Gap+Analysis Iso+Guide65+ +Iafgd5+ +Iso Iec17065 (1)

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ISO Guide 65

IAF GD5

FDIS 17065 /

comments

AGENDAITEM 9.b3

EACC(12)17

Read !om "et to !i#$t% !o&' !o& See t$e 'asic!e*ui!ements o ISO #uide 65

In t$e

secondco"umn%!ead t$e

inte!+!etation+!o,ided as#uide"ines ' IAF

GD5-

Yellow

hidden discriination b! speeding "p

or dela!ing the processing o*applications.



In t$e .!d co"umn ind t$econtent o FDIS 17 065 andcomments-

4.4.1 The policies and proceduresunder which the certification bodyoperates and their administration shall

be non-discriminatory. Procedures shallnot be used to impede or inhibit accessby applicants, other than as provided forin this International Standard.

G.6.2.7To q"ali*!*or

prod"ctcerti*ication8applicantsshalldeonstrate thatthe! ha&e

responsibilit! *orens"ringthatprod"ctscon*or

with thecerti*ication

req"iree

4.4.2 The certification body shall makeits services accessible to all applicantswhose activities fall within the scope of

its operations.

4.4.3 Access to the certificationprocess shall not be conditional uponthe size of the client or membership ofany association or roup, nor shallcertification be conditional upon thenumber of certifications already issued.There shall not be undue financial orother conditions.



ISO Guide 65 IAF GD5 FDIS 17065 / comments!"T# A certification body can decline to accept anapplication or maintain a contract for certification from a clientwhen fundamental or demonstrated reasons e$ist, such as theclient participatin in illeal activities, havin a history ofrepeated non-compliances with certification%product

re&uirements or similar client related issues.

G.6.2.3 Doc"ents cited in cla"se6.2.3 o* I/0(IE1 G"ide #$ thatspeci*! the req"ireents *or theprod"ct8 and other applicablereq"ireents shall be a&ailable to theapplicant and to the p"blic onreq"est. Norati&edoc"ents sho"ld be de&eloped8&alidated and aintained b! a

process enabling technical inp"t o*the interested parties s"ch ass"ppliers8 reg"lators and "sers o* theprod"ct. alidation sho"ld beconsistent with the characteristics o*the prod"ct to be certi*ied.

G.6.2.6 Doc"ents cited in cla"se6.2.3 o* I/0(IE1 G"ide #$ incl"de

those de&

eloped b! sc

hee o

3



wners /ee de*inition o* certi*icationschee5. The schee ownerssho"ld adhere to the saeprinciples *or the de&elopent andaintenance o* the doc"ents.

7.1.2 The re&uirements aainst which the products of aclient are evaluated shall be those contained in specifiedstandards and other normative documents.

!"T# 'uidance for developin normative documentssuitable for this purpose is contained in lS"%I#( )*++*.

7.1.3 If e$planations are re&uired as to the application ofthese documents see *.). for a specific certificationscheme, they shall be formulated by relevant andimpartial persons or committees possessin thenecessary technical competence, and made available bythe certification body upon re&uest.

7.1.2 The re&uirements aainst which the products of aclient are evaluated shall be those contained in specifiedstandards and other normative documents.

!"T# 'uidance for developin normative documentssuitable for this purpose is contained in lS"%I#( )*++*.

7-1-. I* e'planations are req"ired as to theapplication o* these doc"ents see .2.75 *or aspeci*ic certi*ication schee8 the! shall be*or"lated b!rele&ant and ipartial persons or coitteespossessing the necessar! technical copetence8and ade a&ailable

4



ISO Guide 65 IAF GD5 FDIS 17065 / commentsb! the certi*ication bod! "pon req"est.

G.6.2.$ In case o* processcerti*ication8 the doc"ents cited incla"se 6.2.3 o* I/0(IE1

G"ide #$ shall clearl! identi*! theprocesses to be assessed8 therele&ant req"ireents and theethods *or assessent o*con*orit!.

G.6.7.2 Accreditation shall onl! begranted to a bod! which is a legalentit! as re*erenced in cla"se 6.7.d5o* I/0(IE1 G"ide #$8 and will becon*ined to declared scopes andlocations. The accreditation scope*or a prod"ct

certi*ication bod! sho"ld identi*! thecerti*ication schees8 prod"cts and

norati&e doc"ents "sed *or the

certi*ication.

7.1.2 The re&uirements aainst which theproducts of a client are evaluated shall be thosecontained in specified standards and other

normative documents.

!"T# 'uidance for developin normativedocuments suitable for this purpose is containedin lS"%I#( )*++*.

7-1-. I* e'planations are req"ired as tothe application o* these doc"ents see .2.75*or a speci*ic certi*ication schee8 the! shall be*or"lated b!rele&ant and ipartial persons or coittees

possessing

the necessar! technical copetence8 and adea&ailable b! the certi*ication bod! "pon req"est.

6.2.2 :egal responsibilit!The certi*ication bod! shall be a legal entit!8 or ade*ined part o* a legal entit!8 s"ch that the legalentit! can be held legall! responsible *or all itscerti*ication acti&ities. N0TE Ago&ernental certi*ication bod! is deeed to bea legal entit! on the basis o* its go&ernentalstat"s.

(omment/ The content of IA0 '12 may be partof I3A(%IA0 A2 instead4

G.6.7.6 Deonstration that acerti*ication bod! is a legal entit!8

as



req"ired "nder cla"se 6.7.d5 o*I/0(IE1 G"ide #$8 eans that i*an applicant certi*ication bod! canonl! deonstrate

it;s legal entit! stat"s within part o* alarger legal entit!8 accreditation shall

onl! be granted to the larger legal

6.2.2 :egal responsibilit!The certi*ication bod! shall be a legal entit!8 or ade*ined part o* a legal entit!8 s"ch that the legalentit! can be held legall! responsible *or all itscerti*ication acti&it ies. N0TE Ago&ernental certi*ication bod! is deeed to be

a legal entit! on the basis o* its go&ernentalstat"s.



ISO Guide 65 IAF GD5 FDIS 17065 / comments

No clear re*erence in G"ide #$ *or the IA)G"idanceG.6.7.7.

entit!. In the sit"ation where thecerti*ication bod! is part o* a largelegal entit!8 in order to p"rs"especi*ic a"dit trails and(or re&iew

records relating to the certi*icationbod!8 other *"nctions o* the largelegal entit! ight be assessed.This shall be liited to those*"nctions whose acti&ities areintended to *"l*ilthe req"ireents o* I/0(IE1G"ide #$ . G.6.7.7 Theaccreditation scope *orcerti*ication bodies a! bede*ined in ters o* categories o*prod"cts or *ailies o* norati&edoc"ents pro&ided the prod"ctcerti*ication bod! has a pro&encapabilit! as a prod"ct certi*ierand deonstrate it has<- access to copetent personnel *or

the

coplete categor! o* prod"cts- the technical abilit! to de&elop8

e'tend

or odi*! certi*ication schees- proced"res *or the &alidation o*these e'tended or odi*iedschees.

(omment/ The content of IA0 '12 may bepart of I3A(%IA0 A2 instead4

6.7. G.6.7.$ The part o* the legal entit!that *ors the act"al certi*icationbod! a! trade be identi*ied5



"nder a distincti&e nae8 whichsho"ld appear on theaccreditation certi*icate andcerti*icates iss"ed to certi*iedorgani>ations.

6.7.e as abo&e G.6.7. I* the certi*ication bod!and its client are both part o*go&ernent8 the two bodies shallnot directl! report to a



ISO Guide 65 IAF GD5 FDIS 17065 / commentsperson or gro"p ha&ingoperational responsibilit! *orboth. The certi*ication bod!shall8 in &iew o* the ipartialit!

req"ireent8 be able todeonstrate how it deals with acase where both itsel* and itsclient are part o* go&ernent.The certi*ication bod! shalldeonstrate that the applicantrecei&es no ad&antage and thatipartialit! is ass"red.

6.7 G.6.7.7# 1la"se 6.7.*5 o*I/0(IE1 G"ide

#$ req"ires that each decision oncerti*ication is ta?en b! apersons5 di**erent *ro those

who carried o"t the e&al"ation.Testing and inspection8 aongothers8 are e&al"ation tas?s.E&al"ation tas?s incl"de the&eri*ication o* an! correcti&e

actions ta?en toaddress an! noncon*orities

identi*ied.

7.6.2 The certification body shall assin atleast one person to make the certificationdecision based on all information related to the

evaluation, its review, and any other relevantinformation. The certification decision shall becarried out by a person or roup of personse.. a committee, see 2.).5 which has notbeen involved in the process for evaluation*.5.

!"T# The review and certificationdecision can be completed concurrently bythe same person or roup of persons.

6.7 G.6.7.32 The rights entioned incla"se



6.7.g5 a! incl"de a contract with the schee owner or an!other recognition established"nder the schee r"les.

6.7 G.6.7.2# The req"ireent *or*inancial stabilit! re*erred to incla"se 6.7.i5 req"ires thecerti*ication bod! to deonstratethat it has a reasonablee'pectation o* being able topro&ide and to contin"e topro&ide the ser&ice inaccordance with its contract"alobligations. 1erti*ication bodies

are

(omment/ !o correspondin re&uirementin the new standard.

4.3.2 The certification body shall have thefinancial stability and resources re&uired for its

operations.



ISO Guide 65 IAF GD5 FDIS 17065 / commentsresponsible *or pro&iding theaccreditation bod! with s"**iciente&idence to deonstrate &iabilit!8e.g. anageent reports or

in"tes8 ann"al reports8 *inanciala"dit reports8 *inancial plans.

6.7.@5 G.23.3 Man! techniq"es area&ailable to certi*ication bodies tocond"ct s"r&eillance.

These techniq"es a! be

cond"cted at

&ario"s points and at &ar!ing*req"encies d"ring the design-prod"ction-distrib"tion-saleschain. At the sae tie8characteristics o* prod"ctionprocesses can aid or hinderongoing con*orit! withcerti*ication req"ireents. As apart o* eeting the req"ireents

o* cla"se 6.7.@5 o* I/0(IE1 G"ide#$8 certi*ication bodies sho"ldthere*ore ha&e personnelcopetent to a?e appropriatechoices in the design andoperation o* s"r&eillance



progras.6.7 (omment/ !o correspondin re&uirement in

the new standard.

6.7 G.6.7.37 The eans b! whichthe certi*ication bod! obtains*inancial s"pport sho"ld bes"ch to allow the certi*icationbod! to retain its

(omment/ !o re&uirement directly coversthis specific uidance.



ISO Guide 65 IAF GD5 FDIS 17065 / commentsipartialit!.

G.6.7.2 I* the decision toiss"e or withdraw certi*ication

in accordance with cla"se6.7.n5 o* I/0(IE1 G"ide #$ ista?en b! a coitteecoprising8aong others8 representati&es*ro one or ore clients8 theoperational proced"res o* thecerti*ication bod! sho"ld ens"rethat theserepresentati&es do not ha&e a

signi*icant in*l"ence on decision

a?ing. This can 8 *or e'aple8be ass"red b!the distrib"tion o* &oting rightsor soe other eq"i&alenteans.

6.7.o G.6.7.29 1ons"ltanc! ser&ices

on atters that are barriers to certi*ication wo"ld be participation in an acti&e creati&e

anner in the de&elopent andongoing

onitoring(ip

ro&een



t o* the prod"ct8 process8 orser&ice. b!8 *or e'aplea5 pro&iding speci*ics"pport(ad&ise on eleents o*the design.b5 preparing or prod"cingan"al8 handboo?s orproced"res.c5 in&ol&eent in the s"pplier;sonitoring 8 re&iew anddecision a?ing processapplicable to the prod"ct..

5.1.4 The certification body shall have formalrules for the appointment, terms of referenceand operation of any committees that areinvolved in the certification process see *.Such committees shall be free from anycommercial, financial and other pressures thatmiht influence decisions. The certificationbody shall retain authority to appoint andwithdraw members of such committees

(omment/ The aspect of 6balance ofinterests7 has not been taken over from'uide 82 to the new standard. 0urthermoredetails in the uidance are not taken in.

3.2 consultancy

participation in/

a desinin, manufacturin, installin,maintainin or distributin of a certifiedproduct or a product to be certified9 or

b desinin, implementin, operatin ormaintainin of a certified process or aprocess to be certified9 or

c desinin, implementin, providin ormaintainin of a certified service or a

service to be certified

and

5..8 e offer or provide manaement systemconsultancy :.: of IS"%I#( )*+)/+))



or internal auditin to its clients where the certification scheme re&uires the



ISO Guide 65 IAF GD5 FDIS 17065 / commentsevaluation of the client;s manaementsystem.

(omment/ the details of the uideline notcovered in the new standard.

6.7.o G.6.7.76 1erti*ication bodies shalldeonstrate how the! anagetheir certi*ication b"siness andan! other acti&ities so as toeliinate act"al con*lict o* interestand inii>e an! identi*ied ris? to

ipartialit!. The deonstrationshall co&er all potential so"rces o*con*lict o* interest8 whether the!arise *ro within the certi*icationbod! or *ro the acti&ities o*related bodies. Accreditation

bodies

wille'pectc

erti*ic



ation bodies to open "p theseprocesses *or a"dit. This a!incl"de8 to the e'tent practicableand @"sti*ied8 p"rs"it o* a"dit trailsto re&iew records o* both thecerti*ication bod! and its relatedbod! *or the acti&it! "nder

consideration. In considering thee'tent o* s"ch a"dit trails acco"ntsho"ld be ta?en o* the certi*icationbod!;s histor! o* ipartialcerti*ication. I* e&idence o* *ail"reto aintain ipartialit! is *o"ndthere a! be a need to e'tend thea"dit trail bac? into related bodiesto pro&ide ass"rance that controlo&er potential

6.7.3 The certi*ication bod! shall identi*!ris?s to its ipartialit! on an ongoing basis.This shall incl"de those ris?s that arise *ro itsacti&ities8 *ro its relationships8 or *ro therelationships o* its personnel see 6.7.275.owe&er8 s"ch relationships a! notnecessaril! present a certi*ication bod! with a

ris? to ipartialit!.N0TE 2 A relationship presenting a ris? toipartialit! o* the certi*ication bod! can bebased on ownership8 go&ernance8 anageent8personnel8 shared reso"rces8 *inances8contracts8 ar?eting incl"ding branding58 andpa!ent o* a sales coission or otherind"ceent *or the re*erral o* new clients8 etc.N0TE 7 Identi*!ing ris?s does notipl! ris? assessents to I/0 32444.

6.7.6 I* a ris? to ipartialit! is identi* ied8the certi*ication bod! shall be able todeonstrate how it eliinates or inii>ess"ch ris?. This in*oration shall be adea&ailable to the echanis speci*ied in $.7.

(omment/ The latter part of '.5..5 relatesto openness and A< activities which are notcovered by the new standard.



ISO Guide 65 IAF GD5 FDIS 17065 / commentscon*licts o* interest hasbeen re- established.

6.7.o G.6.7.7$ The req"ireents o*cla"se 6 and cla"se $.7.7 o*

I/0(IE1 G"ide #$ ean thatpersonnel8 incl"ding those actingin a anagerial capacit!8 sho"ldnot be eplo!ed to cond"ct ane&al"ation as part o* thecerti*ication process i* the! ha&ebeen in&ol&ed in acti&ities asdescribed "nder cla"se6.7.o5 o* I/0(IE1 G"ide #$in&ol&ing the applicant or s"pplierin q"estion8 or an! bod! related tothe s"pplier8 see G.6.7.748 withinthe last two !ears. /it"ations s"chas an eplo!ee;s c"rrent orpre&io"s in&ol&eent at an! tie

with the s"pplier being e&al"ateda! present a con*lict o* interest.

The certi*ica

tion bod! h

as a re



sponsibilit! to identi*! ande&al"ate s"ch sit"ationsand to assign responsibilitiesand tas?s so as to ens"re thatipartialit! is not coproised.

6.7.o re* 2st sentence5 G.6.7.79 The certi*ication bod!sho"ld be responsible *or

ens"ring that neither relatedbodies8 nor s"b-contractors8 nore'ternal assessors(a"ditorsoperate in breach o* the"nderta?ings that the! ha&e gi&en.It sho"ld also be responsible *oripleenting appropriatecorrecti&e action in the e&ent thats"ch a breach is identi*ied.

4.2.10 =ithin a period specified by thecertification body, personnel shall not be used toreview or make a certification decision for aproduct for which they have providedconsultancy :..

!"T# ) The period can be specified in

the certification scheme or, if specified by thecertification body, it should reflect a period thatis lon enouh so that the review or decisiondoes not compromise impartiality. A specifiedperiod of two years is often used.

!"T# 0or the evaluation personnelfurther impartiality re&uirements are stipulatedin clause 8 of this International Standard andadditional re&uirements can be found in otherrelevant standards mentioned in 8..) and8...)

4.2.11 The certification body shall takeaction to respond to any risks to its impartialityarisin from the actions of other persons, bodiesor oranizations of which it becomes aware.

(omment/ The 6-year uideline7 is not takeninto the new standard. !or is the uideline;saspect of supplier>s related bodies.

4.2.11 The certification body shall takeaction to respond to any risks to its impartialityarisin from the actions of other persons, bodiesor oranizations of which it becomes aware.

(omment/ The new standard does not address



the uideline relatin to responsibility for ensuring that 6breach of undertakins7 does not occur.




G.6.3.2 The certi*ication bod!"st be able to deonstrate tothe accreditation bod! that allcon*orit! assessent acti&ities itcond"cts testing8 inspection8q"alit! anageent s!stee&al"ation8 s"r&eillance etc.5 arecarried o"t in a copetent andreliable anner consistent withthe applicable req"ireents o* thenorati&e doc"ents *or theseacti&ities. Deonstration o* thecopetence o*the testing acti&it! a! be basedon a doc"ented e&al"ation

per*ored b! internal or e'ternalcopetent personnel accordingto appropriate proced"res. I* thee&idence s"pplied b! thecerti*ication bod! does notpro&ide con*idence in the testing

acti&it!8 addit

ional



assessent at the testinglocation sho"ld be considered b!the accreditation bod!. The saeis

6.2.1 Internal resourcesBhen a certi*ication bod! per*ors e&al"ation

acti&ities

either with its internal reso"rces or with otherreso"rces "nder its direct control it shall eetthe applicable req"ireents o* the rele&antInternational /tandards and8 as speci*ied b! the

certi*ication schee8 o* other doc"ents. Therele&ant International /tandards incl"de *ortesting I/0(IE1 247$8 *or inspection I/0(IE12474 and *or anageent s!ste a"ditingI/0(IE1 2472.The ipartialit! req"ireents o* thee&al"ation personnel stip"lated in therele&ant standard shall alwa!s beapplicable.

!"T# #$amples of reasons why some

re&uirements are not applicable include/

- e$pertise is available within the certificationbody when usin the results of the evaluationactivity9

- the e'tent o* control the certi*icationbod! has o&er testing incl"ding

witnessing the testing58 inspection e.g.speci*!ing inspection ethods orparaeters5 or anageent s!ste




applicable to other con*orit!assessent acti&ities. )ors"bcontracted acti&ities seeG.6.6.75.

assessent e.g. req"iring speci*ic details o* aanageent s!ste5.

- a partic"lar req"ireent is co&ered in aeq"i&alent wa! b! this International

/tandard8 or not needed to gi&e con*idencein the certi*ication decision.

6.3 G.6.3.7 %eq"ireents o* speci*iccerti*ication schees shall bea&ailable to the applicant and onreq"est to the p"blic. These a!incl"de doc"ents de*iningacti&ities s"ch as sapling8testing8 inspection8 s"r&eillanceand assessent o* an associated

anageent s!ste asappropriate. /chee doc"entssho"ld be de&eloped andaintained b! a process thatta?es into acco"nt the &iews o*the interested parties.

5.8 Publicly available information Thecertification body shall maintain throuhpublications, electronic media or other meansand make available on re&uest, the followin/a information about or reference tothe certification schemes, includin evaluationprocedures, rules and procedures forrantin, maintainin, e$tendin or reducin

the scope of,suspendin, withdrawin or refusincertification9

(omment/ The re&uirements on publicinformation are not as detailed as theuideline

6.3 as abo&e G.6.3.3 Doc"ents cited incla"se 6.3 incl"de those

de&eloped b! schee owners/ee de*inition o* certi*icationschee in G.3.25.E'aples o* t!picalcopleentar! req"ireents *roschees owners are<



C req"ireents on a"ditorq"ali*ication8

e'perience8 training andregistration

C req"ireents on a"ditreports

C req"ireents on d"ration

and*req"enc! o* the

a"ditsC other g"idance to certi*icationbodies *or con*orit! assessentproced"re

s.




G.6.6.3 E&al"ation o* the reportand the decision on certi*icationshall be ade onl! b! thecerti*ication bod! itsel*8 and not

b! an! other bod!. Bhere @ointe&al"ations are "nderta?en8 eachcerti*ication bod! shall satis*!itsel* that the whole o* thee&al"ation has been satis*actoril!"nderta?en b! copetentpersonnel.Indi&id"als wor?ing "nder *oralagreeent *or the certi*icationbod!8 within the accrediteds!stes8 and "nder the

a"thorit! and control o* the 1anageent are not deeed tobe s"b contractors.

6.2.2.4 The certification bodyshall/

d) take responsibility for all activitiesoutsourced to another body;

e ensure that the body that providesoutsourced services, and the personnel thatit uses, are not involved, either directly orthrouh any other employer, in such a waythat the credibility of the results could becompromised9

f have documented policies, procedures andrecords for the &ualification, assessin andmonitorin of all bodies that provideoutsourced services used for certificationactivities9

maintain a list of approved providers ofoutsourced services9

h implement corrective actions for anybreaches of the contract in 8...: or otherre&uirements in 8.. of which it becomesaware9 and

i inform the client in advance of outsourcinactivities, to provide the client anopportunity to ob?ect.

!"T# If the &ualification, assessin andmonitorin of the bodies which provide



outsourced services is performed by other oranisations such as accreditationbodies, peer assessment bodies or overnmental authorities, the certificationbody can take this &ualification and monitorin into account provided that/

? it is provided for within the scheme re&uirements

? the scope is applicable to the work bein

undertaken9

and




? the validity of the &ualification, assessin

and monitorin arranements is verified at a

periodicity determined by the certification body.

7.5

Review7.5.1 The certification body shall assin at least oneperson to review all information and results related tothe evaluation. The review shall be carried out bypersons which have not been involved in theevaluation process.

7.5.2 @ecommendations for a certification decisionbased on the review shall be documented unless reviewand certification decision are completed concurrently bythe same person.

7.6 Certification decision7.6.1 The certification body shall be responsible for

and shall retain authority for its decisions relatinto certification.

.#.3 The persons5 e'cl"ding eberso* coittees see $.2.65 assigned b! thecerti*ication bod! to a?e a certi*ication decisionshall be eplo!ed b! or "nder contract with- the certi*ication bod!

#.25 or

- an entit! "nder the organi>ational control

o* the certi*ication bod! .#.65

.#.6 A certi*ication bod!;sorgani>ational control shall be<- whole or a@orit! ownership o* another entit!

27




- doc"ented a"thorit! b! the certi*ication bod!

o&er

another entit! in a networ? o* legal entities in which the certi*ication bod! resides5 lin?ed b!ownership or oard o* Directors control.

N0TE 8)or go&ernental certi*icat ionbodies other parts o* the sae go&ernent canbe considered as Flin?ed b! ownershipF to thecerti*ication bod!.

.#.$ The persons eplo!ed b! or "ndercontract with entities "nder organisational controlshall *"l*il the sae req"ireents o* thisInternational /tandard8 as persons being "ndereplo!ent or contract with the certi*icationbod!.

G.6.6.2 A certi*ication bod! a!

s"bcontract wor? to another bod!e.g. testing or inspection or q"alit!anageent s!ste e&al"ation58pro&ided that the arrangeent withthe s"bcontracted bod! req"ire it tocopl! with all the rele&antreq"ireents o* I/0(IE1 G"ide #$and where applicable8 I/0(IE1247$ and 2474 and I/0(IE1

G"ide #7.I* this ass"rance is based partl! orin *"ll on the accreditation o* thes"bcontractor8 the scope o*accreditation sho"ld co&er theacti&ities to be carried o"t "nder

4.2.12 All certification body personnel, either internal or e$ternal, or committees, who could influence thecertification activities, shall act impartially.

6.2.2.1 The certification body shall outsourceevaluation activities only to bodies that meet theapplicable re&uirements of the relevant InternationalStandards and, as specified by the certification schemeof other documents. The relevant InternationalStandards include for testin IS"%I#( )*+2, forinspection IS"%I#( )*++ and for manaement system

auditin IS"%I#( )*+).The impartiality re&uirements of the evaluationpersonnel stipulated in the relevant standard shallalways be applicable.!"T# ) #$amples of reasons why some re&uirements arenot applicable include/

28




as the user of the results of the evaluationactivity9

- the e$tent of control the certification body has over testinincludin witnessin the testin, inspection e.. specifyininspection methods or parameters or manaement system

assessment e.. re&uirin specific details of a manaementsystem.

- a particular re&uirement is covered in a e&uivalent way bythis international standard, or not needed to ive confidencein the certification decision

!"T# This can include outsourcin to other certificationbodies. se of e$ternal personnel under contract is notoutsourcin.

!"T# : 0or the purposes of this International Standard,the terms 6outsourcin7 and 6subcontractin7 are consideredto be synonyms.

6.2.2.2 =here evaluation activities are outsourced tonon independent bodies e.. client laboratories, thecertification body shall assure that the evaluationactivities are manaed in a manner which providesconfidence in the results, and that records are availableto ?ustify the confidence.

6.2.2.3 The certification body shall have a leallybindin contract with the body that provides theoutsourced service, includin confidentiality and

conflict of interests as described in 8.).: c.

6.2.2.4 The certification bodyshall/

b ensure that the body that provides outsourced

.

29



ISO Guide 65 IAF GD5 FDIS 17065 / commentsemployer, in such a way that the credibility of theresults could be compromised9

c have documented policies, procedures and records forthe &ualification, assessin and monitorin of all bodiesthat provide outsourced services used for certificationactivities9

!"T# If the &ualification, assessin and monitorin of thebodies which provide outsourced services is performed by otheroranisations such as accreditation bodies, peer assessmentbodies or overnmental authorities, the certification body can takethis &ualification and monitorin into account provided that/

? it is provided for within the scheme re&uirements

? the scope is applicable to the work bein undertaken9

and

? the validity of the &ualification, assessin and

monitorin arranements is verified at a periodicity

determined by the certification body.

G.6.6.7 I* the s"bcontracted bodies

eplo!ed are not accreditedaccording to the rele&ant standard *orthe speci*ic acti&ities req"ired b! thecerti*ication schees8 the certi*icationbod! shall deonstrate the

copetenceo*thes"

30



bcontracted bod! b! other eans8s"ch as doc"ented e&al"ationper*ored b! q"ali*ied personnelaccording to appropriate proced"resthat incl"des an initial e&al"ation

6-2-2-c5 ha&e doc"ented policies8 proced"res andrecords *or the q"ali*ication8 assessing andonitoring o* all bodies that pro&ide o"tso"rcedser&ices "sed *or certi*ication acti&ities

31




G.6.6.6 Bhere independent testing

*acilities are not "tili>ed8 the

certi*ication bod! shall ens"re thatspeci*ied controls are in place atthe s"pplier;s testing *acilities8 thatthe! are anaged in a anner which pro&ides con*idence in theres"lts obtained*ro the tests8 and that recordsare a&ailable to @"sti*! thecon*idence. In this case thepro&isions o* G.6.6.2 and(or G 6.6.7 also appl! anddepending on the e'tent o* controlsiposed b! the certi*ication bod!soe req"ireents o* I/0(IE1247$ a! not be req"ired orapplicable. The sae is applicableto other con*orit! assessentacti&ities.

6.2.2.2 =here evaluation activities are outsourcedto

non independent bodies e.. client laboratories, thecertification body shall assure that the evaluationactivities are manaed in a manner which providesconfidence in the results, and that records are availableto ?ustify the confidence.

6.2.2.1

N0TE 2 E'aples o* reasons wh!soe req"ireents are not applicableincl"de<- e$pertise is available within the certification body whenusin as the user of the results of the evaluation activity9

- the e$tent of control the certification body has over testinincludin witnessin the testin, inspection e.. specifyininspection methods or parameters or manaement systemassessment e.. re&uirin specific details of a manaementsystem.

- a particular re&uirement is covered in a e&uivalent way bythis international standard, or not needed to ive confidencein the certification decision



G.6.6.$ Note 7 describes a sit"ation

where the certi*ication bod! will bereliant on the wor? o* anotherbod!. /"ch reliance needs to be

7.3.5 If the certification body relies on certifications ithas already ranted to the client or has already rantedto other clients to omit any activities, then thecertification body shall reference the e$istincertifications in its records. If re&uested by the client,



ISO Guide 65 IAF GD5 FDIS 17065 / commentsa technical e&al"ation o* the wor?"nderta?en. /"ch an e&al"ation shallbe doc"ented b! the certi*icationbod!.

shall provide ?ustification for omission of activities.

7.4.5 The certification body shall only rely onevaluation results related to certification completed prior tothe application for certification where it takes responsibilityfor the results and satisfies itself that the body thatperformed the evaluation fulfils the re&uirementscontained in 8.. and those specified by the certificationscheme.

G.6.6.$ 1ontin"ed

Note 3 describes a sit"ation where thecerti*ication bod! will be reliant on the wor? or on a certi*ication o* another

certi*ication bod!. It sho"ld there*oreens"re that in*oration on an!e&al"ation wor? on which it relies is"pdated as appropriate. In cases wherethe certi*ication bod! ta?es into acco"nt wor? pre&io"sl! per*ored b! anothercerti*ication bod! it shall ha&e allrele&ant reports and records todeonstrate the copetence and thecon*orit! with the req"ireentsestablished b! the certi*ication bod!5 o*the other certi*ication bod! *or the

period o* tie when the wor? wascarried o"t.



ISO Guide 65 IAF GD5 FDIS 17065 / commentsG.6.$.2 1la"se 6.$.3.i5 o* I/0(IE1G"ide#$ req"ires the certi*ication bod! toonitor the per*orance o* its ownpersonnel. In addition to other

ethods o* onitoring per*orance8pro&ision sho"ld be ade8 whereapplicable8 *or the periodic witnessingo* those acti&ities norall! "nderta?enb! it;s personnel at s"pplier ands"bcontractor sites.

6.1.2.1 The certification body shall establish,implement and maintain a procedure for manaement ofcompetencies of personnel involved in the certificationprocess see *. The procedure shall re&uire thecertification body to/

e5 onitor the per*orance o* thepersonnel

(omment/ !othin stated about witnessin in the newstandard.

(omment/There is no correspondin re&uirement inthe new standard.

G.6.#.2 Bhere certi*ication iss"spended8 the certi*ication bod!shall req"ire that8 d"ring the periodo* s"spension8 the s"pplier a?es noisleading clais and sho"ld ad&iserele&ant e'isting and potentialp"rchasers regarding the stat"s o*certi*ication8 and ceases to "se thecerti*ication ar? on the prod"ctsan"*act"red since the date o*noti*ication o* s"spension.

A certi*ication bod! shall ha&e

7.6.2 The certification body shall assin at least oneperson to make the certification decision based on allinformation related to the evaluation, its review, and anyother relevant information. The certification decision shallbe carried out by a person or roup of persons e.. acommittee, see 2.).5 which has not been involved in theprocess for evaluation *.5.

!"T# The review and certification decision can becompleted concurrently by the same person or roup ofpersons.

7.11.1 =hen a nonconformity with certificationre&uirements is substantiated, either as a result of

35



surveillance or otherwise, the certification body shall

36



ISO Guide 65 IAF GD5 FDIS 17065 / commentsproced"res in place to ens"re that ade*ecti&e certi*ied prod"ct that ga&erise to s"spension o* certi*ication is<C /"b@ect to correcti&e actionincl"ding8 where appropriate8 prod"ct

recallC re&ented8 b! all practical eans8*ro being placed on the ar?eta*ter the s"spension is in&o?ed.Note $ o* cla"se 26 o* I/0(IE1 G"ide#$ also applies. I.e.<

consider and decide upon the appropriate action.

N0TE Appropriate action canbe<a5 contin"ation o* certi*ication "nder

conditions speci*ied b! the certi*ication bod!8e.g. increased s"r&eillance8b5 red"ction in the scope o* the certi*ication toreo&e noncon*oring prod"ct &ariants8c5 s"spension o* the certi*ication pendingreedial action b! the client8d5 withdrawal o* thecerti*ication.

7.11.2 =hen the appropriate action includes evaluation,review or certification decision, the re&uirements in *.5,*.2 or *.8 shall be fulfilled.

7.11.3 If certification is terminated by re&uest of theclient, suspended or withdrawn, the certification body shalltake actions specified by the certification scheme and shallmake all needed modifications to formal certificationdocuments, public information, authorizations for use ofmarks, etc. to ensure it provides no indication that theproduct continues to be certified. If a scope of certificationis reduced the certification body shall take actionsspecified by the certification scheme and shall make allneeded modifications to formal certification documents,public information, authorizations for use of marks, etc. toensure the reduced scope of certification is clearly

communicated to the client and clearly described incertification documentation and public information.

7.11.4 If certification is suspended, the certification bodyshall assin one or more persons to formulate andcommunicate to the client/




? actions needed to end suspension and restorecertification for the products in accordance withthecertification scheme9 and

? any other actions re&uired by thecertification scheme.

These persons shall be copetent in their?nowledge and "nderstanding o* all aspects o*the handling o* s"spended certi*ications #.25.

7.11.5 Any evaluations, reviews or decisions needed toresolve the suspension or that are re&uired by thecertification scheme shall be completed in accordancewith the applicable parts of sub clauses *.5, *.2, *.8,*.*.: and *.B and*.)).:

7.11.6 If certification is reinstated after suspension thecertification body shall make all needed modifications toformal certification documents, public information,authorizations for use of marks, etc. to ensure allappropriate indications e$ist that the product continuesto be certified. If a decision to reduce the scope ofcertification is made as a condition of reinstatement, thecertification body shall make all needed modifications toformal certification documents, public information,authorizations for use of marks, etc. to ensure thereduced scope of certification is clearly communicatedto the client and clearly described in certification

documentation and public information.

38




39



4.6 Publicly available informationThe certification body shall maintain

throuh publications, electronic media or othermeans and makeavailable on re&uest, the followin/

a information about or reference to the certificationschemes, includin evaluation procedures, rules

and procedures for rantin, maintainin,e$tendin or reducin the scope of, suspendin,withdrawin or refusin certification9

b a description of the means by which thecertification body obtains financial support andeneral information on the fees chared toapplicants and to clients9

c a description of the rihts and duties of applicantsand clients, includin re&uirements, restrictions orlimitations on the use of the certification bodyCsname and certification mark and on the ways ofreferrin to the certification ranted9

d information about procedures forhandlin complaints and appeals.

(omment/ There is no correspondin re&uirement inthe new standard.

6.H.2 . . . 6.#

a information about or reference to the certificationschemes, includin evaluation procedures, rulesand procedures for rantin, maintainin,

e$tendin or reducin the scope of, suspendin,

. . .

40



ISO Guide 65 IAF GD5 FDIS 17065 / commentsthe so"rce o* the in*oration onnorati&e doc"ents to whichprod"cts are certi*ied.

refusin certification9

G.$.7.7 The ter +personnel, canincl"de indi&id"al persons who wor?*or the certi*ication bod! on a contractbasis8 and other e'ternal reso"rces.The certi*ication bod! shall be in aposition to anage8 control and beresponsible *or the per*orance o* allits reso"rces and aintaincoprehensi&e records controllingthe s"itabilit! o* all the sta** it "ses inpartic"lar areas8 whether the!

are eplo!ees8 eplo!ed on contractor pro&ided b! e'ternal bodies.

The certification body shall have

#.2.2.7 The personnel shall be copetent *orthe *"nctions the! per*or8 incl"ding a?ingreq"ired technical @"dgents8 de*ining policies andipleenting the.

(omment/ The details of the uidelines are nottaken into the standard.

41



personnel

assess the products and decide accordance with 4.2 f) of ISO/IE

!uide

"# whether or not to certify a product on the basis of informationfrom the evaluation process$includin% inspection and testresults. %ecords sho"ld show

which personnel are designated ascopetent and the dateo* &alidation.

G.27.6 The persons58 whota?es5 the decision ongranting(withdrawing

42




e

G.$.7.2 The certi*ication bod! shall

h6.1.1.1 The certification body shall employ or have



ha&e

s"**icient personnel *or theoperation o* the prod"ctcerti*ication s!ste and schees8see cla"se 6.7.@5 o* I/0(IE1 G"ide#$. This incl"des technicalpersonnel copetent *or the

de&elopent o* the prod"ctspeci*ic criteria e'planator!doc"ents8 sapling8 testing andinspection req"ireents8anageent s!steseleents(q"alit! s!stese&al"ationand certi*ication5.

6.1.1.1 The certification body shall employ or haveaccess to a sufficient number of personnel to cover itsoperations related to the certification schemes and tothe applicable standards and other normativedocuments.

!"T# The personnel include those normally workin forthe certification body as well as persons workin underindividual contract or a formal areement which places them

within the manaement control and systems%procedures of thecertification body 8.).:.

6.1.1.2 The personnel shall be competent for thefunctions they perform, includin makin re&uiredtechnical ?udments, definin policies and implementinthem.

6.1.2.1 The certification body shall establish,implement and maintain a procedure for manaementof competencies of personnel involved in thecertification process see *. The procedure shallre&uire the certification body to/

a) deterine the criteria for the copetence ofpersonnel for each function in the certificationprocess takin! into account the re"uireentsof the schees;

b identify trainin needs and provide, as necessary,trainin prorammes on certification processes,re&uirements, methodoloies, activities and otherrelevant certification scheme re&uirements9




c demonstrate that the personnel have the re&uiredcompetencies for the duties and responsibilitiesthey undertake9

d formally authorize personnel for functions in thecertification process9

e monitor the performance of the personnel

G.6.7.7$ The req"ireents o*

cla"se 6 6.1.3 Contract wit te !ersonnel



cla"se 6

and cla"se $.7.7 o* I/0(IE1G"ide #$ ean that personnel8incl"ding those acting in aanagerial capacit!8 sho"ld notbe eplo!ed to cond"ct ane&al"ation as part o* the

certi*ication process i* the! ha&ebeen in&ol&ed in acti&ities asdescribed "nder cla"se6.7.o5 o* I/0(IE1 G"ide #$ in&ol&ing

the

applicant or s"pplier in q"estion8 oran! bod! related to the s"pplier8see G.6.7.748 within the last two!ears. /it"ations s"ch as aneplo!ee;s c"rrent or pre&io"sin&ol&eent at an! tie with the s"pplier being e&al"ateda! present a con*lict o* interest.The certi*ication bod! has aresponsibilit! to identi*! ande&al"ate s"ch sit"ations

6.1.3 Contract wit te !ersonnel

The certi*ication bod! shall req"ire personnelin&ol&ed in the certi*ication process to sign acontract or other doc"ent b! which the! coitthesel&es to<a comply with the rules defined by the

certification body, includin those relatin to

confidentiality see5.2 and independence from commercial and otherinterests9

b declare any prior and%or present association ontheir own part, or on the part of their employer,with/

) a supplier or desiner of products, or

a provider or developer of services, or

: an operator or developer of processes

to the evaluation or certification of which they areto be assined9 and

c reveal any situation known to them that may present





(ertification bodies shall use this information as input toidentifyin risks to impartiality raised by the activities ofsuch personnel or by the oranizations that employthem see 5..:.

4.2.10 =ithin a period specified by the certification

body, personnel shall not be used to review or make acertification decision for a product for which they haveprovided consultancy :..

!"T# ) The period can be specified in thecertification scheme or, if specified by the certificationbody, it should reflect a period that is lon enouh sothat the review or decision does not compromiseimpartiality. A specified period of two years is oftenused.

!"T# 0or the evaluation personnel furtherimpartiality re&uirements are stipulated in clause 8 of

this International Standard and additional re&uirementscan be found in other relevant standards mentioned in8..) and 8...)

1oent< Details o* the g"idance related toper*oring e&al"ation are not ta?en into the newstandard8 co"ld appl! to e.g. 1erti*ication o**icersanaging e.g.planning(ordering(coordinating(e&al"ating5 thereq"ired testing8 inspection and a"diting acti&ities witho"t er*orin these hi-(hersel*.




7.10.1 =hen the certification scheme introduces newor revised re&uirements that affect the client thecertification body shall ensure these chanes arecommunicated to all clients. The certification body shallverify the implementation of the chanes by its clients

and shall take actions re&uired by the scheme.

!"T# (ontractual arranements with clients canbe necessary to ensure implementation of thesere&uirements. A model of a license areement for the use ofcertification, includin the aspects related to a notice ofchanes, as far as applicable, can be found in Anne$ # ofIS"%I#( 'uide D/++5.

+ ,

G..2 ersonnel8 incl"ding those

acting7.13.1 The certification body shall have a documentedprocess to receive evaluate and make decisions on



acting

in a anagerial capacit!8 sho"ldnot be eplo!ed to in&estigatean! appeal8 coplaint or disp"te i*there are an! relationships thata! coproise the ipartialit!o* the in&estigation.

process to receive, evaluate and make decisions oncomplaints and appeals. The certification body shallrecord and track complaints and appeals and actionsundertaken to resolve them.

7.13.2 pon receipt of a complaint or appeal, thecertification body shall confirm whether the complaint orappeal relates to certification activities for which it is

responsible, and if so, shall address it.

7.13.3 The certification body shall acknowlede receiptof a formal complaint or appeal.

7.13.4 The certification body shall be responsible foratherin and verifyin all necessary information to thee$tent possible to proress the complaint or appeal toa decision.

7.13.5 The decision resolvin the complaint or appealshall be made by, or reviewed and approved by,persons not involved in the certification activities





to the complaint or appeal.

7.13.6 To ensure that there is no conflict of interest,personnel includin those actin in a manaerialcapacity who have provided consultancy :. for, orbeen employed by a client, , shall not be used by the

certification body to review or approve the resolution ofa complaint or appeal for that client within two yearsfollowin the end of the consultancy or employment.

1oent< The wider scope an! relationships5 o*the g"ideline is not co&ered in the new standard.The cla"se is go&erned b! I/0 A/ 24435

G..3 The policies and proced"res

re*erred to in cla"se 6.7.p5 sho"ldens"re that all appeals8 coplaintsand disp"tes are dealt with in aconstr"cti&e and tiel! anner.

The certi*ication bod! shall ha&e anappeals proced"re that incl"despro&ision *or the *ollowing<C an opport"nit! *or the appellant to*orall! present its caseC ens"ring the ipartialit! o* theappeals processC a written stateent to theappellant8 o* the appeal *indingsincl"ding the reasons *or thedecisions reached.

The certi*ication bod! shall ens"rethat all interested parties are adeaware8 as and when appropriate8 o*

the e'istence o* the appeals

7.13.7 =henever possible, the certification body shallive formal notice of the outcome and end of thecomplaint process to the complainant.

7-1.- The certi*ication bod! shall gi&e

*oral notice o* the o"tcoe and end o* theappeal process to the appellant.

1oent< /oe detail o* the g"idance notco&ered b! the new standard the cla"se isgo&erned b! I/0 A/24435




6.# "blicl! a&ailable in*oration

The certi*ication bod! shall aintain thro"ghp"blications8 electronic edia or other eans5 anda?e a&ailable on req"est8 the *ollowing<

a5 in*oration abo"t or re*erence to5 thecerti*ication schees58 incl"dinge&al"ation proced"res8 r"les andproced"res *or granting8 aintaining8e'tending or red"cing the scope o*8s"spending8 withdrawing or re*"singcerti*ication

1oent< The aspect o* +detailed description, is

not ta?en into the new standard. /ee as well

1oent< No ob&io"s corresponding te't in the

new



standard. 1la"se .2.3 coes closest b"t witho"tp"tting a req"ireent on the 1 to pro&idein*oration to the applicant.

.2.3 I* e'planat ions are req"ired as tothe application o* these doc"ents see .2.75 *or

a speci*ic certi*ication schee8 the! shall be*or"lated b!rele&ant and ipartial persons or coittees

1oent< No ob&io"s corresponding te't in the

new

standard. No req"ireent on the 1 topro&ide in*oration to the applicant onreq"est.




7.4.2 The certification body shall assin personnel toperform each evaluation task which it undertakes with



its internal resources 8..) ).

!"T# "utsourced tasks are completed by personnelusually assined by the oranization to which the task isoutsourced. Such personnel are not normally assined by thecertification body.

6-1-.1ontract with the personnel

The certi*ication bod! shall req"ire personnelin&ol&ed in the certi*ication process to sign acontract or other doc"ent b! which the! coitthesel&es to<a5 copl! with the r"les de*ined b! the certi*ication

bod!8 incl"ding those relating to con*identialit!.$.65 and independence *ro coercial andother interest b5 declare an! prior and(or presentassociation on their own part8 or on the part o*their eplo!er8 with<25 a s"pplier or designer o* prod"cts8 or

75 a pro&ider or de&eloper o* ser&ices8 or35 an operator or de&eloper o* processesto the e&al"ation or certi*ication o* which the! areto be assigned andc5 re&eal an! sit"ation ?nown to the that a!

present

the or the certi*ication bod! with a con*lict o*interests

6.75.1erti*ication bodies shall "se this in*oration asinp"t to identi*!ing ris?s to ipartialit! raised b!the acti&ities o* s"ch personnel or b! the




impartiality on an onoin basis. This shall includethoserisks that arise from its activities, from its relationships,or from the relationships of its personnel see 5..).Eowever, such relationships may not necessarilypresent a certification body with a risk to impartiality.

!"T# ) A relationship presentin a risk to impartiality ofthe certification body can be based on ownership,overnance, manaement, personnel, shared resources,finances, contracts, marketin includin brandin, andpayment of a sales commission or other inducement for thereferral of new clients, etc.

!"T# Identifyin risks does not imply risk assessmentstoIS":)+++.

4.2.4 If a risk to impartiality is identified, the

certification body shall be able to demonstrate how iteliminates or minimizes such risk. This information shallbe made available to the mechanism specified in 2..

4.2.12 All certification body personnel, either internal ore$ternal, or committees, who could influence thecertification activities, shall act impartially.

1oent< The ore direct details o* the I/0G"ide #$ req"ireent related to possible con*licto* interest in per*oring e&al"ation is not directl!co&ered in the new standard. The last paragraph

o* cla"se #.2.3 co"ld be seen as handling thisaspect in an indirect +ob&io"s, anner. The+seq"ence, o* cla"ses is long





G.27.2 The in*oration gatheredd"ring the certi*ication process sho"ldbe s"**icient<C *or the certi*ication bod! to be able to

ta?e an in*ored decision oncerti*icationC *or traceabilit! to be a&ailable in thee&ent8 *or e'aple8 o* an appeal or*or planning *or the ne't acti&it!possibl! b! a di**erent person orbod!5C *or the basis *or ongoings"r&eillance acti&ities to ens"recontin"ed con*orit! withcerti*ication req"ireents.1oent< This g"ideline is s"ggested

to

be better lin?ed with the %eportingand %e&iew acti&ities in the newstandard as copared to with ch27in I/0 G"ide #$.

No corresponding req"ireent in G"ide #$ G.27.2 The in*oration gatheredd"ring the certi*ication processsho"ld be s"**icient<C *or the certi*ication bod! to beable to ta?e an in*ored decisionon certi*ication

C *or traceabilit! to be a&ailable inthe e&ent8 *or e'aple8 o* anappeal or *or planning *or the ne'tacti&it! possibl! b! a di**erentperson or bod!5C *or the basis *or ongoings"r&eillance acti&ities to ens"re

cont

in"ed con*o

rit!

with

certi*i

cation 7.4.# The results of all evaluation activitiesshall be documented prior to review *.2.



p

!"T# ) This documentation can provideopinion whether product re&uirements includinindirect re&uirements such as those for the&uality manaement system under which theproduct is produced, if re&uired by the

certification scheme have been fulfilled.

!"T# The certification scheme shouldindicate whether the evaluation is performed bythe certification body, under its responsibility, orthe evaluation is performed prior to theapplication *. for the certification process. Inthe latter case, the re&uirements of *.5 are notapplicable.

1oent< I/0(IE1 2474 72 7$ req"ires

copletion o* reports that s"bseq"entl! are"sed b! the 1. These standards do not aloneco&er the intention o* the g"ideline.

7.5 Review7.5.1 The certification body shall assin atleast oneperson to review all information and resultsrelated to the evaluation. The review shall be

carried out by persons which have not beeninvolved in the evaluation process.

7.5.2 @ecommendations for a certificationdecision based on the review shall bedocumented unless review and certificationdecision are completed concurrently by the sameperson.




req"ireents.1oent< This g"ideline iss"ggested to be better lin?ed withthe %eporting and %e&iew acti&itiesin the new standard as copared to

with ch27 in I/0 G"ide #$.

G.27.7 An! in*oration on which adecision is based which coes*ro an! so"rce other than thee&al"ation process sho"ld beade ?nown to the applicant or

s"pplier along with in*oration onthe e&al"ation process. Theapplicant or s"pplier sho"ld begi&en the opport"nit! to coenton it.

G.27.6 The persons58 whota?es5 the decision ongranting(withdrawing certi*ication

within the certi*ication bod! shall

ha&e a le&el o* ?no

wledg

58

e and e'perience s"**icient toe&al"ate the in*orationobtained *ro the e&al"ation

4.5.3 Information about the client obtainedfrom sources other than the client e..

l i l h ll b d



obtained *ro the e&al"ationprocess.

G.27.$ Bhere the certi*icationbod! ta?es acco"nt o* wor?related to certi*ication per*oredb! another bod!8 the certi*icationbod! shall ha&e arrangeents inplace *or con*iring the scope8c"rrenc! and applicabilit! o* thecerti*ication as req"ired b! therele&ant certi*ication schee o*the

certi*ication bod!5 it is rel!ing "pon8and

complainant, reulators shall be treated asconfidential.

1oent< Depending on whether cla"se 6.$.3intends to ?eep s"ch in*oration con*idential *orthe applicant8 the intention o* the g"ideline a!

becoe totall! re@ected in the new standard. I*s"ch in*oration is to be transparent to theapplicant8 the new standard still does not co&erthe details o* the g"ideline.

1oent< The details o* the g"idance are notta?en into the new standard. /ee as well cla"se$.7 o* I/0 G"ide #$ abo&e.

7.4.5 The certification body shall only relyon evaluation results related to certificationcompleted prior to the application for certificationwhere it takes responsibility for the results andsatisfies itself that the body that performed theevaluation fulfils the re&uirements contained in8.. and those specified by the certificationscheme.

!"T# This can include work carried outunder reconition areements betweencertification bodies.

59




an! other data pertaining to thecopetenc! o* the bod! it isrel!ing "pon8 be*ore the iss"e o*its own certi*ication see alsocla"se 6.68 Note 7 o* I/0(IE1

G"ide #$5.

G.27.# 1erti*ication shall not begranted "ntil all criteria are et.Noncon*orities8 which raise an!do"bt as to the con*orit! o* theprod"ct"st be corrected and the correction

&eri*ied b! the certi*ication bod!b! site &isit or other appropriate*ors o* &eri*ication5 be*orecerti*ication is granted. Thenoncon*orities andtheir resol"tion sho"ld bedoc"ented b! the certi*icationbod!.

G.27.

)oracerti*ic

ationdoc"en

ttore

present accredited certi*ication itsho"ld be iss"ed b! a certi*icationbod! in accordance with the

1oent< The details o* the g"idance are notta?en into the new standard. /ee as wellG 6 6 $ abo&e



bod! in accordance with theconditions o* its accreditation andsho"ld "nabig"o"sl! identi*! theaccreditation bod! and the iss"ingcerti*ication bod!. Bhere acerti*ication bod! holds ore than

one accreditation co&ering thescope o* the certi*ication8 theaccredited certi*ication doc"entssho"ld identi*! at least oneo* the accreditation bodies.

G.27.H The certi*ication doc"entI/0(IE1 G"ide #$8 cla"se 27.3b525 sho"ld clari*! whether aprod"ct8 ser&ice or process iscerti*ied.

G.6.6.$. abo&e

7-7-. )oral certi*ication doc"entation.5

shall onl! be iss"ed a*ter or conc"rrent with<a the decision to rant or e$tend the

scope of certification *.8.) has beenmade9 and

b certification re&uirements bein fulfilled9 and

c the certificationareement5.). has beencompleted%sined.

1oent< The details o* the g"idance are notta?en into the new standard.

(omment/ 'uidance not taken into thenew standard.

3.1" sco!e of certification

identification of/



(IE1 G"ide #$ sho"ld incl"de8 asappropriate8 testing8 inspectionand(or assessent o* the

7.#.1 If surveillance is re&uired by thecertification scheme or as described insubclauses * B : or * B 5 the certification body



and(or assessent o* theprod"ction and(or o* the q"alit!s!ste etc. see also I/0(IE1G"ide #5. /aples *ors"r&eillance testing sho"ld bet!pical o* prod"ction. The! sho"ld

be

subclauses *.B.: or *.B.5, the certification bodyshall initiate surveillance of the productscovered by the certification decision inaccordance with the certification scheme.

!"T# ) See IS"%I#( 'uide 8* future

IS"%I#( )*+8*for e$amples of surveillanceactivities in certification schemes.

!"T# The criteria and process forsurveillance activities are defined by eachcertification scheme.

7.#.2 =hen surveillance utilizes evaluation,review or certification decision, the re&uirementsin *.5, *.2 or *.8 shall be fulfilled.

ISO Guide 65 IAF GD5 FDIS 17065 / commentsselected b! or "nder the control o*



selected b!8 or "nder the control o*8the

certi*ication bod! *ro the *actor!e.g. prod"ction8 stoc?5 or thear?et e.g. distrib"tors; orretailers; stoc?5 in a anner that

ens"res that the ipartialit! o*selection and the integrit! o* thesaple cannot be coproised.

G.23.7 /"r&eillance req"ireents*or a speci*ic s"pplier a! &ar! asthe s"pplierJs deonstrated abilit!to eet certi*ication req"ireentson an ongoing basis changes. Ins"ch sit"ations8 certi*icationbodies sho"ld ha&e doc"entedproced"res *or adapting

s"r&eillance acti&ities e.g. ta?inginto acco"nt the cople'it! o* theprod"ct8 at"rit! o* the norati&edoc"ents8 e'perience o* thes"pplier8 li*e c!cle o* the prod"ct8changing o* technolog!.

G.23.3 Man! techniq"es area&ailable to certi*ication bodies tocond"ct s"r&eillance.These techniq"es a! becond"cted at &ario"s points andat &ar!ing *req"encies d"ring thedesign- prod"ction-distrib"tion-sales chain. At the sae tie8characteristics o* prod"ctionprocesses can aid or hinder

ongo

ing con*orit!

with c

erti*

ication req"ireents. As a part o*eeting the

1oent< The details o* the g"ideline are notta?en into the new standard.



(omment/ !othin stated in the new standard.

(omment/ The new standard does not coverthe competence re&uirements mentioned inthe uideline.

ISO Guide 65 IAF GD5 FDIS 17065 / commentsreq"ireents o* cla"se 6.7.@5 o*



q @5I/0(IE1 G"ide #$8 certi*icationbodies sho"ld there*ore ha&epersonnel copetent to a?eappropriate choices in the designand operation o* s"r&eillance

progras.G.23.6 /inceC s"r&eillance pla!s a direct rolein achie&ing the intended bene*its*ro a certi*ication s!steC a wide &ariet! o* acti&ities are

a&ailable *ro which tooperate a s"r&eillanceprograandC the eleents o* as"r&eillance progra canchange on an ongoing basiss"r&eillance req"ireentsshall be considered b! theparties e.g. a"thorities5in&ol&ed in the de&elopento* the schee.

1oent< The g"ideline is not co&ered b!the new standard.

G.26.2 The certi*ication bod!

sho"ld a&oid "sing the sae ar?to indicate di**erent certi*ications!stes rod"cts8 KM/ etc.58 andsho"ld a&oid con*"sion betweenthe eaning o* its ar?s. The

c

erti*

ication bod! can "se the saecorporate logo in di**erent s!stesor schees pro&ided the ar?s

l l di i i h bl

6.2.3.2 The certi* ication bod! shalle'ercise the control as speci*ied b! thecerti*ication schee o&er ownership8 "se and



are clearl! disting"ishable. displa! o* licenses8 certi*icates8 ar?s o*con*orit!8 and an! other echaniss *orindicating a prod"ct is certi*ied.N0TE 2 G"idance on the "se o*certi*icates and ar?s peritted b! the

certi*ication bod! can be obtained *roI/0(IE1 G"ide 73.N0TE 7 I/0(IE1 2434 pro&idesreq"ireents *or

ISO Guide 65 IAF GD5 FDIS 17065 / comments"se o* third-part! ar?s.



G.26.3 I* a certi*ication bod!incorrectl! clais accredited

stat"s *or certi*icates iss"edbe*ore appropriate accreditationhas been granted8 theaccreditation bod! a! req"ire its"bseq"entl! to withdraw the.

G.26.6 A certi*ication bod! sho"ldha&e proced"res to ens"re that itsar?s are not "sed in a wa! thata! be li?el! to con*"se orislead the ar?et.

G.26.$ Bhere the certi*icationbod! a?es "se o* a ar? that ithas been assigned b! anotherbod!8 e.g. the owner o* the ar?8its agreeent with that bod! shallens"re con*orit! with the intento* all sections o* this cla"se.

G.26.# The certi*ication bod!sho"ld ha&e doc"ented

proced"res to ens"re a traceablelin? *ro its ar? to the rele&antcerti*ication req"ireents. G.26.7The certi*ication bod! shall ha&edoc"ented proced"res *or the

"se

o*itsar?see also I/0

(IE1

243458 and *or the eas"res tobe adopted in case o* is"se8incl"ding *alse clais as to

1oent< The g"ideline is not clearl!co&ered b! the new standard.

1oent< The g"ideline is not co&ered b!th t d d



the new standard.

6.2.7.7 i5 coplies with an! req"ireents thata! be prescribed in the certi*ication scheethat relate to the "se o* ar?s o* con*orit!8and on in*oration related to the prod"ctN0TE /ee also I/0(IE1 24348 I/0(IE1G"ide 73 and I/0(IE1 G"ide 7.

(omment/ 5.).. i states a re&uirement onwhat to be re&uired%areed with the client in acertification areement. It partially covers theintent of IA0 '12

')5.5. Eowever, the aspect of 6misleadin7 isnot taken into the new standard and '.)5.2 isnotcovered.(omment/ 'uideline not taken into new standard

6.2.3.2 The certi* ication bod! shalle'ercise the control as speci*ied b! thecerti*ication schee o&er ownership8 "se and

displa! o* licenses8 certi*icates8 ar?s o*con*orit!8 and an! other echaniss *orindicating a prod"ct is certi*ied.


certi*ication and *alse N0TE 2 G"idance on the "se o*



"se o* certi*ication bod!ar?s.

certi*icates and ar?s peritted b! thecerti*ication bod! can be obtained *roI/0(IE1 G"ide 73.N0TE 7 I/0(IE1 2434 pro&idesreq"ireents *or "se o* third-part! ar?s.

(omment/ The uideline is not covered by thenew standard. 5.).:.) does not re&uest to havedocumented procedures

No speci*ic cla"ses related to certi*ication o* /er&ices Anne' 2 /er&ice certi*ication1oent< Theanne' incl"des req"ireents to be et b! the1 when per*oring 1erti*ication o* /er&ices.These are not ta?en into the new standard.

No speci*ic cla"ses related to certi*ication o* /er&ices Anne' 2 /er&ice certi*ication 1oent< The anne'

incl"des aspects o* designing schees *or1erti*ication o* ser&ices. These are not ta?eninto the new standard.

No speci*ic cla"ses related tocerti*ication o*rocesses

Anne' 7 rocess certi*ication 1oent< The anne' incl"desreq"ireents to be et b! the 1 whenper*oring 1erti*ication o* rocesses. Theseare not ta?en into the new standard



No speci*ic cla"ses related tocerti*ication o*rocesses

are not ta?en into the new standard.

Anne' 7 rocess certi*ication 1oent< The anne' incl"des aspects o*designing schees *or 1erti*ication o*rocesses. These are not ta?en into the newstandard.

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