Guidance On The Application Of ISO / IEC 17020
AccreditationInternationalAssociation forCertifying BodiesGuidance on the Applicationof ISO / IEC 17020Guidance on the Application of ISO/IEC 17020Page 1 of 16
IntroductionThis guidance document is for ISO/IEC 17020:General Criteria for the operation of various types ofbodies performing inspection (1998). The guidanceon the quality system elements is formulated sothat it can be used in combination with the relevantelements of ISO 9001:2000.The international standard ISO/IEC 17020 sets outgeneral criteria for the operation of various types ofbodies performing inspection. (This standard isidentical to EN 45004). If inspection bodies are tobe accredited in a harmonized manner ascomplying with ISO/IEC 17020 some guidance tothe standard is necessary. These guidance notesprovide it. One aim is to enable accreditationbodies to harmonise their application of thestandard against which they are bound to assessinspection bodies. This is an important steptowards mutual recognition of accreditation. It ishoped that the guidance will also be useful toinspection bodies themselves and to those whosedecisions are guided by their inspection reports/certificates. For ease of reference, identified by therelevant clause number with an appropriate suffix,e.g. 12.2a would be guidance on the requirementsof clause 12.2 of the standard.The term “shall” is used throughout this documentto indicate those provisions which, reflecting therequirements of ISO/IEC17020, are mandatory. Theterm “should” is used to indicate those provisionswhich, although not mandatory, are provided as arecognised means of meeting the requirements.Inspection bodies whose systems do not follow theguidance in any respect will only be eligible foraccreditation if they can demonstrate to theaccreditation body that their solutions meet therelevant clause of ISO/IEC 17020 in an equivalentway.An accreditation body shall at all times maintain itsimpartiality as required by ISO/IEC TR 17010 clause4.2. Nevertheless, it shall be prepared to discussthis guidance and its interpretation with anapplicant body, and, where appropriate, to respondto enquiries.This guidance will form the basis of mutualrecognition arrangements between accreditationbodies, and is considered necessary for theconsistent application of ISO/IEC 17020. Membersof the Multi Lateral Mutual RecognitionArrangement (MLMRA), and applicants formembership in that Arrangement, will assess eachothers’ implementation of ISO/ IEC 17020 and all ofthis guidance is expected to be adopted byaccreditation bodies as part of their general rules ofoperation.Guidance on the Application of ISO/IEC 17020Page 2 of 16
Contents Page1. Scope2. Definitions3. Administrative requirements4. Independence, impartiality and integrity5. Confidentiality6. Organisation and management7. Quality system8. Personnel9. Facilities and equipment10. Inspection methods and procedures11. Handling inspection samples and items12. Records13. Inspection reports and inspection certificates14. Sub-contracting15. Complaints and appeals16. Co-operation335677891010111111121313Appendix 1Appendix 2Appendix 3141516Guidance on the Application of ISO/IEC 17020Page 3 of 16
1.1.1a1.4a22.1aScopeWhen using ISO/IEC 17020 and thisguidance document the accreditation bodyshould neither add to, nor subtract fromthe requirements of the standard. Theapplication of legal, governmental or othernormative requirements shall be reflectedin the scope of accreditation granted.Testing performed by an inspection bodymay fall into one of two categories namelyfunctional and analytical. Functionaltesting, for example load testing of a crane,forms a normal part of the activities of aninspection body and is therefore within thescope of ISO/IEC 17020. Analytical testing,(which must be performed inside alaboratoryunderwell-controlledenvironmental conditions and usingmore sophisticated equipment or testingprocedures) is a laboratory activity andtherefore does not come within the scopeof ISO/IEC 17020. Inspection bodieswishing to undertake such laboratory typeanalytical testing as part of an inspectionwill need to do so in accordance with therelevant requirements in ISO/IEC 17025.DefinitionsThroughout these guidelines the word2.1b2.1c2.1d“product” should be understood to includethe words “product design”, “service”,“process” and “plant” as specified in clause2.1.of the standard.In recognition of the wide range ofindustries represented by inspection bodiesalternative terminology could be used forwhat is inspected.The definition of inspection overlaps withthat of testing and product certificationwhere these activities have commoncharacteristics. However, an importantdifference is that many types of inspectioninvolveprofessionaljudgementtodetermine acceptability against generalrequirements and thus the inspection bodywill have to demonstrate that it has thenecessary competence to perform the task.The scope of ISO/IEC 17020 does not coverquality management system certification. Itmay, however, be necessary for inspectionbodies to examine certain aspects of thequality management system or otherdocumented systems, in order to justify theinspection results, for example, theexamination of processes. See Note 1following Clause 2.1.Some differences between Inspection (ISO/IEC 17020) and Product Certification (ISO/IEC Guide 65)ActivityNature of operationConformityAssuranceDecisionsIssuing of licensesMarking of productsSurveillanceIn-service inspection ofproductsInspectionInspection of individual products, and notnecessarily by third party (direct determinationof conformance)Examined against standards or other normativedocuments and/or general requirementsReport provides condition at the time ofinspectionNo need for separation of those takinginspection decisions from those performinginspectionNo licenses issuedMarks put only on products covered byinspectionOnly where required in order to supportinspectionAlways by inspectionGuidance on the Application of ISO/IEC 17020Product CertificationCertification of series of products andalways by third party (indirectdetermination of conformance)Assessed against standards or othernormative documentsCertification normally providescontinuing assurance of complianceCertification decisions taken by adifferent person(s) from those who havecarried out evaluationGrants license to suppliers to issuecertificateMarks may be put on a certified productunder licenseNormally necessary to providecontinuing assurance of complianceNot by product certificationPage 4 of 16
2.1eGenerally, inspection involves directdetermination of the conformity withspecific or general requirements of unique- often complex or critical - products orsmall series of products, whereas productcertification primarily involves indirectdetermination of the conformance ofproducts manufactured in long series tospecific requirements. While inspection ofproducts in use (in-service inspection) is awell-established discipline, certification(ISO/IEC Guide 65) of products in use doesnot occur. Some further differences areshown in the following table.33.2aAdministrative RequirementsAn organisational diagram is a usefulmeans of illustrating the position of theinspection body in relation to a largerorganisation.Diagramsshowingrelationships with related companies ororganisations and relationships betweendepartments within the same organisationare useful support for claims ofindependence.Accreditation bodies present the scope ofactivity for which accreditation ofinspection bodies is granted in a formalstatement, called, for example, theAccreditation Schedule that ation Schedule is produced by theaccreditation body in consultation with theassessor(s) involved in the assessment ofthe inspection body. It is based on theinformation provided by the inspectionbody in connection with the application foraccreditation and the demonstrated andverified competence of the inspectionbody. The Accreditation Certificate andSchedule should indicate the type of bodyas defined in sub-clause 4.2 of ISO/IEC17020. An example of a layout of anAccreditation Certificate is given atAppendix 1 and of3.3aGuidance on the Application of ISO/IEC 170203.3bThe scope of accreditation should bedefined in the schedule in sufficientlyprecise terms that potential clients mayestablish accurately and unambiguouslythe general field of inspection, the type andrange of inspection and, where applicable,the regulations, standards or specificationscontaining the requirements against whichthe inspection will be performed3.3cContracts or work orders for inspectionshould ensure that there is a clear anddemonstrable understanding between theinspection body and its customer of thescope of the inspection work to beundertaken by the inspection body. Inmany inspection areas (e.g. in-serviceinspection based on national regulations)individual contracts are not signed withclients. In these cases the work order mustbe contained in some underlyingdocumentation, e.g. regulations issued byregulatory authorities.3.4aThe inspection body is expected to be ableto show what factors have been taken intoaccount when determining the necessarylevel of the contracted insurance. One ofthe factors that should be taken in toaccount is the risks associated with theperformance of inspection activities.3.4bIt is not the role of accreditation bodies toapprove the level of insurance cover heldby their clients. The types of liabilitycovered by insurance, for example, mayinclude employers’ liability, public liabilityand professional indemnity.Note: Inspection bodies should pay particularattention to insurance cover when undertakinginspection work in another country, where legalrequirements may differ from those in the body’shome country.3.5aThe conditions referred to in clause 3.5 arecontractual and business conditions, notphysical conditions, of inspection sites.3.6aIt is not the role of accreditation bodies tojudge the adequacy of the financialaccounts.Page 5 of 16
es should be documented toassure inspection body staffs are free fromcommercial, financial or other pressureswhich might affect their judgement.4.2aThe categorisation of inspection bodies asType A, B or C is essentially a measure oftheirindependence.Demonstrableindependence of an inspection body maystrengthen the confidence of theinspection body’s customers in the body’sability to carry out inspection work withimpartiality and objectivity. The terms firstparty and second party, as defined inISO/IEC Guide 2, are not used in ISO/IEC17020, because application of them wouldnot be helpful. However, since conventionalthinking has been in terms of first, secondor third parties for many years, it isnecessary to offer some explanation on therelationship between the two sets ofcategories, as included below.4.2.1a A Type A Inspection Body, to claim to beindependent of the parties involved, shalldemonstrate that it is not linked to a partydirectly involved in design, manufacture,supply, installation, purchase, ownership,use or maintenance of the items inspectedor similar competitive items by common ownership (except where theowners have no ability to influence theoutcome of an inspection), Note 1 common ownership appointees on theboards (or equivalent) of the organisations(except where these have functions thathave no influence on the outcome of aninspection) Note 2 directly reporting to the same higher levelof management contractualarrangements,informalunderstandings or other means that mayhave an ability to influence the outcome ofan inspectionIn addition to the above, an Inspection Body shallnot become a Type A Inspection Body if anotherpart of the same organisation is directly involved indesign, manufacture, supply, installation, purchase,Guidance on the Application of ISO/IEC 17020ownership, use or maintenance of the itemsinspected or similar competitive items, when suchother parts of the organisation do not have aseparate legal identity. The Chief Executive of thelegal entity of which the Inspection Body is a partshall define and document its policy formaintaining the Type A status of the InspectionBody. The Accreditation Body will examine theevidence of implementation of this policy in respectof ownership interests, constitution of board ofdirectors, means of financing, decision makingmethods and other such factors that may have aninfluence on the impartiality, independence andintegrity of a Type A Inspection Body.Note 1 An example of this is a cooperative type ofstructure where there are large numbers ofstakeholders but they (individually or as a group)have no formal means of influencing the policies,strategies or operation of the inspection body.Note2 An example of this is where a bank financinga company may insist on an appointee to the boardto overview how the company is managed but willnot be involved in any decision-making.4.2.2a The two characteristics by which inspectionbodies can be identified as Type Binspection bodies are the following:Type B inspection bodies form ademonstrably separate and identifiablepart of an organisation that is involved inthedesign,manufacture,supply,installation, use or maintenance of itemsthat they inspect;Type B inspection bodies supply inspectionservices only to their parent organisation.A Type B inspection body may form a partof a user organisation or of a supplierorganisation.When a Type B inspection body that formsa part of a supplier organisation inspectsitems that are manufactured by or for itsparent organisation and are to be suppliedto the market or to any other party, itcarries out first party inspection.Page 6 of 16
independenceofothereconomicoperators, non-involvement in erations that characterise Type A andType B inspection bodies. Yet they remainType C inspection bodies as long as theydo not meet all of the requirementsapplicable to Type
elements of ISO 9001:2000. The international standard ISO/IEC 17020 sets out general criteria for the operation of various types of bodies performing inspection. (This standard is identical to EN 45004). If inspection bodies are to be accredited in a harmonized manner as complying with ISO/IEC 17020 some guidance to the standard is necessary.
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