ISO10005-2005质量管理体系 质量计划指南

BRITISH STANDARD BS ISO 10005:2005 Quality management systems — Guidelines for quality plans ICS 03.120.10 ����������� � ��� � ������������������� ��������� ��� ���������� ��� Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI BS ISO 10005:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 July 2005 © BSI 29 July 2005 ISBN 0 580 46489 X National foreword This British Standard reproduces verbatim ISO 10005:2005 and implements it as the UK national standard. It supersedes BS ISO 10005:1995 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee QS/1, Quality management and quality assurance procedures, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. — aid enquirers to understand the text; — present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; — monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 23 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI INTERNATIONAL STANDARD ISO 10005 Second edition 2005-06-01 Reference number ISO 10005:2005(E) Quality management systems — Guidelines for quality plans Systèmes de management de la qualité — Lignes directrices pour les plans qualité BS ISO 10005:2005 Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI ii Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI BS ISO 10005:2005 iii Contents Page 1 Scope .................................................................................................................................................... 1 2 Normative references .......................................................................................................................... 1 3 Terms and definitions .......................................................................................................................... 1 4 Development of a quality plan ............................................................................................................ 3 4.1 Identifying the need for the quality plan ........................................................................................... 3 4.2 Inputs to the quality plan .................................................................................................................... 4 4.3 Scope of the quality plan .................................................................................................................... 4 4.4 Preparation of the quality plan ........................................................................................................... 4 5 Content of the quality plan ................................................................................................................. 5 5.1 General ................................................................................................................................................. 5 5.2 Scope .................................................................................................................................................... 6 5.3 Quality plan inputs .............................................................................................................................. 6 5.4 Quality objectives ................................................................................................................................ 6 5.5 Management responsibilities ............................................................................................................. 6 5.6 Control of documents and data ......................................................................................................... 6 5.7 Control of records ............................................................................................................................... 7 5.8 Resources ............................................................................................................................................ 7 5.9 Requirements ...................................................................................................................................... 8 5.10 Customer communication ................................................................................................................ 8 5.11 Design and development .................................................................................................................. 8 5.12 Purchasing ......................................................................................................................................... 9 5.13 Production and service provision .................................................................................................... 9 5.14 Identification and traceability ......................................................................................................... 10 5.15 Customer property .......................................................................................................................... 10 5.16 Preservation of product .................................................................................................................. 10 5.17 Control of nonconforming product ................................................................................................ 11 5.18 Monitoring and measurement ........................................................................................................ 11 5.19 Audits ............................................................................................................................................... 11 6 Review, acceptance, implementation and revision of the quality plan ......................................... 12 6.1 Review and acceptance of the quality plan .................................................................................... 12 6.2 Implementation of the quality plan .................................................................................................. 12 6.3 Revision of the quality plan .............................................................................................................. 13 6.4 Feedback and improvement ............................................................................................................. 13 Annex A (informative) Simplified examples of formats for the presentation of quality plans ............ 14 Annex B (informative) Correspondence between ISO 10005:2005 and ISO 9001:2000 ....................... 22 Bibliography ............................................................................................................................................... 23 Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI BS ISO 10005:2005 iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10005 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems. This second edition cancels and replaces the first edition (ISO 10005:1995). It constitutes a technical revision of that edition, taking into account ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000. Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI v Introduction This International Standard was prepared to address the need for guidance on quality plans, either in the context of an established quality management system or as an independent management activity. In either case, quality plans provide a means of relating specific requirements of the process, product, project or contract to work methods and practices that support product realization. The quality plan should be compatible with other associated plans that may be prepared. Among the benefits of establishing a quality plan are the increased confidence that requirements will be met, greater assurance that processes are in control and the motivation it can give to those involved. It may also give insight into opportunities for improvement. This International Standard does not replace the guidance given in ISO 9004 or in industry-specific documents. Where quality plans are required for project applications, the guidance provided in this International Standard is intended to be complementary to the guidance provided in ISO 10006. In terms of the process model shown in Figure 1, quality management system planning applies to the whole model. Quality plans, however, apply primarily to the path from customer requirements, through product realization and product, to customer satisfaction. Figure 1 — Model of a process-based quality management system BS ISO 10005:2005 Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI blank Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI 1 Quality management systems — Guidelines for quality plans 1 Scope This International Standard provides guidelines for the development, review, acceptance, application and revision of quality plans. It is applicable whether or not the organization has a management system in conformity with ISO 9001. This International Standard is applicable to quality plans for a process, product, project or contract, any product category (hardware, software, processed materials and services) and any industry. It is focused primarily on product realization and is not a guide to organizational quality management system planning. This International Standard is a guidance document and is not intended to be used for certification or registration purposes. NOTE To avoid undue repetition of “process, product, project or contract”, this International Standard uses the term “specific case” (see 3.10). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2000, Quality management systems — Fundamentals and vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply. Some of the definitions below are quoted directly from ISO 9000, but notes are in some cases omitted or supplemented. 3.1 objective evidence data supporting the existence or verity of something NOTE Objective evidence may be obtained through observation, measurement, test, or other means. [ISO 9000:2000, definition 3.8.1] 3.2 procedure specified way to carry out an activity or a process (3.3) NOTE 1 Procedures can be documented or not. NOTE 2 When a procedure is documented, the term “written procedure” or “documented procedure” is frequently used. The document that contains a procedure can be called a “procedure document”. [ISO 9000:2000, definition 3.4.5] BS ISO 10005:2005 Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI 2 3.3 process set of interrelated or interacting activities which transforms inputs into outputs NOTE Adapted from ISO 9000:2000, definition 3.4.1 (the Notes have not been included). 3.4 product result of a process (3.3) NOTE 1 There are four generic product categories, as follows: — services (e.g. transport); — software (e.g. computer program, dictionary); — hardware (e.g. engine mechanical part); — processed materials (e.g. lubricant). Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example the offered product “automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver's manual), and service (e.g. operating explanations given by the salesman). NOTE 2 Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following: — an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired); — an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); — the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); — the creation of ambience for the customer (e.g. in hotels and restaurants). Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures (3.2) Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods. [ISO 9000:2000, definition 3.4.2] 3.5 project unique process (3.3) consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources NOTE 1 An individual project can form part of a larger project structure. NOTE 2 In some projects, the objectives are refined and the product characteristics defined progressively as the project proceeds. NOTE 3 The outcome of a project may be one or several units of product (3.4). [ISO 9000:2000, definition 3.4.3] 3.6 quality management system management system to direct and control an organization with regard to quality [ISO 9000:2000, definition 3.2.3] BS ISO 10005:2005 Li ce ns ed C op y: In st itu te O f T ec hn ol og y Ta lla gh t, In st itu te o f T ec hn ol og y, T ue N ov 0 7 12 :2 6: 20 G M T+ 00 :0 0 20 06 , U nc on tro lle d Co py , (c ) B SI 3 3.7 quality objective something sought, or aimed for, related to quality NOTE 1 Quality objectives are generally based on the organization's quality policy. NOTE 2 Quality objectives are generally specified for relevant functions and levels in the organization. [ISO 9000:2000, definition 3.2.5] 3.8 quality plan document specifying which processes (3.3), procedures (3.2) and associated resources will be applied by whom and when, to meet the requirements of a specific project (3.5), product (3.4), process or contract NOTE 1 These procedures generally include those referring to quality management processes and to product realization processes. NOTE 2 A quality plan often makes reference to parts of the quality manual or to procedure documents. NOTE 3 A quality plan is generally one of the results of quality planning. 3.9 record document stating results achieved or providing evidence of activities performed NOTE Adapted from ISO 9000:2000, definition 3.7.6 (the Notes have not been included). 3.10 specific case subject of the quality plan (3.8) NOTE This term is used to avoid repetition of “process, product, project or contract” within this International Standard. 4 Development of a quality plan 4.1 Identifying the need for the quality plan The organization should identify what need there may be for quality plans. There are a number of situations where quality plans may be useful or necessary, for example: a) to show how the organization's quality management system applies to a specific case; b) to meet statutory, regulatory or customer requirements; c) in developing and validating new products or processes; d) to demonstrate, internally and/or externally, how quality requirements will be met; e) to organize and manage activities to meet quality requirements and quality objectives; f) to optimize the use of resources in meeting quality objectives; g) to minimize the risk of not meeting quality requirements; h) to use as a basis for monitoring and assessing compliance with the requirements for quality; i) in the absence of a documented quality management system. NOTE There may or may not be a need to prepare a quality plan for a specific case. An organization with an established quality management system may be able to fulfil all of its needs for quality