IS/ISO/IEC Guide 65 (1996): General requirements foor ...€¦ · IS/ISO/IEC Guide 65 (1996): General requirements foor bodies operating product certification systems - Guidelines

Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.

इंटरनेट मानक

“!ान $ एक न' भारत का +नम-ण”Satyanarayan Gangaram Pitroda

“Invent a New India Using Knowledge”

“प0रा1 को छोड न' 5 तरफ”Jawaharlal Nehru

“Step Out From the Old to the New”

“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan

“The Right to Information, The Right to Live”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam

“Knowledge is such a treasure which cannot be stolen”

“Invent a New India Using Knowledge”

है”ह”ह

IS/ISO/IEC Guide 65 (1996): General requirements foorbodies operating product certification systems - Guidelines[MSD 10: Social Responsibility]

lS/lSO/lEC Guide 65:1996

Indian Standard

GENERAL REQUIREMENTS FOR BODIES OPERATINGPRODUCT CERTIFICATION SYSTEMS — GUIDELINES

ICS 03.120.20

@ BIS 2007

BUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

~epf[)lnber ‘200;7 Price Group 4

National Mirror Committee of CASCO. IRD 1

NATIONAL FOREWORD

This Indian Standard which is identical with lSO/l EC Guide 65: 1996 ‘General requirements for bodies

operating product certification systems’ issued by the International Organization for Standardization (ISO)

and International Electrotechnical Commission (l EC) was adopted by the Bureau of Indian Standards

on the recommendations of the National Mirror Committee of CASCO and approval of the Director

General, Bureau of Indian Standards under Rule 8 (3C) of B/S Ru/es.

The text of lSO/lEC Guide has been approved as suitable for publication as an Indian Standard

without deviations. Certain conventions are, however, not identical to those used in Indian Standards.

Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should

be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker, while in Indian Standards, the current

practice is to use a point (.) as the decimal marker.


Contents Page

1

2

3

4

5

6

7

8

9

Scope . ................................. ..........................................................

References ......................................................................................

Definitions .......................................................................................

Certification body ......... ...................................................................

4.1 General provisions ..................................................................

4.2 Organization ................ ...........................................................

4.3 Operations ..............................................................................

4.4 Subcontracting .......................................................................

4.5 Quality system .......................................................................

4.6 CmdRi6ns and procedures for granting, maintaining,extending, suspending andwithdrawlng certification ............

4.7 internal audits and management reviews,,,., ......................

4.8 Documentation ............ ...........................................................

4.9 Records .......................................... .............................. .........

4.10 Confidentiality .........................................................................

Certification body personnel ............................................................

5.1 General ...................................................................................

5.2 Qualification criteria ................................................................

Changes in thecertlfication requirements ......................................

Appeals, complaints and disputes ...................................................

Application for certification ..............................................................

8.1 information on the procedure ................................................

8.2 Theapplication ........................................... .. . . ..... . .. ...

Preparation for evaluation ...............................................................

10 Evaluation .............................................................. .........................

11 Evaluation report .............................................................................

12 Decision on certification ............ .....................................................

13 Surveillance ...................................................................... ...............

14 Useoflicences, certificates andmarks of conformity ....................

15 Complaints to suppliers ..................................................................

1

1

1

2

2

2

3

3

3

4

4

4

5

5

5

5

5

6

6

6

6

7

7

7

7

8

8

8

8

I


Introduction

Certlflcatlon of a product (a term used to include a process or service) is ameans of providing assurance that it complies with specified s?andardsand other normative documents. Some product certification systems mayInclude Initial testing of a product and assessment of Its suppliers’ qualitysystems, followed by surveillance that takes into account the factory qual-ity system and the testing of samples from the factory and the open mar-ket. Other systems rely on initial testing and surveillance testing, while stillothers comprise type testing only.

This Guide specifies requirements, the observance of which IS Intended toensure that certification bodies operate third-party certification systems ina consistent and reliable manner, thereby facilitating their acceptance on anational and international basis and so furthering international trade.

The req~lr~ment~ c~rltained in ttjs Guide are written, above all, to be con-sidered as general criteria for organizations operating product certificationsystems; they may have to be amplified when specific Industrial or othersectors make use of them, or when particular requirements such as healthand safety have to be taken into account.

Assertion of conformity to the appropriate standards or other normativedocuments will be in the form of certificates or marks of conformity. Sys-tems for certifying particular products or product groups to specified stan-dards or other normative documents will, in many cases, require their ownexplanatory documentation.

Whale this Guide is concerned with third-parties providing product certifi-cation, many of its provisions may also be useful in first- and second-dartypr~duct conformity assessment procedures.

The diversity in certification systems may at first seem unnecessary andeven confuse newcomers in the field, clients and operators alike. ThelSO/lEC publication Certif;catjon and related activities is available for back-ground reading and will help to answer questions regarding the practicesof the worldwide conformity assessment community.

II


Indian Standard

GENERAL REQUIREMENTS FOR BODIES OPERATINGPRODUCT CERTIFICATION SYSTEMS — GUIDELINES

1 Scope

1.1 This Guide specifies general requirements that athird-party operating a product certification systemshall meet if It is to be recognized as competent andreliable.

In this Guide the term “certification body”’ is used tocQver any bQdy operating a product certification sys-

tem. The word “product” is used in its widest senseand includes processes and services; the word“standard” IS used to include other normative docu-ments such as specifications or technical regulations.

1.2 The certification system used by the certificationbody may include one or more of the following, whichcould be coupled with production surveillance orassessment and surveillance of the supplier’s qualitysystem or both, as described in lSO/l EC Guide 53:

a)

b)

c)

d)

e)

type testing or examination;

testing or inspection of samples taken from themarket or from suppher’s stock o; from a combi-nation of both;

testing or inspection of every product or of a par-ticular product, whether new or already in use;

batch testing or inspection;

design appraisal.

lSO/l EC Guide 2:1996, Standardization and relatedactivities — General vocabulary.

lSO/lEC Guide 7:1994, Guidelines for drafting ofstandards suitable for use for conformity assessment.

lSO/l EC Guide 23:1982, Metho”ds of indicating con-formlt y with standards for third-party certification sys-tems,

1S0/1EC Guide 25:1990, General requirements for thecompetence of calibration and testing laboratories.

lSO/l EC Guide 27:1983, Guidelines for correctweaction to be taken by a certification body in the eventof misuse of its mark of conformity

1S0/1EC Guide 28:1982, General rules for a modelthird-party certification system for products.

1S0/1EC Guide 39:1988, General requirements for theacceptance of inspection bodies.

lSO/l EC Guide 53:1988, An approach to the ut//izationof a suppher’s quality system in third-party productcertification.

1S0/1EC Guide 62:1996, Genera/ requirements forbodies operating assessment and certif/cat/on/reg/s-tration of qua//ty systems.

NOTE 1 lSO/lEC Guide 28 may be consulted for a modelof one form of a third-party product certification system.

3 Definitions

2 References

ISO 8402:1994, Quahty management and quahtyassurance — Vocabulary.

ISO 10011-1:1990, Guidelines for auditing qualitysystems — Part 1: Auditing.

For the purposes of this Guide, the relevant definitionsgiven in lSO/l EC Guide 2 and ISO 8402 apply, togetherwith the following definition,

3.1 supplier: The party that is responsible forensuring that products meet and, if applicable,continue to meet, the requirements on which thecertification is based.

1


4 Certification body

4.1 General provisions

4.1.1 The policies and procedures under which thecertification body operates and their administrationshall be non-discriminatory and shall be administeredIn a non-discriminatory manner. Procedures shall notbe used to impede or inhibit access by applicants,other than as movided for in this Guide.

4.1.2 The certification body shall make its servicesaccessible to all applicants whose activities fall withinIts declared field of operation. There shall not beundue financial or other conditions. Access shall notbe conditional upon the size of the suppher or mem-bership of any association or group, nor shall certifi-cation be conditional upon the number of certificatesalready issued,

4.1.3 The criteria against whiq,h the products of asupplier are evaluated shall be those outlined in speci-fied standards. Requirements for standards suitablefor this purpose are contained in lSO/lEC Guide 7. Ifexplanation IS required as to the application of thesedocuments for a specific certification system, it shallbe formulated by relevant and impartial committees orpersons possessing the necessary technical com-petence, and published by the certification body.

4.1.4 The certification body shall confine its require-ments, evaluation and decision on certification tothose matters specifically related to the scope of thecertification being considered.

4.2 Organization

The structure of the certification body shall be such asto foster confidence in its certifications. In particular,the certification body shall

a) be Impartial;

b) be responsible for decisions relating to its grant-ing, maintaining, extending, suspending andwithdrawing of certification;

c) Identify the management (committee, group orperson) which shall have overall responsibility forall of the following:

1)

2)

performance of testing, inspection, evalu-ation and certification as definied in thisGuide,

formulation of policy matters relating to theoperation of the certification body,

d)

e)

f)

g)

h)

i)

It

k)

1)

m)

n)

3) decisions on certification,

4) supervision of the implementation of itspolicies,

5) supervision of the finances of the body,

6) delegation of authority to committees orindividuals as required to undertake definedactivities on its behalf,

7) technical basis for granting certlfrcatlon;

have documents which demonstrate it IS a legalentity;

have a documented structure which safeguardsimpartiality including provisions to ensure theimpartiality of the operations of the certificationbody; this structure shall enable the participationof all parties significantly concerned in thedevelopment of policies and principles regardingthe content and functioning of the certificationsystem;

ensure that each decision on certification IS takenby a person(s) different from those who carriedout the evaluation;

have rights and responsibilities relevant to itscertification activities;

have adequate arrangements to cover liabilitiesarising from its operations and/or activities;

have the financial stability and resources requiredfor the operation of a certification system;

employ a sufficient number of personnel havingthe necessary education, training, technicalknowledge and experience for performing certifi-cation functions relating to the type, range andvolume of work performed, under a respons~blesenior executive;

have a quality system giving confidence in itsability to operate a certification system for prod-ucts;

have policies and procedures that distinguishbetween product certification and any other ac-tivities in which the certification body is engaged;

together with its senior executive and staff, befree from any commercial, financial and otherpressures which might influence the results ofthe certification process;

have formal rules and structures for the appoint-ment and operation of any commntees which arerevolved in the certification process; such com-mittees shall be free from any commercial,


financial and other pressures that might influencedecisions; a structure where members arechosen to provide a balance of interests whereno single interest predominates will be deemedto satisfy this provision;

o) ensure that activities of related bodies do notaffect the confidentiality, objectivity and impar-tiality of its certifications, and it shall not

1) supply or design products of the type it cer-tifies,

2) gwe advice or provide consultancy servicesto the applicant as to methods of dealingwith matters which are barriers to the certi-fication requested,

3) provide any other products or serviceswhich could compromise the confidentiality,objectivity or impartiality of its certificationprocess and decisions:

p) have policies and procedures for the resolution ofcomplaints, appeals and disputes received fromsupphers or other parties about the handling ofcertification or any other related matters.

4.3 Operations

The certification body shall take all steps necessaryto evaluate conformance with the relevant productstandards according to the requirements of specificproduct certlf!cation system (see clause 3). Thecertification body shall specify the relevant standardsor parts thereof and any other requirements such assampling, testing and Inspection requirements whichform the basis for the applicable certification system.

In conducting its certification operations, the certifi-cation body shall observe, as appropriate, the require-ments for the suitability and competence of body(ies)or person(s) carrying out testing, inspection and certi-flcatlon/registration as specified in lSO/lEC Guides 25,39 and 62.

4.4 Subcontracting

When a certification body decides to subcontractwork related to certification (e.g. testing or inspection)to an external body or person, a properly documentedagreement covering the arrangements including con-fidentiality and conflict of Interest shall be drawn up.The certification body shall

a) take full responsibility for such subcontractedwork and maintain its responsibility for granting,malntainmg, extending, suspending or with-drawing certification;

b) ensure that the subcontracted body or person iscompetent and complies with the applicable pro-visions of this Guide and other standards andguides relevant to testing, inspection or othertechnical activities (see clause 2), and is notihvolved either directly or through the person’semployer with the design or production of theproduct in such a way that Impartiality would becompromised;

c) obtain the applicant’s consent.

NOTES

2 Where work related to certification has been undertakenprior to the application for certification, the body may takeaccount of it, provided it can take responsibility as detailedin 4.4 a) and satisfy itself regarding the matters deta(led (n4.4 b}.

3 The requirements given in 4.4 a) and b) are also relevant,by extension, when a certification body uses, for grantingits own certification, work performed by another certifi-cation body with which it has signed an agreement.

4.5 Quality system

4.5.1 The management of the certification body hav-ing executive responsibility for quality shall define anddocument its policy for quality and its objectives for,and commitment to, quality. The management shallensure that this policy is understood, Implementedand maintained at all levels of the organization.

4.5.2 The certification body shall operate an effectivequality system in accordance with the relevant el-ements of this Guide and appropriate for the type,range and volume of work performed, This quallty sys-tem shall be documented and the documentation shallbe available for use by the certification body staff. Thecertification body shall ensure effective implemen-tation of the documented quality system, proceduresand instructions. The certification body shall designatea person having direct access to its highest executivelevel who, irrespective of other responsibilities, shallhave defined authority for

a) ensuring that a quality system is established,implemented and maintained In accordance withthis Guide, and

b) reporting on the performance of the quallty sys-tem to the body’s management for review and asa basis for improvement of the quality system.

4.5.3 The quality system shall be documented In aquality manual and associated quality procedures, and

3


the manual shall contain or refer to at least the fol-Iowfng

a)

b)

c)

d)

e)

f)

g)

h)

1)

1)

k)

1)

m)

n)

a quality policy statement:

a brief description of the legal status of the certi-fication body, including the names of its ownersand, If different, names of the persons who con-trol It;

the names, qualifications, experience and termsof reference of the senior executive and othercertification personnel, both internal and external;

an organization chart showing lines of authority,responsibility and allocation of functions stem-ming from the senior executive;

a description of the organization of the certifi-cation body, including details of the management(committee, group or person) identified in 4.2 c),its constitution, terms of reference and rules ofprocedure;

the policy and procedures for conducting man-agement reviews;

administrative procedures including documentcontrol;

the operational and functional duties and servicespertaining to quality, so that the extent and limitsof each person’s responsibility are known to allconcerned;

the procedure for the recruitment, selection andtraining of certification body personnel and moni-toring of their performance;

a list of its approved subcontractors and the pro-cedures for assessing, recording and monitoringtheir competence;

Its procedures for handling nonconformities andfor assuring the effectiveness of any correctiveand preventive actions taken;

the procedures for evaluating products andimplementing the certification process, including

1) the conditions for issue, retention andwithdrawal of certification documents,

2) controls over the use and application ofdocuments employed in the certification ofproducts;

the policy and procedure for dealing with appeals,complamts and disputes;

its procedures for conducting internal audits,based on the provisions of ISO 10011-1.

4.6 Conditions and procedures for granting,maintaining, extending, suspending andwithdrawing certification

4.6.1 The certification body shall spec!fy the con-ditions for granting, maintaining and extending certifi-cation and the conditions under which certificationmay be suspended or withdrawn, partially or In total.

4.6.2 The certification body shall have procedures to

a) grant, maintain, withdraw and, if applicable, sus-pend certification;

b) extend or reduce the scope of certification;

c) re-evaluate, in the event of changes significantlyaffecting the product’s design or specification, orchanges in the standards to which compliance ofthe product is certified, or changes in the owner-ship, structure or management of the supplier, ifrelevant, or in the case of any other informationindicating that the product may no longer camplyw[th the requirements of the certification sys-tem,

4.7 Internal audits and management reviews

4.7.1 The certification body shall conduct periodicinternal audits covering all procedures in a plannedand systematic manner, to verify that the quality sys-tem is Implemented and is effective.

The certification body shall ensure that

a) personnel responsible for the area aud!ted areinformed of the outcome of the audit;

b) corrective action is taken in a timely and appro-priate manner; and

c) the results of the audit are documented.

4,7.2 The body’s management with executive re-sponsibility shall review its quality system at definedintervals which are sufficiently short to ensure itscontinuing suitability and effectiveness in satisfyingthe requirements of this Guide and the stated qualitypolicy and objectives. Records of such reviews shallbe maintained.

4.8 Documentation

4.8.1 The certification body shall provide (throughpublications, electronic media or other means), updateat regular intervals, and make available on request, thefollowing: .

4

MSO/lEC Guide 65:1996

a) Information about the authority under which thecertification body operates;

b) a documented statement of its product certifi-cation system, including its rules and proceduresfor granting, maintaining, extending, suspendingand withdrawing certification;

c) Information about the evaluation procedures andcertlflcatlon process related to each product cer-tification system;

d) a description of the means by which the organ-ization obtains financial support and general in-formation on the fees charged to applicants andto suppliers of certified products;

e) a description of the rights and duties of appli-cants and suppliers of certified products, includ-ing requirements, restrictions or limitations onthe use of the certification body’s logo and onthe ways of referring to the certification granted;

f) Information about procedures for handling com-plamts, appeals and disputes;

g) a directory of certified procfucts and their suP-phers.

4.8.2 The certification body shall establish and main-tain procedures to control all documents and data thatrelate to its certification functions. These documentsshall be reviewed and approved for adequacy by ap-propriately authorized and competent personnel priorto issuing any documents following initial develop-ment or any subsequent amendment or change beingmade. A listing of all appropriate documents with therespective issue and/or amendment status identifiedshall be maintained. The distribution of all such docu-ments shall be controlled to ensure that theappropriate documentation is made available to per-sonnel of the certification body or suppliers when theyare required to perform any function relating to thecertification body’s activlt!es.

4.9 Records

4.9.1 The certification body shall maintain a recordsystem to suit its particular circumstances and tocomply with existing regulations. The records shalldemonstrate that the certification procedures havebeen effectively fulfilled, particularly with respect toapplication forms, evaluation reports, surveillance ac-tivities and other documents relating to granting,maintaining, extending, suspending or withdrawingcertification, The records shall be identified, managedand disposed of in such a way as to ensure the integ-rity of the process and the confidentiality of the in-

formation. The records shall be kept for a period oftime so that continued confidence may be demonstra-ted for at least one full certification cycle, or as re-quired by law.

4.9.2 The certification body shall have a policy andprocedures for retaining records for a period consist-ent with its contractual, legal or other obligations. Thecertification body shall have a policy and proceduresconcerning access to these records consistent with4.10.1.

NOTE 4 The question of the length of time for retention ofrecords requires specific attention in the light of legal cir-cumstances and recognition arrangements,

4.10 Conf identicality

4.10.1 The certification body shall have adequatearrangements consistent with applicable laws to safe-guard confidentiality of the information obtained in thecourse of its certification activities at all levels ofits organization, including committees and externalbodies or individuals acting on its behalf.

4.10.2 Except as requried in this Guide or by law,information gained in the course of certification actwi-ties about a particular product or supplier shall not bedisclosed to a third-party without the written consentof the supplier. Where the law requires information tobe disclosed to a third-party, the supplier shall beinformed of the information provided as permitted bythe law.

5 Certification body personnel

5.1 General

5.1.1 The personnel of the certification body shall becompetent for the functions they perform, includingmaking required technical judgments, framing poli-cies and implementing them,

5.1.2 Clearly documented instructions shall be avail-able to the personnel describing their duties and re-sponsibilities. These instructions shall be maintainedup to date.

5.2 Qualification criteria

5.2.1 In order to ensure that evaluation and certifi-cation are carried out effectwely and uniformly, theminimum relevant criteria for the competence ofpersonnel shall be defined by the certification body,

I

5


5.2.2 The certification body shall require its person-nel Involved in the certification process to sign a con-tract or other document by which they committhemselves

a)

b)

The

to comply with the rules defined by the certifi-cation body, including those relating to confiden-tiality and independence from commercial andother interest; and

to declare any prior and/or present association ontheir own part, or on the part of their employer,with a supplier or designer of products to theevaluation or certification of which they are to beassigned,

certification body shall ensure that, and documenthow, any contracted personnel for their own part, andon the part of their employer if any, satisfy all therequirements for personnel outlined in this Guide.

5,2.3 Information on the relevant qualifications, trai-ningand experience of each member of the personnelInvolved in the certification process shall be main-tained by the certification body. Records of trainingand experience shall be kept up to date, in particularthe following:

a) name and address;

b) organization affiliation and position held;

c) educational qualification and professional status;

d) experience and training in each field of the certi-fication body’s competence;

e) date of most recent updating of records;

f) performance appraisal

6 Changes in the certificationrequirements

The certification body shall give due notice of anychanges it intends to make in its requirements forcertification. It shall take account of views expressedby interested parties before deciding on the preciseform and effective date of the changes. Followingdecision on, and ~ublication of, the changed re~uire-

ments, it shall verify that each supplier-makesnecessary adjustments within such time as, inopinion of the certification body, is reasonable.

7 Appeals, complaints and disputes

anythe

7.1 Appeals, complaints and disputes broughtbefore the certification body by suppliers or other par-

ties shall be subject to the procedures of thecertification body.

7.2

a)

b)

c)

Each certification body shall

keep a record of all appeals, complaints and dis-putes and remedial actions relative to certifl-catlon;

take appropriate subsequent action;

document the action taken and Its effectiveness.

8 Application for certification

8.1 Information on the procedure

8.1.1 The certification body shall provide to appli-cants an up-to-date detailed description of the evalu-ation and certification procedures, appropriate to’ eachcertification scheme, and the documents containingthe requirements for certification, the applicantsrights and duties of suppliers which have certifiedproducts (including fees to be paid by applicants andsuppliers of certified products).

8.1.2 The certification body shall require that a sup-plier

a)

b)

c)

d)

e)

always complies with the relevant provisions ofthe certification programme;

makes all necessary arrangements for the con-duct of the evaluation, including provision forexamining documentation and access to allareas, records (including internal audit reports)and personnel for the purposes of evaluation(e.g. testing, inspection, assessment, surveil-lance, reassessment) and resolution of com-plaints;

makes claims regarding certification only in res-pect of the scope for which certification has beengranted;

does not use its product certification in such amanner as to bring the certification body into dis-repute and does not make any statement regard-ing its product certification which the certificationbody may consider misleading or unauthorized;

upon suspension or cancellation of certification,discontinues its use of all advertising matter thatcontains any reference thereto and returns anycertification documents as required by the certifi-cation body;

6


f)

g)

h)

uses certification only to indicate that productsare certified as being in conformity with specifiedstandards;

endeavors to ensure that no certificate or reportnor any part thereof is used in a misleading man-ner;

In making reference to its product certification incommunication media such as documents, bro-chures or advertising, complies with the require-ments of the certification body.

8.1.3 When the desired scope of certification is re-lated to a specific system or type of system operatedby the certification body, any explanation needed shallbe provided to the apphcant.

8.1.4 If requested, additional application informationshall be provided to the applicant.

8.2 The application

8.2.1 The certification body shall require completionof an official application form, signed by a duly auth-orized representative of the applicant, in which or at-tached to which are the following:

a) the scope of the desired certification;

b) a statement that the applicant agrees to complywith the requirements for certification and tosupply any information needed for evaluation ofDroducts to be certified.

8.2.2 The applicant, as a minimum, shall provide thefollowing information:

a) corporate entity, name, address and legal status;

b) a defm~tion of the products to be certified, thecertification system, and the standards againstwhich each product is to be certified if known tothe applicant.

9 Preparation for evaluation

9.1 Before proceeding with the evaluation, the certi-f{catlon body shall conduct, and maintain records of, areview of the application for certification to ensurethat

a) the requirements for certification are clearly de-fined, documented and understood;

b) any difference in understanding between thecertification body and the applicant is resolved;and

c) the certlfica~ion body has the capability to per-form the certification service with respect to thescope of the certification sought and, If applic-able, the location of the applicant’s operationsand any special requirements such as thelanguage used by the applicant.

9.2 The certification body shall prepare a plan for Itsevaluation activities to allow for the necessary ar-rangements to be managed.

9.3 The certification body shall assign personnelappropriately qualified to perform the tasks for thespecific evaluation. Personnel shall not be assigned Ifthey have been involved in, or been employed by abody involved in, the design, supply, installation ormaintenance of such products in a manner and withina time period which could conflict with impartiality,

9.4 To ensure that a comprehensive and correctevaluation is carried out, the personnel involved shallbe provided with the appropriate working documents,

10 Evaluation

The certification body shall evaluate the products ofthe applicant against the standards covered by thescope defined in its application against all certificationcriteria specified in the rules of the scheme.

11 Evaluation report

The certification body shall adopt reporting proceduresthat suit its needs but, as a mimmum, these pro-cedures shall ensure that

a) personnel appointed to evaluate the conform-ance of the products shall prowde the certifi-cation body with a report of findings as to theconformity with all the certification requirements;

b) a full report on the outcome of the evaluation ISpromptly brought to the applicant’s notice by thecertification body, identifying any nonconformi-tles that have to be discharged in order to complywith all of the certification requirements and theextent of further evaluation or testing required. Ifthe applicant can show that remedial action hasbeen taken to meet all the requirements wlthln aspecified time limit, the certification body shallrepeat only the necessary parts of the Inltlal pro-cedure.

7


12 Decision on certification

12.1 The declslon as to whether or not to certify aproduct shall be taken by the certification body on thebass of the information gathered during the evalu-ation process and any other relevant information.

12.2 The certlflcatlon body shall not delegate auth-ority for granting, maintaining, extending, suspendingor withdrawing certification to an outside person orbody

12.3 The certification body shall provide to eachsupplier offering certified products, formal certificationdocuments such as a letter or a certificate signed byan ~fflcer who has been assigned such responsibility.These formal certification documents shall permitidentification of the following:

a) the name and address of the supplier whoseproducts are the subject of certification;

b) the scope of the certification granted, includlng,as appropriate,

1) the products certified, which may be ident-ified by type or range of products,

2) the product standards or other normativedocuments to which each product or prod-uct type is certified,

3) the applicable certification system;

c) the effective date of certification, and the term ofthe certification if applicable.

12.4 In response to an application for amendment tothe scope of a certificate already granted, the certifi-cation body shall decide what, If any, evaluation pro-cedure is appropriate in order to determine whether ornot the amendment should be made and shall actaccordingly.

Is surveillance

13.1 The certification body shall have documentedprocedures to enable surveillance to be carried out Inaccordance with the criteria applicable to the relevantcertification system.

13.2 The certification body shall require the suppllerto )nform It about any of the changes cited In 4.6.2 c),such as Intended modification to the product, manwfacturing process or, If relevant, its quality system,

which affect the conformity of the product. The certk-cation body shall determine whether the announcedchanges requ!re further investigations. If such E thecase, the supplier shall not be allowed to release cer-tlfled products resulting from such changes until thecertification body has notified the supplier accordingly.

13.3 The certification body shall document its sur-veillance actwities.

13.4 Where the certification body authorizes thecontinuing use of its mark on products of a type whichhave been evaluated, the certification body shallperiodically evaluate the marked products to confirmthat they continue to conform to the standards.

14 Use of Iicences, certificates andmarks of conformity

14.1 The certification body shall exercise propercontrol over ownership, use and display of Iicences,certificates and marks of conformity.

142 Guidance on the use of certificates and markspermitted by the certification body may be obtainedfrom lSO/lEC Guide 23.

14.3 Incorrect references to the certiflcatton systemor misleading use of Iicences, certificates or marks,found in advertisements, catalogues, etc., shall bedealt with by suitable action.

NOTE 5 Such actions are addressed in lSO/lEC Guide 27and can Include corrective action, withdrawal of certlflcate,publication of the transgression and, if necessary, otherlegal action.

15 Complaints to suppliers

The certification body shall require the supplier of cer-tified products to

a) keep a record of all complaints made known tothe supplier relating to a product’s compliancewith requirements of the relevant standard andto make these records available to the certifi-cation body when requested;

b) take appropriate action with respect to such com-plaints and any deficiencies found in products orservices that affect compliance with the require-ments for certification;

c) document the actions taken

8

Bureau of Indian Standards

BIS is a statutory institution established under the Bureau of /rJdian Standards Acf, 1986 to promote

harmonious development of the activities of standardization, marking and quality certification of goods

and attending to connected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of these publications may be reproduced in any

form without the prior permission in writing of BIS. This does not preclude the free use, in course ofimplementing the standard, of necessary details, such as symbols and sizes, type or gradedesignations. Enquiries relating to copyright be addressed to the Director (Publications), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards arealso reviewed periodically; a standard along with amendments is reaffirmed when such reviewindicates that no changes are needed; if the review indicates that changes are needed, it is taken upfor revision. Users of Indian Standards should ascertain that they are in possession of the latestamendments or edition by referring to the latest issue of ‘F31SCatalogue’ and ‘Standards: MonthlyAdditions’.

This Indian Standard has been developed from Dot: No. IRD 1 (012).

Amendments Issued Since Publication

Amendment No. Date of Issue Text Affected

—

BUREAU OF INDIAN STANDARDSHeadquarters:

Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi 110002Telephones: 23230131, 23233375, 23239402 Website www.bis.org. in

Regional Offices: Telephones

Central :

Eastern :

Northern :

Southern :

Western :

Manak Bhavan, 9 Bahadur Shah Zafar Marg

{23237617

NEW DELHI 110002 23233841

1/14, C.I.T. Scheme Vll M, V.I.P. Road, Kankurgachi

{

23378499, 23378561KOLKATA 700054 23378626, 23379120

SCO 335-336, Sector 34-A, CHANDIGARH 160022

{

26038432609285

C.I.T. Campus, IV Cross Road, CHENNAI 600113

{

22541216, 2254144222542519, 22542315

Manakalaya, E9 MlDC, Marol, Andheri (East) ~ 28329295,28327858MUMBAI 400093 ~ 28327891,28327892

Branches: AHMEDABAD. BANGALORE. BHOPAL. BHUBANESHWAR. COIMBATORE. FARIDABAD.GHAZIABAD. GUWAHATI. HYDERABAD. JAIPUR. KANPUR. LUCKNOW. NAGPUR.PARWANOO. PATNA. PUNE. RAJKOT. THIRUVANANTHAPURAM. VISAKHAPATNAM.

Printed at Prabhat Offset Press, New Delhi-2

Documents

IS/ISO/IEC Guide 65 (1996): General requirements foor ...€¦ · IS/ISO/IEC Guide 65 (1996): General requirements foor bodies operating product certification systems - Guidelines