AGENDA ITEM 9.

b3

ISO Guide 65 IAF GD5 FDIS 17065 / comments
In t$e second co"umn% !ead t$e

EAC C(12) 17

hidden discri ination b! speeding "p or dela!ing the processing o* applications.

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

in t$e i!st co"umn)

Yellow highlight = corresponding reqs in new standard a! not be on par with G"ide#$ %ed highlight = new standard does not co&er this aspect Magenta highlight = te't in G"ide#$(IA) GD$ that is probabl! re*erred to as +she e design,-related .see +Introd"ction, to I/0(IE1 234#$5 and th"s e'pected to be handled +o"tside, o* I/0(IE1 234#$

inte!+!etation +!o,ided as #uide"ines '( IAF GD5Yellow highlight = corresponding reqs in new standard a! not be on par with G"ide#$ %ed highlight = new standard does not co&er this aspect Magenta highlight = te't in G"ide#$(IA) GD$ that is probabl! re*ered to as +she e design,-related .see +Introd"ction, to I/0(IE1 234#$5 and th"s e'pected to be handled +o"tside, o* I/0(IE1 234#$ G.6.2.2 1erti*ication bodies shall not practice an! *or o* discri ination s"ch as

In t$e .!d co"umn ind t$e content o FDIS 17 065 and comments-

4.4.1 The policies and procedures under which the certification body operates and their administration shall be non-discriminatory. Procedures shall not be used to impede or inhibit access by applicants, other than as provided for in this International Standard.

G.6.2.7 To q"ali*! *or prod"ct certi*icatio n8 applicants shall de onstr ate that the! ha&e responsib ilit! *or ens"ring that prod"cts con*or with the certi*icatio n req"ire e nts.

4.4.2 The certification body shall make its services accessible to all applicants whose activities fall within the scope of its operations. 4.4.3 Access to the certification process shall not be conditional upon the size of the client or membership of any association or roup, nor shall certification be conditional upon the number of certifications already issued. There shall not be undue financial or other conditions.

ISO Guide 65

IAF GD5

FDIS 17065 / comments
!"T# A certification body can decline to accept an application or maintain a contract for certification from a client when fundamental or demonstrated reasons e$ist, such as the client participatin in ille al activities, havin a history of repeated non-compliances with certification%product re&uirements or similar client related issues.

G.6.2.3 Doc" ents cited in cla"se 6.2.3 o* I/0(IE1 G"ide #$ that speci*! the req"ire ents *or the prod"ct8 and other applicable req"ire ents shall be a&ailable to the applicant and to the p"blic on req"est. Nor ati&e doc" ents sho"ld be de&eloped8 &alidated and aintained b! a process enabling technical inp"t o* the interested parties s"ch as s"ppliers8 reg"lators and "sers o* the prod"ct. 9alidation sho"ld be consistent with the characteristics o* the prod"ct to be certi*ied.

t h o s e d e & e l o p e d b ! s c h e e

G.6.2.6 Doc" ents cited in cla"se 6.2.3 o* I/0(IE1 G"ide #$ incl"de

o

3

7.75 *or a speci*ic certi*ication sche e8 the! shall be *or "lated b! rele&ant and i partial persons or co ittees possessing the necessar! technical co petence8 and ade a&ailable 4 .see *.). The sche e owners sho"ld adhere to the sa e principles *or the de&elop ent and aintenance o* the doc" ents.1.1. they shall be formulated by relevant and impartial persons or committees possessin the necessary technical competence. and made available by the certification body upon re&uest. I* e'planations are req"ired as to the application o* these doc" ents . !"T# 'uidance for developin normative documents suitable for this purpose is contained in lS"%I#( )*++*. !"T# 'uidance for developin normative documents suitable for this purpose is contained in lS"%I#( )*++*. 7-1-. 7.3 If e$planations are re&uired as to the application of these documents .2 The re&uirements a ainst which the products of a client are evaluated shall be those contained in specified standards and other normative documents.1.see 3. 7.2.2 The re&uirements a ainst which the products of a client are evaluated shall be those contained in specified standards and other normative documents.wners ./ee de*inition o* certi*ication sche e5. for a specific certification scheme.-.

ISO Guide 65 IAF GD5 G. !"T# 'uidance for developin normative documents suitable for this purpose is contained in lS"%I#( )*++*. (omment/ The content of IA0 '12 may be part of I3A(%IA0 A2 instead4 a s certi*ication.see 3.6.6 De onstration that a certi*ication bod! is a legal entit!8 . N0TE A go&ern ental certi*ication bod! is dee ed to be a legal entit! on the basis o* its go&ern ental stat"s. I* e'planations are req"ired as to the application o* these doc" ents .7.2.2 Accreditation shall onl! be granted to a bod! which is a legal entit! as re*erenced in cla"se 6.2 :egal responsibilit! The certi*ication bod! shall be a legal entit!8 or a de*ined part o* a legal entit!8 s"ch that the legal entit! can be held legall! responsible *or all its certi*ication acti&ities.6. The accreditation scope *or a prod"ct certi*ication bod! sho"ld identi*! the certi*ication sche es8 prod"cts and nor ati&e doc" ents "sed *or the the necessar! technical co petence8 and ade a&ailable b! the certi*ication bod! "pon req"est.2. 7-1-.3 o* I/0(IE1 G"ide #$ shall clearl! identi*! the processes to be assessed8 the rele&ant req"ire ents and the ethods *or assess ent o* con*or it!.1.7. G.$ In case o* process certi*ication8 the doc" ents cited in cla"se 6.d5 o* I/0(IE1 G"ide #$8 and will be con*ined to declared scopes and locations.7.2 The re&uirements a ainst which the products of a client are evaluated shall be those contained in specified standards and other normative documents.2. FDIS 17065 / comments b! the certi*ication bod! "pon req"est.75 *or a speci*ic certi*ication sche e8 the! shall be *or "lated b! rele&ant and i partial persons or co ittees possessing G. 7. 6.2.6.

2.d5 o* I/0(IE1 G"ide #$8 eans that i* an applicant certi*ication bod! can onl! de onstrate onl! be granted to the larger legal 6.2 :egal responsibilit! The certi*ication bod! shall be a legal entit!8 or a de*ined part o* a legal entit!8 s"ch that the legal entit! can be held legall! responsible *or all its certi*ication acti&ities.it. .7.s legal entit! stat"s within part o* a larger legal entit!8 accreditation shall req"ired "nder cla"se 6. N0TE A go&ern ental certi*ication bod! is dee ed to be a legal entit! on the basis o* its go&ern ental stat"s.

7. IAF GD5 entit!.access to co petent personnel *or the FDIS 17065 / comments (omment/ The content of IA0 '12 may be part of I3A(%IA0 A2 instead4 co plete categor! o* prod"cts= .7.7.be identi*ied5 . In the sit"ation where the certi*ication bod! is part o* a large legal entit!8 in order to p"rs"e speci*ic a"dit trails and(or re&iew records relating to the certi*ication bod!8 other *"nctions o* the large legal entit! ight be assessed. G.proced"res *or the &alidation o* these e'tended or odi*ied sche es.the technical abilit! to de&elop8 e'tend 6.ISO Guide 65 No clear re*erence in G"ide #$ *or the IA) G"idance G.6.7 The accreditation scope *or certi*ication bodies a! be de*ined in ter s o* categories o* prod"cts or *a ilies o* nor ati&e doc" ents pro&ided the prod"ct certi*ication bod! has a pro&en capabilit! as a prod"ct certi*ier and de onstrate it has< . G.7.$ The part o* the legal entit! that *or s the act"al certi*ication bod! a! trade . or odi*! certi*ication sche es= .6. This shall be li ited to those *"nctions whose acti&ities are intended to *"l*il the req"ire ents o* I/0(IE1 G"ide #$ .7.6.

"nder a distincti&e na e8 which sho"ld appear on the accreditation certi*icate and certi*icates iss"ed to certi*ied organi>ations.7.7.6. 6.3 I* the certi*ication bod! and its client are both part o* go&ern ent8 the two bodies shall not directl! report to a .e as abo&e G.

). who carried o"t the e&al"ation.s5 di**erent *ro those .7.7# 1la"se 6. The certi*ication bod! shall8 in &iew o* the i partialit! req"ire ent8 be able to de onstrate how it deals with a case where both itsel* and its client are part o* go&ern ent.7.6. which has not certi*ication is ta?en b! a been involved in the process for evaluation person.ISO Guide 65 6.5. The certification decision shall be carried out by a person or roup of persons #$ req"ires that each decision on . see 2.2 The certification body shall assi n at least one person to make the certification decision based on all information related to the evaluation. &eri*ication o* an! correcti&e actions ta?en to address an! noncon*or ities identi*ied.*5 o* FDIS 17065 / comments 7.7. decision can be completed concurrently by E&al"ation tas?s incl"de the the same person or roup of persons.7 cla"se G. 6.6..*. Testing and inspection8 a ong !"T# The review and certification others8 are e&al"ation tas?s. its review. G.5. The certi*ication bod! shall de onstrate that the applicant recei&es no ad&antage and that i partialit! is ass"red. a committee.7 I/0(IE1 G"ide IAF GD5 person or gro"p ha&ing operational responsibilit! *or both. .32 The rights entioned in .e. and any other relevant information.6.

7.7 G. 4. 6.6. (omment/ !o correspondin re&uirement in the new standard.7.2 The certification body shall have the financial stability and resources re&uired for its operations.g5 a! incl"de a contract with the sche e owner or an! other recognition established "nder the sche e r"les.7.3.i5 req"ires the certi*ication bod! to de onstrate that it has a reasonable e'pectation o* being able to pro&ide and to contin"e to pro&ide the ser&ice in accordance with its contract"al obligations.6. 1erti*ication bodies are .re*erred to in cla"se 6.2# The req"ire ent *or *inancial stabilit! .

ISO Guide 65 IAF GD5 responsible *or pro&iding the accreditation bod! with s"**icient e&idence to de onstrate &iabilit!8 e. FDIS 17065 / comments 6.g.@5 o* I/0(IE1 G"ide #$8 certi*ication bodies sho"ld there*ore ha&e personnel co petent to a?e appropriate choices in the design and operation o* s"r&eillance .23.7. anage ent reports or in"tes8 ann"al reports8 *inancial a"dit reports8 *inancial plans. At the sa e ti e8 characteristics o* prod"ction processes can aid or hinder ongoing con*or it! with certi*ication req"ire ents. These techniq"es a! be cond"cted at &ario"s points and at &ar!ing *req"encies d"ring the designprod"ction-distrib"tion-sales chain.7.3 Man! techniq"es are a&ailable to certi*ication bodies to cond"ct s"r&eillance.@5 G. As a part o* eeting the req"ire ents o* cla"se 6.

7.progra s. . 6.37 The eans b! which the certi*ication bod! obtains *inancial s"pport sho"ld be s"ch to allow the certi*ication bod! to retain its (omment/ !o re&uirement directly covers this specific uidance.7 G.7 (omment/ !o correspondin re&uirement in the new standard.6. 6.

6. G. FDIS 17065 / comments on atters that are barriers to certi*ication wo"ld be participation in an acti&e creati&e anner in the de&elop ent a n d o n g o i n g o n it o ri n g (i p r o & e 6. This can 8 *or e'a ple8 be ass"red b! the distrib"tion o* &oting rights or so e other eq"i&alent eans.7.6.29 1ons"ltanc! ser&ices e n .n5 o* I/0(IE1 G"ide #$ is ta?en b! a co ittee co prising8 a ong others8 representati&es *ro one or ore clients8 the operational proced"res o* the certi*ication bod! sho"ld ens"re that these representati&es do not ha&e a signi*icant in*l"ence on decision a?ing.7.7.23 I* the decision to iss"e or withdraw certi*ication in accordance with cla"se 6.ISO Guide 65 IAF GD5 i part ialit!.o G.7.

manufacturin . desi nin . The certification body shall retain authority to appoint and withdraw members of such committees (omment/ The aspect of 6balance of interests7 has not been taken over from 'uide 82 to the new standard. c5 in&ol&e ent in the s"pplier. 3. b5 preparing or prod"cing an"al8 handboo?s or proced"res.8 e.. offer or provide mana ement system consultancy .2 consultancy participation in/ a. b!8 *or e'a ple= a5 pro&iding speci*ic s"pport(ad&ise on ele ents o* the design.. desi nin . maintainin or distributin of a certified product or a product to be certified9 or b. terms of reference and operation of any committees that are involved in the certification process .1. desi nin . financial and other pressures that mi ht influence decisions. . 0urthermore details in the uidance are not taken in.:.4 The certification body shall have formal rules for the appointment.-.t o* the prod"ct8 process8 or ser&ice. implementin . implementin .: of IS"%I#( )*+-)/-+)). operatin or maintainin of a certified process or a process to be certified9 or c. 5.s onitoring 8 re&iew and decision a?ing process applicable to the prod"ct. Such committees shall be free from any commercial.see *. providin or maintainin of a certified service or a service to be certified and 5. installin .

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

6. (omment/ the details of the uideline not covered in the new standard.o G.ISO Guide 65 IAF GD5 FDIS 17065 / comments evaluation of the client.s mana ement system.7. b o d i e s w il l e ' p e c t c e r t i * i c 6. The de onstration shall co&er all potential so"rces o* con*lict o* interest8 whether the! arise *ro within the certi*ication bod! or *ro the acti&ities o* related bodies. Accreditation .76 1erti*ication bodies shall de onstrate how the! anage their certi*ication b"siness and an! other acti&ities so as to eli inate act"al con*lict o* interest and ini i>e an! identi*ied ris? to i partialit!.7.

This a! incl"de8 to the e'tent practicable and @"sti*ied8 p"rs"it o* a"dit trails to re&iew records o* both the certi*ication bod! and its related bod! *or the acti&it! "nder consideration. I* e&idence o* *ail"re to aintain i partialit! is *o"nd there a! be a need to e'tend the a"dit trail bac? into related bodies to pro&ide ass"rance that control o&er potential 6.-.7. N0TE 7 Identi*!ing ris?s does not i pl! ris? assess ents to I/0 32444.s histor! o* i partial certi*ication.-5 relates to openness and A< activities which are not covered by the new standard.5.7. 6.see 6. In considering the e'tent o* s"ch a"dit trails acco"nt sho"ld be ta?en o* the certi*ication bod!.6 I* a ris? to i partialit! is identi*ied8 the certi*ication bod! shall be able to de onstrate how it eli inates or ini i>es s"ch ris?.3 The certi*ication bod! shall identi*! ris?s to its i partialit! on an ongoing basis.7.ation bodies to open "p these processes *or a"dit. . This in*or ation shall be ade a&ailable to the echanis speci*ied in $. N0TE 2 A relationship presenting a ris? to i partialit! o* the certi*ication bod! can be based on ownership8 go&ernance8 anage ent8 personnel8 shared reso"rces8 *inances8 contracts8 ar?eting . (omment/ The latter part of '. This shall incl"de those ris?s that arise *ro its acti&ities8 *ro its relationships8 or *ro the relationships o* its personnel .incl"ding branding58 and pa! ent o* a sales co ission or other ind"ce ent *or the re*erral o* new clients8 etc.275.7. Aowe&er8 s"ch relationships a! not necessaril! present a certi*ication bod! with a ris? to i partialit!.

748 within the last two !ears.o G.o5 o* I/0(IE1 G"ide #$ in&ol&ing the applicant or s"pplier in q"estion8 or an! bod! related to the s"pplier8 . /it"ations s"ch as an e plo!ee.see G.7.7.7$ The req"ire ents o* cla"se 6 and cla"se $.ISO Guide 65 IAF GD5 con*licts o* interest has been re.7.7.6. .7 o* I/0(IE1 G"ide #$ ean that personnel8 incl"ding those acting in a anagerial capacit!8 sho"ld not be e plo!ed to cond"ct an e&al"ation as part o* the certi*ication process i* the! ha&e been in&ol&ed in acti&ities as described "nder cla"se 6.established.s c"rrent or pre&io"s in&ol&e ent at an! ti e with the s"pplier being e&al"ated a! present a con*lict o* interest.7. FDIS 17065 / comments T h e c e r t i * i c a t i o n b o d ! h a s a r e 6.6.

) 4. personnel shall not be used to review or make a certification decision for a product for which they have provided consultancy .-.6.6. bodies or or anizations of which it becomes aware. (omment/ The 6--year uideline7 is not taken into the new standard.2. !"T# 0or the evaluation personnel further impartiality re&uirements are stipulated in clause 8 of this International Standard and additional re&uirements can be found in other relevant standards mentioned in 8.7.-.79 The certi*ication bod! sho"ld be responsible *or ens"ring that neither related bodies8 nor s"b-contractors8 nor e'ternal assessors(a"ditors operate in breach o* the "nderta?ings that the! ha&e gi&en. (omment/ The new standard does not address . if specified by the certification body.:. it should reflect a period that is lon enou h so that the review or decision does not compromise impartiality. It sho"ld also be responsible *or i ple enting appropriate correcti&e action in the e&ent that s"ch a breach is identi*ied.) and 8. !"T# ) The period can be specified in the certification scheme or.7.-. 4.10 =ithin a period specified by the certification body. !or is the uideline. G.re* 2st sentence5 sponsibilit! to identi*! and e&al"ate s"ch sit"ations and to assign responsibilities and tas?s so as to ens"re that i partialit! is not co pro ised. A specified period of two years is often used..s aspect of supplier>s related bodies.2.2. bodies or or anizations of which it becomes aware.-.11 The certification body shall take action to respond to any risks to its impartiality arisin from the actions of other persons.o . 4.11 The certification body shall take action to respond to any risks to its impartiality arisin from the actions of other persons.

the uideline relatin to responsibility for ensuring that 6breach of undertakin s7 does not occur. .

5 are carried o"t in a co petent and reliable anner consistent with the applicable req"ire ents o* the nor ati&e doc" ents *or these acti&ities.ISO Guide 65 IAF GD5 FDIS 17065 / comments G.2 The certi*ication bod! "st be able to de onstrate to the accreditation bod! that all con*or it! assess ent acti&ities it cond"cts .testing8 inspection8 q"alit! anage ent s!ste e&al"ation8 s"r&eillance etc.6.3. De onstration o* the co petence o* the testing acti&it! a! be based on a doc" ented e&al"ation per*or ed b! internal or e'ternal co petent personnel according to appropriate proced"res. I* the e&idence s"pplied b! the certi*ication bod! does not pro&ide con*idence in the testing a c t i & i t ! 8 a d d i t i o n a l .

The rele&ant International /tandards incl"de *or testing I/0(IE1 2347$8 *or inspection I/0(IE1 23474 and *or anage ent s!ste a"diting I/0(IE1 23472.2.1 Internal resources Bhen a certi*ication bod! per*or s e&al"ation acti&ities either with its internal reso"rces or with other reso"rces "nder its direct control it shall eet the applicable req"ire ents o* the rele&ant International /tandards and8 as speci*ied b! the certi*ication sche e8 o* other doc" ents.the e'tent o* control the certi*ication bod! has o&er testing .incl"ding witnessing the testing58 inspection .e$pertise is available within the certification body when usin the results of the evaluation activity9 .g. The i partialit! req"ire ents o* the e&al"ation personnel stip"lated in the rele&ant standard shall alwa!s be applicable. The sa e is 6.e. !"T# #$amples of reasons why some re&uirements are not applicable include/ .assess ent at the testing location sho"ld be considered b! the accreditation bod!. speci*!ing inspection ethods or para eters5 or anage ent s!ste .

the followin / a. E'a ples o* t!pical co ple entar! req"ire ents *ro sche es owners are< .3. suspendin .6./ee de*inition o* certi*ication sche e in G.25. 6. 5. rules and procedures for rantin .3. includin evaluation procedures.g. e$tendin or reducin the scope of. These a! incl"de doc" ents de*ining acti&ities s"ch as sa pling8 testing8 inspection8 s"r&eillance and assess ent o* an associated anage ent s!ste as appropriate.)or s"bcontracted acti&ities see G.6.6. and make available on re&uest.a partic"lar req"ire ent is co&ered in a eq"i&alent wa! b! this International /tandard8 or not needed to gi&e con*idence in the certi*ication decision.75.s.3. .or reference to.ISO Guide 65 IAF GD5 applicable to other con*or it! assess ent acti&ities. maintainin .8 Publicly available information The certification body shall maintain .throu h publications.3 G. electronic media or other means. information about .6. FDIS 17065 / comments assess ent . req"iring speci*ic details o* a anage ent s!ste 5. the certification scheme.e.3 incl"de those de&eloped b! sche e owners ..7 %eq"ire ents o* speci*ic certi*ication sche es shall be a&ailable to the applicant and on req"est to the p"blic. /che e doc" ents sho"ld be de&eloped and aintained b! a process that ta?es into acco"nt the &iews o* the interested parties. withdrawin or refusin certification9 (omment/ The re&uirements on public information are not as detailed as the uideline 6. .3 as abo&e G.3 Doc" ents cited in cla"se 6.

.C req"ire ents on a"ditor q"ali*ication8 e'perience8 training and registration= C req"ire ents on a"dit reports= C req"ire ents on d"ration and *req"enc! o* the a"dits= C other g"idance to certi*ication bodies *or con*or it! assess ent proced"re s.

and the personnel that it uses. Indi&id"als wor?ing "nder *or al agree ent *or the certi*ication bod!8 within the accredited s!ste s8 and "nder the a"thorit! and control o* the 1D anage ent are not dee ed to be s"b contractors.-. FDIS 17065 / comments 6.-.6. implement corrective actions for any breaches of the contract in 8.-.4 The certification body shall/ d) take responsibility for all activities outsourced to another body. are not involved.2. in such a way that the credibility of the results could be compromised9 f. assessin and of the bodies which provide !"T# monitorin . to provide the client an opportunity to ob?ect. either directly or throu h any other employer.. inform the client in advance of outsourcin activities. have documented policies.ISO Guide 65 IAF GD5 G.of which it becomes aware9 and i.2. procedures and records for the &ualification.3 E&al"ation o* the report and the decision on certi*ication shall be ade onl! b! the certi*ication bod! itsel*8 and not b! an! other bod!. assessin and monitorin of all bodies that provide outsourced services used for certification activities9 . e. Bhere @oint e&al"ations are "nderta?en8 each certi*ication bod! shall satis*! itsel* that the whole o* the e&al"ation has been satis*actoril! "nderta?en b! co petent personnel.6. If the &ualification.: or other re&uirements in 8. ensure that the body that provides outsourced services. maintain a list of approved providers of outsourced services9 h.

peer assessment bodies or overnmental authorities.outsourced services is performed by other or anisations such as accreditation bodies. the certification body 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 .

#.5 Review 7.1 The certification body shall be responsible for and shall retain authority for its decisions relatin to certification.ISO Guide 65 IAF GD5 FDIS 17065 / comments ? the validity of the &ualification.65 3. 7.5.6 A certi*ication bod!.2.65 assigned b! the certi*ication bod! to a?e a certi*ication decision shall be e plo!ed b! or "nder contract with the certi*ication bod! .s. 7.6.25= or .6 Certification decision 7. 3.#.3.an entit! "nder the organi>ational control o* the certi*ication bod! .s5 . The review shall be carried out by person.e'cl"ding e bers o* co ittees E see $.s organi>ational control shall be< . assessin and monitorin arran ements is verified at a periodicity determined by the certification body.#. which have not been involved in the evaluation process.3 The person.#.whole or a@orit! ownership o* another entit! b! the certi*ication bod!= or 27 . 7.1 The certification body shall assi n at least one person to review all information and results related to the evaluation.2 @ecommendations for a certification decision based on the review shall be documented unless review and certification decision are completed concurrently by the same person.5.

or committees. 3. The impartiality re&uirements of the evaluation personnel stipulated in the relevant standard shall always be applicable. !"T# ) #$amples of reasons why some re&uirements are not applicable include/ 28 . as specified by the certification scheme of other documents. either internal or e$ternal.12 All certification body personnel.g.e.2 A certi*ication bod! a! s"bcontract wor? to another bod! . testing or inspection or q"alit! anage ent s!ste e&al"ation58 pro&ided that the arrange ent with the s"bcontracted bod! req"ire it to co pl! with all the rele&ant req"ire ents o* I/0(IE1 G"ide #$ and where applicable8 I/0(IE1 2347$ and 23474 and I/0(IE1 G"ide #7.$ The persons e plo!ed b! or "nder contract with entities "nder organisational control shall *"l*il the sa e req"ire ents o* this International /tandard8 as persons being "nder e plo! ent or contract with the certi*ication bod!.2. who could influence the certification activities. I* this ass"rance is based partl! or in *"ll on the accreditation o* the s"bcontractor8 the scope o* accreditation sho"ld co&er the acti&ities to be carried o"t "nder the certi*ication 4.6.in which the certi*ication bod! resides5 lin?ed b! ownership or Doard o* Directors control.6.2. shall act impartially. G.#.ISO Guide 65 IAF GD5 FDIS 17065 / comments .2. N0TE 8)or go&ern ental certi*ication bodies other parts o* the sa e go&ern ent can be considered as Flin?ed b! ownershipF to the certi*ication bod!. 6.doc" ented a"thorit! b! the certi*ication bod! o&er another entit! in a networ? o* legal entities . for inspection IS"%I#( )*+-+ and for mana ement system auditin IS"%I#( )*+-).1 The certification body shall outsource evaluation activities only to bodies that meet the applicable re&uirements of the relevant International Standards and. The relevant International Standards include for testin IS"%I#( )*+-2.

ISO Guide 65 IAF GD5 sche e and the certi*ication bod! ha&e records a&ailable to show has chec?ed the stat"s accreditation o* the r..2.2.: c. the certification body shall assure that the evaluation activities are mana ed in a manner which provides confidence in the results.. ensure that the body that provides outsourced services.e. 6. specifyin inspection methods or parameters.. and that records are available to ?ustify the confidence. 6. the terms 6outsourcin 7 and 6subcontractin 7 are considered to be synonyms. . or mana ement system assessment .2. are not 29 .the e$tent of control the certification body has over testin . Ase of e$ternal personnel under contract is not outsourcin . client laboratories. !"T# : 0or the purposes of this International Standard.4 The certification body shall/ b. .a particular re&uirement is covered in a e&uivalent way by this international standard. includin confidentiality and conflict of interests as described in 8.2.includin witnessin the testin .e. or not needed to ive confidence in the certification decision !"T# This can include outsourcin to other certification bodies. FDIS 17065 / comments as the user of the results of the evaluation activity9 . . re&uirin specific details of a mana ement system.).3 The certification body shall have a le ally bindin contract with the body that provides the outsourced service.. and the personnel that it uses.e.2 =here evaluation activities are outsourced to non independent bodies .2. . inspection .2. 6.

7 I* the s"bcontracted bodies e plo!ed are not accredited according to the rele&ant standard *or the speci*ic acti&ities req"ired b! the certi*ication sche es8 the certi*ication bod! shall de onstrate the 30 . ? c o p et e n c e o* th e s " G. in such a way that the credibility of the results could be compromised9 c.ISO Guide 65 IAF GD5 FDIS 17065 / comments employer. the certification body 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 arran ements is verified at a periodicity determined by the certification body. peer assessment bodies or overnmental authorities. procedures and records for the &ualification.6. assessin and monitorin of all bodies that provide outsourced services used for certification activities9 !"T# If the &ualification. assessin and monitorin of the bodies which provide outsourced services is performed by other or anisations such as accreditation bodies.6. have documented policies.

bcontracted bod! b! other eans8 s"ch as doc" ented e&al"ation per*or ed b! q"ali*ied personnel according to appropriate proced"res that incl"des an initial e&al"ation 6-2-2-/ c5 ha&e doc" ented policies8 proced"res and records *or the q"ali*ication8 assessing and onitoring o* all bodies that pro&ide o"tso"rced ser&ices "sed *or certi*ication acti&ities 31 .

. . 6.2 =here evaluation activities are outsourced to non independent bodies .. client laboratories.includin witnessin the testin .e. re&uirin specific details of a mana ement system.e$pertise is available within the certification body when usin as the user of the results of the evaluation activity9 .6.2.6.6. inspection .a particular re&uirement is covered in a e&uivalent way by this international standard. the certification body shall assure that the evaluation activities are mana ed in a manner which provides confidence in the results.2 and (or G 6. In this case the pro&isions o* G. or not needed to ive confidence in the certification decision . The sa e is applicable to other con*or it! assess ent acti&ities. .6.e.2.6.2. and that records are available to ?ustify the confidence. or mana ement system assessment .1 N0TE 2 E'a ples o* reasons wh! so e req"ire ents are not applicable incl"de< .6 Bhere independent testing *acilities are not "tili>ed8 the certi*ication bod! shall ens"re that speci*ied controls are in place at the s"pplier.e.the e$tent of control the certification body has over testin . . .2 . specifyin inspection methods or parameters.s testing *acilities8 that the! are anaged in a anner which pro&ides con*idence in the res"lts obtained *ro the tests8 and that records are a&ailable to @"sti*! the con*idence.7 also appl! and depending on the e'tent o* controls i posed b! the certi*ication bod! so e req"ire ents o* I/0(IE1 2347$ a! not be req"ired or applicable.ISO Guide 65 IAF GD5 o* co petence and ongoing o* per*or ance o* the s"b bodi FDIS 17065 / comments G.. 6.

s. /"ch reliance needs to be s"pported b! 7.5 If the certification body relies on certifications it has already ranted to the client or has already ranted to other clients to omit any activities.G. then the certification body shall reference the e$istin certification.$ Note 7 describes a sit"ation where the certi*ication bod! will be reliant on the wor? o* another bod!. the certification body .6.3. If re&uested by the client. in its records.6.

ISO Guide 65 IAF GD5 a technical e&al"ation o* the wor? "nderta?en.. 7.5 The certification body shall only rely on evaluation results related to certification completed prior to the application for certification where it takes responsibility for the results and satisfies itself that the body that performed the evaluation fulfils the re&uirements contained in 8.$ 1ontin"ed Note 3 describes a sit"ation where the certi*ication bod! will be reliant on the wor? or on a certi*ication o* another certi*ication bod!.4. .-. /"ch an e&al"ation shall be doc" ented b! the certi*ication bod!. G. In cases where the certi*ication bod! ta?es into acco"nt wor? pre&io"sl! per*or ed b! another certi*ication bod! it shall ha&e all rele&ant reports and records to de onstrate the co petence and the con*or it! with the req"ire ents . FDIS 17065 / comments shall provide ?ustification for omission of activities.6. It sho"ld there*ore ens"re that in*or ation on an! e&al"ation wor? on which it relies is "pdated as appropriate.6.established b! the certi*ication bod!5 o* the other certi*ication bod! *or the period o* ti e when the wor? was carried o"t.and those specified by the certification scheme.

2.e.. FDIS 17065 / comments 6. !"T# The review and certification decision can be completed concurrently by the same person or roup of persons.#. . its review.6. implement and maintain a procedure for mana ement of competencies of personnel involved in the certification process .s personnel at s"pplier and s"bcontractor sites.11.$..5.2 The certification body shall assi n at least one person to make the certification decision based on all information related to the evaluation.2 1la"se 6.5. a committee.1 The certification body shall establish. In addition to other ethods o* onitoring per*or ance8 pro&ision sho"ld be ade8 where applicable8 *or the periodic witnessing o* those acti&ities nor all! "nderta?en b! it.$.*.ISO Guide 65 IAF GD5 G.2 Bhere certi*ication is s"spended8 the certi*ication bod! shall req"ire that8 d"ring the period o* s"spension8 the s"pplier a?es no isleading clai s and sho"ld ad&ise rele&ant e'isting and potential p"rchasers regarding the stat"s o* certi*ication8 and ceases to "se the certi*ication ar? on the prod"cts an"*act"red since the date o* noti*ication o* s"spension.1. A certi*ication bod! shall ha&e 7. 7. which has not been involved in the process for evaluation . The certification decision shall be carried out by a person or roup of persons . The procedure shall re&uire the certification body to/ e5 onitor personnel the per*or ance o* the in the new (omment/ !othin standard.).3. and any other relevant information. G.see *.i5 o* I/0(IE1 G"ide #$ req"ires the certi*ication bod! to onitor the per*or ance o* its own personnel. see 2. either as a result of 35 .6. stated about witnessin (omment/There is no correspondin re&uirement in the new standard.6.1 =hen a nonconformity with certification re&uirements is substantiated.

the certification body shall 36 .surveillance or otherwise.

8 shall be fulfilled. etc.2 =hen the appropriate action includes evaluation. I. the certification body shall take actions specified by the certification scheme and shall make all needed modifications to formal certification documents.3 If certification is terminated . increased s"r&eillance8 b5 red"ction in the scope o* the certi*ication to re o&e noncon*or ing prod"ct &ariants8 c5 s"spension o* the certi*ication pending re edial action b! the client8 d5 withdrawal o* the certi*ication. public information. N0TE Appropriate action can be< a5 contin"ation o* certi*ication "nder conditions speci*ied b! the certi*ication bod!8 e.4 If certification is suspended. 7. to ensure the reduced scope of certification is clearly communicated to the client and clearly described in certification documentation and public information. 7. authorizations for use of marks. the certification body shall assi n one or more persons to formulate and communicate to the client/ .ISO Guide 65 IAF GD5 proced"res in place to ens"re that a de*ecti&e certi*ied prod"ct that ga&e rise to s"spension o* certi*ication is< C /"b@ect to correcti&e action incl"ding8 where appropriate8 prod"ct recall C Gre&ented8 b! all practical eans8 *ro being placed on the ar?et a*ter the s"spension is in&o?ed.11. Note $ o* cla"se 26 o* I/0(IE1 G"ide #$ also applies.by re&uest of the client. etc.5. public information.e.. *.< FDIS 17065 / comments consider and decide upon the appropriate action. 7.2 or *. review or certification decision. the re&uirements in *. If a scope of certification is reduced the certification body shall take actions specified by the certification scheme and shall make all needed modifications to formal certification documents.11.g.11. to ensure it provides no indication that the product continues to be certified. suspended or withdrawn. authorizations for use of marks.

: and *. to ensure all appropriate indications e$ist that the product continues to be certified.11. 7. 38 . the certification body shall make all needed modifications to formal certification documents. etc. to ensure the reduced scope of certification is clearly communicated to the client and clearly described in certification documentation and public information. authorizations for use of marks. *.6 If certification is reinstated after suspension the certification body shall make all needed modifications to formal certification documents. public information.ISO Guide 65 IAF GD5 FDIS 17065 / comments ? actions needed to end suspension and restore certification for the product. authorizations for use of marks. If a decision to reduce the scope of certification is made as a condition of reinstatement. public information. reviews or decisions needed to resolve the suspension or that are re&uired by the certification scheme shall be completed in accordance with the applicable parts of sub clauses *. etc. ? These persons shall be co petent in their ?nowledge and "nderstanding o* all aspects o* the handling o* s"spended certi*ications .)).2.s. in accordance with the certification scheme9 and any other actions re&uired by the certification scheme.: 7.B and *.11.5.8.5 Any evaluations. *.#.*. *.25.

ISO Guide 65 IAF GD5 FDIS 17065 / comments 39 .

e$tendin or reducin the scope of. e$tendin or reducin the scope of. information about .# a. electronic media or other means. includin evaluation procedures.H. (omment/ There is no correspondin re&uirement in the new standard.2 The in*or ation cla"se 6.2 G. restrictions or limitations on the use of the certification bodyCs name and certification mark and on the ways of referrin to the certification ranted9 information about procedures handlin complaints and appeals. and make available on re&uest.6. suspendin ..s.s. information about .c5 o* I/0(IE1 sho"ld clearl! detail the incl"ded or re*erred to in cla"se I/0(IE1 G"ide #$ and the 6. for b.or reference to.2. maintainin . includin evaluation procedures.throu h publications. withdrawin or 40 . 6. rules and procedures for rantin .H.. maintainin . the certification scheme.4. suspendin . the certification scheme. c. withdrawin or refusin certification9 a description of the means by which the certification body obtains financial support and eneral information on the fees char ed to applicants and to clients9 a description of the ri hts and duties of applicants and clients. the followin / a.or reference to. d.6 Publicly available information The certification body shall maintain . rules and procedures for rantin . includin re&uirements.H.

can incl"de indi&id"al persons who wor? *or the certi*ication bod! on a contract basis8 and other e'ternal reso"rces.7 The personnel shall be co petent *or the *"nctions the! per*or 8 incl"ding a?ing req"ired technical @"dg ents8 de*ining policies and i ple enting the .2.$.7 The ter +personnel.2. 41 .7. FDIS 17065 / comments refusin certification9 G. The certification body shall have #.ISO Guide 65 IAF GD5 the so"rce o* the in*or ation on nor ati&e doc" ents to which prod"cts are certi*ied. The certi*ication bod! shall be in a position to anage8 control and be responsible *or the per*or ance o* all its reso"rces and aintain co prehensi&e records controlling the s"itabilit! o* all the sta** it "ses in partic"lar areas8 whether the! are e plo!ees8 e plo!ed on contract or pro&ided b! e'ternal bodies. (omment/ The details of the uidelines are not taken into the standard.

s5 the decision on granting(withdrawing 42 .27. G. %ecords sho"ld show which personnel are designated as co petent and the date o* &alidation.2 i n !uide "# whether or not to certify a product on the basis of information from the evaluation process$ includin% inspection and test results.personnel assess the products and decide technically competent tof) of ISO/IE accordance with 4.s58 who ta?e.6 The person.

ISO Guide 65 IAF GD5 certi*ication within the bod! shall ha&e a le&el o* and e'perience s"**icient to the in*or ation obtained *ro e&al"ation FDIS 17065 / comments e .

2 The personnel shall be competent for the functions they perform.$.7. methodolo ies.1.1 The certification body shall employ or have access to a sufficient number of personnel to cover its operations related to the certification schemes and to the applicable standards and other normative documents.1.2 The certi*ication bod! shall ha&e s"**icient personnel *or the operation o* the prod"ct certi*ication s!ste and sche es8 see cla"se 6. implement and maintain a procedure for mana ement of competencies of personnel involved in the certification process .1.1 The certification body shall establish.2.1. 6.1.). identify trainin needs and provide.@5 o* I/0(IE1 G"ide #$. The procedure shall re&uire the certification body to/ a) deter ine the criteria for the co petence of personnel for each function in the certification process takin! into account the re"uire ents of the sche es. This incl"des technical personnel co petent *or the de&elop ent o* the prod"ct speci*ic criteria . !"T# The personnel include those normally workin for the certification body as well as persons workin under individual contract or a formal a reement which places them within the mana ement control and systems%procedures of the certification body . definin policies and implementin them..7. 6.e'planator! doc" ents8 sa pling8 testing and inspection req"ire ents8 anage ent s!ste s ele ents(q"alit! s!ste s e&al"ation and certi*ication5. as necessary. 6. . includin makin re&uired technical ?ud ments.8.see *..:. re&uirements. activities and other relevant certification scheme re&uirements9 b.G. trainin pro rammes on certification processes.

demonstrate that the personnel have the re&uired competencies for the duties and responsibilities they undertake9 formally authorize personnel for functions in the certification process9 monitor the performance of the personnel d. . e.ISO Guide 65 IAF GD5 FDIS 17065 / comments c.

The certi*ication bod! has a responsibilit! to identi*! and e&al"ate s"ch sit"ations and to assign responsibilities and 6.s c"rrent or pre&io"s in&ol&e ent at an! ti e with the s"pplier being e&al"ated a! present a con*lict o* interest. /it"ations s"ch as an e plo!ee.see 5. it comply with the rules defined by the certification body. or a provider or developer of services.G. a supplier or desi ner of products. -.7 o* I/0(IE1 G"ide #$ ean that personnel8 incl"ding those acting in a anagerial capacit!8 sho"ld not be e plo!ed to cond"ct an e&al"ation as part o* the certi*ication process i* the! ha&e been in&ol&ed in acti&ities as described "nder cla"se 6. includin those relatin to confidentiality .7.1.o5 o* I/0(IE1 G"ide #$ in&ol&ing the applicant or s"pplier in q"estion8 or an! bod! related to the s"pplier8 . or an operator or developer of processes b. or on the part of their employer.7$ The req"ire ents o* cla"se 6 and cla"se $.see G.3 Contract wit t e !ersonnel The certi*ication bod! shall req"ire personnel in&ol&ed in the certi*ication process to sign a contract or other doc" ent b! which the! co the sel&es to< a. :.7.7. with/ ). reveal any situation known to them that may present them or the certification body with a conflict of .7. to the evaluation or certification of which they are to be assi ned9 and c.6. and independence from commercial and other interests9 declare any prior and%or present association on their own part.2.6.748 within the last two !ears.

see 5..-. planning(ordering(coordinating(e&al"ating5 the req"ired testing8 inspection and a"diting acti&ities witho"t per*or ing these hi -(hersel*.:.2. . 1erti*ication o**icers anaging . if specified by the certification body.-.g. !"T# 0or the evaluation personnel further impartiality re&uirements are stipulated in clause 8 of this International Standard and additional re&uirements can be found in other relevant standards mentioned in 8.) and 8.:. !"T# ) The period can be specified in the certification scheme or.) 1o ent< Details o* the g"idance related to per*or ing e&al"ation are not ta?en into the new standard8 co"ld appl! to e.-. personnel shall not be used to review or make a certification decision for a product for which they have provided consultancy . 4.g. A specified period of two years is often used.e..-.ISO Guide 65 IAF GD5 FDIS 17065 / comments (ertification bodies shall use this information as input to identifyin risks to impartiality raised by the activities of such personnel or by the or anizations that employ them .10 =ithin a period specified by the certification body. it should reflect a period that is lon enou h so that the review or decision does not compromise impartiality.-.

can be found in Anne$ # of IS"%I#( 'uide -D/-++5.ISO Guide 65 IAF GD5 FDIS 17065 / comments 7.10. 1o ent< The aspect o* +interested parties. is not . The certification body shall verify the implementation of the chan es by its clients and shall take actions re&uired by the scheme. includin the aspects related to a notice of chan es. !"T# (ontractual arran ements with clients can be necessary to ensure implementation of these re&uirements. as far as applicable. A model of a license a reement for the use of certification.1 =hen the certification scheme introduces new or revised re&uirements that affect the client the certification body shall ensure these chan es are communicated to all clients.

G.3.2 Gersonnel8 incl"ding those acting in a anagerial capacit!8 sho"ld not be e plo!ed to in&estigate an! appeal8 co plaint or disp"te i* there are an! relationships that a! co pro ise the i partialit! o* the in&estigation.

7.13.1 The certification body shall have a documented process to receive, evaluate and make decisions on complaints and appeals. The certification body shall record and track complaints and appeals and actions undertaken to resolve them. 7.13.2 Apon receipt of a complaint or appeal, the certification body shall confirm whether the complaint or appeal relates to certification activities for which it is responsible, and if so, shall address it. 7.13.3 The certification body shall acknowled e receipt of a formal complaint or appeal. 7.13.4 The certification body shall be responsible for atherin and verifyin all necessary information ,to the e$tent possible. to pro ress the complaint or appeal to a decision. 7.13.5 The decision resolvin the complaint or appeal shall be made by, or reviewed and approved by, person,s. not involved in the certification activities related

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to the complaint or appeal. 7.13.6 To ensure that there is no conflict of interest, personnel includin those actin in a mana erial capacity who have provided consultancy ,:.-. for, or been employed by a client, , shall not be used by the certification body to review or approve the resolution of a complaint or appeal for that client within two years followin the end of the consultancy or employment.

G.3.3 The policies and proced"res re*erred to in cla"se 6.7.p5 sho"ld ens"re that all appeals8 co plaints and disp"tes are dealt with in a constr"cti&e and ti el! anner. The certi*ication bod! shall ha&e an appeals proced"re that incl"des pro&ision *or the *ollowing< C an opport"nit! *or the appellant to *or all! present its case= C ens"ring the i partialit! o* the appeals process= C a written state ent to the appellant8 o* the appeal *indings incl"ding the reasons *or the decisions reached. The certi*ication bod! shall ens"re that all interested parties are ade aware8 as and when appropriate8 o* the e'istence o* the appeals proced"res to be *ollowed.

1o ent< 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 GA/ 234435
7.13.7 =henever possible, the certification body shall ive formal notice of the outcome and end of the complaint process to the complainant.

7-1.-0 The certi*ication bod! shall gi&e *or al notice o* the o"tco e and end o* the appeal process to the appellant. 1o ent< /o e detail o* the g"idance not co&ered b! the new standard .the cla"se is go&erned b! I/0 GA/ 234435

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6.# G"blicl! a&ailable in*or ation The certi*ication bod! shall aintain .thro"gh p"blications8 electronic edia or other eans5 and a?e a&ailable on req"est8 the *ollowing< a5 in*or ation abo"t .or re*erence to5 the certi*ication sche e.s58 incl"ding e&al"ation proced"res8 r"les and proced"res *or granting8 aintaining8 e'tending or red"cing the scope o*8 s"spending8 withdrawing or re*"sing certi*ication= 1o ent< The aspect o* +detailed description, is not ta?en into the new standard. /ee as well

see 3.1o new ent< No ob&io"s corresponding te't in the standard.3 I* e'planations are req"ired as to the application o* these doc" ents .2. 1la"se 3.3 co es closest b"t witho"t p"tting a req"ire ent on the 1D to pro&ide in*or ation to the applicant.75 *or a speci*ic certi*ication sche e8 the! shall be *or "lated b! rele&ant and i partial persons or co ittees possessing the necessar! technical co 1o ent< No ob&io"s corresponding te't petence8 in the new standard. No req"ire ent on the 1D to pro&ide in*or ation to the applicant on req"est.2. 3.2. .

ISO Guide 65 IAF GD5 FDIS 17065 / comments .

6.)).75.-. 1erti*ication bodies shall "se this in*or ation as inp"t to identi*!ing ris?s to i partialit! raised b! the acti&ities o* s"ch personnel or b! the organi>ations that e plo! . !"T# "utsourced tasks are completed by personnel usually assi ned by the or anization to which the task is outsourced. Such personnel are not normally assi ned by the certification body.3.65 and independence *ro co ercial and other interest= b5 declare an! prior and(or present association on their own part8 or on the part o* their e plo!er8 with< 25 a s"pplier or designer o* prod"cts8 or 75 a pro&ider or de&eloper o* ser&ices8 or 35 an operator or de&eloper o* processes to the e&al"ation or certi*ication o* which the! are to be assigned= and c5 re&eal an! sit"ation ?nown to the that a! present the or the certi*ication bod! with a con*lict o* interests . 1ontract with the personnel The certi*ication bod! shall req"ire personnel in&ol&ed in the certi*ication process to sign a contract or other doc" ent b! which the! co it the sel&es to< a5 co pl! with the r"les de*ined b! the certi*ication bod!8 incl"ding those relating to con*identialit! .2 The certification body shall assi n personnel to perform each evaluation task which it undertakes with its internal resources .4.$.8. 6-1-.7.

Identifyin risks does not imply risk assessments 4. shall act impartially..4 If a risk to impartiality is identified. shared resources. either internal or e$ternal. and payment of a sales commission or other inducement for the referral of new clients.-. 4.-.2.)-. overnance.ISO Guide 65 IAF GD5 FDIS 17065 / comments impartiality on an on oin basis. personnel.3 co"ld be seen as handling this aspect in an indirect +ob&io"s.2. Eowever.2. contracts. The last paragraph o* cla"se #. or committees.includin brandin . who could influence the certification activities. The +seq"ence. finances. or from the relationships of its personnel .see 5. from its relationships. mana ement. such relationships may not necessarily present a certification body with a risk to impartiality. o* cla"ses is longI .12 All certification body personnel. This information shall be made available to the mechanism specified in 2. !"T# to IS" :)+++.. !"T# ) A relationship presentin a risk to impartiality of the certification body can be based on ownership. This shall include those risks that arise from its activities. marketin . 1o ent< The ore direct details o* the I/0 G"ide #$ req"ire ent related to possible con*lict o* interest in per*or ing e&al"ation is not directl! co&ered in the new standard. etc. anner. the certification body shall be able to demonstrate how it eliminates or minimizes such risk.

27.ISO Guide 65 IAF GD5 G.possibl! b! a di**erent person or bod!5= C *or the basis *or ongoing s"r&eillance acti&ities to ens"re .27.possibl! b! a di**erent person or bod!5= C *or the basis *or ongoing s"r&eillance acti&ities to ens"re contin"ed con*or it! with certi*ication req"ire ents. G. 1o ent< This g"ideline is s"ggested to FDIS 17065 / comments c o n t i n " e d c o n * o r i t ! w i t h c e r t i * i No corresponding req"ire ent in G"ide #$ be better lin?ed with the %eporting and %e&iew acti&ities in the new standard as co pared to with ch27 in I/0 G"ide #$.2 The in*or ation gathered d"ring the certi*ication process sho"ld be s"**icient< C *or the certi*ication bod! to be able to ta?e an in*or ed decision on certi*ication= C *or traceabilit! to be a&ailable in the e&ent8 *or e'a ple8 o* an appeal or *or planning *or the ne't acti&it! .2 The in*or ation gathered d"ring the certi*ication process sho"ld be s"**icient< C *or the certi*ication bod! to be able to ta?e an in*or ed decision on certi*ication= C *or traceabilit! to be a&ailable in the e&ent8 *or e'a ple8 o* an appeal or *or planning *or the ne't acti&it! .

5 are not applicable. 1o ent< I/0(IE1 23474 E 72 E 7$ req"ires co pletion o* reports that s"bseq"entl! are "sed b! the 1D.*. 7. .2. !"T# ) This documentation can provide opinion whether product re&uirements . !"T# The certification scheme should indicate whether the evaluation is performed by the certification body. under its responsibility. 7.-.s.2 @ecommendations for a certification decision based on the review shall be documented unless review and certification decision are completed concurrently by the same person. These standards do not alone co&er the intention o* the g"ideline. In the latter case.5.. the re&uirements of *.includin indirect re&uirements such as those for the &uality mana ement system under which the product is produced. The review shall be carried out by person.4.*.5. for the certification process. if re&uired by the certification scheme.1 The certification body shall assi n at least one person to review all information and results related to the evaluation.# The results of all evaluation activities shall be documented prior to review .cation 7. or the evaluation is performed prior to the application . which have not been involved in the evaluation process.5 Review 7. have been fulfilled.

7 An! in*or ation on which a decision is based which co es *ro an! so"rce other than the e&al"ation process sho"ld be ade ?nown to the applicant or s"pplier along with in*or ation on the e&al"ation process. a l e & e l o * ? n o w l e d g G.s58 who ta?e. 1o ent< This g"ideline is s"ggested to be better lin?ed with the %eporting and %e&iew acti&ities in the new standard as co pared to with ch27 in I/0 G"ide #$. h a & e G.27.6 The person.s5 the decision on granting(withdrawing certi*ication within the certi*ication bod! shall 58 .27.ISO Guide 65 IAF GD5 FDIS 17065 / comments req"ire ents. The applicant or s"pplier sho"ld be gi&en the opport"nit! to co ent on it.

7 o* I/0 G"ide #$ abo&e. .4. 59 .3 intends to ?eep s"ch in*or ation con*idential *or the applicant8 the intention o* the g"ideline a! beco e totall! re@ected in the new standard..$ Bhere the certi*ication bod! ta?es acco"nt o* wor? related to certi*ication per*or ed b! another bod!8 the certi*ication bod! shall ha&e arrange ents in place *or con*ir ing the scope8 c"rrenc! and applicabilit! o* the certi*ication . G.and those specified by the certification scheme.e and e'perience s"**icient to e&al"ate the in*or ation obtained *ro the e&al"ation process. 1o ent< The details o* the g"idance are not ta?en into the new standard. I* s"ch in*or ation is to be transparent to the applicant8 the new standard still does not co&er the details o* the g"ideline.27. shall be treated as confidential.$.5. complainant.as req"ired b! the rele&ant certi*ication sche e o* the certi*ication bod!5 it is rel!ing "pon8 and 7. /ee as well cla"se $.3 Information about the client obtained from sources other than the client .e. re ulators. 1o ent< Depending on whether cla"se 6.-. !"T# This can include work carried out under reco nition a reements between certification bodies. 4.5 The certification body shall only rely on evaluation results related to certification completed prior to the application for certification where it takes responsibility for the results and satisfies itself that the body that performed the evaluation fulfils the re&uirements contained in 8.

27.see also cla"se 6. 2 7 . The noncon*or ities and their resol"tion sho"ld be doc" ented b! the certi*ication bod!.68 Note 7 o* I/0(IE1 G"ide #$5. 3 ) o r a c e r ti *i c a ti o n d o c " e n t t o r e G. FDIS 17065 / comments G .# 1erti*ication shall not be granted "ntil all criteria are et. Noncon*or ities8 which raise an! do"bt as to the con*or it! o* the prod"ct "st be corrected and the correction &eri*ied b! the certi*ication bod! .b! site &isit or other appropriate *or s o* &eri*ication5 be*ore certi*ication is granted. .ISO Guide 65 IAF GD5 an! other data pertaining to the co petenc! o* the bod! it is rel!ing "pon8 be*ore the iss"e o* its own certi*ication .

*.). the decision to rant or e$tend the scope of certification . 1o ent< The details o* the g"idance are not ta?en into the new standard. G.3 b525 sho"ld clari*! whether a prod"ct8 ser&ice or process is certi*ied. 1o ent< The details o* the g"idance are not ta?en into the new standard. (omment/ 'uidance not taken into the new standard.27.).H The certi*ication doc" ent .3. /ee as well G.present accredited certi*ication it sho"ld be iss"ed b! a certi*ication bod! in accordance with the conditions o* its accreditation and sho"ld "na big"o"sl! identi*! the accreditation bod! and the iss"ing certi*ication bod!. Bhere a certi*ication bod! holds ore than one accreditation co&ering the scope o* the certi*ication8 the accredited certi*ication doc" ents sho"ld identi*! at least one o* the accreditation bodies. has been made9 and b. the certification a reement .I/0(IE1 G"ide #$8 cla"se 27.5. 3.6.-.6.8.$. abo&e 7-7-. certification re&uirements bein fulfilled9 and c.35 shall onl! be iss"ed a*ter or conc"rrent with< a. has been completed%si ned. )or al certi*ication doc" entation .1" sco!e of certification identification of/ .

27.*.see cla"se 2. and other normative document.9 I* there is no re*erence to an e'pir! date on the certi*ication doc" ent8 there shall be eno"gh in*or ation on the doc" ent to readil! con*ir the &alidit! o* the certi*ication within the rele&ant certi*ication s!ste .see cla"se 27.7 o* I/0(IE1 G"ide #$ and(or I/0(IE1 G"ide #35.2 In cases where s"r&eillance is part o* the certi*ication s!ste it sho"ld be s"ch to gi&e con*idence that certi*ied prod"cts contin"e to co pl! with the nor ati&e doc" ents to which the! are certi*ied. *.es.s. for which the certification is ranted9 ? ? the applicable certification scheme9 and the standard. process.s.3 o* I/0(IE1 G"ide #$5.s. process. or service.ISO Guide 65 IAF GD5 The certi*ication doc" ent sho"ld incl"de or re*er to an appropriate description o* the certi*ication sche e .) The certification body shall provide to the client formal certification documentation that clearly conveys.s. 2 o * I / 0 . FDIS 17065 / comments ? the product. includin date of publication to which the product.s. G.es.23. has been ?ud ed to comply G.. or service. or permits identification of/ e5 the ter or e'piration date o* certi*ication i* certi*ication e'pires a*ter an established period= 1o ent< The g"ideline is not co&ered b! the new standard..s. The s"r&eillance proced"res req"ired "nder cla"se 2 3 .

The! sho"ld be 7. /a ples *or s"r&eillance testing sho"ld be t!pical o* prod"ction.B. .#. covered by the certification decision in accordance with the certification scheme.s.5. the re&uirements in *. !"T# ) See IS"%I#( 'uide 8* future IS"%I#( )*+8*for e$amples of surveillance activities in certification schemes.2 =hen surveillance utilizes evaluation.#. the certification body shall initiate surveillance of the product.B.8 shall be fulfilled.(IE1 G"ide #$ sho"ld incl"de8 as appropriate8 testing8 inspection and(or assess ent o* the prod"ction and(or o* the q"alit! s!ste etc. .1 If surveillance is re&uired by the certification scheme or as described in subclauses *. review or certification decision.see also I/0(IE1 G"ide #35. !"T# The criteria and process for surveillance activities are defined by each certification scheme.5.2 or *.: or *. *. 7.

23. G. or retailers.e.ISO Guide 65 IAF GD5 FDIS 17065 / comments selected b!8 or "nder the control o*8 the certi*ication bod! *ro the *actor! .3 Man! techniq"es are a&ailable to certi*ication bodies to cond"ct s"r&eillance. At the sa e ti e8 characteristics o* prod"ction processes can aid or hinder o n g o i n g c o n * o r i t ! w i t h c e r t i * .prod"ction-distrib"tionsales chain.7 /"r&eillance req"ire ents *or a speci*ic s"pplier a! &ar! as the s"pplierJs de onstrated abilit! to eet certi*ication req"ire ents on an ongoing basis changes. In s"ch sit"ations8 certi*ication bodies sho"ld ha&e doc" ented proced"res *or adapting s"r&eillance acti&ities e. ta?ing into acco"nt the co ple'it! o* the prod"ct8 at"rit! o* the nor ati&e doc" ents8 e'perience o* the s"pplier8 li*e c!cle o* the prod"ct8 changing o* technolog!. distrib"tors.g. These techniq"es a! be cond"cted at &ario"s points and at &ar!ing *req"encies d"ring the design. stoc?5 in a anner that ens"res that the i partialit! o* selection and the integrit! o* the sa ple cannot be co pro ised. prod"ction8 stoc?5 or the ar?et .e.g.g.23. G.

As a part o* eeting the 1o ent< The details o* the g"ideline are not ta?en into the new standard. (omment/ The new standard does not cover the competence re&uirements mentioned in the uideline.ication req"ire ents. . (omment/ !othin stated in the new standard.

23.ISO Guide 65 IAF GD5 req"ire ents o* cla"se 6.26. G.Grod"cts8 KM/ etc. The c e r t i * .e.6 /ince C s"r&eillance pla!s a direct role in achie&ing the intended bene*its *ro a certi*ication s!ste = C a wide &ariet! o* acti&ities are a&ailable *ro which to operate a s"r&eillance progra = and C the ele ents o* a s"r&eillance progra can change on an ongoing basis= s"r&eillance req"ire ents shall be considered b! the parties .@5 o* I/0(IE1 G"ide #$8 certi*ication bodies sho"ld there*ore ha&e personnel co petent to a?e appropriate choices in the design and operation o* s"r&eillance progra s.g. FDIS 17065 / comments 1o ent< The g"ideline is not co&ered b! the new standard. G.58 and sho"ld a&oid con*"sion between the eaning o* its ar?s.2 The certi*ication bod! sho"ld a&oid "sing the sa e ar? to indicate di**erent certi*ication s!ste s . a"thorities5 in&ol&ed in the de&elop ent o* the sche e.7.

3. 6. N0TE 2 G"idance on the "se o* certi*icates and ar?s per itted b! the certi*ication bod! can be obtained *ro I/0(IE1 G"ide 73.ication bod! can "se the sa e corporate logo in di**erent s!ste s or sche es pro&ided the ar?s are clearl! disting"ishable.2.2 The certi*ication bod! shall e'ercise the control as speci*ied b! the certi*ication sche e o&er ownership8 "se and displa! o* licenses8 certi*icates8 ar?s o* con*or it!8 and an! other echanis s *or indicating a prod"ct is certi*ied. N0TE 7 I/0(IE1 23434 pro&ides req"ire ents *or .

26.6 A certi*ication bod! sho"ld ha&e proced"res to ens"re that its ar?s are not "sed in a wa! that a! be li?el! to con*"se or islead the ar?et.$ Bhere the certi*ication bod! a?es "se o* a ar? that it has been assigned b! another bod!8 e.# The certi*ication bod! sho"ld ha&e doc" ented proced"res to ens"re a traceable lin? *ro its ar? to the rele&ant certi*ication req"ire ents.g.3 I* a certi*ication bod! incorrectl! clai s accredited stat"s *or certi*icates iss"ed be*ore appropriate accreditation has been granted8 the accreditation bod! a! req"ire it s"bseq"entl! to withdraw the . " s e o * it s a r ? .26. G.26.7 The certi*ication bod! shall ha&e doc" ented proced"res *or the . G. the owner o* the ar?8 its agree ent with that bod! shall ens"re con*or it! with the intent o* all sections o* this cla"se.26.ISO Guide 65 IAF GD5 FDIS 17065 / comments "se o* third-part! ar?s. G.26. G. s e e a l s o I / 0 ( I E 1 G.

(omment/ 'uideline not taken into new standard 6. Eowever.2.)5. (omment/ 5. 6.7. states a re&uirement on what to be re&uired%a reed with the client in a certification a reement.3.-.2 is not covered.i.). .2343458 and *or the eas"res to be adopted in case o* is"se8 incl"ding *alse clai s as to 1o ent< The g"ideline is not clearl! co&ered b! the new standard. 1o ent< The g"ideline is not co&ered b! the new standard. It partially covers the intent of IA0 '12 ')5.5.2 The certi*ication bod! shall e'ercise the control as speci*ied b! the certi*ication sche e o&er ownership8 "se and displa! o* licenses8 certi*icates8 ar?s o* con*or it!8 and an! other echanis s *or indicating a prod"ct is certi*ied.2. the aspect of 6misleadin 7 is not taken into the new standard and '..7 i5 co plies with an! req"ire ents that a! be prescribed in the certi*ication sche e that relate to the "se o* ar?s o* con*or it!8 and on in*or ation related to the prod"ct= N0TE /ee also I/0(IE1 234348 I/0(IE1 G"ide 73 and I/0(IE1 G"ide 73.

Anne' 2 E /er&ice certi*ication 1o ent< The anne' incl"des aspects o* designing sche es *or 1erti*ication o* ser&ices.). N0TE 7 I/0(IE1 23434 pro&ides req"ire ents *or "se o* third-part! ar?s. These are not ta?en into the new standard. (omment/ The uideline is not covered by the new standard.ISO Guide 65 IAF GD5 certi*ication and *alse "se o* certi*ication bod! ar?s. . These are not ta?en into the new standard.) does not re&uest to have documented procedures No speci*ic cla"ses related to certi*ication o* /er&ices No speci*ic cla"ses related to certi*ication o* /er&ices Anne' 2 E /er&ice certi*ication1o ent< The anne' incl"des req"ire ents to be et b! the 1D when per*or ing 1erti*ication o* /er&ices.:. FDIS 17065 / comments N0TE 2 G"idance on the "se o* certi*icates and ar?s per itted b! the certi*ication bod! can be obtained *ro I/0(IE1 G"ide 73. 5.

1o ent< The anne' incl"des aspects o* designing sche es *or 1erti*ication o* Grocesses. .No speci*ic cla"ses related to certi*ication o* Grocesses No speci*ic cla"ses related to certi*ication o* Grocesses Anne' 7 E Grocess certi*ication Anne' 7 E Grocess certi*ication 1o ent< The anne' incl"des req"ire ents to be et b! the 1D when per*or ing 1erti*ication o* Grocesses. These are not ta?en into the new standard. These are not ta?en into the new standard.

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