Below we summarise sections 4-10 of IATF 16949:2016 (sections 1-3 are introductory and are not auditable). The standard continues to be based upon the PDCA cycle and follows ISO 9001 in using ISO’s Annex SL High Level Structure.
Section 4: Context of the organisation – This covers internal and external interested parties for the Quality Management System (QMS) and the issues the organisation needs to take into account when designing the QMS, including in determining the scope and processes required.
Section 5: Leadership – This clause of the standard requires the organisation’s leaders to be accountable for the performance of the QMS and to demonstrate leadership and commitment, including for defining corporate responsibility and the quality policy. Leaders are required to be involved in the system and communication of system requirements.
Section 6: Planning – The automotive industry has a long history of risk-based-thinking and for robust planning to prevent quality problems in production. This clause requires the organisation to address risks and opportunities and to introduce preventive actions (the requirement has recently been taken out of ISO 9001:2015), produce contingency plans, develop quality objectives and plans to achieve them.
Section 7: Support – Here IATF 16949 introduces requirements to manage the organisation’s resources and supporting processes needed for an effective QMS. It defines additional requirements for plant and facilities, people and their competence, work environment (including an option for ISO 45001 certification), monitoring and measuring resources (including Measurement Systems Analysis (MSA) and laboratory accreditation), awareness, motivation and empowerment, and documented information – including for engineering specifications.
Section 8: Operation – IATF 16949 covers all aspects of Operations and includes additional requirements for managing customer communications, design and development (including reference to APQP and / or VDA-RGA) and significant additional requirements for the design process and for individuals involved. As for APQP, IATF 16949 extends design and development into the areas of manufacturing process design. There are significant additional controls for suppliers and clause 8.5 on production and service provision includes sections on control plans and standardised work and total preventive maintenance (at the heart of lean manufacturing). Clause 8.7 covers stringent requirements for control of rework and repair and the need to keep customers involved in any rework and repair decisions.
Section 9: Performance evaluation – In this section IATF 16949 requires organisations to undertake process studies on all manufacturing processes and to use statistical tools including SPC. In this clause the need for Process Failure Modes and Effects Analysis (PFMEA) is reinforced. IATF 16949 introduces further specific requirements for customer satisfaction, internal audits, and management review.
Section 10: Improvement – The last section of IATF 16949 outlines additional requirements for continual improvement including requirements for problem solving, error proofing, warranty management and investigation of field failures.