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1、ISO 9004:2000(E)Quality management systems Guidelines for performance improvements 1 ScopeThis International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness ad efficiency of a quality management system, and consequently the potential
2、 for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties ad the performance of the organization.This International Standard is applicable to the proces
3、ses of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties
4、.This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.2 Normative referenceThe following normative document contains provisions which, through reference in this text
5、, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most rece
6、nt edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.ISO 9000:2000, Quality management systems Fundamentals and vocabulary.3
7、 Terms and definitionsFor the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.The following terms, used in this edition of ISO 9004 to describe the supply-chain, have been changed to reflect the vocabulary currently used:supplier organization customer (inte
8、rested parties )Throughout the text of this International Standard, wherever the term “product” occurs, it ca also mean “service”.4 Quality management system4.1 Managing systems and processesLeading and operating an organization successfully requires managing it in a systematic and visible manner. S
9、uccess should result from implementing and maintaining a management system that is deigned to continually improve the effectiveness and efficiency of the organizations performance by considering the needs of interested parties. Managing an organization includes quality management, among other manage
10、ment disciplines.Top management should establish a customer-oriented organizationa) by defining systems and processes that can be clearly understood, managed and improved in effectiveness a well as efficiency, and b) by ensuring effective and efficient operation and control of processes and the meas
11、ures and data used determine satisfactory performance of the organization.Examples of activities to establish a customer-oriented organization include- defining and promoting processes that lead to improved organizational performance,- acquiring and using process data and information on a continuing
12、 basis,- directing progress towards continual improvement, and- using suitable methods to evaluate process improvement, such as self-assessments and management review.Examples of self-assessment and continual improvement processes are given in annexes A and B respectively.ISO 9001:2000, Quality mana
13、gement systems Requirements4 Quality management system4.1 General requirementsThe organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.The organization s
14、halla)identify the processes needed for the quality management system and their application throughout the organization,b) determine the sequence and interaction of these processes,c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective
15、,d) ensure the availability of resources and information necessary to support the operation and monitoring o these processes,e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes.These processes sha
16、ll be managed by the organization in accordance with the requirements of this International Standard.Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
