IATF 16949:2016 defines the quality management system requirements for the design and development, production and, when relevant, the assembly, installation and services of automotive-related products including products with embedded software. The focus of this automotive standard is the development of a QMS that provides for continual improvement, emphasizing defect prevention and the reduction of waste in the supply chain. Combined with applicable Customer Specific Requirements, IATF 16949 is also fully aligned with the structure and requirements of ISO 9001:2015.
The standard is divided into ten sections – the first three are introductory, with the remaining seven containing the requirements for the Quality Management System. Below is a brief summary of Sections 4-10:
Section 4: Context of the Organization
The organization determines its context in terms of the QMS, including interested parties and their needs and expectations. It also defines the requirements for determining the scope of the QMS, as well as general QMS requirements.
Section 5: Leadership
Top management is required to demonstrate leadership and commitment to the QMS, along with defining corporate responsibility and the quality policy. The top management must also assign process owners along with other roles and responsibilities.
Section 6: Planning
The planning section defines requirements for addressing risks and opportunities and the requirements for risk analysis. This clause also includes requirements for preventive actions, contingency plans, and quality objectives and plans to achieve them.
Section 7: Support
This section covers requirements for supporting processes and resources. It defines requirements for people, infrastructure, work environment, monitoring and measuring resources, organizational knowledge, auditor competence, awareness, communication, and documented information.
Section 8: Operation
The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. IATF 16949 allows for requirements in clause 8.3, regarding design and development of products, to be excluded if they are not applicable to the company.
Section 9: Performance Evaluation
This section includes requirements for monitoring the effectiveness of the QMS – assessing customer satisfaction, internal audits, monitoring and measurement of manufacturing processes, and management review.
Section 10: Improvement
The last section focuses on continual improvement of the QMS, including requirements for nonconformities and corrective actions, problem solving, and error-proofing processes.
These sections are based on a Plan-Do-Check-Act cycle, which uses these elements to implement change within the processes of the organization in order to drive and maintain improvements within the processes.
IATF 16949 is a standard that benefits businesses large and small. The experts at simpleQuE can help your business achieve this standard, ensuring your business cost savings and efficiencies.