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1、,1,AGENDA ISO / TS 16949 Update ISO 9001:2000 Update ISO 14001 Update Enhanced Surveillance Audits Highlights of IASG Sanctioned QS-9000:98 Interpretations (Nov. 1, 1999) AQSR Review Registration Process Question more explicit about quality policy objectives,17,ISO/TS 16949,4.1.2.1.3 Quality respons
2、ibility Management with responsibility and authority for corrective action shall be promptly informed of products or processes which becomes non-compliant with specified requirements. Personnel responsible for quality shall have the authority to stop production to correct quality problems. * note ch
3、anged into a requirement,18,ISO/TS 16949,4.1.2.2.2 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 16949,4.1.3.2 Management review - supplemental These revi
4、ews shall include all elements of the quality system and its performance (see 4.2.8) 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 po
5、or 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 16949,4.1.5 Analysis and use of company level data The supplier shall document trends in quality, operational pe
6、rformance (productivity, costs of poor quality, efficiency, effectiveness) and current quality levels for key product and service features. NOTE These should be compared with those of competitors and/or appropriate benchmarks.,21,ISO/TS 16949,4.1.5 Analysis and use of company level data contd Trends
7、 in data and information shall be compared with progress toward overall business objectives and lead to action to support the following: a) development of priorities for prompt solutions to customer-related problems; b) determination of key customer related trends and correlation to support status r
8、eview, decision making and longer term planning;,22,ISO/TS 16949,4.1.5 Analysis and use of company level data contd c) an information system for the timely reporting of product information arising from usage. * item “c” is new,23,ISO/TS 16949,4.1.6 Employee motivation, empowerment and satisfaction T
9、he 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” c
10、omparison and improvement suggestions.,24,ISO/TS 16949,4.1.6 Employee motivation, empowerment and satisfaction contd The supplier shall have a process for measurement of employee satisfaction and employee understanding of appropriate quality objectives. * new sub-element,25,ISO/TS 16949,4.1.7.1 Prod
11、uct safety - Due care regarding product safety and means to minimize potential risks to employees, customers, users and the environment shall be addressed in the suppliers quality policy and practices, especially in design control (see 4.4) and process control (see 4.9) procedures and practices. The
12、 supplier shall promote internal awareness of safety considerations relative to the suppliers product. * QS-9000:98; 4.2.3.4 more explicit,26,ISO/TS 16949,4.1.7.2 Regulations - The supplier shall have a process to ensure compliance with all applicable government, safety and environmental regulations
13、, including those concerning storage, handling, recycling, eliminating or disposing of materials. * QS-9000:98; 4.6.1.2 more explicit,27,ISO/TS 16949,Product realization In this Technical Specification, quality planning activities of all pre-launch phases have been integrated under the new heading “
14、Product realization”. For suppliers with product design responsibility, product realization also includes product design (see 4.4). Product realization in the context of quality planning is discussed in 4.2.4. The structure is outlined on the next slide:,28,ISO/TS 16949,Product Realization contd 4.2
15、.3Quality planning 4.2.3.1 Quality planning - ISO 9001 : 1994 4.2.3.2 Quality plan requirements 4.2.4Product realization 4.2.4.1 General 4.2.4.2 Measurements 4.2.4.3Review cycle 4.2.4.4Multidisciplinary approach 4.2.4.5Tools and techniques 4.2.4.6 Computer-aided design,29,ISO/TS 16949,Product realiz
16、ation contd 4.2.4.7Special characteristics 4.2.4.8 Feasibility review 4.2.4Product realization continued 4.2.4.9 Management of process design 4.2.4.9.1 General 4.2.4.9.2 Process design input 4.2.4.9.3 Process design output 4.2.4.9.4 Process verification 4.2.4.10 Control plan 4.2.4.11 Product approval process *Renumbered and some new requirements,30,ISO/TS 16949,4.2.8 Quality system performance The supplier shall evaluate the performance of the quality system to veri
