1、 - CEN EN*IS0*9000- II 94 3404569 O066260 O46 BRITISH STANDARD Quality management and quality assurance standards BS EN IS0 Part 1. Guidelines for selection and use Formerly BS 5750 : Section 0.1 The European St,andard EN IS0 9000-1 : 1994 has the status of a British Standard 90oO-1 : 1994 CEN EN*IS
2、O*SOOO- II 94 3404587 0066283 T82 BS EN IS0 9OOO-1: 1994 This British Standard, having been prepared under the direction of the Quality, Managenient and Statistics Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 1 July 1994 G BSI 1994 The
3、 following BSI references relate to the work on this standard: Committee reference and - are planned for complete integration into the architecture and content of future revisions of the IS0 9000 family. In revision of the IS0 9000 family, there are no major changes in the architectures of IS0 9001,
4、 IS0 9002, IS0 9003 and IS0 9004. (However, IS0 9003 does contain additional clauses compared to the 1987 version.) Each of these International Standards has had small-scale changes. These changes move toward future revisions to meet better the needs of users. This Part of IS0 9000 and all other Int
5、ernational Standards in the IS0 9000 family are independent of any specific industry or economic sector. Collectively they provide guidance for quality management and general requirements for quality assurance. Page 3 EN IS0 9ooO-1: 1994 The International Standards in the IS0 9000 family describe wh
6、at elements quality systems should encompass but not how a specific organization implements these elements. It is not the purpose of these International Standards to enforce uniformity of quality systems. Needs of organizations vary. The design and implementation of a quality system must necessarily
7、 be influenced by the particular objectives, products and processes, and specific practices of the organization. This Part of IS0 9000 clarifies the principal quality-related concepts contained within the quality management and quality assurance International Standards generated by ISOlTC 176 and pr
8、ovides guidance on their selection and use. 1 Scope This Part of IS0 9000: a) clarifies principal quality-related concepts and the distinctions and interrelationships among them; b) provides guidance for the selection and use of the IS0 9000 family of International Standards on quality management an
9、d quality assurance. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this Part of IS0 9000. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements b
10、ased on this Part of IS0 9000 are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 8402 : 1994 Quality management and quality assurance - Vocabulary
11、. 3 Definitions This revision of IS0 9000, IS0 9001, IS0 9002, IS0 9003 and IS0 9004 has improved the harmonization of terminology for organizations in the supply chain. %ble 1 shows the supply-chain terminology used in these International Standards. The usage of all of these terms conforms with the
12、ir formal definitions in IS0 8402. The remaining differences in terminology in table 1 reflect, in part, a desire to maintain historical continuity with usage in the 1987 edition of these International St andards . NOTE 1. In all these International Standards, the grammatical format of the guidance
13、or requirements text is addressed to the organization in its role as a supplier of products (the third column of table 1). CEN EN*IS0*7000- L 74 3404587 O066288 337 IS0 9000-1 Page 4 EN IS0 9OOO-1 : 1994 Subsupplier 4 supplier or 4 customer organization IS0 9001, IS0 9002, IS0 9003 IS0 9004-1 Subcon
14、tractor - supplier 4 customer Subcontractor 4 organization 4 customer NTE 2. In the IS0 9000 row of table 1, the use of subsupplier emphasizes the supply-chain relationship of the three organizational units, using the self-defining term in relation to supplier. Where appropriate, especially in discu
15、ssing quality management situations, the term organization is used rather than supplier. NOTE 3. In the IS0 9001, IS0 9002 and IS0 9003 rows of table 1, the use of subcontractor reflects the fact that, in an external quality assurance context, the relevant relationship often is (explicitly or implic
16、itly) contractual. NOTE 4. In the IS0 9004 row of table 1, the use of Organization reflects the fact that quality management guidance is applicable to any organizational unit, irrespective of the categories of products it may supply, or whether it is a free-standing unit or part of a larger organiza
17、tion. For the purposes of this Part of IS0 9000, the definitions given in IS0 8402, together with the following definitions, apply. NOTE 5. For the convenience of users of this Part of IS0 9000, some relevant definitions from IS0 8402 are contained in annex A. 3.1 hardware lhngible, discrete product
18、 with distinctive form. NOTE 6. Hardware normally consists of manufactured, constructed or fabricated pieces, parts andior assemblies. 3.2 software An intellectual creation consisting of information expressed through supporting medium. NOTE 7. Software can be in the form of concepts, transactions or
19、 procedures. NOTE 8. A computer program is a specific example of software. 3.3 processed material lhngible product generated by transforming raw material into a desired state. NOTE 9. The state of processed material can be liquid, gas, particulate material, ingot, filament or sheet. NOTE 10. Process
20、ed material is typically delivered in drums, bags, tanks, cylinders, cans, pipelines or rolls. 3.4 industry/economic sector A grouping of suppliers whose offerings meet similar customer needs and/or whose customers are closely interrelated in the market place. NOTE 11. Dual use of industry sector an
21、d economic sector recognizes that each term is used for the intended meaning in specific countries or languages. NOTE 12. Industry/economic sectors include administration, aerospace, banking, chemicals, construction, education, food, health care, leisure, insurance, mining, retailing, telecommunicat
22、ions, textiles, tourism, and so forth. NCYTE 13. Industry/economic sectors apply to the global economy or a national economy. 3.5 stakeholder An individual or group of individuals with a common interest in the performance of the supplier organization and the environment in which it operates. 3.6 IS0
23、 9 family All those International Standards produced by the technical committee ISOlTC 176. NOTE 14. At present, the family comprises: a) all the International Standards numbered IS0 9000 through to IS0 9004, including all Parts of IS0 9000 and IS0 9004; b) all the International Standards numbered I
24、S0 10001 through to 10020, including ail Parts; and c) IS0 8402. 4 Principal concepts 4.1 Key objectives and responsibilities for quality An organization should: a) achieve, maintain and seek to improvc continuously the quality of its products in relationship to the requirements for quality; b) impr
25、ove the quality of its own operations, so as to meet continually all customers and other stakeholders stated and implied needs; e) provide confidence to its internal management and other employees that the requirements for quality are being fulfilled and maintained, and that quality improvement is t
26、aking place; d) provide confidence to the customers and other stakeholders that the requirements for quality are being, or will be, achieved in the delivered product; e) provide confidence that quality system requirements are fulfilled. CEN EN*ISO*SOOO- II 94 3404589 O066289 273 Page 5 EN IS0 9ooo-1
27、: 1994 4.2 Stakeholders and their expectations Every organization as a supplier has five principal groups of stakeholders: its customers, its employees, its owners, its subsuppliers and society. The supplier should address the expectations and needs of all its stakeholders. Suppliers stakeholders Cu
28、stomers Employees Owners Subsuppliers Society Qpical expectations or needs Product quality Career/work satisfaction Investment performance Continuing business opportunity Responsible stewardship The International Standards in the IS0 9000 family focus their guidance and requirements on satisfying th
29、e customer. The requirements of society, as one of the five stakeholders, are becoming more stringent worldwide. In addition, expectations and needs are becoming more explicit for considerations such as: workplace health and safety; protection of the environment (including conservation of energy and
30、 natural resources); and security. Recognizing that the IS0 9000 family of International Standards provides a widely used approach for management systems that can meet requirements for quality, these management principles can be useful for other concerns of society. Compatibility of the management s
31、ystem approach in these several areas can enhance the effectiveness of an organization. In the same manner that product and process technical specifications are separate from management systems requirements, the technical specifications in these other areas should be separately developed. 4.3 Distin
32、guishing between quality system requirements and product requirements The IS0 9000 family of International Standards makes a distinction between quality system requirements and product requirements. By means of this distinction, the IS0 9000 family applies to organizations providing products of all
33、generic product categories, and to all product quality characteristics. The quality system requirements are complementary to the technical requirements of the product. The applicable technical specifications of the product (e.g. as set out in product standards) and technical specifications of the pr
34、ocess are separate and distinct from the applicable IS0 9000 family requirements or guidance, International Standards in the IS0 9000 family, both guidance and requirements, are written in terms of the quality system objectives to be satisfied. These International Standards do not presci-ibe how to
35、achieve the objectives but leave that choice to the management of the organization. 4.4 Generic product categories It is useful to identify four generic product categories (see clause 3 and annex A), as follows: a) hardware; b) software; e) processed materials; d) services. These four generic produc
36、t categories encompass all the kinds of product supplied by organizations. International Standards in the IS0 9000 family are applicable to all four generic product categories. The quality system requirements are essentially the same for all generic product categories, but the terminology and manage
37、ment system details and emphases may differ. Two or more of the generic product categories usually are present in the marketplace offerings of any organization, whatever the industry/economic sector (see clause 3) in which the organization operates. For example, most organizations that supply hardwa
38、re, software or processed materials have a service component to their offering. Customers (and other stakeholders) will look for value in each generic product category that is present in the offering. Analytical instruments are examples where hardware (i.e. the instrument), software (for computing t
39、asks within the instrument), processed materials (such as titrating solutions or reference standard materials) and services (such as training or maintenance servicing) might all be important features of the offering. A service organization such as a restaurant will have hardware, software and proces
40、sed materials as well as service components. 4.5 Facets of quality Four facets that are key contributions to product quality may be identified as follows. a) Quality due to definition of needs for the product The first facet is quality due to defining and updating the product, to meet marketplace re
41、quirements and opportunities. b) Quality due to product design The second facet is quality due to designing into the product the characteristics that enable it to meet marketplace requirements and opportunities, and to provide value to customers and other stakeholders. More precisely, quality due to
42、 product design is the product design features that influence the intended performance within a given grade, plus product design features that influence the robustness of product performance under variable conditions of production and use. CEN EN*IS0*9000- I 94 3404589 0066270 T95 Page 6 EN IS0 9O00
43、-1 : 1994 e) Quality due to conformance to product design The third facet is quality due to maintaining day-to-day consistency in conforming to product design and in providing the designed characteristics and values for customers and other stakeholders. d) Quality due to product support The fourth f
44、acet is quality due to furnishing support throughout the product life cycle, as needed, to provide the designed characteristics and values for customers and other stakeholders. For some products, the important quality characteristics include dependability characteristics. Dependability (i. e. reliab
45、ility, maintainability and availability) may be influenced by all four facets of product quality. A goal of the guidance and requirements of the International Standards in the IS0 9000 family is to meet the needs for all four facets of product quality. Some facets of quality may be specifically impo
46、rtant, for example, in contractual situations, but, in general, all facets contribute to the quality of the product. The IS0 9000 family explicitly provides generic quality management guidance and external quality assurance requirements on facets a), b), c) and d). When considering the complete prod
47、uct offering, the customer will bear in mind additional factors. These include the following. - The suppliers market status and strategy: if the supplier has an established and reputable market-place status and/or a strategy that is achieving a satisfactory market share, the customer is likely to pl
48、ace higher value on the suppliers offering. - The suppliers financial status and strategy: if the supplier has an established and reputable financial status and/or a strategy that is improving financial performance, the customer is likely to place higher value on the suppliers offering . - The suppl
49、iers human resources status and strategy: if the supplier has an established and reputable human resources status and/or a strategy that is developing improved skills, diversity and commitment in its human resources, the customer is likely to place higher value on the suppliers offering. These additional factors are of vital importance in managing a supplier organization as a total enterprise. NOTE 15. Product value involves both quality and price and, as such, price is not a facet of quality. 4.6 Concept of a process The International Standards in the IS0
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