ISO/TS 16949 in conjunction with ISO 9001, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.
ISO/TS 16949 is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.
Supporting functions, whether on-site or remote (such as design centers, corporate headquarters and distribution centers), form part of the site audit as they support the site, but cannot obtain stand-alone certification to ISO/TS 16949.
ISO/TS 16949 can be applied throughout the automotive supply chain and its requirements are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.
Since the publication of Annex SL - the standard that defines the high-level structure for all ISO management systems standards - all ISO management systems must be developed following this structure:
So, if your company have already a management system implemented don’t forget that clauses 4, 5, 7, 9, and 10, have a similar text, so it can be unified without compromising the individual standards. It is the beginning of integration!
ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system.
The ISO 9000 family of standards lays out the fundamentals and provides terminology, requirements and guidance for implementing, maintaining and improving an effective quality management system, that can be applied to all type of organizations with any size.
ISO 9000 is a quality management standard that presents guidelines intended to increase business efficiency and customer satisfaction. Based on ISO 9001, the goal of ISO 13485 is to embed a quality management system within an organization, increasing productivity, reducing unnecessary costs, and ensuring quality of processes and products.
Seven Quality Management Principles behind ISO9001 requirements: