Title
Procedure for setting up the accreditation of new conformity
assessment schemes
Reference
PG-13-01
Revision
00
Confidentiality
1
Date
2015-04-21
NOTE: The present document represent the English version of document under reference at the specified
revision. In case of conflict the Italian version will prevail . To identify the revised parts reference must be made
to version in Italian language only.
Preparation
Approval
Authorization of issue
Application date
Management System Head
Officer
Directive Council
General Director
2015-04-30
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CONTENTS
0.
INTRODUCTION................................................................................................................ 3
1.
SCOPE AND FIELD OF APPLICATION............................................................................. 3
2.
REFERENCE DOCUMENTS AND ABBREVIATIONS ....................................................... 3
3.
DEFINITIONS ..................................................................................................................... 4
4.
PROCESS OF APPROVAL OF A NEW CAS AND SETTING UP OF ACCREDITATION. . 6
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0.
INTRODUCTION
Market necessities lead to the request to start new certification activities for bodies applying for accreditation.
Applications for the accreditation of a conformity assessment scheme shall be carefully evaluated by
ACCREDIA owing to the fact that not all of them are acceptable for reasons as described in the present
document and which derive from a conformity assessment of the scheme against all the requirements of the
applicable accreditation standards of the ISO/IEC 17000 series, as well as other reference documents which
are mandatory in accordance with ACCREDIA’s membership of the MLA, EA, IAF and MRA ILAC multilateral
agreements. Also applicable are the provisions contained in the ministerial decree of 22.12.2009 for the
designation of ACCREDIA.
1.
SCOPE AND FIELD OF APPLICATION
The present document has been drawn up in order to clarify the modalities of approval and the setting up of
accreditation of new schemes of conformity assessment (CAS) by ACCREDIA regarding Levels 4 and 5 of
Table A (given below).
2.
REFERENCE DOCUMENTS AND ABBREVIATIONS
2.1
Applicable standards and EA/IAF/ILAC guidelines
-
UNI CEI EN ISO IEC 17000:2005 “Conformity assessment – vocabulary and general principles”;
UNI CEI EN ISO/IEC 17011:2005 “General requirements for accreditation bodies accrediting CABs” (§.
4.6.3 of the current version);
UNI CEI EN ISO/IEC 17020 “Conformity assessment – requirements for the functioning of various types
of bodies performing inspections” in the current version;
UNI CEI EN ISO/IEC 17021 “Requirements for bodies performing audits and certifications of
management systems” in the current version;
UNI CEI EN ISO IEC 17024:2012 “Conformity assessment – requirements for bodies operating
certification of persons” in the current version;
UNI CEI EN ISO/IEC 17025 “General requirements for the competence of Testing and Calibration Labs”
in the current version;
UNI CEI EN ISO IEC 17065:2012 ”Conformity assessment – requirements for bodies certifying products,
processes and services” in the current version;
ISO/IEC 17007 “Conformity assessment — Guidance for drafting normative documents suitable for use
for conformity assessment” in the current version;
ISO/IEC 17067 “Conformity assessment — Fundamentals of product certification and guidelines for
product certification schemes”, in the current version;
UNI CEI 70099:2008 “International metrology vocabulary – basic and general concepts and related terms
(VIM)”; in the current version;
UNI CEI EN 45020 “Standardization and related activities – general vocabulary”, in the current version;
EA 1/06 A AB:2013 rev.07 “EA Multilateral Agreement Criteria for signing Policy and procedures for
development”;
EA-1/22 A-AB: 2014 rev.02 “EA procedure and criteria for the evaluation of Conformity Assessment
Schemes by EA Accreditation Body Members”;
ILAC R6:02/2013 “Structure of the ILAC Mutual Recognition Arrangement and Procedure for Expansion
of the Scope of the ILAC Arrangement”.
Note: The assessment modalities of new accreditation schemes regarding Level 2 and Level 3 standards as
shown in Table A are described in PG-13.
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2.2
Internal documents
MQ “ACCREDIA management manual”;
ST “ACCREDIA statute”;
ST-01 “Regulation for the application of the Statute”;
RG 04 “Regulation for the functioning of the Accreditation Committee”.
-
2.3
Abbreviations
The following abbreviations used in the original Italian version are retained in the English translation:
CD
CdA
CSA
DG
DDD
CAS
SO
CAB
Directive Council;
Committee for Accreditation Activities;
Sectoral Accreditation Committee;
General Director;
Director of Department;
Conformity assessment scheme (see below);
Scheme Owner (owner of a conformity assessment scheme - see below);
Conformity Assessment Body.
3.
DEFINITIONS
The standard UNI CEI EN ISO/IEC 17000 contains the definitions and general principles related to
conformity assessment activities.
Below are the definitions related to the need to demonstrate that a product, process, person or organization
is in conformity with the applicable requirements.
-
Conformity assessment (2.1): showing that the specific requirements (3.1) regarding a product (3.3),
process, system, person or organization have been fulfilled.
-
Specific requirement (3.1): necessity or expectation established.
-
Product (3.3): result of a process.
-
Test (4.2): identification of one or more characteristics of the object of a conformity assessment, in
accordance with the procedure (3.2).
-
Inspection (4.3): examination of a project, product (3.3), process or installation, and decision regarding its
conformity with the specific requirements or, based on a professional judgment, with the general
requirements.
-
Audit (4.4): systematic process, independent and documented for records, demonstration of facts or other
relevant information and their objective evaluation for determining to what extent the specific
requirements (3.1) have been fulfilled.
The results of the above activities may be included in a report or in a series of other documents. They shall,
however, be submitted for review (5.1) to verify conformity with the requirements. This review constitutes the
basis for establishing conformity, and confirmation is formalized with the issue of the attestation (5.2) and,
subsequently, the certification (5.5).
To ensure the continuity of conformity with the requirements, surveillance activities may be carried out for
subsequent surveillance activities (6.1).
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Consistent with the above, the following definitions are also considered:
Calibration: an operation performed in specific conditions. In the first phase a relation is established
between the quantity values, with the respective measurement uncertainties provided by the measurement
samples and the corresponding indications which include the associated measurement uncertainties. In the
second phase this information is used to establish a relation whereby it is possible to obtain a measurement
result starting from an indication.
NOTE 1 A calibration may be expressed by means of a declaration, a function of calibration, a diagram of calibration, a curve of
calibration or a table of calibration. In some cases it may consist of a correction which is an addition or a multiplication, accompanied by
the associated measurement uncertainty.
NOTE 2 The calibration should not be confused with the setting of a measurement system which, in certain sectors, is often wrongly
called “self-calibration” and it should also not be confused with an audit of the status of calibration.
NOTE 3 Often only the first phase referred to in the present definition is interpreted as a calibration.
Technical specification: a document setting out the technical requirements to be fulfilled by products,
processes or services (a technical specification shall indicate, where necessary, the modalities with which it
is possible to ascertain if the requirements have been fulfilled).
Accreditation scheme: the rules and procedures for the granting, maintenance and extension of
accreditation in accordance with the accreditation standards (e.g. UNI CEI EN ISO/IEC 17021, UNI CEI EN
ISO/IEC 17025) as shown in Table A. The accreditation scheme may be drawn up by an accreditation body,
by associations of accreditation bodies or by standardization bodies.
Standard: (UNI CEI EN 45020) a document created with consent and approved by a recognized body which
provides, for common and repeated use, the rules, guidelines or characteristics regarding certain activities or
the results of these activities in order to obtain the best order in a determined context.
Note: a standard should be based on proven scientific, technological and experimental results and have, as an objective, the promotion
of benefits for the community.
Moreover, and not in conflict with the above definition, in compliance with Regulation UE 1025 of the
European Parliament and Council of 2012-10-25, the term “standard” is used with the following meaning:
“A specific technique used by a recognized standardization body, for repeated or continuous application,
without obligatory compliance and belonging to one of the following categories:
- international standard: a standard used by an international standardization body;
- European standard: a standard used by a European standardization body;
- harmonized standard: a European standard used on the basis of a request by the
commission for the implementation of EC legislation on harmonization;
- national standard: a standard used by a national standardization body.”
Standards, therefore, are documents defining the characteristics (dimensions, performance, environmental,
safety, organizational etc.) of a product, process or service, in accordance with the state of the art and they
are the result of the work of national and international experts.
Reference documents: documents introducing technical provisions and applicable sector models of
technical standards, created on the basis of a rapid process of consultation limited to the authors under the
operative leadership of the standardization body and drawn up by it after verifying the absence of standards
(or projects of standards) regarding the same matter, both nationally and internationally.
The main two definitions are set out in EA-1/22 A-AB rev. 02 and the others are contained in EA-1/22.
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Conformity assessment scheme (CAS) § 2.1 EA 1-22: for the purposes of the present document, a CAS,
as defined in UNI CEI EN ISO/IEC 17000, is a publicly accessible document containing the following
requirements:
-
the object of the conformity assessment (e.g. product, process, service, system or person);
-
the requirements regarding the conformity assessment;
-
the modalities for determining conformity, e.g. testings, inspections or audits, as well as all other
activities carried out to ensure conformity;
-
all requirements regarding the CAB made by the SO and every specific request or interpretation,
where applicable;
-
every required specification or interpretation of UNI CEI EN ISO/IEC 17011, where applicable.
Note (ACCREDIA):
a CAS is defined as a “mandatory regulation” when it is required by law or by national or International
regulations;
a CAS is defined as “voluntary” when it is not required by law or by national or International
regulations. A voluntary CAS shall take into consideration any mandatory factors related to the object
of the certification.
-
Scheme Owner - SO § 2.2 EA 1-22: the SO is the identifiable organization which has planned and defined a
CAS. Some examples of a SO:
(1)
-
a standardization body
;
-
a CAB;
-
organizations using the services of a CAB;
-
organizations buying or selling products submitted to conformity assessment;
-
producers or associations of producers which have established their own CAS.
A national accreditation body (NAB) cannot be a scheme owner.
4.
PROCESS OF APPROVAL AND ACCREDITATION OF A NEW CONFORMITY
ASSESSMENT SCHEME
4.1
Examination of the application for accreditation of a new CAS
The main reference document is EA-1/22 rev.02.
The document is in the original language and in the Italian translation available on ACCREDIA’s website.
The Italian translation of EA-1/22 rev.02 is an attachment to the present procedure as are the two
questionnaires (Annex 1 and Annex 2 of EA-1/22 rev.2) which shall be used and completed by the SO and
sent to ACCREDIA together with the application form DR-02 for the examination of the new CAS.
The cost of the examination of these documents is met by the applicant, in accordance with the ACCREDIA
pricelist, TA-00 rev. 06.
Below are some specifications regarding the applicability of EA-1/22 rev.02 and of the requirements
contained in Annexes 1 and 2. The use differs according to the area of application of the scheme (national or
international).
Note (1) excluding cases where the scheme is entirely defined by the standard and the role of the
standardization body is limited to the issue of the standard itself.
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A) National area
-
if the CAS refers to conformity assessment activities in the voluntary area it is necessary to adhere
to the requirements defined in EA-1/22 rev.02 with regard both to the requirements pertaining to the
SO (see Annex 1), and to those pertaining to the scheme (CAS) (see Annex 2), but the
documentation shall not be transmitted to EA for assessment.
-
If the CAS refers to the mandatory and/or regulated area the requirements of EA-1/22 rev. 2 shall
be used as a simple guide for the technical analysis of the characteristics of the SO and of the CAS,
as above. If any requirements are pointed out as inapplicable, they shall be submitted for
deliberation to ACCREDIA’s CdA (see below). Also in this case the documentation shall not be
transmitted to EA for assessment.
-
If the scheme is based on an official standard (UNI, ISO, BSI etc.) or a para-normative document
(e.g. PdR UNI, PAS of BSI, CWA of CEN) it is not necessary to complete the questionnaire or to
proceed with the assessment of the scheme, but it is necessary to prepare a brief report for
presentation to the CdA;
2
B) International area
-
If the CAS refers to conformity assessment activities in the voluntary area all the requirements of
EA-1/22 rev. 02 shall be met.
In this case it is necessary to follow the procedure of approval of the CAS as set out in EA-1/22 rev.
02, both on the part of ACCREDIA (hAB) and by the EA secretariat and of the other ABs, signatory
to the EA MLA agreements.
This procedure is applicable also when the scheme is based on a para-normative document (e.g.
PdR UNI, PAS of BSI, CWA of CEN).
If, however, the CAS is the property of only one CAB (the CAB must be the SO and it shall not
concede to other CABs the possibility of certification against the same scheme), it is necessary to
adhere to the requirements of EA-1/22 rev. 02, both with regard to the requirements pertaining to the
SO
(see Annex 1), and to those pertaining to the scheme (CAS) (see Annex 2), but the
documentation shall
not be transmitted to EA for assessment.
-
If the CAS refers to the mandatory and/or regulated area, the requirements of EA-1/22 rev. 02 are
used as a guide for the technical analysis of the characteristics of the SO and of the CAB, as above.
If any requirements are pointed out as inapplicable, they shall be submitted for deliberation to
ACCREDIA’s CdA (see below). Also in this case the documentation shall not be transmitted to EA
for assessment.
2
In cases where an officially issued standard defines the CAS completely (both the technical requirements
of the conformity assessment and the certification regulations), the conformity of the CAS is taken as valid
and accreditation activities can go ahead (see Note 1 above Definition of SO), informing the CdA, the
relevant CSA and submitting it to the CD for approval.
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-
If the scheme is based on an official standard (UNI, ISO, BSI etc.) it is not necessary to complete
the questionnaire or to proceed with the assessment of the scheme, but it is necessary to prepare a
brief report for presentation to the CdA.
4.2 Examination of the application for accreditation of a new CAS by the CdA and approval
by the CD.
The SO completes the form DR-02 and the questionnaires and sends them to ACCREDIA together with a
brief presentation report of the new CAS.
ACCREDIA personnel present the report of the new CAS to the CdA for approval to go ahead with the
technical examination of the CAS.
Following approval, ACCREDIA – in accordance with the pricelist – sends the quotation to the SO which
quantifies the effort needed to carry out a detailed technical analysis of the CAS, depending on the typology
of request as set out in § 4.1.
Once the SO has accepted the quotation, ACCREDIA carries out the technical analysis on the basis of the
questionnaires in Annexes 1 and 2 and any additional information ACCREDIA needs from the SO.
If the result of the examination is positive, the proposal for the start of the CAS is submitted to the CD for
final approval, also with regard to any economic impacts resulting from the start-up.
If the result of the examination is negative the applicant is informed and is given the explanation.
If the SO intends to apply the CAS only in its own country, ACCREDIA begins accreditation activities for
each applicant CAB.
Following approval by the CD, the CdA evaluates the proposal of the ACCREDIA management regarding
any needs for competences among the assessors or in the relevant CSA.
The ACCREDIA management communicates to the relevant CSA the technical details of the new CAS for
the presentation of the first accreditation file.
If the relevant CSA specifies the need to define specific regulations for accreditation, a Technical Regulation
is drawn up (RT) following ACCREDIA’s internal procedures.
If the CAS is intended for international application ACCREDIA sends to the EA secretariat the outcomes of
the technical examination in line with EA-1/22 rev.02. Any remarks and/or requests from other EA ABs shall
be managed by ACCREDIA in agreement with the SO until all criticalities have been overcome in
accordance with EA-1/22 rev.02.
Note: the evaluation phase of the CAS is different from the evaluation phase for the granting or extension of accreditation
of the CAB applying for such accreditation.
Note: if the standards applicable to the CAS are considered not to be sufficiently detailed, ACCREDIA shall not define
specific conformity assessment rules as this is the task of the SO (EA-1/22 § 2.2).
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4.3
Publication of information
In compliance with § 4.2 of EA-1/22 rev.02, after positive completion of the above activities both for national
and International conformity assessment schemes, ACCREDIA places the information regarding the start of
the new CAS on its website.
4.4
Modifications to the CAS
The SO shall communicate to ACCREDIA any modification to the CAS. ACCREDIA shall evaluate such
modifications and decide what action to take regarding supplementary assessments and/or the need to
modify the accreditation documents, following examination and decision by the relevant CSA.
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TABLE A
ISO/IEC 17011
Level 1
MLA Main Scopes
Calibration
Testing
Inspection
Certification
Verification
Level 2
Level 3
ISO/IEC 17025
Level 4
ISO 15195
27006
27006270
ISO/IEC 17025
CEN/TS 15675
EN 15259
Level 5
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ISO/IEC 17020
ISO 15189
ISO 22870
Management
Systems
Products
Persons
ISO/IEC 17021
ISO/IEC 17065
ISO/IEC 17024
ISO/IEC 27006
27006270
ISO/TS 22003
27006
27006270
Scope of Accreditation (Results Equally Reliable)
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ISO 14065
& Schemes