CHECKLIST ISO/IEC GUIDE 65 Product Certification ... - Sanas

F 70-06CHECKLIST ISO/IEC GUIDE 65Product CertificationIncludes IAF Guidance of December 2006GD5:2006 ISSUE 3Organisation’sSANAS No/s.OrganisationAssessorArea / field ofoperationOrganisation’sRepresentativeThis report covers the following:Document Review onlyImplementation onDocument Reviewand Site VisitDateAssessment ofcompany filesSite Visit onlyNote: Product includes processes and servicesStandard includes normative references such as specifications and/or technical regulations.ISO/IEC ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAGuideSection1.2 The certification system used by the certification bodymay include one or more of the following which couldbe coupled with:1) Production surveillance or assessment2) Surveillance of the suppliers quality system or3) BothSee ISO/IEC Guide 53a) Type testing or examination.b) Testing or inspection of samples taken frommarket or supplier stock or combination of both.c) Testing or inspection of every product.d) Batch testing or inspection.e) Design appraisal4.1 CERTIFICATION BODY (SECTION 4)4.1.1 Are policies and procedures non-discriminatory?Are this administered in a non-discriminatory way?Are applicants impeded/inhibited in any manner?2009-06-05 ©SANAS Page 1 of 27

ISO/IECGuideSectionG4.2.9F 70-06ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NA- EvaluationImpartiality, as required by clause 4.2a) of ISO/IECGuide 65 can only be safeguarded by a structure, asrequired by clause 4.2e) of ISO/IEC Guide 65, thatenables “the participation of all parties significantlyconcerned in the development of policies and principlesregarding the content and functioning of the certificationsystem.”4.2 (b) Does it maintain responsibility for all certificationdecision (granting, withdrawing etc.)?4.2 (c) Has the certification body identified management withresponsibility for:1) Performance of testing, inspection evaluate.2) Formulation of policy matters.3) Decisions on certification.4) Supervision of the implementation of policies.5) Supervision of the finances of the body.6) Delegation of authority to committees orindividuals required to undertake defined activitieson its behalf.7) Technical basis for granting certification.G4.2.10The structure required by ISO/IEC Guide 65, clause4.2e) for the safeguarding of impartiality should beseparate from the management established to meet therequirements of ISO/IEC Guide 65, clause 4.2c), unlessthe entire management function is performed by acommittee or group that is constituted to enableparticipation of all parties as required by ISO/IEC Guide65, clause 4.2e).4.2 (d) Does the organisation have documentary evidence thatit is a legal entity?G4.2.1Accreditation shall only be granted to a body which is alegal entity as referenced in clause 4.2d) of ISO/IECGuide 65, and will be confined to declared scope andlocations.G4.2.1The accreditation scope for a product certification bodyshould identify the certification schemes, products andnormative documents used for the certification.2009-06-05 ©SANAS Page 3 of 27

F 70-06ISO/IECGuideSectionG4.2.4G4.2.5ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAAudit of the Requirements of ISO/IEC Guide 65 asapplicable to or provided by functions of larger LegalEntity.The part of the legal entity that forms the actualcertification body may trade (be identified) under adistinctive name, which should appear on theaccreditation certificate and certificates issued tocertified organizations.G4.2.6 For the purposes of clause 4.2d) of ISO/IEC Guide 65,certification bodies which are part of government, or aregovernment departments, will be deemed to be legalentities on the basis of their governmental status.The status and structure of such bodies shall beformally documented and the bodies shall comply withall the requirements of ISO/IEC Guide 65.G4.2.7If the certification body and its client are both part ofgovernment, the two bodies shall not directly report to aperson or group having operational responsibility forboth.The certification body shall, in view of the impartialityrequirement, be able to demonstrate how it deals with acase where both itself and its client are part ofgovernment.The certification body shall demonstrate that theapplicant receives no advantage and that impartiality isassured.G4.2.2Factors to be taken into account when families ofproducts are to be considered / requested for inclusionin the Scope of Accreditation.4.2 (e) Does it have a documented structure that(i)Safeguards impartiality of operations.(ii)Is the structure such that it safeguardsimpartiality?(ii)Allows for participation of all significant parties.G4.2.9Impartiality, as required by clause 4.2a) of ISO/IECGuide 65 can only be safeguarded by a structure, asrequired by clause 4.2e) of ISO/IEC Guide 65, thatenables “the participation of all parties significantlyconcerned in the development of policies and principlesregarding the content and functioning of the certificationsystem.”G4.2.3 If the accreditation activities are carried out by a legalentity which is part of a larger organisation, the links2009-06-05 ©SANAS Page 4 of 27

ISO/IECGuideSectionG4.2.3F 70-06ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAwith other parts of the larger organisation shall beclearly defined and should demonstrate that no conflictor interest exists as defined in guidance G4.2.20 toG4.2.22.Relevant information on activities performed by theother parts of the larger organisation shall be given bycertification body to the accreditation body.G4.2.11The structure required by ISO/IEC Guide 65, clause4.2e) should be such that commercial or other financialconsiderations do not prevent the consistent, objectiveprovision of the certification body’s service.G4.2.12Clause 4.2e) of ISO/IEC Guide 65, requires that thedocumented structure of the certification body containsprovision for the participation of all the significantlyconcerned parties. This should normally be throughsome kind of committee, or similar input mechanisms.G4.2.13Additional guidance on the Role of the Committee orequivalent.This committee, or equivalent, shalla)assist in developing the policies relating to impartialityof its certification activities,b) counteract any tendency on the part of the owners ofcertification body to allow commercial or otherconsiderations to prevent the consistent objectiveprovision of certification activities,c) advise on matters affecting confidence in certification,including openness and public perception.G4.2.14 Application of clause 4.2e) of ISO/IEC Guide 65requires judgment of whether all parties significantlyconcerned in the system are able to participate. Whatare essential is that all identifiable major interestsshould be given the opportunity to participate, and thata balance of interests, where no single interestpredominates, is achieved.The members should normally be chosen at least fromamong representatives of the following groups:manufacturers or suppliers, users, consumers,conformity assessment experts. For practical reasonsthere may be a need to restrict the number of persons.G4.2.15On request of the committee or equivalent referred to inclause 4.2e) of ISO/IEC Guide 65, the managementresponsible for the various functions described inclause 4.2c) of ISO/IEC Guide 65 should provide to thatcommittee or equivalent all the necessary information,including the reasons for all significant decisions,actions, and the selection of persons responsible forparticular activities, in respect of certification, to enablethe certification body to ensure proper and impartialcertification.2009-06-05 ©SANAS Page 5 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAIf the advice of this committee or equivalent is notrespected in any matter by the management, thecommittee or equivalent shall take appropriatemeasures, which may include informing theaccreditation body.4.2 (f) Does it ensure that certification decisions are taken bypeople different to those who carried out theevaluation?G5.2.2The certification body shall have personnel technicallycompetent to assess the products and decide inaccordance with 4.2f) of ISO/IEC Guide 65 whether ornot to certify a product on the basis of information fromthe evaluation process, including inspection and testresults.G4.2.26Verification of Corrective Actions is part of theevaluation process and not within the separatecertification decision process.4.2 (g) Does it have rights and responsibilities relevant tocertification activities?G4.2.31The rights mentioned in clause 4.2g) may include acontract with the scheme owner or any otherrecognition established under the scheme rules.G4.2.27The senior executive, staff and/or personnel need tonecessarily be full-time personnel, but their otherprofessional activities shall not be such as tocompromise their impartiality.4.2 (h) Does it have adequate liability cover?4.2 (i) Is it financially stable and have adequate resourcesrequired for operating a certification scheme.G4.2.32The means by which the certification body obtainsfinancial support should be such to allow thecertification body to retain its impartiality.G4.2.16Example of evidence relating to Financial stability:4.2 (j) Does the certification body employ sufficient staff with(i)Necessary education.(ii)Training.(iii)Technical knowledge.Experience related to type, range and volume of work.2009-06-05 ©SANAS Page 6 of 27

F 70-06ISO/IEC ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAGuideSectionG13.3 Many techniques are available to certification bodies toconduct surveillance. These techniques may beconducted at various points and at varying frequenciesduring the design-production-distribution-sales chain.At the same time, characteristics of productionprocesses can aid or hinder ongoing conformity withcertification requirements. As a part of meeting therequirements of clause 4.2j) of ISO/IEC Guide 65.G13.3 Certification bodies should therefore have personnelcompetent to make appropriate choices in the designand operation of surveillance programs.4.2 (k) Does it have a quality system?4.2 (l) Does it have policies and procedures that distinguishbetween product certification and other activities?4.2 (m) Is it and senior executive free from commercialpressures, financial pressures and others, which mayresults of certification?4.2 (n) Does it have formal (documented) rules for theappointment and operation of any committees involvedin certification?G4.2.17If the decision to issue or withdraw certification inaccordance with clause 4.2n) of ISO/IEC Guide 65 istaken by a committee comprising, among others,representatives from one or more clients, theoperational procedures of the certification body shouldensure that these representatives do not have asignificant influence on decision making. This can, forexample, be assured by the distribution of voting rightsor some other equivalent means.4.2 (o) Does the certification body ensure that related activitiesdo not affect theconfidentialityobjectivityimpartialityof its certificationsThe certification body shall NOT(i)Supply or design products of the type it certifies.(ii)Provide advice or consultancy on matters,which are barriers to the certification requested.Provide any other products/services, which couldcompromise confidentiality objectivity or impartiality.G4.2.18Clause 4.2o) of ISO/IEC Guide 65 addresses twoseparate requirements. First, the certification bodytogether with the senior executive and the staff shall notunder any circumstances provide the services identifiedin sub-paragraphs 1), 2) and 3) of that clause.2009-06-05 ©SANAS Page 7 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NASecondly, although there is no specific restriction on theservices or activities a related body may provide, theseshall not affect the confidentiality, objectivity orimpartiality of the certification body.G4.2.19a)Example of Consultation Services:providing specific support/advise on elements of thedesign.b) preparing or producing manual, handbooks orprocedures.c) Involvement in the supplier’s monitoring, review anddecision making process applicable to the product.G4.2.28The certification body should require all sub-contractorsinvolved in evaluation or external assessors/auditors togive undertakings regarding the marketing of anyactivities under clause 4.2o) equivalent to thoserequired by guidance G4.2.20 and 21.G4.2.20 Activities listed under clause 4.2o) of ISO/IEC Guide 65performed by a related body and certification shouldnever be marketed in such a manner as to give theimpression that the two activities are related in a waythat might compromise the impartiality of thecertification body.G4.2.21Nothing should be said by a certification body thatwould suggest that certification would be simpler, easieror less expensive if any specified activities under clause4.2o) of ISO/IEC Guide 65 were used.G4.2.22A related body, as referred to in clause 4.2o) ofISO/IEC Guide 65, is one which is linked to thecertification body by common ownership in whole orpart, common directors, contractual arrangements, acommon name, informal understanding or other meanssuch that the related body has a vested interest in anycertification decision or has a potential ability toinfluence the process.G4.2.23The certification body should analyse and document therelationship with related bodies to determine thepossibilities for conflict of interest with provision ofcertification and identify those bodies and activities thatcould, if not subject to appropriate controls, affectconfidentiality, objectivity or impartiality.G4.2.24 Certification bodies shall demonstrate how theymanage their certification business and any otheractivities so as to eliminate actual conflict of interestand minimize any identified risk to impartiality.2009-06-05 ©SANAS Page 8 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAAre these bodies accredited?G4.3.1In house inspection and testing competency may bedemonstrated by a documented evaluation by thecertification body consistent with G.4.4.2 fordemonstrating competence of sub-contractor providinginspection and testing services.G4.3.2Requirements of specific certification schemes shall beavailable to the applicant and on request of the public.G4.3.2These may include documents defining activities such asampling, testing, inspection, surveillance andassessment of an associated management system asappropriate.Scheme documents should be developed andmaintained by a process that takes into account theviews of the interested parties.G4.3.3Documents cited in clause 4.3 include those developedby scheme owners (See definition of certificationscheme in G.3.1).Examples of typical complementary requirements fromschemes owners are:- requirements on auditor qualification, experience,training and registration;- requirements on audit reports;- requirements on duration and frequency of theaudits- other guidance to certification bodies for conformityassessment procedures.4.4 SUBCONTRACTINGDoes a formal documented agreement exist forsubcontracted work (testing and inspection)?Does such an agreement cover confidentiality?Conflict of interest.G4.4.1A certification body may subcontract work to anotherbody (e.g. testing or inspection or quality managementsystem evaluation), provide that the arrangement withthe subcontracted body require it to comply with all therelevant requirements of ISO/IEC Guide 65 and whereapplicable, ISO/IEC 17025 and 17020 and ISO/IEC17021.2009-06-05 ©SANAS Page 10 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAcertification body shall ensure that specified controlsare in place at the supplier’s testing facilities, that theyare managed in a manner which provides confidence inthe results obtained from the tests and that records areavailable to justify the confidence.In this case the provisions of G4.4.1 and/or G4.4.2 alsoapply and depending on the extent of controls imposedby the certification body some requirements of ISO/IEC17025 may not be required or applicable.The same is applicable to other conformity assessmentactivities.G4.4.5Note 2 describes a situation where the certificationbody will be reliant on the work of another body. Suchreliance needs to be supported by a technicalevaluation of the work undertaken. Such an evaluationshall be documented by the certification body.Note 3 describes a situation where the certificationbody will be reliant on the work or on a certification ofanother certification body. It should therefore ensurethat information on any evaluation work on which itrelies is updated as appropriate.In cases where the certification body takes into accountwork previously performed by another certification bodyit shall have all relevant reports and records todemonstrate the competence and the conformity withthe requirements (established by the certification body)of the other certification body for the period of timewhen the work was carried out.G4.4.6The certification body should confirm the scope,currency and applicability of any certification oraccreditation it is relying upon (as required by therelevant certification scheme of the certification body).4.5 QUALITY SYSTEM4.5.1 Does management define and document its policy forquality and objectives for a commitment to quality?Does management ensure the policy is:UnderstoodImplementedMaintained at all levels.4.5.2 Is the quality system documented?2009-06-05 ©SANAS Page 12 of 27

ISO/IECGuideSectionF 70-06ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAIs the quality system available to all staff?How is implementation of the quality system affected?4.5.3 Has the certification body designated a person who hasaccess to the highest executive level and who hasauthority for:(a)Ensuring quality system is established, implementedand maintained.(b)Brief description of its legal status and names ofowners.4.5.3 (c) Names, qualifications, experience and terms ofreference of senior executive and other certificationpersonnel (internal and external).(d)An organisational chart/lines of authority/ responsibility.(e)Description of the organisation, constitution, rules ofprocedures etc.(f)Policies and procedures for conducting managementreview.(g)Administrative procedures including document control.(h)Operational and functional duties and services (jobdescription or similar).(i)Procedure for recruitment, selection and training ofpersonnel and for monitoring their performance.G4.5.1Clause 4.5.3i) of ISO/IEC Guide 65 requires thecertification body to monitor the performance of its ownpersonnel.In addition to other methods of monitoring performance,provision should be made, where applicable, for theperiodic witnessing of those activities normallyundertaken by its personnel at supplier andsubcontractor sites.4.5.3 (j) A list of approved subcontractors and the proceduresfor assessing, recording and monitoring theirperformance.G5.2.1The certification body shall have sufficient personnel forthe operation of the product certification system andschemes, see clause 4.2j) of ISO/IEC Guide 65. This2009-06-05 ©SANAS Page 13 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAincludes technical personnel competent for thedevelopment of the product specific criteria(explanatory documents, sampling, testing andinspection requirements, management systemselements/quality systems evaluation and certification).4.5.3 (k) Procedures for handling non-conformities and assuringeffectiveness of any corrective action or preventativeaction.4.5.3 (l) Procedures for evaluating products and implementingthe certification process including:(i)Conditions for issue retention and withdrawalof certification documents.(ii)Control over the use and application ofdocuments used in certification process.4.5.3 (m) Policy/Procedure for appeals/disputes, complaints.4.5.3 (n) Procedures for conducting internal audits based on19011.4.6 CONDITIONS AND PROCEDURES FOR GRANTING,MAINTAINING, EXTENDING, SUSPENDING ANDWITHDRAWING CERTIFICATION4.6.1 Does the certification body specify the conditions forgranting, maintaining and extending certification?Does it specify conditions under which certification maybe suspended or withdrawn.4.6.2 Does it have procedures for the above?Does it have procedures for extending or reducing thescope?Does it have procedures for re-evaluation in the eventof significant changes affecting the products design orspecification or changes in the standard or changes in:ownershipstructuremanagement of the supplier.Or for other reasons where the products compliancemay be called into question.G4.6.1Where certification is suspended, the certification bodyshall require that, during the period of suspension, thesupplier makes no misleading claims and should adviserelevant existing and potential purchasers regarding the2009-06-05 ©SANAS Page 14 of 27

ISO/IECGuideSectionF 70-06ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAstatus of certification,And ceases to use the certification mark on theproducts manufactured since the date of notification ofsuspension.A certification body shall have procedures in place toensure that a defective certified product that gave riseto suspension of certification is:- subject to corrective action including, whereappropriate, product recall- prevented, by all practical means, from beingplaced on the market after the suspension isinvoked.Note 5 of clause 14 of ISO/IEC Guide 65 also applies.4.7 INTERNAL AUDITS AND MANAGEMENT REVIEW4.7.1 Does it conduct internal audits annually covering allaspects?G4.7.1Internal audit frequency can be on the basis of a riskbases approach, and management reviews of thecertification body’s quality management system asrequired by ISO/IEC Guide 65 should be carried out atleast once each year.4.7.1(a)Does the person responsible for internal audits ensure:Persons responsible for the area audited are informedof the outcome.(b)Corrective action is taken timeously.(c)The results of the audit are documented.4.7.2 Does executive management review the quality systemannually to ensure its suitability and effectiveness?G4.7.2The records of internal audits and management reviewsshould be made available to the accreditation body onrequest.4.8 DOCUMENTATION4.8.1(a)Does the certification body make available(electronically or otherwise)Information about the authority under which it operates.(b)A documented statement on product certificationincluding rules and procedures for granting,maintaining, extending, suspending and withdrawing2009-06-05 ©SANAS Page 15 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAcertification.(c) Informative on the evaluation procedures andcertification process related to each product certificationsystem.G4.8.1The information required by clause 4.8.1c) of ISO/IECGuide 65 should clearly detail the elements included orreferred to in clause 1.2 of ISO/IEC Guide 65 and theinformation or the source of the information onnormative documents to which products are certified.4.8.1 (d) Description on how it obtains financial support andinformation on the fees charged.(e)Description of the rights and duties of applicants andsupplies of certified products including:requirementsrestrictionslimitations on use of the logo and way of referring to thecertification granted.4.8.1 (f) Information on handling complaints, appeals anddisputes.(g)A directory of certified products and their suppliers.4.8.2 Does it have procedures for controlling documentationand data?Are the procedures reviewed for adequacy?Does an index of all documents that exists with issuenumbers, amendments etc.Is the distribution of all such documents controlled?4.9 RECORDS4.9.1 Does it have a suitable record system thatdemonstrates compliance with these requirementsHave records been identified, managed and disposedof in such a manner as to ensure the integrity of theprocess and confidentiality?Are records kept for a period of at least one fullcertification cycle?4.9.2 Does the certification body have a policy andprocedures for the retaining of records for periodsconsistent with contractual, legal and other obligations?2009-06-05 ©SANAS Page 16 of 27

ISO/IECGuideSectionF 70-06ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NADoes it have a policy concerning the access of records?4.10 CONFIDENTIALITY4.10.1 Does it have adequate procedures to safeguardconfidentiality at all levels (committees etc.)Do procedures require written consent prior todisclosure?5 CERTIFICATION BODY PERSONNEL5.2 QUALIFICATION CRITERIA5.2.1 Has the certification body specified the minimumrelevant criteria for the competence of personnel?G5.2.2The term “personnel” can include individual personswho work for the certification body on a contract basis,and other external resources.G5.2.2The certification body shall be in a position to manage,control and be responsible for the performance of all itsresources and maintain comprehensive recordscontrolling the suitability of all the staff it uses inparticular areas, whether they are employees,employed on contract or provided by external bodies.The certification body shall have personnel technicallycompetent to assess the products and decide inaccordance with 4.2f) or ISO/IEC Guide 65 whether ornot to certify a product on the basis of information fromthe evaluation process, including inspection and testresults.Records should show which personnel are designatedas competent and the date of validation.5.2.2 Have the personnel involved in certification signed acontract that commits them to:a) Comply with the rules of the certification body(confidentiality, independence from commercial andother interests)b) Declare and disclose any association by them ortheir employees with any supplier or designer ofproducts where they have been assigned toevaluate them for certification?Has the certification body documented how contractedpersonnel met the above requirements?5.2.3 Do personnel records have the following information in2009-06-05 ©SANAS Page 17 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAthem?a) name and address;b) organisation affiliation and position held;c) educational qualification and professional status;d) experience and training in each field ofcertification body’s competence;e) date of most recent updating of records;f) performance appraisal.6 CHANGES IN THE CERTIFICATIONREQUIREMENTSDoes the certification body give sufficient notice toclients of any changes in certification requirements?Does it take into account the views expressed byinterested parties before deciding on the change andthe effective date of the change?6 Does the certification body verify that the supplier’simplements the necessary changes within the agreedtime periods?7 APPEALS, COMPLAINTS AND DISPUTES7.1 The certification body shall have procedures forappeals, complaints and disputes.Does the certification body:a) Keep all record of appeals, complaints and disputesand any remedial actions taken in their regard?b) Take all necessary subsequent actions?c) Document any actions taken and theireffectiveness?G7.1 Personnel, including those acting in a managerialcapacity, should not be employed to investigate anappeal, complaint or dispute if there are anyrelationships that may compromise the impartiality ofthe investigation.G7.2 Appeals, complaints and disputes represent a source ofinformation as to possible non conformity with ISO/IECGuide 65. When non conformities are identified, thecertification body should take appropriate action.2009-06-05 ©SANAS Page 18 of 27

ISO/IECGuideSectionF 70-06ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAG7.3 The Policies and procedures referred to in clause 4.2p)should ensure that all appeals, complaints and disputesare dealt with in a constructive and timely manner. Thecertification body shall have an appeals procedure thatincludes provision for the following:- an opportunity for the appellant to formallypresent its case;- ensuring the impartiality of the appeals process;- a written statement to the appellant, of the appealfindings including the reasons for the decisionsreached.The certification body shall ensure that all interestedparties are made aware, as and when appropriate, ofthe existence of the appeals procedures to be followed.8 APPLICATION FOR CERTIFICATION8.1 INFORMATION ON THE PROCEDURE8.1.1a)Does the certification body supply to the applicant;An up to date detailed description of the evaluation andcertification procedures appropriate to the specificscheme?8.1.1 b) Documents containing the requirements forcertification?c) The applicants’ rights and duties of suppliers whichhave certified products?8.1.2a)Does the certification require that a supplier;Always complies with the requirement of thecertification program?b) Makes the necessary arrangements for the conduct ofthe evaluation, including provision for examiningdocumentation and access to all areas, records andpersonnel for the process of the evaluation?c) Only makes claims regarding certification in respect ofthe scope for which certification has been granted?d) Does not use its product certification in such a manneras to bring the certification body into disrepute anddoes not make any misleading statements?e) When certification is suspended or cancelleddiscontinue all advertising matter that containsreference to certification and returns all documentationrequired by the certification body?2009-06-05 ©SANAS Page 19 of 27

F 70-06ISO/IEC ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAGuideSectionf) Uses certification only to indicate that products arecertified as being in conformity with specifiedstandards?g) Endeavors to ensure that no certificate or report is usedin a misleading manner?h) Makes sure that all references in media and advertisingcomply with the requirements of the certification body.8.1.3 Are all necessary explanations supplied when thedesired scope of certification is related to a specificsystem or type of system operated by the certificationbody?8.1.4 Does the certification provide additional applicationinformation if requested by the applicant?8.2 THE APPLICATION8.2.1 Does the certification body require a completedapplication form signed by an authorized person?a) Are the following attached to the application form;The scope of the desired certification;8.2.1 b) A statement by the applicant that they agree to complywith the requirements?8.2.2a)Does the applicant as a minimum supply the following;Corporate entity, name and legal status;b) A definition of the products to be certified, thecertification system and the standards against whicheach product is to be certified if known to the applicant.9 PREPARATION FOR EVALUATION9.1 Does the certification body prepare a plan for theevaluation activities?Does the review ensure that;a)The requirements for certification are clearly defined,documented and understood;b) Any difference in understanding between the applicantand the certification body is resolved;c) The certification body has the capability to perform thecertification based on the scope applied for.2009-06-05 ©SANAS Page 20 of 27

ISO/IECGuideSectionF 70-06ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NA9.2 Does the certification body assign appropriatelyqualified staff to do the evaluation?G9.1 Depending on the characteristics of the certificationscheme and the product requirements, the planreferenced in clause 9.2 can be either a generic planapplicable to all activities, including evaluation of thesuppliers quality system when applicable or a specificone for a particular activity or a combination of both.9.3 Does the certification body assign appropriatelyqualified staff to do the evaluation?Does the certification body have a policy that prohibitsthe assignment of staff that have been involved in theapplicant for a period greater than two (2) years afterthey have ceased the association?9.4 Is the staff performing the evaluation provided with allnecessary working documents?10 EVALUATIONDoes the certification body evaluate the productsagainst the standards covered by the scope as definedin the application and against all certification criteriaspecified in the rules of the scheme?11 EVALUATION REPORTDoes the certification body have reporting proceduresthat ensure;a)The staff appointed to evaluate the conformance ofproducts provide the certification body with a report offindings as to the conformity with all certificationfindings?b) A report on the outcome of the evaluation is given tothe applicant identifying any non conformities that haveto be cleared and the extent of any further testing orevaluation if required?Note: if the applicant can demonstrate remedial actionhas been taken to meet all requirements within aspecified time limit the certification shall repeat only thenecessary parts of the initial evaluation.12 DECISION ON CERTIFICATION12.1 Does the certification body take the decision to certifyon the basis of the information gathered during theevaluation and any other relevant information?G12.1 The information gathered during the certificationprocess should be sufficient:2009-06-05 ©SANAS Page 21 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NA- for the certification body to be able to make aninformed decision on certification;- for traceability to be available in the event, forexample, of an appeal or for planning for the nextactivity (possibly by a different person or body);- for the basis for ongoing surveillance activities toensure continued conformity with certificationrequirements.12.2 The certification SHALL not delegate the authority to forgranting, maintaining, extending, withdrawing orsuspending certification to any person or body outsidethe certification body.G12.2 Any information on which a decision is based whichcomes from any source other than the evaluationprocess should be made known to the applicant orsupplier along with information on the evaluationprocess.The applicant or supplier should be given theopportunity to comment on it.G12.3 Records should provide objective evidence to supportthe evaluation and decision.12.3 Does the certification body supply to each supplieroffering certified products formal certificationdocumentation signed by an authorized officer?Does these formal documents permit identification ofthe following:a)The name, address of the supplier whose products arecertified.b) The scope of the certification granted including asappropriate;1) the products certified, which may be identified bytype or range of products,2) the product standards or other normativedocuments to which each product or product typeis certified.3) the applicable certification scheme.2009-06-05 ©SANAS Page 22 of 27

ISO/IECGuideSectionF 70-06ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAc) The effective date of certification and the applicableterm of certification.G12.9 If there is no reference to an expiry date on thecertification document, there shall be enoughinformation on the document to readily confirm thevalidity of the certification within the relevantcertification system.12.4 Does the certification body on receipt of an applicationfor amendment to the scope already granted decidewhat, if any evaluation procedure is appropriate in orderto determine whether or not the amendment should bemade?G12.4 The person(s), who take(s) the decision ongranting/withdrawing certification within the certificationbody shall have a level of knowledge and experiencesufficient to evaluate the information obtained from theevaluation process.G12.5 Where the certification body takes account of workrelated to certification performed by another body, thecertification body shall have arrangements in place forconfirming the scope, currency and applicability of thecertification (as required by the relevant certificationscheme of the certification body) it is relying upon, andany other data pertaining to the competency of the bodyit is relying upon, before the issue of its own certification(see also clause 4.4, Note 2 of ISO/IEC Guide 65).G12.6 Certification shall not be granted till all criteria are met.Nonconformities, which raise any doubt as to theconformity to the product must be corrected and thecorrection verified by the certification body (by site visitor other appropriate forms of verification) beforecertification is granted. The nonconformities and theirresolution should be documented by the certificationbody.G12.7 For a certification document to represent accreditedcertification it should be issued by a certification body inaccordance with the conditions of its accreditation andshould unambiguously identify the accreditation bodyand the issuing certification body.Where a certification body holds more than oneaccreditation covering the scope of the certification, theaccredited certification documents should identify atleast one of the accreditation bodies.G12.8 The certification document should clarify whether aproduct, service or process is certified.2009-06-05 ©SANAS Page 23 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NA13 SURVEILLANCE13.1 Does the certification body have documentedprocedures for carrying out surveillance?G13.1 In cases where surveillance is part of the certificationsystem it should be such to give confidence thatcertification products continue to comply with thenormative documents to which they are certified.The surveillance procedures required under clause 13.1of ISO/IEC Guide 65 should include, as appropriate,testing, inspection and/or assessment of the productionand/or of the quality system etc. (see also ISO/IECGuide 67).Samples for surveillance testing should be typical ofproduction. They should be selected by, or under thecontrol of, the certification body from the factory (e.g.production, stock) or the market (e.g. distributors’ orretailers’ stock) in a manner that ensures that theimpartiality of selection made the integrity of thesamples cannot be compromised.G13.2 Surveillance requirements for a specific supplier mayvary as the supplier’s demonstrated ability to meetcertification requirements on an ongoing basis changes.In such situations, certification bodies should havedocumented procedures for adapting surveillanceactivities e.g. taking into account the complexity of theproduct, maturity of the normative documents,experience of the supplier, life cycle of the product,changing of technology.G13.3 Many techniques are available to certification bodies toconduct surveillance. These techniques may beconducted at various points and at varying frequenciesduring the design-production-distribution-sales chain.At the same time, characteristics of productionprocesses can aid or hinder ongoing conformity withcertification requirements. As a part of meeting therequirements of clause 4.2j) of ISO/IEC Guide 65,certification bodies should therefore have personnelcompetent to make appropriate choices in the designand operation of surveillance programs.G13.4 Since- surveillance plays a direct role in achieving theintended benefits from a certification system;- a wide variety of activities are available fromwhich to operate a surveillance program;2009-06-05 ©SANAS Page 24 of 27

ISO/IECGuideSectionF 70-06ITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAand- elements of a surveillance program can changeon an ongoing basis;surveillance requirements shall be considered by theparties (e.g. authorities) involved in the development ofthe scheme.13.2 Does the certification body require the supplier toinform it of any of changes such as modifications to theproduct, manufacturing process or quality system,which affects the conformity of the product?Does the certification body decide if the changesrequire further investigations?Where relevant does the certification body prohibit thesupplier from releasing such products until after all suchinvestigations have been completed?13.3 Does the certification body document its surveillanceactivities?13.4 Does the certification body periodically evaluate themarked products to confirm that they continue toconform to the standards where the certification bodyhas authorized continuing use of its mark on suchproducts?G13.5 If the certification body licenses or grants a supplier theauthorization to affix a mark on conforming products, anappropriate surveillance regime shall be established.14USE OF LICIENCES, CERTIFICATES AND MARKSOF CONFORMITY14.1 Does the certification body have proper control overownership, use and display of licenses, certificates andmarks of conformity?G14.1 The certification body should avoid using the samemark to indicate different certification systems(Products, QMS etc), and should avoid confusionbetween the meaning of its marks.The certification body can use the same corporate logoin different systems or schemes provided the marks areclearly distinguishable.14.2 Refer to ISO/IEC guide 23 for more detail regarding theuse and control of marks.G14.2 The certification body shall have documented2009-06-05 ©SANAS Page 25 of 27

F 70-06ISO/IECGuideSectionITEM TO BE CHECKED COMMENT BY ASSESSOR C NC NAprocedures for the use of the mark (see also ISO/IEC17030), and for the measures to be adopted in case ofmisuse, including false claims as to certification andfalse use of certification body marks.14.3 Does the certification body have suitable means fordealing with incorrect references to the certificationsystem or misleading use of licenses, certificates ormarks found in advertisements, catalogues etc.G14.3 If a certification body incorrectly claims accreditedstatus for certificates issued before appropriateaccreditation has been granted, the accreditation bodymay require it subsequently to withdraw them.G14.4 A certification body should have procedures to ensurethat its marks are not used in a way that may be likelyto confuse or mislead the market.G14.5 Where the certification body makes use of the mark thatis has been assigned by another body, e.g. the ownerof the mark, its agreement with that body shall ensureconformity with the intent of all sections of this clause.G14.6 The certification body should have documentedprocedures to ensure a traceable link from its mark tothe relevant certification requirements.15 COMPLAINTS TO SUPPLIERSDoes the certification body require the supplier ofcertified products to,a)Keep a record of all complaints made known to thesupplier relating to a products compliance withrequirements of the relevant standard and make themavailable to the certification body;15 b) Take appropriate action on such complaints and anydeficiencies found in products or services that effectcompliance with requirements for certification;c) Document the actions taken.2009-06-05 ©SANAS Page 26 of 27

F 70-06Signed :Lead Assessor /AssessorDate2009-06-05 ©SANAS Page 27 of 27