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1、ISO9000Quality Management System,2005-2,2 The idea and development of ISO9000 2.1Development of quality management,2.2 Total quality management via ISO9000,全面质量管理（TQM）一个组织以质量为中心，以全员参与为基础，目的在以通过让顾客满意和本组织所有成员及社会受益而达到长期成功的管理途径。 全面质量管理源于美国，费根堡姆博士于1961年出版的全面质量管理一书中首次提出TQM。 60年代以后，日本大力推行TQM并取得显著成效，引起世界瞩目，
2、在发达国家很快得到发展，形成全面质量管理学科。 87年颁布ISO9000族系列标准，使TQM更加完善，形成一门崭新的学科，具有自己的理论、方法和体系。 TQM是ISO9000产生的基础，ISO9000是TQM深化的基础，将TQM推向科学化、规范化和标准化。互为基础、不断促进、互为深化。,2.3 Development of ISO9000,工业生产的规模化、现代化、标准化，贸易全球化，社会进步、质量要求的不断提高、市场竞争加激等诸因素促进了质量认证的发展。 80年ISO/IEC176技术委员会开始工作， 87年首次颁布ISO9000族系列标准。 1994年“有限修改”，发布实施94版ISO90
3、00族标准。 2000年在总体结构和技术内容上作较大的全新修改，2000年12月28日发布2000版ISO9000族标准，2001年6月1日实施）,2.4 Four Core Standards,ISO 9000:2000, Quality management systems Fundamentals and vocabulary ISO 9001:2000, Quality management systems Requirements ISO 9004:2000, Quality management systems Guidelines for performance improvem
4、ents ISO 19011, Guidelines on Quality and/or Environmental Management Systems Auditing (currently under development),2.5 Quality management principles,Principle 1 Customer focus Principle 2 Leadership Principle 3 Involvement of people Principle 4 Process approach Principle 5 System approach to manag
5、ement Principle 6 Continual improvement Principle 7 Factual approach to decision making Principle 8 Mutually beneficial supplier relationships,Principle 1 Customer focus,Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer re
6、quirements and strive to exceed customer expectations.,Principle 2 Leadership,Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.,Principle
7、3 Involvement of people,People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit. Principle 4 Process approach A desired result is achieved more efficiently when activities and related resources are managed as
8、 a process.,Principle 5 System approach to management,Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives. Principle 6 Continual improvement Continual improvement of the organizations ove
9、rall performance should be a permanent objective of the organization.,Principle 7 Factual approach to decision making,Effective decisions are based on the analysis of data and information. Principle 8 Mutually beneficial supplier relationships An organization and its suppliers are interdependent and
10、 a mutually beneficial relationship enhances the ability of both to create value,2.6 Requirement and Methods,Process approach P-D-C-A 5W1H: What Why Who When Where How ISO9001:2000 Standard ISO9001:2000 illustration,2.7 Guidance on the Process Approach to Quality Management Systems,Process Approach:
11、 a desired result is achieved more efficiently when activities and related resources are managed as a process. ISO 9000:2000 clause 3.4.1 defines a “Process“ as: “Set of interrelated or interacting activities which transforms inputs into outputs NOTE 1 Inputs to a process are generally outputs of ot
12、her processes. NOTE 2 Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to add value.“,Schematic representation of a Process,The “Plan-Do-Check-Act“ cycle,The “Plan-Do-Check-Act“ cycle,The “Plan-Do-Check-Act“ cycle was first developed in the 1920s
13、 by Walter Shewhart, and was popularised later by W. Edwards Deming. For that reason it is often referred to as “The Deming Cycle“. Extensive literature exists about the PDCA cycle in numerous languages, and users of the ISO 9000:2000 family of standards are encouraged to consult this for a deeper u
14、nderstanding of the concept. The PDCA concept is something that is present in all areas of our professional and personal lives, and is used continually, either formally of informally, consciously or sub-consciously in everything we do. Every activity, no matter how simple or how complex, falls into
15、this never-ending pattern:,Typical network of interacting processes,Fig1. Model of a process-based quality management system (Taken from ISO 9000:2000),Implementation of the Process Approach in relation to ISO 9001:2000 Requirements,Clause 0.2 in the introduction of ISO 9001:2000 states, referring t
16、o the process approach: “When used within a quality management system process, such an approach emphasizes the importance of: a) the understanding and meeting of requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement.“,2.8 Document,Definitions :information and its supporting medium Clause 4
