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EN ISO 9000-1:1994Licensed for use in Croner-i Health and Safety Expert BSI Standards LtdIntroductionOrganizations – industrial, commercial orgovernmental – supply products intended to satisfycustomers’ needs and/or requirements. Increasedglobal competition has led to increasingly morestringent customer expectations with regard toquality. To be competitive and to maintain goodeconomic performance, organizations/suppliersneed to employ increasingly effective and efficientsystems. Such systems should result in continualimprovements in quality and increased satisfactionof the organization’s customers and otherstakeholders (employees, owners, subsuppliers,society).Customer requirements often are incorporated in“specifications”. However, specifications may not inthemselves guarantee that a customer’srequirements will be met consistently, if there areany deficiencies in the organizational system tosupply and support the product. Consequently,these concerns have led to the development ofquality system standards and guidelines thatcomplement relevant product requirements given inthe technical specifications. The InternationalStandards in the ISO 9000 family are intended toprovide a generic core of quality system standardsapplicable to a broad range of industry and economicsectors (clause 7).The management system of an organization isinfluenced by the objectives of the organization, byits products and by the practices specific to theorganization and, therefore, quality systems alsovary from one organization to another. A majorpurpose of quality management is to improve thesystems and processes so that continualimprovement of quality can be achieved.This Part of ISO 9000, which has the role of roadmap for the ISO 9000 family, has been expandedsubstantially. In particular, it contains guidanceconcepts not included in the 1987 version. Theseadditional concepts:— are needed for effective understanding andcurrent application of the ISO 9000 family; and— are planned for complete integration into thearchitecture and content of future revisions of theISO 9000 family.In revision of the ISO 9000 family, there are nomajor changes in the architectures of ISO 9001,ISO 9002, ISO 9003 and ISO 9004. (However,ISO 9003 does contain additional clauses comparedto the 1987 version.) Each of these InternationalStandards has had small-scale changes. Thesechanges move toward future revisions to meetbetter the needs of users. BSI 10-1998This Part of ISO 9000 and all other InternationalStandards in the ISO 9000 family are independentof any specific industry or economic sector.Collectively they provide guidance for qualitymanagement and general requirements for qualityassurance.The International Standards in the ISO 9000 familydescribe what elements quality systems shouldencompass but not how a specific organizationimplements these elements. It is not the purpose ofthese International Standards to enforce uniformityof quality systems. Needs of organizations vary. Thedesign and implementation of a quality system mustnecessarily be influenced by the particularobjectives, products and processes, and specificpractices of the organization.This Part of ISO 9000 clarifies the principalquality-related concepts contained within thequality management and quality assuranceInternational Standards generated by ISO/TC 176and provides guidance on their selection and use.1 ScopeThis Part of ISO 9000:a) clarifies principal quality-related concepts andthe distinctions and interrelationships amongthem;b) provides guidance for the selection and use ofthe ISO 9000 family of International Standardson quality management and quality assurance.2 Normative referenceThe following standard contains provisions which,through reference in this text, constitute provisionsof this Part of ISO 9000. At the time of publication,the edition indicated was valid. All standards aresubject to revision, and parties to agreements basedon this Part of ISO 9000 are encouraged toinvestigate the possibility of applying the mostrecent edition of the standard indicated below.Members of IEC and ISO maintain registers ofcurrently valid International Standards.ISO 8402:1994 Quality management and qualityassurance — Vocabulary.3 DefinitionsThis revision of ISO 9000, ISO 9001, ISO 9002,ISO 9003 and ISO 9004 has improved theharmonization of terminology for organizations inthe supply chain. Table 1 shows the supply-chainterminology used in these International Standards.3

EN ISO 9000-1:1994Table 1 — Relationships of organizations in the supply chainISO 9000-1Licensed for use in Croner-i Health and Safety Expert BSI Standards LtdISO 9001,ISO 9002,ISO 9003ISO 9004-1Subsupplier supplier ororganization customerSubcontractor supplier customerSubcontractor organization customerThe usage of all of these terms conforms with theirformal definitions in ISO 8402. The remainingdifferences in terminology in Table 1 reflect, in part,a desire to maintain historical continuity with usagein the 1987 edition of these InternationalStandards.NOTE 1 In all these International Standards, the grammaticalformat of the guidance or requirements text is addressed to theorganization in its role as a supplier of products (the third columnof Table 1).NOTE 2 In the ISO 9000 row of Table 1, the use of “subsupplier”emphasizes the supply-chain relationship of the threeorganizational units, using the self-defining term in relation to“supplier”. Where appropriate, especially in discussing qualitymanagement situations, the term “organization” is used ratherthan “supplier”.NOTE 3 In the ISO 9001, ISO 9002 and ISO 9003 rows ofTable 1, the use of “subcontractor” reflects the fact that, in anexternal quality assurance context, the relevant relationshipoften is (explicitly or implicitly) contractual.NOTE 4 In the ISO 9004 row of Table 1, the use of“organization” reflects the fact that quality managementguidance is applicable to any organizational unit, irrespective ofthe categories of products it may supply, or whether it is afree-standing unit or part of a larger organization.For the purposes of this Part of ISO 9000, thedefinitions given in ISO 8402, together with thefollowing definitions, apply.NOTE 5 For the convenience of users of this Part of ISO 9000,some relevant definitions from ISO 8402 are contained inannex A.3.1hardwaretangible, discrete product with distinctive formNOTE 6 Hardware normally consists of manufactured,constructed or fabricated pieces, parts and/or assemblies.3.2softwarean intellectual creation consisting of informationexpressed through supporting mediumNOTE 7 Software can be in the form of concepts, transactionsor procedures.NOTE 8 A computer program is a specific example of software.3.3processed materialtangible product generated by transforming rawmaterial into a desired state4NOTE 9 The state of processed material can be liquid, gas,particulate material, ingot, filament or sheet.NOTE 10 Processed material is typically delivered in drums,bags, tanks, cylinders, cans, pipelines or rolls.3.4industry/economic sectora grouping of suppliers whose offerings meet similarcustomer needs and/or whose customers are closelyinterrelated in the market placeNOTE 11 Dual use of “industry sector” and “economic sector”recognizes that each term is used for the intended meaning inspecific countries or languages.NOTE 12 Industry/economic sectors include administration,aerospace, banking, chemicals, construction, education, food,health care, leisure, insurance, mining, retailing,telecommunications, textiles, tourism, and so forth.NOTE 13 Industry/economic sectors apply to the globaleconomy or a national economy.3.5stakeholderan individual or group of individuals with a commoninterest in the performance of the supplierorganization and the environment in which itoperates3.6ISO 9000 familyall those International Standards produced by thetechnical committee ISO/TC 176NOTE 14 At present, the family comprises:a) all the International Standards numbered ISO 9000through to ISO 9004, including all Parts of ISO 9000 andISO 9004;b) all the International Standards numbered ISO 10001through to 10020, including all Parts; andc) ISO 8402.4 Principal concepts4.1 Key objectives and responsibilities forqualityAn organization should:a) achieve, maintain and seek to improvecontinuously the quality of its products inrelationship to the requirements for quality;b) improve the quality of its own operations, so asto meet continually all customers’ and otherstakeholders’ stated and implied needs; BSI 10-1998

Licensed for use in Croner-i Health and Safety Expert BSI Standards LtdEN ISO 9000-1:1994c) provide confidence to its internal managementand other employees that the requirements forquality are being fulfilled and maintained, andthat quality improvement is taking place;d) provide confidence to the customers and otherstakeholders that the requirements for qualityare being, or will be, achieved in the deliveredproduct;e) provide confidence that quality systemrequirements are fulfilled.4.2 Stakeholders and their expectationsEvery organization as a supplier has five principalgroups of stakeholders: its customers, its employees,its owners, its subsuppliers and society. Thesupplier should address the expectations and needsof all its yeesOwnersSubsuppliersSocietyTypical expectations or needsProduct qualityCareer/work satisfactionInvestment performanceContinuing business opportunityResponsible stewardshipThe International Standards in the ISO 9000 familyfocus their guidance and requirements on satisfyingthe customer.The requirements of society, as one of the fivestakeholders, are becoming more stringentworldwide. In addition, expectations and needs arebecoming more explicit for considerations such as:workplace health and safety; protection of theenvironment (including conservation of energy andnatural resources); and security. Recognizing thatthe ISO 9000 family of International Standardsprovides a widely used approach for managementsystems that can meet requirements for quality,these management principles can be useful for otherconcerns of society. Compatibility of themanagement system approach in these severalareas can enhance the effectiveness of anorganization. In the same manner that product andprocess technical specifications are separate frommanagement systems requirements, the technicalspecifications in these other areas should beseparately developed. BSI 10-19984.3 Distinguishing between quality systemrequirements and product requirementsThe ISO 9000 family of International Standardsmakes a distinction between quality systemrequirements and product requirements. By meansof this distinction, the ISO 9000 family applies toorganizations providing products of all genericproduct categories, and to all product qualitycharacteristics. The quality system requirementsare complementary to the technical requirements ofthe product. The applicable technical specificationsof the product (e.g. as set out in product standards)and technical specifications of the process areseparate and distinct from the applicable ISO 9000family requirements or guidance.International Standards in the ISO 9000 family,both guidance and requirements, are written interms of the quality system objectives to besatisfied. These International Standards do notprescribe how to achieve the objectives but leavethat choice to the management of the organization.4.4 Generic product categoriesIt is useful to identify four generic productcategories (see clause 3 and annex A), as follows:a) hardware;b) software;c) processed materials;d) services.These four generic product categories encompass allthe kinds of product supplied by organizations.International Standards in the ISO 9000 family areapplicable to all four generic product categories. Thequality system requirements are essentially thesame for all generic product categories, but theterminology and management system details andemphases may differ.Two or more of the generic product categoriesusually are present in the marketplace offerings ofany organization, whatever the industry/economicsector (see clause 3) in which the organizationoperates. For example, most organizations thatsupply hardware, software or processed materialshave a service component to their offering.Customers (and other stakeholders) will look forvalue in each generic product category that ispresent in the offering.5

Licensed for use in Croner-i Health and Safety Expert BSI Standards LtdEN ISO 9000-1:1994Analytical instruments are examples wherehardware (i.e. the instrument), software(for computing tasks within the instrument),processed materials (such as titrating solutions orreference standard materials) and services (such astraining or maintenance servicing) might all beimportant features of the offering. A serviceorganization such as a restaurant will havehardware, software and processed materials as wellas service components.4.5 Facets of qualityFour facets that are key contributions to productquality may be identified as follows.a) Quality due to definition of needs for theproductThe first facet is quality due to defining andupdating the product, to meet marketplacerequirements and opportunities.b) Quality due to product designThe second facet is quality due to designing intothe product the characteristics that enable it tomeet marketplace requirements andopportunities, and to provide value to customersand other stakeholders. More precisely, qualitydue to product design is the product designfeatures that influence the intended performancewithin a given grade, plus product designfeatures that influence the robustness of productperformance under variable conditions ofproduction and use.c) Quality due to conformance to productdesignThe third facet is quality due to maintainingday-to-day consistency in conforming to productdesign and in providing the designedcharacteristics and values for customers andother stakeholders.d) Quality due to product supportThe fourth facet is quality due to furnishingsupport throughout the product life cycle, asneeded, to provide the designed characteristicsand values for customers and other stakeholders.For some products, the important qualitycharacteristics include dependabilitycharacteristics. Dependability (i.e. reliability,maintainability and availability) may be influencedby all four facets of product quality.6A goal of the guidance and requirements of theInternational Standards in the ISO 9000 family is tomeet the needs for all four facets of product quality.Some facets of quality may be specificallyimportant, for example, in contractual situations,but, in general, all facets contribute to the quality ofthe product. The ISO 9000 family explicitly providesgeneric quality management guidance and externalquality assurance requirements on facets a), b), c)and d).When considering the complete product offering, thecustomer will bear in mind additional factors.These include the following.— The supplier’s market status and strategy: ifthe supplier has an established and reputablemarket-place status and/or a strategy that isachieving a satisfactory market share, thecustomer is likely to place higher value on thesupplier’s offering.— The supplier’s financial status and strategy: ifthe supplier has an established and reputablefinancial status and/or a strategy that isimproving financial performance, the customer islikely to place higher value on the supplier’soffering.— The supplier’s human resources status andstrategy: if the supplier has an established andreputable human resources status and/or astrategy that is developing improved skills,diversity and commitment in its humanresources, the customer is likely to place highervalue on the supplier’s offering.These additional factors are of vital importance inmanaging a supplier organization as a totalenterprise.NOTE 15 Product value involves both quality and price and, assuch, price is not a facet of quality.4.6 Concept of a processThe International Standards in the ISO 9000 familyare founded upon the understanding that all work isaccomplished by a process (see Figure 1). Everyprocess has inputs. The outputs are the results ofthe process. The outputs are products, tangible orintangible. The process itself is (or should be) atransformation that adds value. Every processinvolves people and/or other resources in some way.An output may be, for example, an invoice,computing software, liquid fuel, a clinical device, abanking service, or a final or intermediate productof any generic category. There are opportunities tomake measurements on the inputs, at variousplaces in the process, as well as on the outputs. Asshown in Figure 2, inputs and outputs are of severaltypes. BSI 10-1998

EN ISO 9000-1:1994Licensed for use in Croner-i Health and Safety Expert BSI Standards LtdTypeProduct-related(solid lines inFigure 2)Information-related(dashed lines inFigure 2)ExamplesRaw materialsIntermediate productFinal productSampled productProduct requirementsProduct characteristicsand status informationSupport-functioncommunicationsFeedback on productperformance and needsMeasurement data fromsampled productFigure 2 shows the supplier in a supply chainrelationship to a subsupplier and a customer. In thissupply chain structure, the various inputs andoutputs need to flow in different directions, asillustrated in Figure 2. It is emphasized that in thiscontext “product” includes all four generic productcategories.Quality management is accomplished by managingthe processes in the organization. It is necessary tomanage a process in two senses:— the structure and operation of the processitself within which the product or informationflows; and— the quality of the product or informationflowing within the structure.4.7 Network of processes in an organizationEvery organization exists to accomplishvalue-adding work. The work is accomplishedthrough a network of processes. The structure of thenetwork is not usually a simple sequentialstructure, but typically is quite complex.In an organization there are many functions to beperformed. They include production, product design,technology management, marketing, training,human resources management, strategic planning,delivery, invoicing and maintenance. Given thecomplexity of most organizations, it is important tohighlight the main processes and to simplify andprioritize processes for quality managementpurposes.Figure 1 — All work is accomplished by a process BSI 10-19987

Licensed for use in Croner-i Health and Safety Expert BSI Standards LtdEN ISO 9000-1:1994Figure 2 — Supply chain relationship of processes, with product-relatedand information-related flowAn organization needs to identify, organize andmanage its network of processes and interfaces. Theorganization creates, improves and providesconsistent quality in its offerings through thenetwork of processes. This is a fundamentalconceptual basis for the ISO 9000 family. Processesand their interfaces should be subject to analysi

by ISO Technical Committee ISO/TC 176, Quality management and quality assurance, in 1990. In 1994 the European Committee for Standardization (CEN) accepted ISO 9000-1:1994 as European Standard EN ISO 9000-1. Cross-references International standard Corresponding British Standard Normative reference ISO 8402:1994