4 Context of the organization

4.1 Understanding the organization and its context
See ISO 9001:2015 requirements

4.2 Understanding the needs and expectations of interested parties
See ISO 9001:2015 requirements

4.3 Determining the scope of the Quality Management System
See ISO 9001:2015 requirements

4.3.1 Determining the scope of the Quality Management System – Supplemental
Supporting functions, whether on-site or remote (such as design centres, corporate headquarters, and
distribution centres), shall be included in the scope of the Quality Management System (QMS).

The only permitted exclusion for this Automotive QMS Standard relates to the product design and
development requirements within ISO 9001, Section 8.3. The exclusion shall 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
Customer-specific requirements shall be evaluated and included in the scope of the organization’s
quality management system.

4.4 Quality management system and its processes

4.4.1
See ISO 9001:2015 requirements

4.4.1.1 Conformance of products and processes
The organization shall 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

The organization shall have documented processes for the management of product-safety related
products and manufacturing processes, which shall include but not be limited to the following, where
applicable:

a) identification by the organization of statutory and regulatory product-safety requirements;
b) customer notification of requirements in item a);
c) special approvals for design FMEA;
d) identification of product safety-related characteristics;
e) identification and controls of safety-related characteristics of product and at the point of
manufacture;
f) special approval of control plans and process FMEAs;
g) reaction plans (see Section 9.1.1.1);
h) defined responsibilities, definition of escalation process and flow of information, including top
management, and customer notification;
i) training identified by the organization or customer for personnel involved in product-safety
related products and associated manufacturing processes;
j) 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);
k) transfer of requirements with regard to product safety throughout the supply chain, including
customer-designated sources (see Section 8.4.3.1);
l) product traceability by manufactured lot (at a minimum) throughout the supply chain (see
Section 8.5.2.1);
m) lessons learned for new product introduction.
NOTE__Special approval is an additional approval by the function (typically the customer) that is responsible to approve such documents
with safety-related content.

4.4.2
See ISO 9001:2015 requirements