7 Support

7.1 Resources
7.1.1 General
See ISO 9001:2015 requirements

7.1.2 People
See ISO 9001:2015 requirements

7.1.3 Infrastructure
See ISO 9001:2015 requirements

7.1.3.1 Plant, facility, and equipment planning
The organization shall 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 shall:

a) optimize material flow, material handling, and value-added use of floor space including control
of nonconforming product, and

b) facilitate synchronous material flow, as applicable.
Methods shall be developed and implemented to evaluate manufacturing feasibility for new product
or new operations. Manufacturing feasibility assessments shall include capacity planning. These
methods shall also be applicable for evaluating proposed changes to existing operations

The organization shall maintain process effectiveness, including periodic re-evaluation 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).

Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to
management reviews (see ISO 9001, Section 9.3).
NOTE_1__These requirements should include the application of lean manufacturing principles.
NOTE_2__These requirements should apply to on-site supplier activities, as applicable.

7.1.4 Environment for the operation of processes
See ISO 9001:2015 requirements
NOTE__Where third-party certification to ISO 45001 (or equivalent) is recognized, it may be used to demonstrate the organization's
conformity to the personnel safety aspects of this requirement.

7.1.4.1 Environment for the operation of processes – supplemental
The organization shall maintain its premises in a state of order, cleanliness, and repair that is
consistent with the product and manufacturing process needs.

7.1.5 Monitoring and measuring resources

7.1.5.1 General
See ISO 9001:2015 requirements

7.1.5.1.1 Measurement System Analysis
Statistical studies shall be conducted to analyse 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 shall conform to those in reference manuals on measurement systems
analysis. Other analytical methods and acceptance criteria may be used if approved by the customer.

Records of customer acceptance of alternative methods shall be retained along with results from
alternative measurement systems analysis (see Section 9.1.1.1).
NOTE__Prioritization of MSA studies should focus on critical or special product or process characteristics

7.1.5.2 Measurement traceability

See ISO 9001:2015 requirements
NOTE 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

The organization shall have a documented process for managing calibration/verification records.
Records of the calibration/verification activity for all gauges 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 shall be retained.

The organization shall ensure that calibration/verification activities and records shall include the
following details

a) revisions following engineering changes that impact measurement systems;
b) any out-of-specification readings as received for calibration/verification;
c) an assessment of the risk of the intended use of the product caused by the out-of-specification
condition;
d) 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 shall be retained, including the associated
standard's last calibration date and the next due date on the calibration report;
e) notification to the customer if suspect product or material has been shipped;
f) statements of conformity to specification after calibration/verification;
g) verification that the software version used for product and process control is as specified;
h) records of the calibration and maintenance activities for all gauging (including employee-
owned equipment, customer-owned equipment, or on-site supplier-owned equipment);
i) production-related software verification used for product and process control (including
software installed on employee-owned equipment, customer-owned equipment, or on-site
supplier-owned equipment).

7.1.5.3 Laboratory Requirements

7.1.5.3.1 Internal laboratory

An organization's internal laboratory facility shall have a defined scope that includes its capability to
perform the required inspection, test, or calibration services. This laboratory scope shall be included
in the quality management system documentation. The laboratory shall specify and implement, as a
minimum, requirements for:

a) adequacy of the laboratory technical procedures;
b) competency of the laboratory personnel;
c) testing of the product;
d) capability to perform these services correctly, traceable to the relevant process standard (such
as ASTM, EN, etc.); when no national or international standard(s) is available, the organization
shall define and implement a methodology to verify measurement system capability;
e) customer requirements, if any;
f) review of the related records.

NOTE__Third-party accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate the organization's in-house laboratory
conformity to this requirement.

7.1.5.3.2 External laboratory
External/commercial/independent laboratory facilities used for inspection, test, or calibration
services by the organization shall have a defined laboratory scope that includes the capability to
perform the required inspection, test, or calibration, and either:

− the laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include the
relevant inspection, test, or calibration service in the scope of the accreditation (certificate);
the certificate of calibration or test report shall include the mark of a national accreditation
body; or

− there shall be evidence that the external laboratory is acceptable to the customer.

NOTE__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.

Calibration services may be performed by the equipment manufacturer when a qualified laboratory is
not available for a given piece of equipment. In such cases, the organization shall ensure that the
requirements listed in Section 7.1.5.3.1 have been met.
Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject
to government regulatory confirmation, if required.

7.1.6 Organizational knowledge
See ISO 9001:2015 requirements

7.2 Competence
See ISO 9001:2015 requirements

7.2.1 Competence – supplemental
The organization shall establish and maintain a documented process(es) for identifying training needs
including awareness (see Section 7.3.1) and achieving competence of all personnel performing
activities affecting conformity to product and process requirements. Personnel performing specific
assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer
requirements.

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

7.2.3 Internal auditor competency
The organization shall have a documented process(es) 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 shall maintain a list of qualified internal auditors.

Quality management system auditors, manufacturing process auditors, and product auditors shall all
be able to demonstrate the following minimum competencies:

a) understanding of the automotive process approach for auditing, including risk-based thinking;
b) understanding of applicable customer-specific requirements;
c) understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of
the audit;
d) understanding of applicable core tool requirements related to the scope of the audit;
e) understanding how to plan, conduct, report, and close out audit findings.

Additionally, manufacturing process auditors shall demonstrate technical understanding of the
relevant manufacturing process(es) to be audited, including process risk analysis (such as PFMEA)
and control plan. Product auditors shall 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 shall be retained to
demonstrate the trainer’s competency with the above requirements.

Maintenance of and improvement in internal auditor competence shall be demonstrated through:
f) executing a minimum number of audits per year, as defined by the organization; and
g) 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
The organization shall demonstrate the competence of the auditors undertaking the second-party
audits. Second-party auditors shall meet customer specific requirements for auditor qualification and
demonstrate the minimum following core competencies, including understanding of:

a) the automotive process approach to auditing, including risk based thinking;
b) applicable customer and organization specific requirements;
c) applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;
d) applicable manufacturing process(es) to be audited, including PFMEA and control plan;
e) applicable core tool requirements related to the scope of the audit;
f) how to plan, conduct, prepare audit reports, and close out audit findings.

7.3 Awareness
See ISO 9001:2015 requirements

7.3.1 Awareness – Supplemental
The organization shall 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 non- conforming product

7.3.2 Employee motivation and empowerment
The organization shall maintain a documented process(es) to motivate employees to achieve quality
objectives, to make continual improvements, and to create an environment that promotes innovation.
The process shall include the promotion of quality and technological awareness throughout the whole
organization.

7.4 Communication
See ISO 9001:2015 requirements

7.5 Documented information
7.5.1 General
See ISO 9001:2015 requirements

7.5.1.1 Quality management system documentation
The organization's quality management system shall be documented and include a quality manual,
which can be a series of documents (electronic 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 shall be
retained of the documents that comprise the quality manual for the organization.

The quality manual shall include, at a minimum, the following:

a) the scope of the quality management system, including details of and justification for any
exclusions;
b) documented processes established for the quality management system, or reference to them;
c) the organization’s processes and their sequence and interactions (inputs and outputs),
including type and extent of control of any outsourced processes;
d) a document (i.e., matrix) indicating where within the organization's quality management
system their customer-specific requirements are addressed.

NOTE__A matrix of how the requirements of this Automotive QMS standard are addressed by the organization’s processes may be used to assist with linkages of the organization’s processes and this Automotive QMS.

7.5.2 Creating and updating
See ISO 9001:2015 requirements

7.5.3 Control of documented information

7.5.3.1 and 7.5.3.2
See ISO 9001:2015 requirements

7.5.3.2.1 Record retention
The organization shall define, document, and implement a record retention policy. The control of
records shall satisfy statutory, regulatory, organizational, and customer requirements.
Production part approvals, tooling records (including maintenance and ownership), product and
process design records, purchase orders (if applicable), or contracts and amendments shall 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.
NOTE__Production part approval documented information may include approved product, applicable test equipment records, or approved
test data.

7.5.3.2.2 Engineering specifications
The organization shall 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.

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 process 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.
Review should be completed within 10 working days of receipt of notification of engineering
standards / specifications changes.

NOTE__A change in these standards/specifications may require an updated record 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 FMEAs), etc.