IATF 16949:2016 QMS REQUIREMENTS (Clause 4.1 to 4.3)

4. Context of the organization

IATF 16949 Picture

4.1 Understanding the organization and its context

• The organization shall 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.
• The organization shall monitor and review information about these external and internal issues.

4.2 Understanding the needs and expectations of interested parties

• Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

a) the interested parties that are relevant to the quality management system;

b) the requirements of these interested parties that are relevant to the quality management system.

• The organization shall monitor and review information about these interested parties and their relevant requirements.

4.3 Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider:

a. the external and internal issues referred to in 4.1;

b. the requirements of relevant interested parties referred to in 4.2;

c. the products and services of the organization.

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system. The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this International Standard 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. 

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 (Klic to Next)