【正文】 ISO 9001:2023 Update ISO 14001 Update Enhanced Surveillance Audits Highlights of IASG Sanctioned QS9000:98 Interpretations (Nov. 1, 1999) AQSR Review Registration Process Question Answer 2 ISO / TS 16949 Quality Systems 3 ISO/TS 16949 What is it? ? ISO/TS 16949 is an ISO Technical Specification prepared by the International Automotive Task Force (IATF) and representatives from ISO/TC 176, Quality Management and Quality Assurance, and its submittees. Particular requirements for the application of ISO 9001:1994 are incorporated into ISO/TS 16949. ? ISO/TS 16949 harmonizes the supplier quality system requirements of the United States, Germany, Italy, France, with the purpose of having a single document and registration scheme that the European and . automotive industry would accept. 4 ISO/TS 16949 FIAT IVECO PSA (Peugot Citoen) RENAULT FIEV AVSQ EAQF ADAM OPEL AUDI BMW DAIMLER BENZ FORD WERKE VW CHRYSLER FORD GM VDA QS9000 Technical Specification ISO/TS 16949 Quality Systems Automotive Suppliers Particular requirements for the application of ISO 9001:1994 5 ISO/TS 16949 ? This document follows the same structure as ISO 9001: 1994, with some additional requirements drawn from the following documents: – QS9000 Quality System Requirements, Third Edition – VDA 6, Part 1: Quality System Audit – AVSQ’94 Guida per l’applicazione (guidelines for use) – Evaluation Aptitude Qualit233。 Fournisseur (EAQF 94) 6 ISO/ TS 16949 ? The elements of the ISO/TS are closely aligned with the elements of the four automotive standards. ? Most of the elements of the ISO/TS can be traced to a minimum of one of the four automotive standards many elements can be traced to all four standards. 7 ISO/TS 16949 ? The goal of this Technical Specification is the development of fundamental quality systems that provide for continuous improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. 8 ISO/TS 16949 Why the new standard? – Create a Global Quality System Language – Create Global Recognition of Certificates – Reduction in multiple 3rd party registrations – Provide a petitive advantage – Advantages for upgrading QMSystem – Advantages for global sourcing 9 ISO/TS 16949 What39。 more explicit about quality policy objectives 17 ISO/TS 16949 Quality responsibility ? Management with responsibility and authority for corrective action shall be promptly informed of products or processes which bees nonpliant with specified requirements. ? Personnel responsible for quality shall have the authority to stop production to correct quality problems. * note changed into a requirement 18 ISO/TS 16949 Shift resources ? Especially concerning the production process, all the shifts shall be staffed with personnel in charge of, or delegated responsibility for quality. * new requirement 19 ISO/TS 16949 Management review supplemental ? These reviews shall include all elements of the quality system and its performance (see ) over time as an essential part of the continuous improvement process. ? Part of the management review shall be the monitoring of strategic quality objectives, and the regular reporting and evaluation of the cost of poor quality. NOTE Management review should be conducted with sufficient frequency to ensure that the established quality system is effective. * more explicit about what to review 20 ISO/TS 16949 Analysis and use of pany level data ? The supplier shall document trends in quality, operational performance (productivity, costs of poor quality, efficiency, effectiveness) and current quality levels for key product and service features. NOTE These should be pared with those of petitors and/or appropriate benchmarks. 21 ISO/TS 16949 Analysis and use of pany level data cont’d ? Trends in data and information shall be pared with progress toward overall business objectives and lead to action to support the following: a) development of priorities for prompt solutions to customerrelated problems。 22 ISO/TS 16949 Analysis and use of pany level data cont’d c) an information system for the timely reporting of product information arising from usage. * item “c” is new 23 ISO/TS 16949 ? Employee motivation, empowerment and satisfaction ? The supplier shall have a process for motivation of employees to achieve quality objectives and to make continuous improvements. The process shall include promotion of quality awareness on all levels. NOTE Quality reviews should be conducted to provide appropriate information, such as “plan/actual” parison and improvement suggestions. 24 ISO/TS 16949 Employee motivation, empowerment and satisfaction cont’d ? The supplier shall have a process for measurement of employee satisfaction and employee understanding of appropriate quality objectives. * new subelement 25 ISO/TS 16949 Product safety Due care regarding product safety and means to minimize potential risks to employees, customers, users and the environment shall be addressed in the supplier?s quality policy and practices, especially in design control (see ) and process control (see ) procedures and practices. The supplier shall promote internal awareness of safety considerations relative to the supplier?s product. * QS9000:98。 more explicit 27 ISO/TS 16949 Product realization ? In this Technical Specification, quality planning activities of all prelaunch phases have been integrated under the new heading “Product realization”. ? For suppliers with product design responsibility, product realization also includes product design (see ).