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 ह ै” Bhartṛhari—Nītiśatakam “Knowledge is such a treasure which cannot be stolen” IS/ISO/IEC 17000 (2004): Conformity assessment - Vocabulary and general principles [PGD 7: Industrial Engineering]
Transcript
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 17000 (2004): Conformity assessment -Vocabulary and general principles [PGD 7: IndustrialEngineering]
BUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
. .
.8,
Price Group 7
..+.. — .A . ..-
National Mirror Committee of CASCO, IRD 1
NATIONAL FOREWORD
This Indian Standard which is identical with lSO/lEC 17000:2004 ‘Conformity assessment — Vocabularyand generaI principles’ issued by the International Organization for Standardization (ISO) and InternationalElectrotechnical Commission (lEC) jointly was adopted by the Bureau of Indian Standards on therecommendations of the National Mirror Committee of CASCO and approval of the Director General, Bureauof Indian Standards under Rule 8(3)C of B/S Ru/es, 1987.
The text of lSO/lEC Standard has been approved as suitable for publication as an Indian Standard withoutdeviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention isparticularly 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 touse a point (,) as the deGimal marker.
Only the English text has been retained while adopting it as an Indian Standard and as such the pagenumbers given here are not the same as i~he International Standard.
lS/lSO/lEC 17000:2004
Contents
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2
3
4
5
6
7
Page
Introduction ................................................................................................................................ .................. ii
AiphabetiGai index ................................................................!.................................................................. ........!14
lS/lSO/lEC 17000:2004
0 Introduction
0.1 Terms and definitions applicable to conformity assessment
ISO and lSO/IEC Guides and, more recently, International Standards relating generically to conformityassessment activities such as testing, inspection and various forms of certification are prepared by workinggroups of the ISO Committee on conformity assessment (CASCO). For many years, ISO/lEC Guide 2, lastrevised in 1996, has included a core vocabulary for conformity assessment, built up from a small number ofterms and definitions first compiled to facilitate communication and understanding about product certificationbased on standards for traditional manufactured goods.
In 2000, CASCO decided to take conformity assessment terminology (Clauses 12 to 17) out oflSO/lEC Guide 2 and provide instead a self-contained vocabulary more readily applicable within the plannedlSO/lEC 17000 series of standards and in the drafting or revision of related guides. CASCO Worldng Group 5,Definitions, has accordingly prepared this International Standard in consultation with other acthe CASCOworking groups, as a consistent framework within which more specific concepts maybe defined appropriatelyand denoted by the most appropriate terms. Extra terms for concepts unique to particular activities withinconformity assessment, such as accreditation, certification of persons and marks of conformity, are found inthe International Standard or Guide related to that activity. Such concepts are not included in this InternationalStandard.
Until pre-existing CASCO publications are revised, the terminology used in those documents remains valid inits context; this International Standard is not intended to be applied retrospectively.
Conformity assessment interacts with other fields such as management systems, metrology, standardizationand statistics. This International Standard does not define the boundaries of conformity assessment. Theseremain elastic.
0.2 Terms and definitions applicable to trade policy
Clause 7 includes some terms and definitions, drawn mainly from the superseded clauses oflSO/lEC Guide 2, for several broader concepts. These are intended not only to standardize usage within theconformity assessment community, but also to help policy makers concerned with the facilitation of tradewithin regulatory and international treaty frameworks.
0.3 A functional approach to conformity assessment
The terms and definitions specified in this International Standard, particularly under Clauses 4 and 5, reflectthe adoption by CASCO in November 2001 of the functional approach recommended earlier that year in thefinal report of a CASCO - CEN/CENELEC TC 1 joint working group.
To provide a better understanding of the defined concepts, their grouping and their relationships, a descriptionof the functional approach is included in Annex A for information.
0.4 Selection of terms and definitions
Some of the terms included in this International Standard relate to concepts it was considered essential todefine. Others it was thought helpful to explain. Many of the general terms used to distinguish conformityassessment concepts are used in common language in a broader sense or with a wider range of meanings.Some also appear in other standard vocabularies with definitions specific to the relevant field of application.
An alphabetical index lists the terms defined in this International Standard. Standards defining other relevantterms are given in Annex B with separate alphabetical lists. First are terms applicable to specific aspects ofconformity assessment, as defined in other standards in the lSO/lEC 17000 series. Second are terms forwhich the definitions given in either the /nternationa/ vocabulary of basic and genera/terms in rnetdogy (VIM)or ISO 9000 are generally applicable in conformity assessment contexts. For the terms “procedure” and“product”, both used extensively in other definitions, the ISO 9000:2000 definitions are reproduced in 3.2and 3.3.
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0.5 Changes in terminology
Attention is drawn to significant changes in the terms or their definitions from the superseded clauses oflSO/lEC Guide 2.
This International Standard does not include a definition of “conformity” on the grounds that it is not necessaryto do so. “Conformity” does not feature in the definition of “conformity assessment”. The concept of“conformity assessment” is concerned with “fulfillment of specified requirements”, not with the wider concept of“conformity”. A definition of the term “specified requirement” (3.1) is included. In English, the term“compliance” is used to distinguish the action of doing what is required (e.g. an organization “complies” bymaking something conform or by fulfilling a regulatory requirement).
The ISO 9000 definition of “product” (3.3) includes services as a product category, so that it is no longercorrect to refer to “products and services”.
Instead of “product, process or service”, the generic expression used in lSO/lEC Guide 2 for the “subject ofstandardization”, Note 2 to 2.1 introduces the expression “object of conformity assessment” as a means ofreferring to the product, process, system, person or body to which conformity assessment is applied. (The“subject” would more logically be the body doing the assessment.)
Instead of “assurance of conformity”, the term “attestation” (5.2) is used for the activity of conveying assurancethrough the issue of a “statement of conformity”.
The term ‘ac~reditatian” k now applicable only to attestation regarding a conformity assessment body. Thedefinition in lSO/lEC Guide 2, by contrast, would have been equally applicable to the certification of persons,as specified in lSO/lEC 17024. Following this change, the terms “conformity assessment body” (2.5) and“accreditation body” (2.6) are defined separately. More specific terms relating to accreditation are defined inlSO/lEC 17011,
To avoid ambiguity, the term “body” is used in this International Standard only when referring to conformityassessment bodies or accreditation bodies. Otherwise, the term “organization” is used in its general meaning,as in the ISO 9000 definition. The more specific lSO/lEC Guide 2 definition of an organization as a bodybased on membership is not applicable to the field of conformity assessment.
This International Standardspecifies general terms anddefinitions relating to CQnfOrmityassessment, including theaccreditation of conformityassessment bodies, and to theuse of conformity assessment tofacilitate trade. A description ‘ofthe functional approach toconformity assessment isincluded in Annex A, as a furtheraid to understanding among usersof conformity assessment, con-formity assessment bodies and
their accreditation bodies, in bothvoluntary ahd regulatory environ-ments.
This International Standard doesnot set out to provide avocabulary for all “of the conceptsthat may need to be used indescribing particular conformityassessment activities. Terms anddefinitions are given only wherethe concept defined would not beunderstandable from the generallanguage use of the term, orwhere an existing standarddefinition is not applicable.
NOTE 1 The notes appended tocertain definitions offer clarification orexamples to facilitate understandingof the concepts described. In certaincases, the notes may differ in differentlanguages for linguistic reasons, oradditional notes may be given.
NOTE 2 The terms and definitionsare laid out in a systematic order, withan alphabetical index. A term in adefinition or note that is defined inanother entry is indicated By bold-
face followed by its entry number inparentheses. Such terms may bereplaced by their complete definition.
lS/lSO/lEC 17000:2004
2 Terms relating to conformityassessment in general
2.1conformity assessmentdemonstration that specified requirements (3.1 )relating to a product (3.3), process, system, personor body are fulfilled
NOTE 1 The subject field of conformity assessmentincludes activities defined elsewhere in this InternationalStandard, such as testing (4.2), inspection (4.3) andcertification (5.5), as well as the accreditation (5.6) ofconformity assessment bodies (2.5).
2.4third-party conformity assessment activityconformity assessment activity that is performed by aperson or body that is independent of the person ororganization that provides the object, and of userinterests in that object
NOTE 1 Criteria for the independence of conforrn”~assessment bodies and accreditation bodies are providedin the International Standards and Guides applicable totheir activities (see Bibliography).
NOTE 2 See Note to 2.2.
NOTE 2 The expression “object of conformity 2.5assessment” or “object” is used in this International conformity assessment bodyStandard to encompass any particular material, product, body that performs conformity assessment servicesinstallation, process, system, person or body to whichconformity assessment is applied. A service is covered by NOTE An accreditation body (2.6) is not a conformitythe definition of a product (see Note 1 to 3.3). assessment body.
2.62.2 accreditation bodyfirst-party conformity assessment activity authoritative body that performs accreditation (5.6)conformity ‘assessment activity that is performed ‘bythe person or organization that provides the object NOTE The authority of an accreditation body is generally
derived from government.
NOTE The first-, semnd- and third-party descriptorsused to characterize conformity assessment activities withrespect to a given object are not to be cmfused with thelegal identification of the relevant paties to a contract. 2.7
conformity assessment systemrules, procedures (3.2) and management forcarrying out conformMy assessment (2.1)
NOTE Conformity assessment systems may be operatedat international, regional, national or sub-national level.
2.3second-party conformity assessment
activityconformity assessment activity that is performed by aperson or organization that has a user interest in theobject
NOTE 1 Persons or organizations performing second-party conformity assessment activities include, forexample, purchasers or users of products, or potentialcustomem seeking to rely on a supplier’s managementsystem, or organizations representing those interests.
2.8conformity assessment schemeconformity assessment programmeconformity assessment system (2.7) related tospecified objects of conformity assessment, to whichthe same specified requirements (3.1 ), specificrules and procedures (3.2) apply
NOTE Conformity assessment schemes may be operatedat international, regional, national or sub-national level.NOTE 2 See”Note to 2.2.
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.
2.9accessaccess to a system or schemeopportunity for an applicant to obtain conformityassessment (2.1 ) under the rules of the system orscheme
2.10participantpatilcipant in a system or schemebody that operates under the applicable rules withouthaving the opportunity to take part in themanagement of the system or scheme
3.2procedurespecified way to carry out an activity or a process
[ISO 9000:2000, 3.4.5]
3.3productresult of a process
[ISO 9000:2000, 3.4.2]
NOTE 1 Four generic product categories are noted inISO 9000:2000 services (e.g. transport); software (e.g.computer program, dictionary); hardware (e.g. engine,mechanical partJ; processed materials (e.g. lubricant),Many products comprise elements belonging to differentgeneric product categories. Whether the product is thencalled service, software, hardware or processed materialdepends on the dominant element,
NOTE 2 The statement of conformity described inNote 1 to 5.2 can be regarded as a product of attestation(5.2).
2.11membermember of a system or scheme 4 Conformity assessment termsbody that operates under the applicable rules and relating to selection and determinationhas the opportunity to take part in the management (see Figure A.1 )of the system or scheme
4.1samplingprovision of a sample of the object of conformityassessment, according to a procedure (3.2)
3 Basic terms
3.1specified requirementneed or expectation that is stated
4.2testingdetermination of one or more characteristics of anobject of conformity assessment, according to aprocedure (3.2)
NOTE “Testing” typically applies to materials, products orprocesses,
NOTE Specified requirements may be stated in nonmativedocuments such as regulations, standards and technicalspecifications.
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4.3inspectionexamination of a product design, product (3.3),process or installation and determination of its con-formity with specific requirements or, on the basis ofprofessional judgement, with general requirements
NOTE Inspection of a process may include inspection ofpersons, facilities, technology and methodology.
4.4auditsystematic, independent, documented process forobtaining records, statements of fact or otherrelevant information and assessing them objectivelyto determine the extent to which specified require-ments (3.1) are fulfilled
NOTE Whilst “audit” applies to management systems,“assessment” applies to conformity assessment bodies aswell as more generally.
4.5peer assessmentassessment of a body against specifiedrequirements (3. 1) by representatives of otherbodies in, or candidates for, an agreement group(7.10)
5 Conformity assessment termsrelating to review and attestation(see Figure A.1 )
5.1reviewverification of the suitability, adequacy and effective-ness of selection and determination activities, andthe results of these activities, with regard to fulfillmentof specified requirements (3.1) by an object ofconformity assessment
4
5.2attestationissue of a statement, based on a decision followingreview (5. 1), that fulfillment of specified require-ments (3. 1) has been demonstrated
NOTE 1 The resulting statement, referred to in thisInternational Standard as a ‘statement of confomnity”,conveys the assurance that the specified requirementshave been fulfilled. Such an assurance does not, of itself,afford contractual or other legal guarantees.
NOTE 2 First-party and third-party attestation activitiesare distinguished by the terms 5.4 to 5.6. For second-partyattestation, no special term is available,
5.3scope of attestationrange or characteristics of objects of conformityassessment covered by attestation (5.2)
5.4declarationfirst-party attestation (5.2)
5.5certificationthird-party attestation (5.2) related to products,processes, systems or persons
NOTE 1 Certification of a management system is some-times also called registration.
NOTE 2 Certification is applicable to all objects of con-formity assessment except for conformity assessmentbodies (2.5) themselves, to which accreditation (5.6) isapplicable.
5.6accreditationthird-party attestation (5.2) related to a conformityassessment body (2.5) conveying formal demon-stration of its competence to carry out specificconformity assessment tasks
6 Conformity assessment termsrelating to surveillance (see Figure A. 1)
6.1surveillancesystematic iteration of conformity assessment activi-ties as a basis for maintaining the validity of thestatement of conformity
6.2suspensiontemporary invalidation of the statement of conformityfor all or part of the specified scope of attestation(5,3)
6.3withdrawalrevocationcancellation of the statement of conformity
6.4appealrequest by the provider of the object of conformityassessment to the conformity assessment body(2.5) or accreditation body (2.6) for reconsiderationby that body of a decision it has made relating to thatobject
6.5complaintexpression of dissatisfaction, other than appeal(6.4), by any person or organization to a conformityassessment body (2.5) or accreditation body(2.6), relating to the activities of that body, where aresponse is expected
lS/lSO/lEC 17000:
7 Terms relating to conformityassessment and facilitation of trade
2004
NOTE The general expression “conformity assessmentresult” is used in 7.4 to 7.9 to mean the product (3.3) ofany conformity assessment activity (e.g. a report orcertificate) and may include a finding of nonconformity.
7.1approvalpermission for a product (3.3) or process to bemarketed or used for stated purposes or understated conditions
NOTE Approval can be based on fulfillment of specifiedrequirements (3. 1) or completion of specified procedures(3.2).
7.2designationgovernmental authorization of a conformityassessment body (2.5) to perform specifiedconformity assessment activities
7.3designating authoritybody established within government or empoweredby government to designate conformity assess-ment bodies (2.5), suspend or withdraw their desig-nation or remove their suspension from designation(7.2)
7.4equivalenceequivalence of conformity assessment
resultssufficiency of different conformity assessment resultsto provide the same level of assurance of conformitywith regard to the “same specified requirements(3.1)
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7.5recognitionrecognition of conformity assessment
resultsacknowledgement of the validity of a conformityassessment result provided by another person orbody
7.6acceptanceacceptance of conformity assessment
resuitsuse of a conformity assessment result provided byanother person or body
7.7unilateral arrangementarrangement whereby one party recognizes or ac-cepts the conformity assessment results of anotherparty
7.0biiaterai arrangementarrangement whereby two parties recognize oraccept each other’s conform ity assessment results
7.9multilateral arrangementarrangement whereby more than two patiles recog-nize or accept one another’s conformity assessmentresults
7.10agreement groupbodies that are signatories to the agreement onwhich an arrangement is based
7.11reciprocityrelationship between two parties where both havethe same rights and obligationstowards each other
NOTE 1 Reciprocity can exist within a multilateralarrangement comprising a network of bilateral reciprocalrelationships.
NOTE 2 Although rights and obligations are the same,opportunitiesemanating from them cm diffeE this can leadto unequal relationships between parties.
7.12equal treatmenttreatment accorded to products (3.3) or processesfrom one supplier that is no less favorable than thataccorded to like products or processes from anyother supplier, in a comparable situation
7.13nationai treatmenttreatment accorded to products (3.3) or processesoriginating in other countries that is no less favora-ble than that accorded to like products or processesof national origin, in a comparable situation
7.14equai and nationai treatmenttreatment accorded to products (3.3) or processesoriginating in other countries that is no less favora-ble than that accorded to like products or processesof national origin, or originating in any other country,in a comparable situation
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Annex A(informative)
Principles of conformity assessment
A.1 Functional approach
A.1.l Conformity assessment isa series of three functions thatsatisfy a need or demand fordemonstration that specifiedrequirements are fulfilled:
— selection;
— determination; and
— review and attestation.
Such demonstration can add sub-stance or credibility to claims thatspecified requirements are ful-filled, giving users greater confi-dence in such claims. Standardsare often used as the specifiedrequirements since they representa broad consensus of what iswanted in a given situation. As aresult, conformity assessment isoften viewed as a standards-related activity.
A.1.2 Conformity assessmentmay be applied to products(defined to include services),processes, systems and persons,
and also to those bodies thatperform conformity assessmentservices. For convenience withinthis International Standard, theexpression “object of conformityassessment” is used to refercollectively to any or all of theseentities.
A.1,3 Each of the various kindsof users of conformity assessmenthas their own specific needs. As aresult, there is much variety inthe different types of conformityassessment performed. However,all types of conformity assess-ment follow the same generalapproach as shown in Figure A.1.
A.I.4 Shape A in Figure A.1represents a conformity assess-ment function. The specific activi-ties in each function can vary fromone type of conformity assess-ment to another, based on theneeds of users, the nature of thespecified requirements and theobject of conformity assessmentinvolved.
A.I.5 Shape B in Figure A.1represents output from a functionand is also the input to the nextfunction. The nature of the outputvaries, depending on the specificactivities that have been under-taken.
A.1.6 The solid arrows in Fig-ure A. 1 link the conformity as-sessment functions and theiroutputs/inputs. The broken arrowsexpress the possible needs ordemands for conformity assess-ment.
A.1.7 Conformity assessmentactWities can be characterized as‘first-party”, ‘second-party” or“third-party”. Generally, for eachof these categories
— the conformity assessmentactivities are under thecontrol or direction of the typeof individual or body stated inthe definition, and
— the critical decision on whichattestation is based is madeby the type of individual orbody stated in the definition.
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Need todemonstratefutfilmentof sIMcMsd requirements
Selection Informationon seledad items
*
Infon-n*n on fulfifment ofspedfiid
Determination requirements
Fulfihnentof specifiedrequirementRwiew and attast%tion demonstrated
■
I I I 1 I J
VEND
Key
ml shape P.
D shape B
Figure A.1 — Functional approach to conformity assessment
lS/lSO/lEC 17000:2004
A.2 Selection
A.2.I Selection involves plan-ning and preparation activities inorder to collect or produce all theinformation and input needed forthe subsequent determinationfunction. Selection activities varywidely in number and complexity.In some instances, very littleselection activity may be needed.
A.2.2 Some consideration mayneed to be given to selection ofthe object of conformity assess-ment. Frequently, the object maybe a large number of identicalitems; ongoing production; a con-tinuous process or a system; orinvolve numerous locations. Insuch cases, consideration mayneed to be given to sampling, orselection of specimens to be usedfor determination activities. Forexample, the sampling plan forriver water related to a demon-stration that pollution require-ments are fulfilled would be anexample of a sizeable and signifi-cant sampling activity. However,occasionally the object may bethe whole population, for instancewhen a single, individual productis the object of conformityassessment, Even in such cases,sampling may be necessary toselect a part of the entire objectthat is representative of the whole(e.g. selection of critical parts of abridge for a determination ofmaterial fatigue).
taken when applying the pre-existing requirements to thespecific object of conformityassessment. For example, cautionmight be needed when applying astandard written for metal pipes toplastic pipes. In some cases, onlya very general set of requirementsmay exist which must be ex-panded for assessment to bemeaningful or acceptable to theusers. For example, a govern-ment regulator may require thatproducts pose no unacceptablesafety risks (the general require-ment) and expect a certificationbody to establish specific re-quirements for individual certifiedproducts or types of products. Or,general management system re-quirements may need to be morefocused when the managementsystem addresses fulfillment ofspecific service requirements.
A.2.4 Selection may also in-clude choice of the most appro-priate procedures (for example,testing methods or inspectionmethods) to be used for determi-nation activities. It is not uncom-mon that new or modifiedmethods need to be developed toconduct determination activities. Itmay be necessary to select theproper locations and the properconditions, or the individuals toperform the procedure.
that specified requirements arefulfilled will be effective. For ex-ample, the scope of testing to becovered by laboratory accredita-tion must be identified before ap-propriate determination activitiescan be performed. Or, a descrip-tion of a service may be neededbefore performing appropriatedetermination activities. Also, adetermination activity may be areview of information alone, andthat information must be identifiedand collected. For example, acopy of a product’s instructions foruse or warning markings may beneeded.
A.2.6 In Figure A.1, all the in-formation, samples (if sampling isused), decisions and other outputfrom the selection function isrepresented as “information onselected items”.
A.3 Determination
A.3.1 Determination activitiesare undertaken to developcomplete information regardingfulfillmentof the specified require-ments by the object of conformityassessment or its sample. Sometypes of determination activitiesare defined in Clause 4.
A.2.3 It may also be necessary A.3.2 The terms testing (4.2),
to consider the specified require- A.2.5 Finally, additional infor- inspection (4.3), audit (4.4), and
ments. In many cases, a standard mation may be needed in order to peer assessment (4.5), which
or other pre-existing requirements perform determination activities are defined as types of determi-
exist. However, care should be properly so that the demonstration nation activities only, may be
IS/ISO/lEC 17000:2004
used with “system” or”scheme”todescribe conformity assessmentsystems or schemes that includethe type of determination activityindicated. Thus, a “peer assess-ment system” is a conformityassessment system that includespeer assessment as the determi-nation activity.
A.3.3 Various determinationactivities have no specific nameor designation. An example is theexamination or analysis of adesign, or other descriptive infor-mation, in relation to specifiedrequirements, Individual sub-fieldsof conformity assessment (e.g.testing, certification, accreditation)may have terms defined fordetermination activities that areunique to that sub-field. There isno generic term used in this inter-national Standard or in practiceto represent all determinationactivities.
A.3.4 Care should be taken tounderstand clearly the determi-nation activities characterized astesting or inspection.
A.4 Review andattestation
A.4.1 Review (5.1) constitutesthe final stage of checking beforetaking the important decision as towhether or not the object of con-formity assessment has beenreliably demonstrated to fulfil thespecified requirements. Attests-.tion (5.2) results in a “statement”in a form that most readilyreaches all of the potential users.“Statement of conformity” is ageneric expression used toinclude all means of communi-cating that fulfillment of specifiedrequirements has been demon-
~strated.
A.4.2 If fulfillment of the speci-fied requirements has not beendemonstrated, the finding of non-conformity may be reported.
A.4.3 The terms declaration(5.4), certification (5.5) andaccreditation (5.6), which aredefined as types of attestationonly, may be used with “system” or“scheme” to describe conformityassessment systems or schemesthat include the type of attestationactivity indicated as the final step.Thus, a “certification system” is aconformity assessment systemthat includes selection, determi-nation, review and finally certifica-tion as the attestation activity.
A.5 Need for surveillance
A.6.I Conformity assessmentcan end when attestation is per-formed. However, in some casessystematic iteration of the func-tions in Figure A.1 may beneeded to maintain the validityof the statement resulting fromattestation. The needs of usersdrive such activities. For example,an object of conformity assess-ment may change over time,which could affect its continuingfulfiiment of specified require-ments. Or, users may demandongoing demonstration that speci-fied requirements are fulfilled; forexample, when a product isproduced continuously.
A.5.2 The activities undertakenin surveillance are planned in or-der to satisfy the need to maintainthe validity of an existing state-ment resulting from attestation.A complete repeat of the initialassessment is usually not necess-ary in every iteration of surveil-lance to satisfy this need. Thus,the activities in each function inFigure A.1 during surveillancemay be reduced, or different from,the activities undertaken in theinitial assessment.
A.3.5 In Figure A.1, all the out-put from the determination func-tion is represented as “informationon fulfillment of specified require-ments”. The output is a combina-tion of all the information created A.5.3 Selection activities takethrough determination activity, as A.4.4 In Figure A.1, all the out-well as all the input to the deter- put from the review and attest-
place in both the initial assess-
mination function. The output isment and in surveillance, How-
ation function is represented as ever, en~re[y different choices
usually structured to facilitate “fulfillment of specified require- mi9ht be made in surveillance
review and attestation activities. ments demonstrated”. For example, a test for a product
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lS/lSO/lEC 17000:2004
may have been selected in theinitial assessment. In surveillance,an inspection might be selected todetermine that a sample of theproduct is the same as the sam-ple originally tested. In fact, thechoices in selection may changefrom time to time, based on infor-mation from previous iterations ofsurveillance and other inputs. On-going risk analysis or considera-tion of market feedback regardingactual fulfillment of specifiedrequirements may be part ofselection activities in surveillance.
A,5.4 Choices about the speci-fied requirements can be differentas well. For example, only a sub-set of the specified requirementsmight be selected in any giveniteration of surveillance. Or,similarly, only a portion of the
object of conformity assessmentmay be selected for determinationactivities in surveillance; forexample, only a portion of anaccredited certification body maybe audited during surveillance.
A.5.5 As noted above, the dif-ferent choices in selection canlead to different determinationactivities for surveillance pur-poses. However, in both initialassessment and surveillance, theoutput from selection defines thedetermination activities and howthey will be carried out.
A.5.6 The review and attest-ation function is also used in bothinitial assessment and surveil-
lance. In surveillance, a reviewof all the ,inputs and outputs inFigure A. 1 leads to a decisionwhether the statement resultingfrom attestation continues to bevalid. In many cases, no specialaction is taken if the statementcontinues to be valid. In othercases, for example, if the scope ofattestation has been extended, anew statement of conformitymight be issued.
A.5.7 If the decision is that thestatement of conformity is nolonger valid, appropriate activitiesare necessary to advise users;for example, that the scope ofattestation has been reduced orthat the statement has beensuspended or withdrawn.
11
lS/lSO/lEC 17000:2004
—
B.1 General terms givenspecific meanings in otherstandards in thelSO/lEC 17000 series
6.1.1 Compound termsdefined for the purposes oflSO/lEC 17011, relating toaccreditation
accreditation body logo
accreditation certificate
accreditation symbol
extending accreditation
reducing accreditation
scope of accreditation
suspending accreditation
Annex B(informative)
Related terms definedin other documents
B;l.2 General terms givenspecific meanings for thepurposes of lSO/lEC 17024,relating to certification ofpersons
competence
evaluation
examiner
qualification
B.1.3 Compound termsdefined for the purposes oflSO/lEC 17030, relating tomarks of conformity
issuer of a third-party markof conformity
owner of a third-party markof conformity
third-party mark of conformity
B.2 Terms defined instandards outside thelSO/IEC 17000 series
calibration VIM
capability 1s0 9000
characteristic 1s0 9000
competence 1s0 9000
conformity Iso 9000
customer Iso 9000
document Iso 9000
information 1s0 9000
measurement VIM
organization 1s0 9000
process 1s0 9000
specification 1s0 9000
supplier Iso 9000
system 1s0 9000
validation 1s0 9000
verification Iso 9000
12
lS/lSO/lEC 17000:2004
Bibliography
For conformity assessmentsystems based ondetermination activity
[1]
[2]
[3]
[4]
lSO/lEC 17020:1998, Gen-eral criteria for the operationof various types of bodiesperforming inspection
lSO/lEC 17025:1999, Gen-eral requirements for thecompetence of testing andcalibration laboratories
BIS is a statutory institution established under the Bureau of hdian Standards Act, 1986 to promoteharmonious development of the activities of standardization, marking and quality certification ofgoods and attending to connected matters in the country.
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form without the prior permission in writing of BIS. This does not preclude the free use, in the courseof implementing 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 review indicatesthat no changes are needed; if the review indicates that changes are needed, it is taken up for revision,Users of Indian Standards should ascertain that they are in possession of the latest amendments oredition by referring to the latest issue of ‘BIS Catalogue’ and ‘Standards: Monthly Additions’.
This Indian Standard has been developed from Dot: No. IRD 1 (006).
Amendments Issued Since Publication
Amend No. Date of Issue Text Affected
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