ISO9001_94英文版

1、 管理標(biāo)準(zhǔn)ISO9001：1994ENGLISH VERSION15 / 15ISO9001：1994 StandardQuality systeemsModel for quality assurance in design,development,production,installation and servicing1 Scope This International Standard specifies quality system requirements for use where a suppliers capability to design and supply confo

2、rming product needs to be demonstrated.The requirements specified are aimed primarily at achieving customer satisfaction by prevent nonconformity at all stages from design through to servicing.This International Standard is applicable in situations when design is required and the product requirement

3、s are stated principally in performance terms, or they need to be established, and confidence in product conformance can be attained by adequate demonstration of a suppliers capabilities in design, development, production, installation and servicing.NOTE 1 For informative references, see annex A.Nor

4、mative referenceThe following standard contains provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this Internat

5、ional Standard are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.ISO 8402:1994, Quality management and quality assuranceVocabulary.DefinitionsFor the

6、purposes of this International Standard, the definitions given in ISO 8402 and the following definitions duct: Result of activities or processes.NOTESA product may include service, hardware, processed materials, software or a combination thereof.A product can be tangible (e.g. assemblies or

7、 processed materials) or intangible (e.g. knowledge or concepts), or a combination thereof.For the purposes of this International Standard, the term “product” applies to the intended product offering only and not to unintended “by-products” affecting the environment. This differs from the definition

8、 given in ISO 8402.tender: Offer made by a supplier in response to an invitation to satisfy a contract award to provide product.3.3 contract: Agreed requirements between a supplier and customer transmitted by anymeans.4 Quality system requirements4.1Management responsibility4.1.1Quality policyThe su

9、ppliers management with executive responsibility shall define and document its policy for quality including objectives for and commitment to quality. The quality policy shall be relevant to the suppliers organizational goals and the expectations and needs of its customers.The supplier shall ensure t

10、hat the policy is understood, implemented and maintained at all levels of the organization.4.1.2OrganizationResponsibility and authorityThe responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented, parti

11、cularly for personnel who need the organizational freedom and authority to:a) initiate action to prevent the occurrence of any nonconformities relating to the product, process and quality system;b) identify and record any problems relating to the product, process and quality system;c) initiate, reco

12、mmend or provide solutions through designated channels;d) verify the implementation of solutions;e) control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.ResourcesThe supplier shall identify resource r

13、equirements and provided adequate resources, including the assignment of trained personnel for management, performance of work and verification activities including internal quality audits.Management representativeThe suppliers management with executive responsibility shall appoint a member o

14、f the suppliers own management who irrespective of other responsibilities, shall have defined authority for:a) ensuring the quality system is established, implemented and maintained in accordance with the appropriate standard, andb) reporting on the performance of the quality system to the suppliers

15、 management for review and as a basis for improvement of the quality system.NOTE 5 The responsibility of a management representative may also include liaison with external parties on matters relating to the suppliers quality system.4.1.3Management reviewThe suppliers management with executive respon

16、sibility reviews the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of the appropriate standard and the suppliers stated quality policy and objectives.Records of such reviews shall be maintained.4.2Quality system4.

17、2.1GeneralThe supplier shall establish, document and maintain a quality system as a means of ensuring that product conforms to specified requirements.The supplier shall prepare a quality manual covering the requirements of the appropriate standard.The quality manual includes or makes reference to th

18、e quality system procedures and outlines the structure of the documentation used.4.2.2 Quality system proceduresThe supplier shall:a) prepare documented procedures consistent with the requirements of the appropriate standard and the suppliers stated quality policy, andb) effectively implemente the q

19、uality system and its documented procedures.4.2.3Quality planningThe supplier shall define and document how the requirements for quality will be met. Quality planning is consistent with all other requirements of the suppliers quality system and is documented in a format to suit the suppliers method

20、of operation.The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts:a) the preparation of quality plans;b) the identification and acquisition of any controls, processes, equipment (including inspect

21、ion and test equipment), fixtures, resources and skills that may be needed to achieve the required quality;c) ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures and the applicable documentation;d) the updating, as necessary, of q

22、uality control, inspection and testing techniques, including the development of new instrumentation;e) the identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;f) the identification of

23、 suitable verification at appropriate stages in the realization of product;g) the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;h) the identification and preparation of quality records.4.3Contract review4.3.1GeneralT

24、he supplier shall establish and maintain documented procedures for contract review and for the coordination of these activities.4.3.2 ReviewBefore submission of a tender, or the acceptance of a contract or order (statement of requirement), the tender, contract or order is reviewed by the supplier to

25、 ensure that:a) the requirements are adequately defined and documented; where no written statement of requirement is available for an order received by verbal means, the supplier shall ensure that the order requirements are agreed before their acceptance;b) any differences between the contract or or

26、der requirements and those in the tender are resolved;c) the supplier has the capability to meet the contract or order requirements.4.2.3Amendment to a contractThe supplier shall identify how an amendment to a contract is made and correctly transferred to the functions concerned within the organizat

27、ion.4.3.3RecordsRecords of contract reviews are maintained.4.4 Design control4.4.1GeneralThe supplier shall establish and maintain documented procedures to control and verify the design of the product in order to ensure that the specified requirements are met.4.4.2Design and development planningThe

28、supplier shall prepare plans for each design and development activity.The plans describe or reference design activities, and define responsibility for their implementation.The design and development activities are assigned to qualified personnel equipped with adequate resources.The plans are be upda

29、ted as the design evolves.4.4.3Organizational and technical interfacesOrganizational and technical interfaces between different groups which input into the design process are defined and the necessary information documented, transmitted and regularly reviewed.4.4.4Design inputDesign input requiremen

30、ts relating to the product, including applicable statutory and regulatory requirements, are identified, documented and their selection reviewed by the supplier for adequacy.Incomplete, ambiguous or conflicting requirements are resolved with those responsible for imposing the requirements.Design inpu

31、t take into consideration the results of any contract review activities.4.4.5Design outputDesign output is documented and expressed in terms that can be verified and validated against design input requirements.Design output:a) meets the design input requirements;b) contains or makes reference to acc

32、eptance criteria;c) identifies those characteristics of the design that are crucial to the safe and proper functioning of the product.Design output documents are reviewed before release.4.4.6Design reviewAt appropriate stages of design, formal documented reviews of the design results are planned and

33、 conducted.Participants at each design review include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required.Records of such reviews are maintained.4.4.7 Design verificationAt appropriate stages of design, design verificati

34、on is performed to ensure that the design stage output meets the design stage input requirements.The design verification measures are recorded.4.4.8Design validationDesign validation is performed to ensure that product conforms to defined used needs and/or requirements.4.4.9Design changesAll design

35、changes and modifications are identified, documented, reviewed and approved by authorized personnel before their implementation.4.5Document and data control4.5.1GeneralThe supplier shall establish and maintain documented procedures to control all documents and data that relate to the requirements of

36、 the appropriate standard including, to the extent applicable, documents of external origin such as standards and customer drawings.4.5.2 Document and data approval and issueThe documents and data are reviewed and approved for adequacy by authorized personnel prior to issue.A master list or equivale

37、nt document control procedure identifying the current revision status of documents shall be established and is readily available to preclude the use of invalid and/or obsolete documents.The control ensures that:a) the pertinent issues of appropriate documents are available at all locations where ope

38、rations essential to the effective functioning of the quality system are performed;b) invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;c) any obsolete documents retained for legal and/or knowledge-preservation purpose

39、s are suitably identified.4.5.3Document and data changesChanges to documents and data are reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise.The designated functions/organizations have access to pertinen

40、t background information upon which to base their review and approval.The nature of changes is identified in the document or on appropriate attachments, whichever is practical.4.6Purchasing4.6.1GeneralThe supplier shall establish and maintain documented procedures to ensure that purchased product co

41、nforms to specified requirements.4.6.2Evaluation of subcontractorsThe supplier shall:a) evaluated and selected subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requirements;b) defined the type and extent of

42、control exercised over subcontractors.the control is dependent upon the type of product, the impact of subcontracted product on the quality of final product and, where applicable, on the quality audit reports and/or quality records of the previously demonstrated capability and performance of the sub

43、contractor;c) established and maintained quality records of acceptable subcontractors.4.6.3Purchasing dataPurchasing documents contain data clearly describing the product ordered, including where applicable:a) the type, class, grade or other precise identification;b) the title or other positive iden

44、tification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel;c) the title, number and issue of the quality s

45、ystem standard to be applied.The supplier reviews and approves purchasing documents for adequacy of the specified requirements prior to release.4.6.4Verification of purchased productSupplier verification at subcontractors premisesWhen the supplier verifies purchased product at the subcontract

46、ors premises, verification arrangements and the method of product release are specified in the purchasing documents.Customer verification of subcontracted productWhere specified in the contract, the suppliers customer of the customers representative is afforded the right to verify at the subc

47、ontractors premises and the suppliers premises that subcontracted product conforms to specified requirements.Such verification is not used by the supplier as evidence of effective control of quality by the subcontractor.Verification by the customer does not absolve the supplier of the responsibility

48、 to provide acceptable product, nor does it preclude subsequent rejection by the customer.4.7Control of customer-supplied productThe supplier shall establish and maintain documented procedures for the control of verification, storage and maintenance of customer-supplied product provided for incorpor

49、ation into the supplies or for related activities.Any such product that is lost, damaged or is otherwise unsuitable for use is recorded and reported to the customer.Verification by the supplier does not absolve the customer of the responsibility to provide acceptable product.Customer supplied produc

50、t is controlled in accordance with the procedure.4.8Product identification and traceabilityWhere appropriate, the supplier shall establish and maintain documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery and installation.Prod

51、uct is identified in accordance with the procedures.Where and to the extent that traceability is a specified requirement, the supplier shall establish and maintain documented procedures for unique identification of individual product or batches.This identification shall be recorded.Product traceabil

52、ity is maintained in accordance with the procedures.4.9 Process controlThe supplier shall identify and plan the production, installation and servicing processes which directly affect quality and has ensured that these processes are carried out under controlled conditions. Controlled conditions inclu

53、de the following:a) documented procedures defining the manner of production, installation and servicing, where the absence of such procedures could adversely affect quality;b) use of suitable production, installation and servicing equipment, and a suitable working environment;c) compliance with refe

54、rence standards/codes, quality plans and/or documented procedures;d) monitoring and control of suitable process parameters and product characteristics;e) the approval of processes and equipment, as appropriate;f) criteria for workmanship, which shall be stipulated in the clearest practical manner (e

55、.g. written standards, representative samples or illustrations); andg) suitable maintenance of equipment to ensure continuing process capability.Where the results of processes cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies

56、 may become apparent only after the product is in use, the processes are carried out by qualified operators and/or require continuous monitoring and control of process parameters to ensure that the specified requirements are met.The requirements for any qualification of process operations, including

57、 associated equipment and personnel, are specified.Records are maintained for qualified processes, equipment and personnel, as appropriate.4.10Inspection and testing4.10.1GeneralThe supplier shall establish and maintained documented procedures for inspection and testing activities in order to verify

58、 that specified requirements for the product are met.The required inspection and testing, and the records to be established, are be detailed in the quality plan or documented procedures.4.10.2Receiving inspection and testingThe supplier ensures that incoming product is not used or processed (except in ) until it has been inspected or otherwise verified as conforming to specified requirements.Verification of conformance to th