Raad voor Accreditatie
(Dutch Accreditation Council
RvA)
Assessment of Conformity
Assessment Schemes
Document code:
RvA-T033-UK
Version 3, 28 februari 2014
A Rv A-Explanatory note describes the policy and/or the procedures of the Rv A concerning a specif ic f ield of
accreditation. In case the policy and/or procedures f or a specif ic f ield of accreditation as described in a Rv A
Explanatory note, is documented by EA, ILAC or IAF, the Rv A will bring it s policy en procedures in line with
the EA, ILAC or IAF-document.
A current v ersion of the Explanatory is av ailable through the website of the Rv A. (www.rv a.nl).
Contents
1
Introduction__________________________________________________ 5
2
Conceptual framework _________________________________________ 6
2.1
ISO/IEC 17000 ________________________________________________ 6
2.2
Conformity Assessment Scheme ________________________________ 7
3
Explanation of the requirements _________________________________ 8
3.1
General requirements__________________________________________ 8
3.1.1 Competence in scheme development and administration ____________ 8
3.1.2 Validation ___________________________________________________ 8
3.1.3 Scheme documents ___________________________________________ 9
3.2
Legal requirements ___________________________________________ 9
3.3
Calibration, tests and inspection ________________________________ 9
3.4
Certification_________________________________________________ 10
3.4.1 Product certification in accordance with ISO/IEC 17065 _____________ 10
3.4.2 Management system certification on the basis of ISO/IEC 17021 _____ 11
3.4.3 Person certification in accordance with ISO/IEC 17024 _____________ 12
3.5
Validation/verification of greenhouse gases on the basis of ISO 14065 13
4
The process of assessment of schemes _________________________ 15
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4.1
General ____________________________________________________ 15
4.2
New schemes _______________________________________________ 15
4.2.1 In-house schemes ___________________________________________ 15
4.2.2 Schemes of an accepted scheme administrator ___________________ 16
4.2.3 Schemes accepted by EA. _____________________________________ 17
4.3
Existing schemes ____________________________________________ 17
4.3.1 Existing schemes ____________________________________________ 17
4.3.2 Amendment of an existing scheme______________________________ 18
5
Changes compared with the previous version ____________________ 19
Appendix 1: Questions in the development of schemes* _________________ 20
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1 Introduction
Accredited bodies, or bodies applying for accreditation, perform conformity assessments
according to established methods and procedures which, in the terminology of ISO/IEC
17000, are part of a ‘conformity assessment scheme’. In this explanatory note the RvA
describes the way in which it assesses schemes for the performance of conformity
assessments. The document also contains an explanation of the requirements employed in
the assessment of schemes, to the extent that they are not clearly described in the relevant
accreditation standards.
With this explanation the RvA aims to contribute to the reliability of conformity assessment
activities in general, while in particular giving the developers and administrators of schemes
information about the requirements for schemes. Finally, the document will assist the
harmonisation of the assessments of schemes by the RvA.
This document applies to bodies seeking accreditation, or previously accredited, under policy
rule RvA-BR002. This explanation also applies to bodies wishing to be accepted as, or that
are already, scheme administrators under policy rule RvA-BR013 or regulation RvA-R013.
Three situations are distinguished in the assessment of conformity assessment schemes:
1. The scheme has been developed and is administered by an accredited body (‘inhouse’ scheme) that is also seeking the accreditation.
2. The scheme is administered by a body that has been accepted for this scheme under
RvA-BR013 or RvA-R013, or is seeking acceptance, the ‘scheme administrator’.
3. The scheme has been accepted by the European cooperation for Accreditation (EA)
on the basis of an assessment against EA-1/22.
Where an accredited body uses or wishes to use a scheme administered by another
accredited body, the procedures in respect of the assessment of this scheme are similar to
those for schemes of accepted scheme administrators. The accredited administrator of the
scheme is also regarded as scheme administrator in this connection. The accredited
administrator of the scheme is not however assessed against the requirements of RvABR013 or RvA-R013.
If an accredited body uses or wishes to use a scheme administered by a body not accepted
or accredited by the RvA, this scheme will be assessed as being an ‘in-house’ scheme of the
applicant.
Chapter 2 contains an explanation of the conceptual framework that is important for this
document; further explanation of the term ‘conformity assessment scheme’ is given here.
Chapter 3 gives an explanation of the requirements of schemes for the different types of
conformity assessment, while chapter 4 describes the procedures for the assessment of
schemes and the notification of changes.
This document contains no relevant explanations for laboratories and inspection bodies; it is
however relevant to the development, the administration and the assessment of schemes
used by a number of laboratories and/or inspection bodies.
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2 Conceptual framework
2.1
ISO/IEC 17000
ISO/IEC 17000 contains the definitions and general principles for conformity assessments.
The text printed in bold below with numbers between brackets refers to the definitions in
ISO/IEC 17000.
A Conformity assessment (2.1) is performed on the basis of a need to demonstrate that a
Product (3.3), process, system, person or organisation meets Specific requirements (3.1).
The following activities may form part of a conformity assessment:
 Testing (4.2): Determination of one or more properties of an object according to a
specific way of working.
 Calibration: Activity which, under fixed conditions and subject to all the associated
measurement uncertainties, establishes a connection between the measurement
result of an instruction and the associated measured quantities that have been laid
down by means of measurement standards (for a formal definition see ISO/IEC Guide
99).
 Inspection (4.3): Examining a product design, product, process or installation and
determination of its conformity with specific requirements or, on the basis of expert
opinion, with general requirements.
 Audit (4.4): Systematic, independent, documented process for obtaining records,
factual statements or other relevant information and the independent assessment
thereof to determine the degree to which the specific requirements are met.
 (medical) Testing (ISO 15189:2012, 3.7): Set of activities designed to determine the
(medical) properties of an object.
 Examination (ISO/IEC 17024:2012, 3.9): Mechanism that is part of the assessment
which measures a candidate’s competence by one or more means, such as written
oral, practical and observational, as defined in the certification scheme.
 Validation/verification (ISO 14065:2013, 3.3.1, 3.3.6): Systematic, independent and
documented process for evaluating a greenhouse gas assertion relating to a
greenhouse gas project plan against agreed validation/verification criteria.
There are other activities that can be used to ‘determine’ conformity, which often cannot be
designated by a clear term, for example the assessment or analysis of a design or an
assessment to determine whether a person meets particular requirements.
The result of the activities listed above may be a report or a combination of documents, on
the basis of which an Assessment (5.1) takes place, consisting of a verification of the
suitability, applicability, effectiveness and results of the activities mentioned above, in relation
to making a decision about the specific requirements being met. This assessment leads to a
decision and a statement (Confirmation (5.2), also called attestation) of whether or not the
object meets the requirements. Where the conformity assessment is done by a third party
this confirmation is called Certification (5.5). In the case of verification (or validation), as
referred to in ISO 14065, a review takes place (equivalent to the above Assessment),
followed by a verification (or validation) statement about the reliability of the assessed
greenhouse gas assertion.
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A conformity assessment may end with the confirmation that it has been demonstrated that
the requirements have been met. In certain cases there is a need for a repetition of the
activities described above, to maintain the validity of the certificate. This is the case if the
market deems the permanent demonstrability of the conformity desirable. In that case the
activities will (in part) be gone through repeatedly and this is Supervision (6.1), also called
surveillance or control.
2.2
Conformity Assessment Scheme
The specification of the activities described above for a specific application takes place in a
Conformity Assessment Scheme (2.8) (or Conformity Assessment Programme). Such a
scheme means the system of rules, procedures and administration aspects for the
performance of (parts of) the conformity assessment for specific objects to which the same
specific requirements apply. A scheme contains the following elements:
1. The what of the conformity assessment in the form of:
a) identification of the subject of the conformity assessment, such as product, process,
service, system, person, installation, sample, batch or (emissions) data;
b) the requirements, including any interpretations thereof, against which the assessment
of the subject takes place, such as certification standard, product, system or process
specifications, legal standards;
2. The how of the conformity assessment, involving:
a) the way in which the conformity assessment body establishes the conformity, such as
audit or verification method, inspection protocols, test or assessment method,
inspection instruction, examination method and the process or procedure descriptions
required;
b) if applicable, the way in which supervision takes place, such as control frequencies,
content and scope of organisation/project-based surveillances and reassessments;
3. The who, meaning the bodies that perform the assessments:
a) the requirements, including any interpretations thereof, that apply to the conformity
assessment body with regard to its organisation, procedures, personnel, equipment,
reporting, certificates, etc.
The degree of detail in which the said elements are set out depends on the intended use of
the scheme.
A document that only describes one of the above aspects, such as a normative document or
an interpretation document, will not be regarded as a scheme.
A scheme administrator can give further details in the scheme about the way in which the
RvA carries out accreditations, for example:
 the method of assessing bodies to be accredited or accredited bodies;
 the frequency and scope of these assessments;
 the way to define scopes of accreditation.
In an assessment of elements of this kind the RvA will for instance establish whether these
details are acceptable with a view to the requirements made of the RvA and the feasibility of
the details. It is advisable to contact the RvA about this before adopting the scheme. The
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scheme administrator must clearly identify these further details of the method of accreditation
in the scheme.
3 Explanation of the requirements
3.1
3.1.1
General requirements
Competence in scheme development and administration
All schemes must be drawn up and administered by people who are demonstrably
competent, the requirements for competence of personnel under the different accreditation
standards also applying to the development and administration of schemes. These
competence requirements also relate to both the specific field of expertise of the scheme and
the method of conformity assessment.
As a rule the competence requirements relating to the method of conformity assessment will
be met if conformity assessment bodies, accredited for the accreditation standard concerned
and for activities that are similar to the activities in the new scheme, have demonstrably been
involved in the creation of schemes in an effective manner. This involvement shall at least
mean that the scheme has been presented to such bodies for comment in the design phase
and that the comments received have been taken on board, which can be demonstrated by
means for example of minutes or summaries of criticism.
3.1.2
Validation
A scheme will have to be validated before it is used under accreditation. In the assessment
of the validation of a scheme the RvA uses the elements for design control referred to in ISO
9001:2008, criterion 7.3 (design and development). The main questions to be answered in a
validation are:
 What is the purpose of the conformity assessment and is it achieved with this
scheme?
 Is the conformity assessment described feasible in practice?
 Are the results reproducible and reliable?
Validation at least means that a new or modified scheme has been tested in practice and that
it has been demonstrated that the conformity assessment described in the scheme is
feasible in practice and meets the expectations of the scheme administrator. For a change in
a scheme reasons must be given as to why a new validation is not needed or is only needed
to a limited degree. In the case of category 2 or category 3 changes (as indicated on form
F106) the scheme administrator must link the reason(s) for changing the scheme to the
reasons why she deems validation is not necessary or limited.
The basic principle in the validation is that the duty to demonstrate the reliability of a
conformity assessment lies with the administrator of the scheme. See also RvA-BR003,
Article 11 regarding validation. The following requirements under the accreditation standards
are also relevant in this context:
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






ISO/IEC 17020:2012
ISO/IEC 17021:2011
ISO/IEC 17024:2012
ISO/IEC 17025:2005
ISO/IEC 17065:2012
ISO 15189:2012
ISO 14065:2013
3.1.3
7.1.1, 7.1.2, 7.1.3
9.1
9.2, 9.3
5.4.5
7.1, 7.10
5.5.1
5.3.d, 7.1.b
Scheme documents
The documents in which a scheme is set out must be managed and published in a way that
meets the requirements laid down in the different accreditation documents under the
headings “document control” and “publications” (such as ISO/IEC 17021: subsections 10.3.3
and 8.1.1 respectively; ISO/IEC 17024: subsections 10.2.3 and 7.2 respectively; ISO/IEC
17065: subsections 8.3 and 4.6 respectively). In particular it will be guaranteed that the
documents are published in a way that makes it clear to all concerned what requirements
and procedures are or have been valid at a given time.
Reference to other documents can be made in a scheme. The RvA accepts that such
documents are used within a scheme, but fall outside the area of control of the scheme
administrator or owner if it can be demonstrated that:
 publication and versions of these documents are managed, and
 the documents are publicly accessible (not necessarily obtainable free of charge).
3.2
Legal requirements
Private-law schemes are schemes that are not laid down by the Minister. It is possible for
reference to be made to private-law schemes in statutory regulations, but the Minister does
not determine the content of the private-law scheme in this way. Private-law schemes must
at least contain requirements that are non-statutory, that is requirements that do not follow
directly from legal requirements. If the legal requirements are also described in such a
private-law scheme, they will be mentioned explicitly with reference to the legislation
concerned. A transitional period of three (3) years applies for all schemes for this explicit
mention of the legal requirements with the publication of version 3 of RvA-T033.
The RvA assesses schemes on meeting the accreditation requirements and whether the
requirements are assessable, not on the way in which legislation and regulations are
implemented.
3.3
Calibration, tests and inspection
The term ‘scheme’ is not generally employed in calibration, (medical) tests and inspection,
although in fact the accredited bodies have drawn up their own schemes in the form of work
procedures, method descriptions, etc (based on standards or otherwise) and have therefore
put elements 1, 2 and 3 of subsection 2.2. Supervision (element 2b) does not usually apply
here. Since the requirements of these elements have been sufficiently clearly described in
the accreditation standards concerned, the RvA does not consider use of RvA-T033 relevant
in the assessment of laboratories and inspection bodies.
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It is however possible that a scheme for calibration, (medical) tests or inspection will be
drawn up by the interested parties in which the different elements under subsection 2.2 are
worked out in more detail, with the purpose to harmonise the procedures and methods of
accredited bodies. In this case this RvA-T033 will apply and particular account will be taken
of the explanations described in subsection 3.1 and chapter Fout! Verwijzingsbron niet
gevonden. in the assessment of the scheme concerned.
3.4
Certification
In certification the activities, procedures and ways of working in the context of the certification
of a specific object are described in a certification scheme. When designing a certification
scheme it is worth while paying attention to the questions contained in Annex 1 to this
document, to monitor the completeness of a scheme.
3.4.1
Product certification in accordance with ISO/IEC 17065
In ISO/IEC 17067 - Fundamentals of product certification and guidelines for product
certification schemes – a product certification scheme is defined as (3.1) the rules,
procedures and management for carrying out certification for (3.2) specified products, to
which the same specified requirements, specific rules and procedures apply. In accordance
with this definition, the terms in ISO/IEC 17000, the accreditation standard for product
certification ISO/IEC 17065, ISO/IEC 17007 - ‘Guidance for drafting normative documents
suitable for use for conformity assessments’, ISO/IEC Guide 28 - ‘Guidance on a third-party
certification system for products’, ISO/IEC Guide 53 - ‘Guidance on the use of an
organization’s quality management system in product certification’, the following explanations
are relevant for a product certification scheme (the criteria from the standard ISO/IEC 17065
are shown in bold print):
The certificate of conformity issued by the certification body relates to a clearly identified
product, process or service (criterion 7.7.1).
2. The certification body must employ a scheme in which the certification activities have
been laid down (criterion 7.1.1). The requirements against which the product, the service
or the process are assessed have been clearly specified (criterion 7.1.2). This is possible
by referring to other documents such as legislation, standards or technical specifications.
The RvA uses ISO/IEC 17007 as a guide in assessing the specified requirements. The
way in which the requirements are described must make objective determination of
conformity possible. Use of subjective terms such as “satisfactory” must therefore be
avoided. Limit values and tolerances must also be given. Annex B of ISO/IEC 17065
applies specifically to the certification of services and processes.
3. If requirements are also made of the (quality) management system within the scheme,
they must be regarded as supporting. The fact that such requirements have been
included in the scheme may not lead to a certificate of conformity for this management
system (criteria 4.4.4, 7.7).
4. The activities of the certification body used to establish conformity (criterion 7.4) may
consist of, for example, testing, inspection and the performance of audits or combinations
of these activities. The methods employed for this must be demonstrably suitable for the
intended purpose. The method must also describe whether and how spot checks are
1.
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5.
6.
7.
8.
9.
carried out (and for example samples are taken). The scheme must guarantee that these
activities are carried out on a harmonised basis and that account is taken of the relevant
testing, inspection and audit requirements (criterion 6.2).
A scheme must describe the way in which the results are to be interpreted and what the
consequences are of results (criteria 7.4, 7.5, 7.6, 7.10, 7.11). This also means that it
must be laid down which non-conformities prevent certification or are reason for
suspending or withdrawing a certificate. If legal requirements have been included in the
scheme, the non-fulfilment of such requirements must always prevent certification or be
reason for suspending or withdrawing a certificate.
Requirements to be made of the competences for personnel involved in the certification
process must be laid down in the scheme (criterion 6.1).
The scheme must describe the way in which supervision is implemented (criterion 7.9). If
supervision exists, the type of product certification scheme under ISO/IEC 17067 must be
taken into consideration in this regard.
The certificate of conformity (criterion 7.7) issued on the basis of the certification
evaluation must be in accordance with the assessment carried out. A scheme describes
the way in which the scope of certification (criterion 7.7) is defined if relevant.
Where the certification gives entitlement to the use of a certification mark (criterion 4.1.3),
the general requirements under ISO/IEC 17030 apply. ISO Guide 27, “Guidelines for
corrective action to be taken by a certification body in the event of misuse of its mark of
conformity”, applies in the case of requirements for quality marks granted by a third party.
3.4.2
Management system certification on the basis of ISO/IEC 17021
A management system certification scheme consists of the specific rules and procedures for
certifying a specific management system against specific requirements. The requirements
employed in assessing these schemes are based on ISO/IEC 17021. The RvA has also used
the conceptual framework given in ISO 9000, ISO 14004, ISO/IEC Directives part 1, Annex
SL, Appendix 2 and the IAF Mandatory Documents (IAF-MDs). In assessing schemes the
RvA will also take the documents published by ISO into consideration (for example ISO-TS
22003, ISO/IEC 27006, ISO/IEC 17021-2 and -3) to the extent that they may be regarded as
relevant for the subject of certification concerned. The following explanations are relevant for
management system certification schemes (the criteria from the standard ISO/IEC 17021
are shown in bold print):
1. The certificate of conformity of the certification body concerns a clearly identified type of
management system (subsection 1, criterion 8.2).
2. The requirements against which the management system is assessed have been clearly
specified (criteria 8.2.3.e, 8.6.1.b). These requirements may be set out in an international
or national standard or in some other document. In this latter case the RvA will in
particular check that all the “Plan-Do-Check-Act” (PDCA) elements are present.
The absence of one or more of these elements means that the RvA will not regard the
management system as a management system as referred to in ISO/IEC 17021 and that
the RvA cannot accredit the certification against these requirements. An exception will be
made for legally prescribed control systems (for example, for module D systems under
the global new approach).
The certification assessment, that is the activity to establish conformity, will consist of an
audit, in which the requirements from (criteria 9.1, 9.2) apply. For the scope of an audit
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3.
4.
5.
6.
7.
8.
the RvA employs the principles from the relevant IAF Mandatory Documents. It is very
unlikely that schemes will be accepted whose audit effort is less comprehensive than
relevant IAF documents describe.
Requirements to be made of the competences for personnel involved in the certification
process must be laid down in the scheme (criteria 7.1, 7.2).
The scheme must describe the way in which supervision is implemented. This
supervision must consist of surveillance and recertification as described in criteria 9.3,
9.4.
A scheme must describe the way in which the results are to be interpreted and what the
consequences are of results (criteria 5.1.3, 8.1.1, 8.6.1, 9.2.5, 9.6). This also means that
it must be laid down which non-conformities prevent certification or are reason for
suspending or withdrawing a certificate. One of the objectives of a management system
may be the assurance of compliance with legislation and regulations. Where such a
requirement exists, the non-assurance of compliance must prevent certification or be
reason for suspending or withdrawing a certificate.
The certificate issued on the basis of the certification evaluation must be in accordance
with the assessment carried out (criterion 8.2). The certificate must clearly state the type
of management system that has been certified.
A scheme describes the way in which the scope of certification is defined (criterion 8.2.3)
if relevant.
Where the certification gives entitlement to the use of a certification mark (criterion 8.4),
the general requirements of ISO/IEC 17030 apply.
3.4.3
Person certification in accordance with ISO/IEC 17024
The certification of the competence of persons takes place according to a certification
scheme in which the specific rules and procedures have been laid down for the certification
of a specific competence. The requirements to be made of such a scheme are described in
ISO/IEC 17024, chapter 8 Certification schemes. The following explanations are relevant for
certification schemes for certification of the competence of persons (the criteria from the
standard ISO/IEC 17024 are shown in bold print):
1. The certificate of conformity issued by the certification body concerns clearly described
competences (subsection 3.6, criterion 8.2).
2. The scheme describes what the scope of certification is (criterion 8.2.a).
3. The requirements against which the competences of persons are assessed have been
clearly specified. This is possible by referring to other documents, such as legislation or
standards. The way in which the requirements have been described must make objective
establishment of conformity possible. The description of the requirements must be clear
and understandable for the target group (criteria 8.2.e, 8.3.a, 8.3.c, 8.3.d, 8.3.e), while
the requirements for competences must be based on a clear description and analysis of
the job or practice and its tasks (criteria 8.2.b, 8.4.e).
4. The establishment of the conformity of the competences of persons takes place by
assessing the competences by one or more forms of examination or some other form of
assessment of the competences (criteria 8.3.b, 8.3.c, 8.4.b).
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5. The scheme must describe the way in which supervision and recertification are
implemented (criteria 8.3.c, 8.3.a, 8.3.b, 9.6.1).
6. The certificate of conformity must be in accordance with the assessment carried out and
within the scope concerned (subsection 3.5, criteria 8.2.a, 9.4.8).
7. The scheme describes the way in which the results of evaluations prevent certification or
are reason for suspending or withdrawing the certificate (criteria 9.4.6, 8.3.d, 9.5).
8. Where a certification mark is used (criterion 9.7), the general requirements of ISO/IEC
17030 apply.
3.5
Validation/verification of greenhouse gases on the basis of ISO 14065
A verification scheme for the validation and/or verification of emissions data consists of the
specific rules and procedures for the validation and/or verification of emissions data against
specific requirements. The requirements employed in the assessment of these schemes are
based on ISO 14065 (with references to ISO 14064-3) and IAF-MD6. The following
explanations are relevant for verification schemes for emissions data (the criteria from the
standard ISO 14065 are shown in bold print, to ISO 14064-3 in italics):
1. The statement of conformity of the validation/verification body relates to the fact that the
emissions data has come about according to the prescribed requirements and that there
are no material errors in the customer’s greenhouse gas assertion (subsection 3.1.2).
The verification statement (sections 3.3.4 and 3.3.8) issued on the basis of the validation
(3.3.1) and/or verification (3.3.6) investigation must be in accordance with the
investigation carried out (criterion 8.5).
2. The scheme clearly describes the required degree of reliability of the validation and/or
verification statement (criteria 8.2.3, 8.5, referring also to ISO 14064-3, 4.9) and how it
impacts on the subsequent assessment.
3. The requirements concerning how the emissions data has come about (the GHG
information system) are clearly specified (for further details see ISO 14064-1 and -2).
These requirements may be set out in legislation (permit), an internal monitoring plan or
in an international or national standard or in some other document. They should be
referenced in the validation/verification criteria (section 8.2.3, referencing ISO 14064-3,
4.3.3).
4. The validation or verification activity, that is the activity to establish conformity, will consist
of an assessment (criterion 8.4), in which reference will usually be made to the
requirements of ISO 14064-3, clause 4.
5. Requirements to be made of the competences for personnel involved in the validation /
verification process must be laid down in the scheme (criterion 6).
6. The scheme must ensure that it is clear to which data the validation and/or verification
statement refers and whether particular qualifications apply (criterion 8.5, described in
detail in ISO 14064-3, clause 4.9).
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7. A scheme must describe the way in which the results are to be interpreted and what the
consequences are of results. This means that materiality levels must be laid down and
that it must be laid down which are the consequences of other non-conformities (e.g.
prevent validation or verification) (criteria 3.4.8, 3.4.9, 8.4, 8.5).
8. A scheme describes the type of emissions and the (industrial) sectors to which the
scheme applies, any exclusions in particular being clearly indicated (for guidance refer to
ISO 14064-1 or -2). These shall be part of the scope of the validation or verification
agreement (criterion 8.2.3).
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4 The process of assessment of schemes
4.1
General
A distinction is made in the assessment of schemes between schemes that have not yet
been accepted by the RvA (subsection 4.2) and schemes that have been accepted by the
RvA in which a change in the scheme is made (subsection 4.3).
4.2
4.2.1
New schemes
In-house schemes
An application for accreditation for a new scheme is submitted by means of an accreditation
application using the accreditation application form (RvA-F001a) or an extension application
using the application form for an extension of accreditation (RvA-F105). In addition to these
forms the applicable supplementary application form must be completed. The application is
subject to the rules of policy rule RvA-BR002.
Two Annexes have been specifically included in the supplementary application forms (RvAF051, RvA-F052 and RvA-F053) for the assessment of certification schemes. The first must
be used for a summary description of the scheme, while the second sets out the structure of
an internal assessment of the scheme that the body should provide to the RvA with the
application for accreditation for a scheme.
The RvA assesses the application for the assessment of the scheme. In addition to an
assessment of completeness of the application for instance, the following questions are
answered:
a. Is the chosen accreditation standard correct in relation to the conformity assessment
concerned?
b. Does the scheme have a connection with legislation and regulations and does one or
other form of notification or recognition take place on the basis of the conformity
assessment concerned?
c. Does the scheme have an international context so that the RvA must seek
harmonisation with EA, IAF, ILAC or one of its fellow bodies?
The scope of and the way of working in the assessment of the scheme are laid down on the
basis of this application assessment.
The assessment of the scheme takes the form of a preliminary assessment and involves a
document assessment with the addition of a visit to the body to explain the results of the
document assessment. If the scheme concerns a new field of activity of the body, the
assessment of the scheme will be extended with an assessment of the composition of the
scheme committee or the committee that must guarantee the impartiality of the body.
The reporting states the deficiencies that have been found in respect of the scheme.
Demonstrable correction of deficiencies is needed for a positive conclusion of the
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assessment of the scheme. The accepted scheme, including version indication, will be
included in report part A of the body concerned.
The RvA decides whether and in what way the assessment for the accreditation will take
place on the basis of the scheme assessment. In this regard the nature and the scope of the
assessment depend on the scheme and any other accreditations that the body is applying for
or already has. The way of working for the assessment is in accordance with the rules laid
down in RvA-BR002. On conclusion of the accreditation assessment and a positive decision
by the management, the scheme concerned is included in the scope of accreditation without
version indication.
4.2.2
Schemes of an accepted scheme administrator
The assessment of a scheme of an accepted scheme administrator consists of the following
steps (see also policy rule RvA-BR013 or regulation RvA-R013):
1. The scheme administrator sends the scheme to the RvA with the application form RvAF002 or with form F108 for an extension of the existing acceptance, accompanied by the
results of an in-house assessment showing that the requirements as explained in chapter
Fout! Verwijzingsbron niet gevonden. of this T033 are met. To this end the Annexes in
the supplementary application forms RvA-F051, RvA-F052 or RvA-F053 must also be
used for certification activities and form RvA-F050 for inspection activities.
2. The RvA assesses the application for the assessment of the scheme. In addition to an
assessment for completeness of the application, the following questions are answered:
a. Is the chosen accreditation standard correct in relation to the conformity
assessment concerned?
b. Does the scheme have a connection with legislation and regulations and does
one or other form of instruction or recognition take place on the basis of the
conformity assessment concerned?
c. Does the scheme have an international context so that the RvA must seek
harmonisation with EA, IAF, ILAC or one of its fellow bodies?
3. The RvA determines the scope of and the way of working in the assessment of the
scheme on the basis of this application assessment.
4. The assessment of the scheme takes the form of a preliminary assessment and involves
a document assessment with the addition of a visit to the body to explain the results of
the document assessment. If the scheme concerns a new field of activity of the scheme
administrator, the assessment of the scheme will be extended with an assessment of the
composition of the committee that must guarantee the support for the scheme. The report
states the deficiencies that have been found in respect of the scheme. Demonstrable
correction of deficiencies is needed for a positive conclusion of the assessment of the
scheme.
5. Following a positive acceptance assessment and a positive decision by the management,
the scheme, including version indication, will be included in the scope of acceptance. In
the event of a transitional period in which both old and new versions of the scheme are
valid, this will be stated in the scope of acceptance.
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4.2.3
Schemes accepted by EA.
If a scheme has been accepted by EA on the basis of an assessment against EA-1/22, the
RvA is obliged to accept it without additional assessment.
A scheme administrator cannot apply for acceptance for schemes that have previously been
accepted by the EA.
4.3
Existing schemes
4.3.1
Existing schemes
If the RvA finds non-conformities in its assessments (surveillances, reassessments or
assessments for extension of accreditation) in existing schemes, on the basis of explanations
in this RvA-T033, a non-conformity will be reported to the body at which the assessment
concerned is taking place. A distinction will be made between in-house schemes and
accepted schemes in its handling.
Change in accreditation standard
In the event of a change of the accreditation standard under which the scheme is applied, it
is the responsibility of the scheme administrator to ensure that the scheme continues to meet
the accreditation requirements. In the event of a change of an accreditation standard, the
RvA will publish an explanatory note (T-document) about the introduction of the new
standard, including transitional period. A failing in a scheme that would not have been a
failing under the old standard will be regarded as category “(B)”. The periods specified in the
T-document concerned apply to these (B) deficiencies.
In-house schemes
Non-conformities are categorised as B; for them the normal period as laid down in policy rule
RvA-BR004 applies.
Accepted schemes
The RvA will also report a non-conformity that only affects the contents of the scheme (not its
application by the conformity assessment body) to the scheme administrator as a nonconformity. The way of working then is as follows:
 Non-conformities are categorised as B; for them the normal period as laid down in
policy rule RvA-BR004 applies.
 The scheme administrator will notify the other users of the scheme of the nonconformity and of corrective action to rectify the non-conformity.
 A non-conformity in a scheme of an accepted scheme administrator, in case of failure
to close one or more non-conformities within the period set, will lead to suspension of
the acceptance of the scheme.
 The extension of an accreditation for an existing scheme in which these nonconformities have been found will not be held up in this period if other bodies have
previously been accredited for the scheme. In this way the RvA wants to prevent a
new body experiencing disadvantage from the discovery of non-conformities in an
existing scheme while other bodies can continue using the scheme.
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 If a suspension of a scheme has not been lifted within six months, the acceptance of
the scheme will be withdrawn and at the same time the accreditation of the conformity
assessment bodies for this scheme will be suspended for six months.
4.3.2
Amendment of an existing scheme
The accredited body or the accepted administrator will inform the RvA about changes in a
scheme, in accordance with the conditions set for accreditation and/or in accordance with the
conditions for acceptance. A change will be notified using form RvA-F106, with which the
information as stated in F106 will be provided.
The RvA will decide on the way in which a scheme change will be assessed on the basis of
this information, while distinguishing the following categories of change:
1. A textual or editorial change: the RvA will not assess this.
2. A substantive change that has no consequences for meeting the requirements as
explained in this RvA-T033 or the accreditation or acceptance requirements in general
(accreditation worthiness). The RvA will not in principle perform an assessment of the
amended scheme if the internal assessment provides sufficient confidence. If this internal
assessment provides insufficient confidence, the RvA will then perform an assessment of
the changes.
In the framework of its supervision the RvA can specifically include an amended scheme
whose changes have not been assessed by the RvA, in the sample of its regular
accreditation assessments. If this shows that the scheme does not actually meet the
requirements, the regular periods for corrective action apply and there is a risk of
suspension of the accreditation or acceptance if the non-conformities cannot be rectified
in time.
3. Changes with consequences for meeting the requirements as explained in this RvA-T033
or the accreditation or acceptance requirements in general (accreditation worthiness); the
RvA will perform an assessment of the changes. The nature and scope of this
assessment depends on the nature and scope of the changes. These scheme changes
may be reason for also carrying out an assessment of the performance of the conformity
assessment activities at the accredited bodies. This will for example take place if the
changes in the scheme:
a. lead to significant change in the competence requirements of personnel of the
conformity assessment body as a result of which it is not self-evident that the body
still possesses these competences, or
b. mean a significant change in the way in which the conformity assessments are
carried out as a result of which it is not self-evident that the assessments are carried
out in a reliable manner.
On receipt of the notification of the change in the scheme, the RvA will inform the body about
the consequences of this notification within four weeks. If it is a category 1 or category 2
change by an accepted scheme administrator that will not be assessed, the scope of
acceptance will be adjusted on the basis of the notification. If it is an in-house scheme, part A
of the CBI concerned will be adjusted. If the RvA needs additional documentation and/or will
perform an assessment of the scheme, the body will be informed about it.
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Acceptance of a scheme or accreditation for an in-house scheme may be suspended or
withdrawn. See the way of working as described in RvA BR013/R013.
5 Changes compared with the previous version
Compared with the version from 2011 the following significant changes have been made in
this version:

The latest versions of the accreditation standards have led to detail changes.
Explanations of these changes in the accreditation standards are included in the
relevant T-documents.
 The notification of changes has been modified; changes must be notified immediately
to the RvA using an F106.
 The process of assessing schemes and changes in schemes is better described.
 The transitional arrangement for the second version no longer applies, so deleted.
 ISO 15189 has been added.
 The following changes have been made because of the introduction of accreditation
in accordance with ISO 14065:
 In the conceptual framework the definitions of types of assessment have been
supplemented with “validation” and “verification”;
 The text has generally been supplemented in various places with the relevant
examples for validation and verification;
 In 3.4 a description of the items that must at least have been regulated in a
verification scheme has been added.
 Subsection 3.1.4 has been added, the text about legal requirements in schemes was
only mentioned under the product certification subsection, but has now been
formulated in more general terms. A transitional period of three years applies for the
explicit mention of the legal requirements in a scheme.
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Appendix 1: Questions in the development of schemes*
Subject
What is the subject of the scheme;
- To which (group of) products, services, processes, systems or
competences does your certificate relate?
- About which aspect of the product, service, process, system or
competence is your certificate concerned?
Authors
By whom has the scheme been drawn up?
Certificate
What is your actual certificate of conformity?
What are the conditions of validity of the certificate?
 How long is the certificate valid?
 How can the certificate lose its validity?
 Where can the user check the validity?
How is the applicable certification system mentioned or how is
reference made to it?
Certification mark
What do you communicate to the market as significance of the mark?
Certification requirements Which standard or which normative document contains the
requirements?
- How do you show that assessable requirements have been
formulated?
- Have any legal requirements been included?
- In what way are the legal requirements acted on?
- Have only legal requirements been included?
- Is there an explanation/interpretation of the requirements?
- Has the explanation/interpretation been published?
Certification method Which method do you have to reach decisions on the conformity?
- How do you show that your method is suitable to support the
certificate of conformity (product certification: ISO/IEC 17065;
certification of management systems: ISO/IEC 17021;
certification of competence: ISO/IEC 17024)?
- Which method do you have for monitoring that the certificate
holder continues to meet the requirements?
- How do you show that your method is suitable for monitoring that
the certificate holder continues to meet the requirements?
Conditions
What provisions and evaluation criteria have you laid down for
granting, maintaining, extending, curtailing, renewing, suspending or
withdrawing certification?
- Is your definition of non-conformity in accordance with the
definition in the accreditation standard and/or IAF guidance?
- If the scheme contains legal requirements: are the legal
requirements met by the granting of a certificate?
- What rights and obligations have you laid down for yourself and
the applicants and/or certificate holders and in which documents?
- How and in which document have you laid down that the
certificate holder is continuing to meet the provisions?
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Procedures
Competence
Openness
- What arrangements have you made regarding the recording of
complaints by the certificate holders?
Have you described your certification procedures?
- How can you show that your procedures are appropriate?
- In what way has validation taken place?
Which competence requirements have you described?
- Which competence requirements have you described for your
assessors?
- Which competence requirements have you described for your
deciders?
- Which competence requirements have you described for other
personnel?
- How can you argue that your competence requirements are
appropriate?
Which documents are in the public domain?
- How are they brought into the public domain?
- How do you publish the list of certificate holders?
- What information is provided in so doing?
* Questions can also be used as a basis in the development of schemes in accordance with
other accreditation standards. For inspection the questions regarding the validity conditions
and continuing to meet the requirements do not apply.
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