – supplemental requires preservation to include identification,
handling, contamination control, packaging, storage, transmission or
transportation, and protection. Preservation must also apply to materials
and components form external and/or internal providers from receipt
through processing, including shipment and until delivery to/acceptance by
the customer. In order to detect deterioration, the organization must assess
at appropriate planned intervals the condition of product in stock, the
place/type of storage container, and the storage environment. It also
requires the organization to use an inventory management system to
optimize inventory turns over time and ensure stock rotation, such as “First-
in-first-out” (FIFO.) Finally, the organization must ensure that obsolete
product is controlled in a manner similar to that of nonconforming product.
Organizations must comply with preservation, packaging, shipping, and
labeling requirements as provided by their customer.
8.5.5 Post-delivery activities requires the organization to meet requirements for post-
delivery activities associated with the products and services. It further requires the
organization (when determining the extent of post-delivery activities that are
required) to consider any applicable statutory and regulatory requirements, the
potential undesired consequences associated with its products and services, the
nature, use and intended lifetime of its products and services, any applicable
customer requirements, and any relevant customer feedback.
8.5.5.1 Feedback of information from service requires the organization to ensure

that a process for communication of information on service concerns to
manufacturing, material handling, logistics, engineering, and design
activities is established. Two notes are provided. First that the intent of the
addition of “service concerns” to this sub-clause is to ensure the
organization is aware of nonconforming products and materials that may be
identified at the customer location or in the field. Secondly, that “Service
Concerns” should include the results of field failure test analysis (see
Section 10.2.6) where applicable.
8.5.5.2 Service agreement with customer requires that when there is a service
agreement with the customer, the organization will verify that the relevant
service centers comply with applicable requirements, verify the effectiveness
of any special purpose tools or measurement equipment; and ensure that all
service personnel are trained in applicable requirements.
8.5.6 Control of changes requires the organization to review and control changes for
production or service provision, to the extent necessary to ensure continuing
conformity with requirements. It further requires the organization to retain
documented information describing the results of the review of changes, the
person(s) authorizing the change, and any necessary actions arising from the review.

8.5.6.1 Control of changes – supplemental requires the organization to have a
documented process to control and react to changes that impact product
realization. The effects of any change, including those changes caused by
the organization, the customer, or any supplier, must be assessed. It goes
on to require the organization to design verification and validation activities
to ensure compliance with customer requirements, validate changes before
implementation, document the evidence of related risk analysis, and retain
records of verification and validation. Changes, including those made at
suppliers, should require a production trial run for verification of changes
(such as changes to part design, manufacturing location, or manufacturing
process) to validate the impact of any changes on the manufacturing
process. When required by the customer, the organization must notify the
customer of any planned product realization changes after the most recent
product approval, obtain documented approval, prior to implementation of
the change, and complete additional verification or identification
requirements, such as production trial run and new product validation.
8.5.6.1.1 Temporary change of process controls requires the organization

to identify, document, and maintain a list of the process controls,
including inspection, measuring, test, and error-proofing devices,
that includes the primary process control and the approved back-
up or alternate methods. It also requires the organization to
document the process that manages the use of alternate control
methods. The organization must include in this process, based on
risk analysis (such as FMEA), severity, and the internal
approvals to be obtained prior to production implementation of
the alternate process control method. Before shipping product
that was inspected or tested using the alternate method, if
required, the organization must obtain approval from the
customer. The organization must maintain and periodically
review a list of approved alternate process control methods that
are referenced in the control plan.
It also requires that standard work instructions be available for

each alternate process control method. The organization must
review the operation of alternate process controls on a daily
basis, at a minimum, to verify implementation of standard work
with the goal to return to the standard process as defined by the
control plan as soon as possible. Example methods include daily
quality focused audits (e.g. layered process audits, as
applicable); and daily leadership meeting. Restart verification is
documented for a defined period based on severity and
confirmation that all features of the error proofing device or
process are effectively reinstated. Finally, the organization must
implement traceability of all product produced while any
alternate process control devices or processes are being used
(e.g. verification and retention of first piece and last piece from
every shift.)
8.6 Release of products and services requires the organization to implement planned
arrangements, at appropriate stages, to verify that the product and service requirements have
been met. It further requires the release of products and services to the customer not to
proceed until the planned arrangements have been satisfactorily completed, unless otherwise
approved by a relevant authority and, as applicable, by the customer. Lastly it requires the
organization to retain evidence of conformity with the acceptance criteria, and ensure
traceability to the person(s) authorizing the release.
8.6.1 Release of products and services – supplemental requires the organization to ensure
that the planned arrangement to verify that the product and service requirements
have been met encompass the control plan and are documented as specified in the
control plan. It also requires the organization to ensure that the planned
arrangements for initial release of products and services encompass product or
service approval. Finally, it requires the organization to ensure that product or
service approval is accomplished after changes following initial release, according
to ISO 9001, Section 8.5.6.
8.6.2 Layout inspection and functional testing requires a layout inspection and a
functional verification to applicable customer engineering material and performance
standards be performed for each product as specified in the control plans. Results of
same must be available for customer review. Two notes are provided, The first
indicates that layout inspection is the complete measurement of all product
dimensions shown on the design record(s.) The second establishes that the frequency
of layout inspection is determined by the customer.
8.6.3 Appearance items requires that any organization manufacturing parts designated by
the customer as “appearance items”, must provide appropriate resources, including
lighting, for evaluation, masters for color, grain, gloss, metallic brilliance, texture,
distinctness of image (DOI), and haptic technology, as appropriate, maintenance and
control of appearance masters and evaluation equipment, and verification that
personnel making appearance evaluations are competent and qualified to do so.
8.6.4 Verification and acceptance of conformity of externally provided products and

services requires the organization to have a process to ensure the quality of
externally provided processes, product, and services utilizing (one or more of these)
receipt and evaluation of statistical data provided by the supplier to the
organization, receiving inspection and/or testing, such as sampling based on
performance, second party or third party assessments or audits of supplier sites
when coupled with records of acceptable delivered product conformance to
requirements, part evaluation by a designated laboratory, or another method agreed
with the customer.
8.6.5 Statutory and regulatory conformity requires that prior to release of externally
provided products into its production flow, the organization must confirm and be
able to provide evidence that externally provided processes, products, and services
conform to the latest applicable statutory, regulatory, and other requirements in the
countries where they are manufactured and in the customer-identified countries of
destination, if provided.
8.6.6 Acceptance criteria requires that acceptance criteria be defined by the organization
and, where appropriate or required, approved by the customer. For attribute data
sampling, the acceptance level shall be zero defects (see Section 9.1.1.1.)
8.7 Control of Nonconforming Outputs
8.7.1 Requires the organization to ensure that outputs that do not conform to their
requirements are identified and controlled to prevent their unintended use or delivery.
It further requires the organization to take appropriate action based on the nature of
the nonconformity and its effect on the conformity of products and services. This also
applies to nonconforming products and services detected after delivery of products,
during or after the provision of services. Additionally, this requirement mandates
that the organization deal with nonconforming outputs in one or more of the
following ways. These include correction, segregation, containment, return or
suspension of provision of products and services, informing the customer, and
obtaining authorization for acceptance under concession. Lastly, it requires that
conformity to the requirements must be verified when nonconforming outputs are
corrected.
8.7.1.1 Customer authorization for concession requires the organization to obtain

a customer concession or deviation permit prior to further processing
whenever the product or manufacturing process is different from that which
is currently approved. It further requires the organization to obtain
customer authorization prior to further processing for “use as is” and
rework dispositions of nonconforming product. If subcomponents are reused
in the manufacturing process, that subcomponent reuse must be clearly
communicated to the customer in the concession or deviation permit.
Finally, this requirement stipulates that the organization maintain a record
of the expiration date or quantity authorized under concession. The
organization must also ensure compliance with the original or superseding
specifications and requirements when the authorization expires. Material
shipped under concession must be properly identified on each shipping
container (this applies equally to purchased product). The organization
must approve any requests from suppliers before submission to the
customer.
8.7.1.2 Control of nonconforming product – customer-specified process requires

the organization to comply with applicable customer-specified controls for
nonconforming product.
8.7.1.3 Control of suspect product requires the organization to ensure that product
with unidentified or suspect status be classified and controlled as
nonconforming product. The organization must ensure that all appropriate
manufacturing personnel receive training for containment of suspect and
nonconforming product.

8.7.1.4 Control of reworked product requires the organization to utilize risk
analysis (such as FMEA) methodology to assess risks in the rework process
prior to a decision to rework the product. If required by the customer, the
organization must obtain approval from the customer prior to commencing
rework of the product. This requirement also indicates that the organization
must have a documented process for rework confirmation in accordance
with the control plan or other relevant documented information to verify
compliance to original specifications. Instructions for disassembly or
rework, including re-inspection and traceability requirements, must be
accessible to and utilized by the appropriate personnel. Finally, the
organization must obtain a documented customer authorization for
concession for the product to be repaired, and must retain documented
information on the disposition of repaired product including quantity,
disposition, disposition date, and applicable traceability information.
8.7.1.6 Customer notification requires the organization to immediately notify the

customer in the event that nonconforming product has been shipped. Initial
communication must be followed with detailed documentation of the event.
8.7.1.7 Nonconforming product disposition requires the organization to have a

documented process for disposition of nonconforming product not subject to
rework or repair. For product not meeting requirements, the organization
must verify that the product to be scrapped is rendered unusable prior to
disposal. It goes on to require that the organization not divert
nonconforming product to service or other use without prior customer
approval.
8.7.2 Requires the organization to retain documented information that describes the
nonconformity, describes the actions taken, describes any concessions obtained, and
identifies the authority deciding the action in respect of the nonconformity.
9 – Performance Evaluation
9.1 Monitoring, Measurement, Analysis and Evaluation
9.1.1 General requires the organization to determine what needs to be monitored and
measured, the methods for monitoring, measurement, analysis and evaluation needed
to ensure valid results, when the monitoring and measuring to be performed, and
when the results from monitoring and measurement to be analyzed and evaluated.
Furthermore, it requires the organization to evaluate the performance and the
effectiveness of the quality management system. Lastly, it requires the organization
to retain appropriate documented information as evidence of the results.

9.1.1.1 Monitoring and measurement of manufacturing processes requires the
organization to perform process studies on all new manufacturing
(including assembly or sequencing) processes to verify process capability
and to provide additional input for process control, including those for
special characteristics. A note is given that indicates for some
manufacturing processes, it may not be possible to demonstrate product
compliance through process capability. For those processes, alternate
methods such as batch conformance to specification may be used.
This requirement goes on to mandate that the organization maintain

manufacturing process capability or performance results as specified by the
customer’s part approval process requirements. The organization must also
verify that the process flow diagram, PFMEA, and control plan are
implemented, including adherence to measurement techniques, sampling
plans, acceptance criteria, records of actual measurement values and/or test
results for variable data, and reaction plans and escalation process when
acceptance criteria are not met. It further requires that significant process
events, such as tool change or machine repair, be recorded and retained as
documented information. Finally, it requires the organization to initiate a
reaction plan indicated on the control plan and evaluated for impact on
compliance to specifications for characteristics that are either not
statistically capable or are unstable. Such reason plans must include
containment of product and 100 percent inspection, as appropriate. A
corrective action plan must be developed and implemented by the
organization indicating specific actions, timing, and assigned
responsibilities to ensure that the process becomes stable and statistically
capable. The plans must be reviewed with and approved by the customer,
when required. Lastly, this requirement indicates that the organization must
maintain records of effective dates of process changes.
9.1.1.2 Identification of statistical tools requires the organization to determine the

appropriate use of statistical tools. The organization must verify that
appropriate statistical tools are included as part of the advanced product
quality planning (or equivalent) process and included in the design risk
analysis (such as DMEA) (where applicable), the process risk analysis (such
as PFMEA), and the control plan.
9.1.1.3 Application of statistical concepts requires statistical concepts, such as

variation, control (stability), process capability, and the consequences of
over-adjustment, be understood and used by employees involved in the
collection, analysis, and management of statistical data.
9.1.2 Customer satisfaction requires the organization to monitor customers’ perceptions

of the degree to which their needs and expectations have been fulfilled. Further the
organization is required to determine the methods for obtaining, monitoring and
reviewing this information.

9.1.2.1 Customer satisfaction – supplemental requires customer satisfaction with
the organization be monitored through continual evaluation of internal and
external performance indicators to ensure compliance to the product and
process specification and other customer requirements. Performance
indicators must be based on objective evidence and include delivered part
quality performance, customer disruptions, field returns, recalls, and
warranty (where applicable), delivery schedule performance (including
incidents of premium freight), and customer notifications related to quality
or delivery issues, including special status. This requirement also stipulates
that the organization monitor the performance of manufacturing processes
to demonstrate compliance with customer requirements for product quality
and process efficiency. The monitoring must include the review of customer
performance data including online customer portals and customer
scorecards, where provided.
9.1.3 Analysis and evaluation requires the organization to analyze and evaluate
appropriate data and information arising from monitoring and measurement.
Furthermore, it requires that the results of analysis be used to evaluate conformity of
products and services, the degree of customer satisfaction, the performance and
effectiveness of the quality management system, if planning has been implemented
effectively, the effectiveness of actions taken to address risks and opportunities, the
performance of external providers, and the need for improvements to the quality
management system.
9.1.3.1 Prioritization requires that trends in quality and operational performance

be compared with progress toward objectives and lead to action to support
prioritization of actions for improving customer satisfaction.
9.2 Internal Audit
9.2.1 Requires the organization to conduct internal audits at planned intervals to provide
information on whether the quality management system conforms to the
organization’s own requirements for its quality management system, as well as the
requirements of ISO 9001:2015, and to ensure that the quality management system is
effectively implemented and maintained.
9.2.2 Requires the organization to plan, establish, implement and maintain an audit
program(s) including the frequency, methods, responsibilities, planning requirements
and reporting, which must take into consideration the importance of the processes
concerned, changes affecting the organization, and the results of previous audits. The
organization is further required to define the audit criteria and scope for each audit, to
select auditors and conduct audits to ensure objectivity and the impartiality of the
audit process, to ensure that the results of the audits are reported to relevant
management, to take appropriate correction and corrective actions without undue
delay, and to retain documented information as evidence of the implementation of the
audit program and the audit results.

9.2.2.1 Internal Audit Program requires the organization to have a documented
internal audit process. The process must include the development and
implementation of an internal audit program that covers the entire quality
management system, including quality management system audits,
manufacturing process audits, and product audits. It also mandates that the
audit program be prioritized based upon risk, internal and external
performance trends and criticality of the processes. Additionally, where the
organization is responsible for software development, the organization must
include software development capability assessments in their internal audit
program. Finally, it is required that the frequency of audits be reviewed,
and where appropriate, adjusted based on occurrence of process changes,
internal and external nonconformities, and/or customer complaints. The
effectiveness of the audit program must be reviewed as a part of
management review.
9.2.2.2 Quality management system audit requires the organization to audit all
quality management system processes over each three-year calendar period,
according to an annual program, using the process approach to verify
compliance with this Automotive QMS Standard. Integrated with these
audits, the organization must also sample customer specific quality
management system requirements for effective implementation.
9.2.2.3 Manufacturing process audit requires the organization to audit all

manufacturing processes over each three year calendar period to determine
their effectiveness and efficiency using customer specific require approach
for process audits. Where not defined by the customer, the organization
must determine the approach to be used. It goes on to mandate that within
each individual audit plan, each manufacturing process must be audited on
all shifts where it occurs, including the appropriate sampling of the shift
handover. Finally, it stipulates that the manufacturing process audit include
an audit of the effective implementation of the process risk analysis (such as
PFMEA), control plan, and associated documents.
9.2.2.4 Product audit requires the organization to audit products using customer
specific required approaches at appropriate stages of production and
delivery to verify conformity to specified requirements. Where not defined
by the customer, the organization must determine the approach to be used.
9.3 Management Review
9.3.1 General requires top management to review the organization’s quality management
system, at planned intervals, to ensure its continuing suitability, adequacy,
effectiveness and alignment with the strategic direction of the organization.

9.3.1.1 Management review – supplemental requires management review be
conducted at least annually. The frequency of management review must be
increased based on risk to compliance with customer requirements resulting
from internal or external changes impacting the quality management system
and performance related issues.
9.3.2 Management review inputs stipulates that the management review be planned and
carried out taking into consideration the status of actions from previous management
reviews, any changes in external and internal issues that are relevant to the quality
management system, any information on the performance and effectiveness of the
quality management system, including trends in customer satisfaction/feedback from
relevant interested parties, the extent to which quality objectives have been met,
process performance and conformity of products and services, nonconformities and
corrective actions, monitoring and measurement results, audit results, and the
performance of external providers. It further requires that inputs include a discussion
of the adequacy of resources, the effectiveness of actions taken to address risks and
opportunities (per 6.1), and any opportunities for improvement.
9.3.2.1 Management review inputs – supplemental requires input to management

review also include cost of poor quality (cost of internal and external
nonconformance), measures of process effectiveness, measures of process
efficiency, product conformance, assessments of manufacturing feasibility
made for changes to existing operations and for new facilities or new
product (see Section 7.1.3.1), customer satisfaction (see ISO 9001, Section
9.1.2), review of performance against maintenance objectives, warranty
performance (where applicable), review of customer scorecards (where
applicable), identification of potential field failures identified through risk
analysis (such as FMEA), and actual field failures and their impact on
safety or the environment.
9.3.3 Management review outputs requires the outputs of the management review to
include decisions and actions related to opportunities for improvement, any need for
changes to the quality management system, and resource needs. It further requires
the organization to retain documented information as evidence of the results of
management reviews.
9.3.3.1 Management review outputs – supplemental requires that top management

document and implement an action plan when customer performance targets
are not met.

10 – Improvement
10.1 General requires the organization to determine and select opportunities for improvement
and implement any necessary actions to meet customer requirements and enhance customer
satisfaction. It further requires that improvement action must include improving products
and services to meet requirements as well as to address future needs and expectations, as
well as correcting, preventing or reducing undesired effects and improving the performance
and effectiveness of the quality management system.
10.2 Nonconformity and Corrective Action
10.2.1 Requires that when a nonconformity occurs, including those arising from
complaints, the organization must react to the nonconformity and, as applicable
take action to control and correct it and deal with the consequences. Furthermore,
it requires the organization to evaluate the need for action to eliminate the cause(s)
of the nonconformity, in order that it does not recur or occur elsewhere, by
reviewing and analyzing the nonconformity, by determining the causes of the
nonconformity, by determining if similar nonconformities exist, or could
potentially occur, by implementing any action needed, by reviewing the
effectiveness of any corrective action taken, u updating risks and opportunities
determined during planning, if necessary, and by making changes to the quality
management system, if necessary. Furthermore it requires that corrective actions
be appropriate to the effects of the nonconformities encountered.
10.2.2 Requires the organization to retain documented information as evidence of the

nature of the nonconformities and any subsequent actions taken, as well as the
results of any corrective action.
10.2.3 Problem solving requires the organization to have a documented process

for problem solving including defined approaches for various types and
scale of problems (e.g. new product development, current manufacturing
issues, field failures, audit findings, etc.), containment, interim actions,
and related activities necessary for control of nonconforming outputs (see
ISO 9001, Section 8.7), root cause analysis, methodology used, analysis,
and results, implementation of systemic corrective actions, including
consideration of the impact on similar processes and products,
verification of the effectiveness of implemented corrective actions, and
reviewing, and where necessary, updating the appropriate documented
information (e.g., PFMEA, control plan, etc.) It goes on to require that
where the customer has specified prescribed processes, tool, or systems
for problem solving, the organization must use those processes, tools or
systems unless otherwise approved by the customer.

10.2.4 Error proofing requires the organization to have a documented process to
determine the use of appropriate error proofing methodologies. Details of
the method used must be documented in the process risk analysis (such as
PFMEA) and test frequencies must be documented in the control plan. It
also requires that the process include the testing of error proofing devices
for failure or simulated failure. Records of this must be maintained.
Challenge parts, when used, must be identified, controlled, verified, and
calibrated where feasible. Error proofing device failures must have a
reaction plan.
10.2.5 Warranty management systems requires that when it is required to

provide warranty for their products, the organization implement a
warranty management process. The organization must include in the
process a method for warranty party analysis, including NTF (no trouble
found.) When specified by the customer, the organization must implement
the required warranty management process.
10.2.6 Customer complaints and field failure test analysis requires the
organizations to perform analysis on customer complaints and field
failures, including any returned parts, and to initial problem solving and
corrective action to prevent recurrence. It goes on to indicate that (where
requested by the customer) this must include analysis of the interaction of
embedded software of the organization’s product within the system of the
final customer’s product. Finally, this requirement mandates that the
organization communicate the results of testing/analysis to the customer
and also within the organization.
10.3 Continual improvement requires the organization to continually improve the suitability,
adequacy and effectiveness of the quality management system.
10.3.1 Continual improvement – supplemental requires the organization to have a

documented process for continual improvement. This process must include
identification of the methodology used, objectives, measurement, effectiveness, and
documented information, a manufacturing process improvement action plan with
emphasis on the reduction of process variation and waste, and risk analysis (such
as FMEA.) A note is provided indicating that continual improvement is
implemented once manufacturing processes are statistically capable and stable or
when product characteristics are predictable and meet customer requirements.

CUSTOMER-SPECIFIC REQUIREMENTS __________________________
IATF 16949 offers a set of global automotive quality management systems requirements. But not all
requirements could be harmonized. Therefore, each participating automaker has established
customer-specific requirements for its suppliers, which must be included in the registration audit in
order to obtain customer recognition of IATF 16949 registration.
As a result, applicable customer-specific requirements are audited as part of IATF 16949 registration
and the particular automaker(s) are listed on the supplier’s registration certificate.
These customer-specific requirements are set forth in company publications typically found in the
official IATF website: www.iatfglobaloversight.org. Information on these requirements can also be
obtained from the organizations listed below.
International Automotive Oversight Bureau (IAOB)

26200 Lahser Road, Suite 320
Southfield, Michigan 48033
USA
Phone: (248) 799-3939
Fax: (248) 799-3943
E-mail: quality@iaob.org
Website: www.iaob.org
Society of Motor Manufacturers and Traders (SMMT) Ltd.

71 Great Peter Street
London SW1P 2BN
United Kingdom
Phone: 011-44-0-20-7235-7000
Fax: 011-44-0-20-7235-7112
E-mail: quality@smmt.co.uk
Website: www.smmt.co.uk
Verbrand der Automobilindustrie e.V. (VDA) Qualitätsmanagement Center (QMC)

Behrenstrasse 35
10117 Berlin
Germany
Phone: 011-49-0-30-89-78-42-0
Fax: 011-49-0-30-89-78-42-605
Email: info@vda-qmc.de
Website: www.vda-qmc.de

IATF France
79 rue Jean Jacques Rousseau
92158 Suresnes Cedex
France
Phone: 011-33-1-46-25-02-64
E-mail: iatf@iatf-france.com
Website: www.iatf-france.com
Associazione Nazionale Fra Industrie Automobilistiche (ANFIA)

Corso Gallileo Ferraris, 61
10128 Torino
Italy
Phone: 011-39-011-54-46-511/505
Fax: 011-39-011-54-59-86
E-mail: anfia@anfia.it
Website: www.anfia.it

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IATF 16949 QUALITY MANAGEMENT SYSTEM

4 – Context of the Organization

IATF 16949 Executive Overview - PJC Page 15 12/16

4.3.2 Customer Specific Requirements requires that customer specific requirements be

4.4.1.1 Conformance of products and processes requires the organization to

IATF 16949 Executive Overview - PJC Page 16 12/16

A supplemental note defines special approval as an additional approval by

4.4.2 Requires the organization to maintain documented information to support the

5.1 Leadership and Commitment

5.1.1.1 Corporate responsibility requires the organization to define and implement

IATF 16949 Executive Overview - PJC Page 17 12/16

5.1.2 Customer focus requires top management to demonstrate leadership and

5.3.1 Organizational roles, responsibilities, and authorities – supplemental requires top

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6.1 Actions to Address Risks and Opportunities

6.1.2.2 Preventive action requires the organization to determine and implement

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It further requires the organization to include, as a supplement to the

6.2 Quality Objectives and Planning to Achieve Them

6.2.2.1 Quality objectives and planning to achieve them – supplemental requires

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7.1.4.1 Environment for the operation of processes – supplemental requires the

7.1.5 Monitoring and measuring resources

7.1.5.1.1 Measurement systems analysis requires statistical studies be

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IATF 16949 provides a note indicating that a number or another identifier

7.1.5.2.1 Calibration/verification records requires the organization to

It further requires that when a piece of inspection, measurement,

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7.1.5.3 Laboratory requirements is split into two pieces.

7.1.5.3.1 Internal laboratory requires that an organization’s internal

7.1.5.3.2 External laboratory requires any external/commercial/

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7.1.6 Organizational knowledge requires the organization to determine the knowledge

7.2.1 Competence – supplemental requires the organization to establish and maintain a

7.2.2 Competence – on-the-job training requires the organization to provide on-the-job

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Additionally, it requires that manufacturing process auditors demonstrate technical

Where training is provided to achieve competency, documented information must be

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7.3.1 Awareness – supplemental requires the organization to maintain documented

7.3.2 Employee motivation and empowerment requires the organization to maintain a

7.5 Documented Information

7.5.1 General requires the organization’s quality management system to include

7.5.1.1 Quality management system documentation requires the organization’s

7.5.3 Control of documented information

7.5.3.1 Requires documented information required by the quality management

7.5.3.2 Requires the organization (as it pertains to control of documented

7.5.3.2.1 Record retention requires the organization to define, document,

7.5.3.2.2 Engineering specifications requires the organization to have a

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8.2 Requirements for Products and Services

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8.2.1.1 Customer communication – supplemental requires written or verbal

8.2.2.1 Determining the requirements for products and services – supplemental

8.2.3 Review of the Requirements for Products and Services

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