ISO IEC 17020

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Transcript of ISO IEC 17020

Page 1: ISO IEC 17020

IAF/ILAC-A4:2004Guidance on the Application

of ISO/IEC 17020

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© Copyright ILAC/IAF 2004

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IAF/ILAC-A4:2004Guidance on the Application

of ISO/IEC 17020

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Guidance on the Application of ISO/IEC 17020

Introduction

This guidance document is for ISO/IEC 17020:General Criteria for the operation of various types ofbodies performing inspection (1998). The guidance onthe quality system elements is formulated so that itcan be used in combination with the relevantelements of ISO 9001:2000.

The international standard ISO/IEC 17020 setsout general criteria for the operation of varioustypes of bodies performing inspection. (Thisstandard is identical to EN 45004). If inspectionbodies are to be accredited in a harmonisedmanner as complying with ISO/IEC 17020 someguidance to the standard is necessary. Theseguidance notes provide it. One aim is to enableaccreditation bodies to harmonise their applicationof the standard against which they are bound toassess inspection 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 bythe relevant clause number with an appropriatesuffix, e.g. 12.2a would be guidance on therequirements of clause 12.2 of the standard.

This guidance will form the basis of mutualrecognition arrangements between accreditationbodies, and is considered necessary for theconsistent application of ISO/IEC 17020.Members of the ILAC/IAF Multi Lateral MutualRecognition Arrangement (MLMRA), andapplicants for membership in that Arrangement,will assess each others’ implementation of ISO/IEC 17020 and all of this guidance is expected tobe adopted by accreditation bodies as part of theirgeneral rules of operation.

The term “shall” is used throughout this documentto indicate those provisions which, reflecting therequirements of ISO/IEC17020, are mandatory.The term “should” is used to indicate thoseprovisions which, although not mandatory, areprovided by ILAC/IAF as a recognised means ofmeeting the requirements. Inspection bodieswhose systems do not follow the ILAC/IAFguidance 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 anequivalent way.

An accreditation body shall at all times maintain itsimpartiality as required by ISO/IEC TR 17010clause 4.2. Nevertheless, it shall be prepared todiscuss this guidance and its interpretation with anapplicant body, and, where appropriate, to respondto enquiries.

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Contents Page

1 Scope 6

2 Definitions 6

3 Administrative requirements 7

4 Independence, impartiality and integrity 7

5 Confidentiality 9

6 Organisation and management 9

7 Quality system 10

8 Personnel 11

9 Facilities and equipment 11

10 Inspection methods and procedures 12

11 Handling inspection samples and items 13

12 Records 13

13 Inspection reports and inspection certificates 13

14 Sub-contracting 13

15 Complaints and appeals 14

16 Co-operation 14

Appendix 1 15

Appendix 2 16

Appendix 3 17

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1 Scope

1.1a When using ISO/IEC 17020 and thisguidance document the accreditation bodyshould neither add to, nor subtract from therequirements of the standard. The applica-tion of legal, governmental or other norma-tive requirements shall be reflected in thescope of accreditation granted.

1.4a Testing performed by an inspection bodymay fall into one of two categories namelyfunctional and analytical. Functional testing,for example load testing of a crane, forms anormal part of the activities of aninspection body and is therefore within thescope of ISO/IEC 17020. Analyticaltesting, (which must be performed inside alaboratory under well-controlledenvironmental conditions and using moresophisticated 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.

2 Definitions

2.1a Throughout these guidelines the word“product” should be understood to includethe words “product design”, “service”,“process” and “plant” as specified in clause2.1.of the standard.

2.1b In recognition of the wide range ofindustries represented by inspection bodiesalternative terminology could be used forwhat is inspected.

2.1c The definition of inspection overlaps withthat of testing and product certificationwhere these activities have commoncharacteristics. However, an importantdifference is that many types of inspectioninvolve professional judgement todetermine acceptability against generalrequirements and thus the inspection bodywill have to demonstrate that it has thenecessary competence to perform the task.

2.1d The scope of ISO/IEC 17020 does notcover quality management systemcertification. It may, however, be necessaryfor inspection bodies to examine certain

Some differences between Inspection (ISO/IEC 17020) and Product Certification (ISO/IEC Guide 65)

Activity Inspection Product Certification

Nature of operation Inspection of individual products, Certification of series of products andand not necessarily by third party always by third party (indirect(direct determination of conformance) determination of conformance)

Conformity Examined against standards or other Assessed against standards or othernormative documents and/or normative documentsgeneral requirements

Assurance Report provides condition at the time Certification normally providesof inspection continuing assurance of compliance

Decisions No need for separation of those Certification decisions taken by ataking inspection decisions from those different person(s) from those who haveperforming inspection carried out evaluation

Issuing of licences No licences issued Grants licence to suppliers to issuecertificate

Marking of products Marks put only on products covered Marks may be put on a certified productby inspection under licence

Surveillance Only where required in order to Normally necessary to providesupport inspection continuing assurance of compliance

In-service inspection of Always by inspection Not by product certification products

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aspects of the quality management systemor other documented systems, in order tojustify the inspection results, for example,the examination of processes. See Note 1following Clause 2.1.

2.1e Generally, inspection involves directdetermination of the conformity withspecific or general requirements of unique -often complex or critical - products or smallseries 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 usedoes not occur. Some further differencesare shown in the following table.

3 Administrative Requirements

3.2a An organisational diagram is a useful meansof illustrating the position of the inspectionbody in relation to a larger organisation.Diagrams showing relationships with relatedcompanies or organisations and relationshipsbetween departments within the sameorganisation are useful support for claimsof independence.

3.3a Accreditation bodies present the scope ofactivity for which accreditation ofinspection bodies is granted in a formalstatement, called, for example, theAccreditation Schedule that accompaniesthe Accreditation Certificate. TheAccreditation 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 inspection body.The Accreditation Certificate and Scheduleshould indicate the type of body as definedin sub-clause 4.2 of ISO/IEC 17020. Anexample of a layout of an AccreditationCertificate is given at Appendix 1 and of anAccreditation Schedule at Appendix 2.

3.3b The scope of accreditation should bedefined in the schedule in sufficientlyprecise terms that potential clients may

establish accurately and unambiguously thegeneral field of inspection, the type andrange of inspection and, where applicable,the regulations, standards or specificationscontaining the requirements against whichthe inspection will be performed.

3.3c Contracts 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. In manyinspection areas (e.g. in-service inspectionbased on national regulations) individualcontracts are not signed with clients. Inthese cases the work order must becontained in some underlyingdocumentation, e.g. regulations issued byregulatory authorities.

3.4a The 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.

3.4b It 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 particular attention toinsurance cover when undertaking inspection workin another country, where legal requirements maydiffer from those in the body’s home country.

3.5a The conditions referred to in clause 3.5 arecontractual and business conditions, notphysical conditions, of inspection sites.

3.6a It is not the role of accreditation bodies tojudge the adequacy of the financial ac-counts.

4 Independence, impartiality and integrity

4.1a Procedures should be documented to assureinspection body staff are free fromcommercial, financial or other pressureswhich might affect their judgement.

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4.2a The categorisation of inspection bodies asType A, B or C is essentially a measure oftheir independence. Demonstrableindependence of an inspection body maystrengthen the confidence of the inspectionbody’s customers in the body’s ability tocarry out inspection work with impartialityand objectivity. The terms first party andsecond party, as defined in ISO/IEC Guide 2,are not used in ISO/IEC 17020, becauseapplication of them would not be helpful.However, since conventional thinking hasbeen in terms of first, second or thirdparties for many years, it is necessary tooffer some explanation on the relationshipbetween the two sets of categories, asincluded 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, useor maintenance of the items inspected orsimilar competitive items by! common ownership (except where the

owners have no ability to influence theoutcome of an inspection), Note 1

! common ownership appointees on theboards (or equivalent) of theorganisations (except where these havefunctions that have no influence on theoutcome of an inspection) Note 2

! directly reporting to the same higherlevel of management

! contractual arrangements, informalunderstandings or other means that mayhave an ability to influence the outcomeof an inspection

In addition to the above, an InspectionBody shall not become a Type A InspectionBody if another part of the sameorganisation is directly involved in design,manufacture, supply, installation, purchase,ownership, use or maintenance of the itemsinspected or similar competitive items, whensuch other parts of the organisation do nothave a separate legal identity.

The Chief Executive of the legal entity ofwhich the Inspection Body is a part shalldefine and document its policy formaintaining the Type A status of theInspection Body. The Accreditation Bodywill examine the evidence of

implementation of this policy in respect ofownership interests, constitution of boardof directors, means of financing, decisionmaking methods and other such factors thatmay have an influence on the impartiality,independence and integrity of a Type AInspection 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 financing acompany 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 involvedin the design, manufacture, supply,installation, use or maintenance of itemsthat they inspect;

! Type B inspection bodies supplyinspection services only to their parentorganisation.

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.

When a Type B inspection body that formsa part of a user organisation inspects itemsto be supplied for use by its parentorganisation by a supplier organisation thatis not its parent organisation and not relatedto it, it carries out second party inspection.

4.2.3a Type C inspection bodies are involved, inthe design, manufacture, supply, installation,use or maintenance of items that theyinspect. Inspections carried out by themmay include first party inspections and

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second party inspections of the same typeas carried out by Type B bodies. However,Type C inspection bodies are distinct fromType B inspection bodies for the followingreasons:

A Type C inspection body need not be aseparate part but shall be identifiable withinthe organisation. A Type C body may itselfbe the designer, manufacturer, supplier,installer, user or maintainer of items that itinspects.

A Type C inspection body may offer itsinspection service on the open market or toany other party and supply inspectionservice to external organisations. Forexample, it may inspect products suppliedby it or by its parent organisation and usedby another organisation. It may also supplyother organisations with inspection of itemsthat are similar to those designed,manufactured, supplied, installed, used ormaintained by it or by its parentorganisation, and which may therefore beregarded as competitive.

Inspections carried out by Type Cinspection bodies cannot be classified asthird party inspections because they do notmeet the requirements of independence ofoperations as stipulated for Type Ainspection bodies in Annex A of ISO/IEC17020. Type C inspection bodies mayconform to some of the criteria concerningindependence of other economic operators,non-involvement in ‘conflicting” activitiesand non-discriminatory operations thatcharacterise Type A and Type B inspectionbodies. Yet they remain Type C inspectionbodies as long as they do not meet all of therequirements applicable to Type A or TypeB inspection bodies.

The design/manufacture/supply/installation/servicing/maintenance and theinspection of an entity carried out by aType C inspection body should not beundertaken by the same person. Anexception to this is where a regulatory orother authoritative requirement explicitlyallows an individual person from a Type Cinspection body to undertake both thedesign/ manufacture/supply/installation/servicing/maintenance and the inspectionof an entity.

5 Confidentiality

5a The inspection body should have a policy,documented in its quality system, concern-ing the observance of the confidentialityrequirements of the client by the inspectionbody (see clause 12.3 of ISO/IEC 17020)and by any sub-contractors engaged by it(see clause 14 of ISO/IEC 17020), takinginto account any relevant legal require-ments. For mandatory inspections theprocedures should set out who, besides theclient, is entitled to have access to theresults.

6 Organization and management

6.1a The size, structure and composition of aninspection body, taken together should besuitable for the competent performance ofthe tasks with which the inspection body isconcerned.

6.2a The inspection body should maintain anup-to-date organisational chart clearlyshowing the functions and lines of authorityfor staff within the inspection body and therelationship, if any, between the inspectionfunction and other activities of theorganisation. The position of the technicalmanager and quality manager should beclearly shown in the chart.

6.2b For each position in the organisation thatcould have an effect on the quality ofinspections, or records of inspection, detailsof responsibility should be included in thequality system documentation.

6.2c The degree of complexity of documenta-tion and the extent to which staff memberscan hold several functions will depend uponthe size of the organisation.

6.3a Different persons may take up the role oftechnical manager for different activities.Where more than one person acts as thetechnical manager, the specific responsibili-ties of each person must be defined anddocumented.

6.4a The inspection body should be able todemonstrate that it is organised in such away that the work of the staff performinginspections is supervised by personnel whoare familiar with the objectives of the

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inspections, the inspection methods andprocedures being used and the assessmentsof the inspection results. The extent, natureand level of supervision exercised shouldtake in to account the qualifications,experience, training and technical knowledgeof the inspection staff and the inspectionsbeing undertaken.

6.4b Effective supervision of inspections can beclaimed only in situations where asupervisor is able to review, if required,actual observations and inspection decisionsor otherwise personally verify thatinspection decisions are reliable.

6.4c Supervision of inspection personnel mayinclude, but not be limited to, the regularreview of inspection reports to ensure thatthey are in accordance with relevantlegislation, inspection body’s procedures andas necessary, contractual obligations agreedwith the client.(See also Clause 10.5c & d)

6.4d Monitoring of performance of inspectionsshould include on-site witnessing ofinspections. On-site witnessing ofinspections should be carried out bytechnically competent personnel, who aresufficiently independent to carry out thewitnessing of inspections objectively.

6.4e The inspection body’s programme forwitnessing inspectors should be designed sothat a representative sample of inspectors iswitnessed. As a minimum, every inspectorshould be witnessed at least once during thenormal accreditation cycle (typically 3 - 4years) performing each field of inspectionfor which they are authorised by theinspection body. Records of observedinspections shall be kept.

6.5a The purpose of nominating a deputy is tosatisfy the need for competent managementin the absence of the manager. The deputydoes not have to be permanently employed(see 8.1a) by the inspection body.

6.5b In an organisation, where the absence of akey person causes the cessation of work,the requirement for deputies may bewaived.

6.6a Positions, which could affect the quality ofinspection services, may include managerial,clerical and other staff, as well as inspectors.

7 Quality system

7.3a For easy reference, it is recommended thatthe inspection body’s quality manual indicatewhere in the Quality System therequirements of ISO/IEC 17020 areaddressed, e.g., a cross reference table maybe included in the Quality Manual.

7.4a The position of the quality manager(however named) should be clearly shown inthe organisational chart referred to inguidance to clause 6.2. The quality managershall be free from any influences orconflicts of interest that may affect thequality of his/her work.

7.7a The purpose of internal quality audits is toverify that the documented operationalprocedures of the inspection body are beingimplemented as required. Quality audits arenormally planned and organised by thequality manager and carried out inaccordance with a pre-determined schedulethat encompasses all aspects of the qualitysystem, including the performance ofinspections. The scopes, dates and thedetailed scheduling of audits should beplanned and conducted in accordance with adocumented procedure. Competent outsidebodies may carry out internal audits. As arule, internal audits should be arranged sothat the quality system is examined at leastonce per year. Internal audits should ensurethat the guidance given in 6.4e is met.

7.7b Where an inspection body has more thanone operational site all aspects of the qualitysystem and all sites shall have a full internalaudit during an accreditation cycle.

Note: In this context an “operational site” is an office(other than the head office) which keeps records ofinspection work and of the local implementation ofthe quality system independently of the head office.

7.9a Management reviews should take accountof any relevant information, such as reportsfrom supervisory and managerial staff, theoutcome of internal quality audits andexternal assessments, complaints fromclients, changes needed in the qualitysystem, the adequacy of current human andequipment resources, future plans, estimatesfor new work, and additional human

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resources, as well as the need for training ofboth new and existing staff. The frequencyof management reviews should be deter-mined by the inspection body, takingaccount of the results from internal auditsand previous reviews and reports from anaccreditation body. Once a year is normallyconsidered acceptable

8 Personnel

8.1a Permanent personnel are those who areemployed by or under long term contract tothe inspection body. They may be employedeither on a full-time basis or on a part-timebasis. Where it is necessary to use personnelfor temporary situations, such personnelshould be formally contracted for theperiod that the inspection body uses them.The inspection body should ensure thatsuch personnel are effectively supervised(see 6.4b) and competent and that theywork in accordance with the inspectionbody’s quality system.

8.1b The inspection body shall have a sufficientnumber of permanent competent personnelhaving the education, training, technicalknowledge, skills and experience necessaryfor handling the category, range and volumeof the work performed.

8.2a An accredited inspection body should defineand document the qualifications, training,experience and the level of knowledgerequired for the inspections to be carriedout (see also clause 6.6 of ISO/IEC17020). Accreditation bodies should assessthe appropriateness of such qualifications,training, experience and the level ofknowledge for the scope of inspections tobe accredited.

Note: Achievement of qualifications and completion oftraining and experience is not a guarantee ofpractical competence in inspection or the develop-ment of sound professional judgement.

8.3a Inspection bodies may use competentexternal organisations for staff training.

8.3b Identification of training needs for eachperson should normally take place at leastonce per year. This review should result indocumented plans for further training or astatement that no further training isrequired for the individual at present.

The purpose of these records is to demon-strate the competency of each member ofthe staff to perform specific inspectiontasks and, where relevant, to use specificequipment.

8.5a This guidance may be in the form of acode of conduct. It may include issuesrelating to work ethics, impartiality, personalsafety, relationship with customers, companyrules and any other issues needed to assurethe proper conduct of inspection bodystaff.

9 Facilities and equipment

9.1a The inspection body need not be the ownerof the facilities or equipment that it uses.Facilities and equipment may be borrowed,rented, hired, leased or provided by anotherparty (e.g. the installer of the equipment).In all cases access to the equipment must bedefined and meet the requirements of ISO/IEC 17020. However, the responsibility forthe suitability and the calibration status ofthe equipment used in inspection, whetherowned by the inspection body or not, liessolely with the inspection body.

9.1b If controlled environmental conditions areneeded and premises outside those of theinspection body are used, the inspectionbody should monitor the environmentalconditions in these premises with calibratedequipment, record the results and note ifconditions are outside the limits withinwhich inspection can be performed.

9.2a Use of facilities and equipment byunauthorised persons should not bepermitted. If any item is found to have leftthe inspection body’s direct control,measures must be taken to confirm itscontinuing suitability before its return touse. Typical measures would include visualinspection, functional checks and/or re-calibration

9.4a Unique identification of items ofequipment is important even when theorganisation has only one example of aparticular item. This enables tracking whenitems are replaced for whatever reason.

9.6a All equipment used for measurements andtests, where the results of such

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measurements and tests have a significantinfluence on the results of the inspection,i.e. the conclusion about conformance withrequirements, shall be traceably calibrated.

9.6b Where equipment not under the directcontrol of the inspection body is used, theinspection body shall verify that theequipment meets all relevant requirementsof ISO/IEC 17020 before using it forinspection. The verification procedure shallbe documented and verification recordsshall be kept. Where such verification is notpractical, the report shall not be issuedunder accreditation or, where accreditationis mandatory, this fact shall be prominentlystated in the inspection report and the clientshall be informed of it.

9.7a Equipment identified under the criteria in9.6, as clarified in 9.6a, should be traceablycalibrated to national or internationalstandards where possible.

9.7b Where the calibrations are performed in-house, traceability to national standardsshould be assured by using referencestandards of measurement for which theinspection body holds a current calibrationcertificate or equivalent from a competentbody. The certificate or equivalent shoulddetail an uncertainty of measurement that isappropriate for the equipment that is to becalibrated from the reference standard. Forfurther information on uncertainty ofmeasurement see ILAC G8.

10 Inspection methods and procedures

10.1a The requirements against which theinspection is performed are normallyspecified in regulations, standards orspecifications. Specifications may includecustomer or in-house requirements.

When the inspection methods andprocedures are not defined in regulations,standards or specifications the inspectionbody itself shall define and document themethods and procedures for inspection.

10.1b In certain circumstances the inspectionbody’s customer may supply informationfor the inspection body to take intoconsideration when performing itsinspection. If the inspection body uses suchinformation supplied by any other party as

part of the inspection body’s determinationof conformity, then it should be able todemonstrate the measures taken to verifythe integrity of such information.

10.3a A standard inspection method is one thathas been published, for example, inInternational, Regional or Nationalstandards or by reputable technicalorganisations or by co-operation of severalinspection bodies or in relevant scientifictext or journals. This means that methodsdeveloped by any other means, including bythe inspection body itself or by thecustomer, are considered to be non-standard methods.

10.5a Where appropriate (see note) each contractor request should be reviewed by theinspection body to ensure that:

1. the client’s requirements are adequatelydefined, documented and understood,and

2. the inspection body has the capability tomeet the client’s requirements, and

3. contract conditions are agreed, and4. special equipment needs are identified,

and5. personnel training needs are identified,

and6. statutory requirements are identified,

and7. special safety requirements are

identified, and8. the extent of subcontracting

arrangements required are identified,and

9. documentation needs are identified, and10. the final contract or request accepted by

the inspection body agrees with theoriginal version that was reviewed as in(1), (2) and (3) above.

Records of contract review shall beretained.

Note: For routine or repeat work requests, review may belimited to considerations of time and humanresources and an acceptable record in such caseswould be a signed acceptance of the contract by anappropriately authorised person.

10.5b In situations where verbal agreements areacceptable, the inspection body should keepa record of all requests and instructionsreceived verbally, dates and the identity ofthe client’s representative.

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10.6a Worksheets, notebooks etc used to recordobservations during inspections shall beretained for reference for a defined period.

10.8a Documented procedures should includeprocedures to ensure the safety ofpersonnel and, where appropriate,protection of the surrounding environment.

11 Handling inspection samples anditems

12 Records

13 Inspection reports and inspectioncertificates

13.1a The terms “report” and “certificate” areused synonymously in this clause. However,in this guidance document it is assumed that“reports” are detailed descriptions of theinspection and its results whereas“certificates” are generally short formalstatements of conformity with requirementsissued, for example, in connection withmandatory inspection.

13.1b Where the inspection body issues aninspection certificate, it may not be possibleto cover all of the work carried out by theinspection body in the certificate itself. Inthose circumstances it would be acceptableto maintain separate documentation todemonstrate the work carried out by theinspection body, provided suchdocumentation can be traceable to thecorrect inspection certificate.

13.2a The fact that the client does not require adetailed report does not remove therequirement for detailed inspection recordsto be kept.

13.2b The content of an inspection report orinspection certificate may vary dependingon the type of inspection and legalrequirements. Appendix 3 contains a list ofelements to be included in inspectionreports and inspection certificates. Some ofthese elements are considered to bemandatory for compliance with ISO/IEC17020. The mandatory elements ofAppendix 3 are marked with an asterisk (*).The list should be considered when draftinginspection reports and inspectioncertificates.

13.2c Where inspection is for legal purposesnational authorities may place specialrequirements on the reporting of inspectionresults.

13.2d Under its accreditation the inspection bodymay issue inspection reports or certificates,indicating accreditation status, for inspectionactivities described in generic terms in theaccreditation, provided that such reports orcertificates are issued for a defined type ofinspection using a defined technicalprocedure and that they are referring to adefined field of inspection.

13.3a In all cases it must be possible to identifythe person accepting responsibility for theverification and release of the inspectionreport or certificate.

13.3b An example of an “otherwise approved”inspection report or inspection certificate isone approved by secure electronicauthorisation or by seal. In such cases theinspection body must be able todemonstrate that authorisation is secure andaccess to the electronic storage medium isstrictly controlled.

13.4a It must not be possible for ambiguity toexist between a report or certificate with anerror and the corresponding correctedreport. This is most commonly avoided byissuing a replacement report or certificatewith words such as “this report/certificatereplaces report/certificate No. XYZ”.

14 Sub-contracting

14.1a Sub-contracting of inspections which arewithin the inspection body’s scope ofaccreditation may take place only when anyof the following conditions apply:

1. It is necessary because there has been anunforeseen or abnormal overload, keyinspection staff members areincapacitated or key facilities or items ofequipment are temporarily unfit for use.

2. A small part of the contract from theclient involves inspection not covered bythe inspection body’s accreditation or isbeyond the capability or resources ofthe Inspection Body. This does notprevent the inspection body subcontract-ing testing.

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14.1b Whenever work, which forms part of aninspection, is carried out by sub-contractors, theresponsibility for determination of conformity ofthe inspected item with the requirements alwaysremains with the inspection body.

14.2a Where the inspection body engagesindividuals or employees of other organisations toprovide additional resources or expertise, theseindividuals are not considered to besub-contractors provided they are formallycontracted to operate under the inspection body’squality system and have equivalent training andrecords to permanent employees. (See alsoguidance to clause 8.1)

14.2b Competence of a sub-contractor may bedemonstrated either:

by the sub-contractor having accreditationto ISO/IEC 17020 or ISO/IEC 17025 forthe relevant inspections/tests and providingendorsed reports or certificates.

or

by the inspection body itself assessing thecompetence of the sub-contractor to therequirements of ISO/IEC 17020 or ISO/IEC 17025, as applicable.

14.2c Where the assessment of the sub-contractoris carried out by the inspection body, itshould be able to demonstrate that theassessment team is technically competentand knowledgeable in the application ofISO/IEC 17020 or ISO/IEC 17025.

14.3a If the competence of the subcontractor isbased partly or in full on its accreditation,the scope of its accreditation shall cover theactivities to be subcontracted and theinspection body shall have records availableto show that it has checked the status of thesubcontractor.

If the subcontracted bodies are notaccredited according to the relevantstandard for the specific activities to besubcontracted, the inspection body shallprovide appropriate evidence of thesubcontracted body’s competence, such asrecords of evaluation performed by quali-fied personnel according to appropriateprocedures.

15 Complaints and appeals

15.1a Causes of complaints should be analysed aspart of management review so thatcommon causes can be identified andappropriate action taken to minimise suchcomplaints in future.

15.2a It should be noted that Appeals proceduresare required only if the inspection body isappointed to undertake work by a nationalauthority.

16 Cooperation

16a The purpose of this clause is to encourageinspection bodies to exchange knowledge,subject to commercial sensitivities andconfidentiality, and learn from each other toimprove the general standard andconsistency of accredited inspection results.

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Appendix 1: Example of layout of an Accreditation Certificate

[Name of Accreditation Body]

Controlled Inspection LtdUnit K

Impartial Business CentreSometown

Somecountry

AccreditationNo. 1234

is accredited to undertake inspections as a Type A body as detailed in the Schedule bearing theabove accreditation number and [name of accreditation body] logo.

From time to time this Schedule may be revised and reissued by [name of accreditation body].

This Accreditation shall remain in force until further notice subject to continuingcompliance with the [name of accreditation body] requirements

and regulations specified by [name of accreditation body].

Accredited inspection bodies meet the requirements of ISO 17020.

Signed by Chief Executive [name of accreditation body]

Issued on [date] Initial Accreditation [date]

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Appendix 2: Example of layout of an Accreditation Schedule

[Name and logo of Accreditation Body]

NAME of Inspection BodyAccreditation No 1234

Type A

Address of Inspection Body: Inspection Body Contact

Telephone: Issue No:Facsimile: Date:

Field of Inspection, such as: Type and Range of Inspection Methods and Procedures,Product Design, Products (e.g, In-Service Inspection or such as:(specified as Materials Inspection of New Products) Regulations, Standards,or Equipment), Installations, Specifications, InternalPlant, Premises, Processes, ProceduresServices and Surveys

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1* Designation of the document, i.e. as aninspection report or an inspectioncertificate, as appropriate

2* Identification of the document, i.e. date ofissue and unique identification

3* Identification of the issuing body

4* Identification of the client

5* Description of the inspection work ordered

6* Date(s) of inspection

7* Identification of the object(s) inspected and,where applicable, identification of thespecific components that have beeninspected and identification of locationswhere e.g. NDT methods have been applied

8* Information on what has been omittedfrom the original scope of work

9* Identification or brief description of theinspection method(s) and procedure(s) used,mentioning the deviations from, additions toor exclusions from the agreed methods andprocedures

10 Identification of equipment used formeasuring/testing.

11 Where applicable, and if not specified in theinspection method or procedure, referenceto or description of the sampling methodand information on where, when, how andby whom the samples were taken

12* If any part of the inspection work has beensubcontracted, the results of this work shallbe clearly identified

13 Information on where the inspection wascarried out

14 Information on environmental conditionsduring the inspection, if relevant

15* The results of the inspection including adeclaration of conformity and any defectsor other non-compliances found (results canbe supported by tables, graphs, sketches andphotographs)

16 A statement that the inspection results relateexclusively to the work ordered or theobject(s) or the lot inspected

17 A statement that the inspection report shallnot be reproduced except in full without theapproval of the inspection body and theclient

18 The inspector’s mark or seal

19* Names (or unique identification) of thestaff members who have performed theinspection and in cases when secureelectronic authentication is not undertaken,their signature, (see also clause 13.3 ofISO/IEC 17020)

Note: The elements of inspection reports/certificates that are considered to be mandatory for compliance with ISO/IEC17020 are marked with an asterisk (*).

Appendix 3: Elements of inspection reports and inspection certificates

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