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Iso - Iec 17000.2004 PDF
Iso - Iec 17000.2004 PDF
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Indian Standard
CONFORMITY ASSESSMENT — VOCABULARY AND
GENERAL PRINCIPLES
@ BIS 2006
.8,
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
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National Mirror Committee of CASCO, IRD 1
NATIONAL FOREWORD
This Indian Standard which is identical with lSO/lEC 17000:2004 ‘Conformity assessment — Vocabulary
and generaI principles’ issued by the International Organization for Standardization (ISO) and International
Electrotechnical Commission (lEC) jointly 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(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 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 deGimal marker.
Only the English text has been retained while adopting it as an Indian Standard and as such the page
numbers given here are not the same as i~he International Standard.
lS/lSO/lEC 17000:2004
Contents Page
5 Conformity assessment terms reiating to review and attestation (see Figure A. 1) ............................ 4
0 Introduction
ISO and lSO/IEC Guides and, more recently, International Standards relating generically to conformity
assessment activities such as testing, inspection and various forms of certification are prepared by working
groups of the ISO Committee on conformity assessment (CASCO). For many years, ISO/lEC Guide 2, last
revised in 1996, has included a core vocabulary for conformity assessment, built up from a small number of
terms and definitions first compiled to facilitate communication and understanding about product certification
based on standards for traditional manufactured goods.
In 2000, CASCO decided to take conformity assessment terminology (Clauses 12 to 17) out of
lSO/lEC Guide 2 and provide instead a self-contained vocabulary more readily applicable within the planned
lSO/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 CASCO
working groups, as a consistent framework within which more specific concepts maybe defined appropriately
and denoted by the most appropriate terms. Extra terms for concepts unique to particular activities within
conformity assessment, such as accreditation, certification of persons and marks of conformity, are found in
the International Standard or Guide related to that activity. Such concepts are not included in this International
Standard.
Until pre-existing CASCO publications are revised, the terminology used in those documents remains valid in
its context; this International Standard is not intended to be applied retrospectively.
Conformity assessment interacts with other fields such as management systems, metrology, standardization
and statistics. This International Standard does not define the boundaries of conformity assessment. These
remain elastic.
Clause 7 includes some terms and definitions, drawn mainly from the superseded clauses of
lSO/lEC Guide 2, for several broader concepts. These are intended not only to standardize usage within the
conformity assessment community, but also to help policy makers concerned with the facilitation of trade
within regulatory and international treaty frameworks.
The terms and definitions specified in this International Standard, particularly under Clauses 4 and 5, reflect
the adoption by CASCO in November 2001 of the functional approach recommended earlier that year in the
final 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 description
of the functional approach is included in Annex A for information.
Some of the terms included in this International Standard relate to concepts it was considered essential to
define. Others it was thought helpful to explain. Many of the general terms used to distinguish conformity
assessment 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 relevant
terms are given in Annex B with separate alphabetical lists. First are terms applicable to specific aspects of
conformity assessment, as defined in other standards in the lSO/lEC 17000 series. Second are terms for
which 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 3.2
and 3.3.
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lS/lSO/lEC 17000:2004
Attention is drawn to significant changes in the terms or their definitions from the superseded clauses of
lSO/lEC Guide 2.
This International Standard does not include a definition of “conformity” on the grounds that it is not necessary
to 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” by
making 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 longer
correct to refer to “products and services”.
Instead of “product, process or service”, the generic expression used in lSO/lEC Guide 2 for the “subject of
standardization”, Note 2 to 2.1 introduces the expression “object of conformity assessment” as a means of
referring 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 assurance
through the issue of a “statement of conformity”.
The term ‘ac~reditatian” k now applicable only to attestation regarding a conformity assessment body. The
definition 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 in
lSO/lEC 17011,
To avoid ambiguity, the term “body” is used in this International Standard only when referring to conformity
assessment 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 body
based on membership is not applicable to the field of conformity assessment.
...
Ill
lS/lSO/lEC 17000:2004
Indian Standard
CONFORMITY ASSESSMENT — VOCABULARY AND
GENERAL PRINCIPLES
2.6
2.2 accreditation body
first-party conformity assessment activity authoritative body that performs accreditation (5.6)
conformity ‘assessment activity that is performed ‘by
NOTE The authority of an accreditation body is generally
the person or organization that provides the object
derived from government.
NOTE The first-, semnd- and third-party descriptors
used to characterize conformity assessment activities with
respect to a given object are not to be cmfused with the
legal identification of the relevant paties to a contract. 2.7
conformity assessment system
rules, procedures (3.2) and management for
carrying out conformMy assessment (2.1)
NOTE Conformity assessment systems may be operated
at international, regional, national or sub-national level.
2.3
second-party conformity assessment
activity
conformity assessment activity that is performed by a
2.8
person or organization that has a user interest in the
conformity assessment scheme
object
conformity assessment programme
NOTE 1 Persons or organizations performing second- conformity assessment system (2.7) related to
party conformity assessment activities include, for specified objects of conformity assessment, to which
example, purchasers or users of products, or potential the same specified requirements (3.1 ), specific
customem seeking to rely on a supplier’s management rules and procedures (3.2) apply
system, or organizations representing those interests.
NOTE Conformity assessment schemes may be operated
NOTE 2 See”Note to 2.2. at international, regional, national or sub-national level.
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lS/lSO/lEC 17000:2004
2.9 3.2
access procedure
access to a system or scheme specified way to carry out an activity or a process
opportunity for an applicant to obtain conformity
[ISO 9000:2000, 3.4.5]
assessment (2.1 ) under the rules of the system or
scheme
3.3
product
result of a process
2.11
member
member of a system or scheme 4 Conformity assessment terms
body that operates under the applicable rules and relating to selection and determination
has the opportunity to take part in the management (see Figure A.1 )
of the system or scheme
4.1
sampling
provision of a sample of the object of conformity
assessment, according to a procedure (3.2)
4.2
testing
3 Basic terms determination of one or more characteristics of an
object of conformity assessment, according to a
procedure (3.2)
3.1
specified requirement NOTE “Testing” typically applies to materials, products or
need or expectation that is stated processes,
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lS/lSO/lEC 17000:2004
4.3 5.2
inspection attestation
examination of a product design, product (3.3), issue of a statement, based on a decision following
process or installation and determination of its con- review (5. 1), that fulfillment of specified require-
formity with specific requirements or, on the basis of ments (3. 1) has been demonstrated
professional judgement, with general requirements
NOTE 1 The resulting statement, referred to in this
NOTE Inspection of a process may include inspection of International Standard as a ‘statement of confomnity”,
persons, facilities, technology and methodology. conveys the assurance that the specified requirements
have been fulfilled. Such an assurance does not, of itself,
afford contractual or other legal guarantees.
5.4
declaration
first-party attestation (5.2)
4.5
peer assessment
assessment of a body against specified
requirements (3. 1) by representatives of other
5.5
bodies in, or candidates for, an agreement group
certification
(7.10)
third-party attestation (5.2) related to products,
processes, systems or persons
5.1
review 5.6
verification of the suitability, adequacy and effective- accreditation
ness of selection and determination activities, and third-party attestation (5.2) related to a conformity
the results of these activities, with regard to fulfillment assessment body (2.5) conveying formal demon-
of specified requirements (3.1) by an object of stration of its competence to carry out specific
conformity assessment conformity assessment tasks
4
lS/lSO/lEC 17000: 2004
7.1
approval
permission for a product (3.3) or process to be
6.2
marketed or used for stated purposes or under
suspension
stated conditions
temporary invalidation of the statement of conformity
for all or part of the specified scope of attestation NOTE Approval can be based on fulfillment of specified
(5,3) requirements (3. 1) or completion of specified procedures
(3.2).
6.3 7.2
withdrawal designation
revocation governmental authorization of a conformity
cancellation of the statement of conformity assessment body (2.5) to perform specified
conformity assessment activities
7.3
designating authority
6.4 body established within government or empowered
appeal by government to designate conformity assess-
request by the provider of the object of conformity ment bodies (2.5), suspend or withdraw their desig-
assessment to the conformity assessment body nation or remove their suspension from designation
(2.5) or accreditation body (2.6) for reconsideration (7.2)
by that body of a decision it has made relating to that
object
7.4
6.5 equivalence
complaint equivalence of conformity assessment
expression of dissatisfaction, other than appeal results
(6.4), by any person or organization to a conformity sufficiency of different conformity assessment results
assessment body (2.5) or accreditation body to provide the same level of assurance of conformity
(2.6), relating to the activities of that body, where a with regard to the “same specified requirements
response is expected (3.1)
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lS/ISO/lEC 17000:2004
7.5 7.10
recognition agreement group
recognition of conformity assessment bodies that are signatories to the agreement on
results which an arrangement is based
acknowledgement of the validity of a conformity
assessment result provided by another person or
body
7.11
reciprocity
relationship between two parties where both have
the same rights and obligations towards each other
7.12
equal treatment
treatment accorded to products (3.3) or processes
from one supplier that is no less favorable than that
7.7
accorded to like products or processes from any
unilateral arrangement
other supplier, in a comparable situation
arrangement whereby one party recognizes or ac-
cepts the conformity assessment results of another
party
7.13
nationai treatment
treatment accorded to products (3.3) or processes
7.0 originating in other countries that is no less favora-
biiaterai arrangement ble than that accorded to like products or processes
arrangement whereby two parties recognize or of national origin, in a comparable situation
accept each other’s conform ity assessment results
7.14
equai and nationai treatment
7.9 treatment accorded to products (3.3) or processes
multilateral arrangement originating in other countries that is no less favora-
arrangement whereby more than two patiles recog- ble than that accorded to like products or processes
nize or accept one another’s conformity assessment of national origin, or originating in any other country,
results in a comparable situation
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lS/lSO/lEC 17000:-2004
Annex A
(informative)
A.1 Functional approach and also to those bodies that A.I.5 Shape B in Figure A.1
perform conformity assessment represents output from a function
services. For convenience within and is also the input to the next
this International Standard, the function. The nature of the output
A.1.l Conformity assessment is expression “object of conformity varies, depending on the specific
a series of three functions that assessment” is used to refer activities that have been under-
satisfy a need or demand for collectively to any or all of these taken.
demonstration that specified entities.
requirements are fulfilled:
— selection;
— determination; and
— review and attestation. A.1.6 The solid arrows in Fig-
ure A. 1 link the conformity as-
Such demonstration can add sub- A.1,3 Each of the various kinds sessment functions and their
stance or credibility to claims that of users of conformity assessment outputs/inputs. The broken arrows
specified requirements are ful- has their own specific needs. As a express the possible needs or
filled, giving users greater confi- result, there is much variety in demands for conformity assess-
dence in such claims. Standards the different types of conformity ment.
are often used as the specified assessment performed. However,
requirements since they represent all types of conformity assess-
a broad consensus of what is ment follow the same general
wanted in a given situation. As a approach as shown in Figure A.1.
result, conformity assessment is
often viewed as a standards- A.1.7 Conformity assessment
related activity. actWities can be characterized as
‘first-party”, ‘second-party” or
“third-party”. Generally, for each
of these categories
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lS/lSO/lEC 17000:2004
Fulfihnentof specifiedrequirement
Rwiew and attast%tion demonstrated
■
I I I 1
I J
V
END
Key
ml shape P.
D shape B
A.2 Selection taken when applying the pre- that specified requirements are
existing requirements to the fulfilled will be effective. For ex-
specific object of conformity ample, the scope of testing to be
A.2.I Selection involves plan- assessment. For example, caution covered by laboratory accredita-
ning and preparation activities in might be needed when applying a tion must be identified before ap-
order to collect or produce all the standard written for metal pipes to propriate determination activities
information and input needed for plastic pipes. In some cases, only can be performed. Or, a descrip-
the subsequent determination a very general set of requirements tion of a service may be needed
function. Selection activities vary may exist which must be ex- before performing appropriate
widely in number and complexity. panded for assessment to be determination activities. Also, a
In some instances, very little meaningful or acceptable to the determination activity may be a
selection activity may be needed. users. For example, a govern- review of information alone, and
ment regulator may require that that information must be identified
products pose no unacceptable and collected. For example, a
safety risks (the general require- copy of a product’s instructions for
ment) and expect a certification use or warning markings may be
body to establish specific re- needed.
quirements for individual certified
A.2.2 Some consideration may
products or types of products. Or,
need to be given to selection of
general management system re-
the object of conformity assess-
quirements may need to be more
ment. Frequently, the object may
focused when the management
be a large number of identical
system addresses fulfillment of
items; ongoing production; a con-
specific service requirements.
tinuous process or a system; or
involve numerous locations. In
such cases, consideration may
need to be given to sampling, or
A.2.6 In Figure A.1, all the in-
selection of specimens to be used
formation, samples (if sampling is
for determination activities. For
used), decisions and other output
example, the sampling plan for
from the selection function is
river water related to a demon-
represented as “information on
stration that pollution require- A.2.4 Selection may also in- selected items”.
ments are fulfilled would be an clude choice of the most appro-
example of a sizeable and signifi- priate procedures (for example,
cant sampling activity. However, testing methods or inspection
occasionally the object may be methods) to be used for determi-
the whole population, for instance nation activities. It is not uncom-
when a single, individual product mon that new or modified A.3 Determination
is the object of conformity methods need to be developed to
assessment, Even in such cases, conduct determination activities. It A.3.1 Determination activities
sampling may be necessary to may be necessary to select the are undertaken to develop
select a part of the entire object proper locations and the proper complete information regarding
that is representative of the whole conditions, or the individuals to fulfillmentof the specified require-
(e.g. selection of critical parts of a perform the procedure. ments by the object of conformity
bridge for a determination of assessment or its sample. Some
material fatigue). types of determination activities
are defined in Clause 4.
used with “system” or”scheme”to A.4 Review and A.5 Need for surveillance
describe conformity assessment attestation
systems or schemes that include
the type of determination activity
indicated. Thus, a “peer assess- A.4.1 Review (5.1) constitutes
ment system” is a conformity the final stage of checking before A.6.I Conformity assessment
assessment system that includes taking the important decision as to can end when attestation is per-
peer assessment as the determi- whether or not the object of con- formed. However, in some cases
nation activity. formity assessment has been systematic iteration of the func-
reliably demonstrated to fulfil the tions in Figure A.1 may be
specified requirements. Attests-. needed to maintain the validity
tion (5.2) results in a “statement” of the statement resulting from
in a form that most readily attestation. The needs of users
reaches all of the potential users. drive such activities. For example,
A.3.3 Various determination “Statement of conformity” is a an object of conformity assess-
activities have no specific name generic expression used to ment may change over time,
or designation. An example is the include all means of communi- which could affect its continuing
examination or analysis of a cating that fulfillment of specified fulfiiment of specified require-
design, or other descriptive infor- requirements has been demon- ments. Or, users may demand
mation, in relation to specified ~strated. ongoing demonstration that speci-
requirements, Individual sub-fields fied requirements are fulfilled; for
of conformity assessment (e.g. example, when a product is
testing, certification, accreditation) produced continuously.
may have terms defined for
determination activities that are
unique to that sub-field. There is A.4.2 If fulfillment of the speci-
no generic term used in this inter- fied requirements has not been
national Standard or in practice demonstrated, the finding of non-
to represent all determination conformity may be reported.
activities.
10
lS/lSO/lEC 17000:2004
may have been selected in the object of conformity assessment lance. In surveillance, a review
initial assessment. In surveillance, may be selected for determination of all the ,inputs and outputs in
an inspection might be selected to activities in surveillance; for Figure A. 1 leads to a decision
determine that a sample of the example, only a portion of an whether the statement resulting
product is the same as the sam- accredited certification body may from attestation continues to be
ple originally tested. In fact, the be audited during surveillance. valid. In many cases, no special
choices in selection may change action is taken if the statement
from time to time, based on infor- continues to be valid. In other
mation from previous iterations of cases, for example, if the scope of
surveillance and other inputs. On- attestation has been extended, a
going risk analysis or considera- new statement of conformity
tion of market feedback regarding might be issued.
actual fulfillment of specified
A.5.5 As noted above, the dif-
requirements may be part of
ferent choices in selection can
selection activities in surveillance.
lead to different determination
activities for surveillance pur-
poses. However, in both initial
assessment and surveillance, the
output from selection defines the
determination activities and how
they will be carried out. A.5.7 If the decision is that the
statement of conformity is no
longer valid, appropriate activities
are necessary to advise users;
for example, that the scope of
A,5.4 Choices about the speci- attestation has been reduced or
fied requirements can be different that the statement has been
as well. For example, only a sub- suspended or withdrawn.
set of the specified requirements
might be selected in any given A.5.6 The review and attest-
iteration of surveillance. Or, ation function is also used in both
similarly, only a portion of the initial assessment and surveil-
11
lS/lSO/lEC 17000:2004
—
Annex B
(informative)
B.1 General terms given B;l.2 General terms given B.2 Terms defined in
specific meanings in other specific meanings for the standards outside the
standards in the purposes of lSO/lEC 17024, lSO/IEC 17000 series
lSO/lEC 17000 series relating to certification of
persons
calibration VIM
12
lS/lSO/lEC 17000:2004
Bibliography
1) To be published.
13
lS/lSO/lEC 17000:2004
Alphabetical index
A I u
acceptance 7.6 inspection 4.3 unilateral arrangement 7.7
acceptance of conformity
assessment results 7.6
access 2.9 w
M
access to a system or scheme 2.9
accreditation 5.6 withdrawal 6.3
member 2.11
accreditation body 2.6 member of a system or
agreement group 7.10 scheme 2.11
appeal 6,4 multilateral arrangement 7.9
approval 7.1
attestation 5,2
audit 4.4
N
participant 2.10
c participant in a system or
scheme 2.10
certification 5.5
peer assessment 4.5
complaint 6.5
procedure 3,2
conformity assessment 2.1
product 3.3
conformity assessment body 2.5
conformity assessment
programme 2.8
conformity assessment R
scheme 2.8
conformity assessment reciprocity 7.11
system 2.7 recognition 7.5
recognition of conformity
assessment results 7.5
review 5.1
D
revocation 6.3
declaration 5.4
designating authority 7.3
designation 7.2 s
sampling 4.1
E scope of attestation 5.3
second-party conformity
equal and national treatment 7.14 assessment activity 2.3
equal treatment 7.12 specified requirement 3.1
equivalence 7.4 surveillance 6,1
equivalence of conformity suspension 6.2
assessment results 7.4
T
F
testing 4.2
first-party conformity assessment third-party conformity assessment
activity 2.2 activity 2,4
14
—. I
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