IATF 16949:2016 QMS REQUIREMENTS (Clause 4.4. to 4.4.2 )

4.4 Quality management system and its processes

4.4.1 The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

• determine the inputs required and the outputs expected from these processes;
• determine the sequence and interaction of these processes;
• 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;
• determine the resources needed for these processes and ensure their availability;
• assign the responsibilities and authorities for these processes;
• address the risks and opportunities as determined in accordance with the requirements of 6.1;
• evaluate these processes and implement any changes needed to ensure that these processes achieve
• improve the processes and the quality management system.

Automotive Picture

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);

4.4.2 To the extent necessary, the organization shall:

• maintain documented information to support the operation of its processes;
• retain documented information to have confidence that the processes are being carried out as planned.

5.1 Leadership and commitment (clik to Next)