Raad voor Accreditatie (Dutch Accreditation Council RvA) Assessment of Conformity Assessment Schemes

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1 Raad voor Accreditatie (Dutch Accreditation Council RvA) Assessment of Conformity Assessment Schemes Document code: RvA-T033-UK Version 3, 28 februari 2014

2 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 its 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. ( a.nl).

3 Contents 1 Introduction 5 2 Conceptual framework ISO/IEC Conformity Assessment Scheme 7 3 Explanation of the requirements General requirements Competence in scheme development and administration Validation Scheme documents Legal requirements Calibration, tests and inspection Certification Product certification in accordance with ISO/IEC Management system certification on the basis of ISO/IEC Person certification in accordance with ISO/IEC Validation/verification of greenhouse gases on the basis of ISO The process of assessment of schemes 15 Dutch Accreditation Council (RvA) page 3 of 21

4 4.1 General New schemes In-house schemes Schemes of an accepted scheme administrator Schemes accepted by EA Existing schemes Existing schemes Amendment of an existing scheme 18 5 Changes compared with the previous version 19 Appendix 1: Questions in the development of schemes* 20 Dutch Accreditation Council (RvA) page 4 of 21

5 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 RvA- BR013 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. Dutch Accreditation Council (RvA) page 5 of 21

6 2 Conceptual framework 2.1 ISO/IEC ISO/IEC 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 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. Dutch Accreditation Council (RvA) page 6 of 21

7 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 Dutch Accreditation Council (RvA) page 7 of 21

8 scheme administrator must clearly identify these further details of the method of accreditation in the scheme. 3 Explanation of the requirements 3.1 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 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: Dutch Accreditation Council (RvA) page 8 of 21

9 ISO/IEC 17020: , 7.1.2, ISO/IEC 17021: ISO/IEC 17024: , 9.3 ISO/IEC 17025: ISO/IEC 17065: , 7.10 ISO 15189: ISO 14065: 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 and respectively; ISO/IEC 17024: subsections 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. Dutch Accreditation Council (RvA) page 9 of 21

10 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 Product certification in accordance with ISO/IEC In ISO/IEC 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 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 are shown in bold print): 1. 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 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 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 Dutch Accreditation Council (RvA) page 10 of 21

11 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). 5. 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. 6. Requirements to be made of the competences for personnel involved in the certification process must be laid down in the scheme (criterion 6.1). 7. 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 must be taken into consideration in this regard. 8. 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. 9. Where the certification gives entitlement to the use of a certification mark (criterion 4.1.3), the general requirements under ISO/IEC 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 Management system certification on the basis of ISO/IEC 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 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 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 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 e, 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 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 Dutch Accreditation Council (RvA) page 11 of 21

12 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. 3. 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). 4. 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, 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. 6. 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. 7. A scheme describes the way in which the scope of certification is defined (criterion 8.2.3) if relevant. 8. Where the certification gives entitlement to the use of a certification mark (criterion 8.4), the general requirements of ISO/IEC apply Person certification in accordance with ISO/IEC 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 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). Dutch Accreditation Council (RvA) page 12 of 21

13 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 apply. 3.5 Validation/verification of greenhouse gases on the basis of ISO 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 (with references to ISO ) and IAF-MD6. The following explanations are relevant for verification schemes for emissions data (the criteria from the standard ISO are shown in bold print, to ISO 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 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 , 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 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 , 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 , clause 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 , clause 4.9). Dutch Accreditation Council (RvA) page 13 of 21

14 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 or -2). These shall be part of the scope of the validation or verification agreement (criterion 8.2.3). Dutch Accreditation Council (RvA) page 14 of 21

15 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 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 (RvA- F051, 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 Dutch Accreditation Council (RvA) page 15 of 21

16 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 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 RvA- F002 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. Dutch Accreditation Council (RvA) page 16 of 21

17 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 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. Dutch Accreditation Council (RvA) page 17 of 21

18 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 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. Dutch Accreditation Council (RvA) page 18 of 21

19 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/R 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 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 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. Dutch Accreditation Council (RvA) page 19 of 21

20 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? Dutch Accreditation Council (RvA) page 20 of 21

21 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. Dutch Accreditation Council (RvA) page 21 of 21

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