Title Requirements for accreditation with flexible scope, Department of Certification and Inspection Bodies

Transcription

1 Title Requirements for accreditation with flexible scope, Department of Certification and Inspection Bodies Reference RT-37 Revision 00 Date NOTE: The present document represents the English version of document under reference at the specified revision. In case of conflict, the Italian version will prevail. To identify the revised parts reference must be made to version in Italian language only. Preparation Approval Authorization Application date The Director of the Department The Directive Council The President TECHNICAL REGULATION RT-37 rev.00 pag. 1/10

2 CONTENTS 1. INTRODUCTION SCOPE AND FIELD OF APPLICATION NORMATIVE REFERENCES TERMS AND DEFINITIONS REQUIREMENTS FOR ACCREDITATION WITH FLEXIBLE SCOPE OF ACCREDITATION GENERAL FIRST APPLICATION FOR THE FLEXIBLE SCOPE OF ACCREDITATION MAINTENANCE, EXTENSION AND RENEWAL OF THE FLEXIBLE SCOPE OF ACCREDITATION PERFORMANCE OF ASSESSMENTS OBLIGATIONS OF THE CAB OBLIGATIONS OF ACCREDIA-DC EXAMPLES OF THE APPLICABILITY OF THE FLEXIBLE SCOPE OF ACCREDITATION FOR DIFFERENT ACCREDITATION SCHEMES... 8 TECHNICAL REGULATION RT-37 rev.00 pag. 2/10

3 1. INTRODUCTION The description of the competences of an accredited CAB (CB or IB) is given in the scope of accreditation, which shall be kept available for the clients, for other interested parties and for the market in general. The scope of accreditation shall be defined precisely and unambiguously so as to identify the activities covered by accreditation. The fixed scope of accreditation (see definition below) is set out by ACCREDIA s Department of Certification and Inspection (ACCREDIA-DC) in the document attached to the certificate. The description, however, has its limitations, because if there are any changes or extensions to the scope the CAB shall make a specific request to ACCREDIA-DC, followed by evaluation and approval with, if necessary, the performance of further assessments. The scope of flexible accreditation (see definition below) enables the CAB, within the field of accreditation already attained, to respond to the requests of clients and authorities, and to extend its application to new technical standards for products, personnel or inspection procedures, as long as they belong to the same category or typology regarding the requirements for competences and resources used in conformity assessment activities. 2. SCOPE AND FIELD OF APPLICATION The present document defines the requirements for the application of the flexible scope of accreditation in accordance with the requirements of the standard ISO/IEC : When the accreditation body uses flexible scopes it shall have documented procedures on how it addresses and manages flexible scopes. The procedure shall include how the AB addresses (a) to (h) in 7.8.3, including specifying how information required for (a) to (h) shall be maintained and made available on request. The flexible scope of accreditation may be applied for CABs certifying product, personnel or by inspection and verification bodies. Regarding certification bodies certifying management systems, ACCREDIA-DC adopts the fixed scope of accreditation as set out in the IAF/EA sectors where the body has shown competence (for management systems where such are applicable). It is not necessary to include the NACE code detail in the certificate or to require the CAB to do so. The present document is also applicable in cases of different or particular accreditations of management systems for which the flexible scope is suitable. CBs operating in the mandatory/regulated area retain the fixed scope, unless the flexible scope is applicable on specific request of the competent authorities. The requirements of the present Regulation constitute the criteria used by ACCREDIA-DC, in conformity with the standard ISO/IEC 17011, as indicated above, for the management of flexible scopes where such are requested and adopted by the CAB. These criteria are applied in the verification and approval of the flexibility of the flexible scopes of accreditation of each CAB. TECHNICAL REGULATION RT-37 rev.00 pag. 3/10

4 3. NORMATIVE REFERENCES UNI CEI EN ISO/IEC in the version in force; UNI CEI EN ISO/IEC in the version in force; UNI CEI EN ISO/IEC in the version in force; UNI CEI EN ISO/IEC in the version in force; UNI CEI EN ISO in the version in force; ISO/IEC Conformity assessment Requirements for accreditation bodies accrediting conformity assessment bodies; RG-01 Regulation for the accreditation of Certification, Inspection, Verification and Validation Bodies general requirements, in the version in force; RG Regulation for the accreditation of Certification Bodies providing certification of management systems - in the version in force; RG Regulation for the accreditation of personnel Certification Bodies - in the version in force; RG Regulation for the accreditation of product Certification Bodies - in the version in force; RG Regulation for the accreditation of Inspection Bodies - in the version in force; RG Regulation for the accreditation of Verification and Validation Bodies of the emission of greenhouse gases in the version in force. 4. TERMS AND DEFINITIONS Scope of accreditation: specific conformity assessment services for which accreditation has been requested or granted (standard ISO/IEC ). Scope of fixed accreditation: meaning the description of the scope of accreditation giving full details of the standards, specifics and product schemes, the standards and procedures of inspection and the standards and procedures of personnel certification schemes. Flexible scope of accreditation: meaning the more general description of the scope of accreditation concerning management systems of product, personnel, inspection activities, taking into account the possibility, on the part of the CAB and on the basis of assessed competences, to modify and/or extend the scope of application, to use new revisions of the standards, procedures, schemes, or to add new products, personnel or inspections, provided that the conformity assessment activities require the same competences and resources as already covered by accreditation. For example: for product CBs (ISO 17065): to add new products (and the relative applicable standards) where the technical competences regarding the product of the inspection personnel and of decision-takers, as well as the requirements for performing tests, are the same as other products (and the relative applicable standards/specifics) already covered by accreditation; TECHNICAL REGULATION RT-37 rev.00 pag. 4/10

5 for IBs (ISO 17020): to add inspection procedures product CBs (ISO 17065): to add new products (and the relative applicable standards) where the technical competences and technical skills of the inspectors are the same as for other inspection activities (and the relative applicable standards/specifics) already covered by accreditation; for CBs of personnel (ISO 17024): to add sector professionals requiring the competences of examiners and decision-takers which are the same as those already covered by accreditation. More detailed examples are given in the final paragraph 5.7. Note: the flexible scope is also applied in cases where the certificate of accreditation alongside the standards/specifics, rules of certification and inspection do not state the year or revision of issue. 5. REQUIREMENTS FOR ACCREDITATION WITH FLEXIBLE SCOPE OF ACCREDITATION 5.1. GENERAL Accreditation with flexible scope requires greater responsibility on the part of the CAB in showing that its operative modalities are valid, suitable for the scope and competently and coherently undertaken. It is the applicant CAB s task to determine exactly the limits of the flexibility proposed in terms of the congruity of the competences and resources needed, and to show to ACCREDIA-DC the validity and effectiveness of this choice. The technical capacity of the CAB to manage autonomously the flexible scope is the key factor. For this reason accreditation with flexible scope can only be issued when the CAB has shown that it has a development process in place for managing certifications within the flexible scope for which it has applied (see EA-2/ and 4.2). The CAB shall possess the technical competences for managing its activities in the flexible scope, and also the controlled list of products/inspection activities/personnel for the scope in question. The controlled list shall be made available to ACCREDIA-DC (published in the reserved area of ACCREDIA s website) and also to the public. If an IB operates according to client specifics it does not have to keep a controlled list, but it shall have the list of specifics regarding orders which must be available for ACCREDIA-DC but not for the public FIRST APPLICATION FOR THE FLEXIBLE SCOPE OF ACCREDITATION The first application for flexible scope accreditation is to be considered an extension as it can be requested only if the CAB already has fixed scope accreditation for a specific accreditation standard for at least two years. In modifying the flexible scope it is possible to add new products/inspection areas/sector professionals, provided that the conformity assessment methods are based on the same competences and the same test/inspection/exam techniques. TECHNICAL REGULATION RT-37 rev.00 pag. 5/10

6 This possibility does not include the introduction of new techniques of certification/inspection/exam. The CAB shall demonstrate that it has applied procedures for the management of the flexible scope, including, at least: the responsibility, at internal level, of the person who sets the typology/product category/inspection activities/personnel for which the CAB intends to apply the flexible scope; the operative modalities for verifying the correct application of the flexible scope; the responsibility and operative modalities for management of the controlled list and of all the elements included in the flexible scope and how the list is made available to ACCREDIA- DC (published in the reserved area of ACCREDIA s website) and also to the public. The application for extension for the flexible scope shall describe the scope of application (typology/product category, inspections, personnel) and it shall include: the motives and evidence ensuring the homogeneity of the elements contained in the flexible scope for each typology/category identified; the procedure prepared and made available by the CAB for the complete management of the flexible scope. The first application for extension for the flexible scheme is evaluated by the technical officer after consultation with the department director, with support when necessary from technical experts and, subsequently, the positive outcome of an assessment at the CAB, by the competent sector accreditation committee for the decision concerning accreditation MAINTENANCE, EXTENSION AND RENEWAL OF THE FLEXIBLE SCOPE OF ACCREDITATION If a CAB already holding accreditation for the flexible scope applies for extension to other typologies/categories different from those on the list with flexible scope, provided that it has been has fixed scope accreditation for two years, against a specific accreditation standard, it shall send the application, completed following the indications of the previous paragraph, and including: the motives and evidence ensuring the homogeneity of the elements contained in the flexible scope for each typology/category identified. The technical officer, with the department director and sector experts where necessary, agree the necessity or otherwise to perform an assessment at the CAB PERFORMANCE OF ASSESSMENTS The assessment of the flexible scope of accreditation requires taking great care of the following factors: competence and responsibility of staff involved in the management of certifications/inspections in the flexible scope; TECHNICAL REGULATION RT-37 rev.00 pag. 6/10

7 conduct of the process of management of the flexible scope, of the controlled list of the flexible scope (responsibilities, inclusion modalities, modifications and/or cancellations of certified or inspected elements, certification data, accessibility for ACCREDIA-DC and for the public etc.). The ACCREDIA-DC assessors and the technical officer, during the preparation of the surveillance and/or renewal assessment of the CAB with flexible scope, always check the CAB s controlled list to assess the elements in the flexible scope in order to choose the most important elements for examination during the assessment. These elements are reviewed during the assessment with the objective of ascertaining: that the elements contained in the CAB s controlled list are consistent with what the CAB made available and was approved by ACCREDIA-DC and that elements were not included which do not belong to the approved category/typology with respect to the consistency of necessary competences and resources (usually these are the competences of assessors, the methodology for testing/measuring and the equipment used); the responsibilities and modalities for the controlled management of the list and its public availability; the completeness and accuracy of the records regarding the inspection performed by the CAB to establish that the new element of certification/inspection has effectively been included in the flexible scope and does not require an extension to the accreditation. The planning of the assessment as above takes into consideration the need, if necessary, to perform a witness assessment of factors which the CAB has included in the flexible scope. If the result of the above assessments is positive ACCREDIA-DC informs the CAB of the decision taken by the sector accreditation committee regarding the issuance, renewal and/or extension of the flexible scope of accreditation. 5.5 OBLIGATIONS OF THE CAB The CAB shall have an internal procedure identifying the responsibilities and operative modalities observed for the inclusion of each new element in the flexible scope. The CAB shall show that it possesses and applies a development process of its flexible scope with respect to including new products/services, professional persons, inspection activities within the flexible scope Detailed list of the activities managed with flexible scope of accreditation The CAB shall keep and make publicly available an updated list of the elements managed in the flexible scope Apart from the normative references and accreditation regulations, this list shall contain at least, the following: typology/category of product, inspection activity; product, service, professional person, inspection area; TECHNICAL REGULATION RT-37 rev.00 pag. 7/10

8 the standard or normative document of certification/inspection with the code of identification, the year and the revision; the document containing the rules for the issuance of certification of the product or person with the code of identification, the year and the revision; the date of inclusion by the CAB of the element in the flexible scope Management of non-conformities and sanctions imposed by ACCREDIA-DC Apart from the motives normally contained in the regulation in force, any failures in the flexible scope may lead to the imposition of sanctions in accordance with the case in question. Restoration of the fixed scope, reduction of the scope and/or suspension of accreditation decided by the relevant sector accreditation committee which also sets the duration of the sanction and the time for restoration of accreditation OBLIGATIONS OF ACCREDIA-DC In addition to the above requirements, ACCREDIA-DC shall update accreditation certificates as set out below. At the time of decision of the sector accreditation committee regarding flexible scope for a CAB for a typology/category of product, personnel or inspection activity, the accreditation certificate is modified. Corresponding to each typology/category of the flexible scope, the list of elements present is removed and the following wording is placed: For this typology ACCREDIA-DC has approved the scope of flexible accreditation. The details concerning the products/professional persons/accredited inspection activities and standards/reference documents are reported in the specific list available on the website of the CAB. If ACCREDIA-DC is asked to confirm the details of a flexible certificate, ACCREDIA-DC shall send the request to the CAB in question which has the responsibility of keeping the document updated and of providing explanations to ACCREDIA-DC, to the authorities, and to the market regarding management of the scope (correct list, competences, activities undertaken etc.) EXAMPLES OF THE APPLICABILITY OF THE FLEXIBLE SCOPE OF ACCREDITATION FOR DIFFERENT ACCREDITATION SCHEMES Below are some examples of how the flexible scope works in the case of three reference accreditation schemes. These examples are merely indicative because every flexible scope must be the object of assessment and approval by ACCREDIA-DC (see 5.2 above). TECHNICAL REGULATION RT-37 rev.00 pag. 8/10

9 For Certification Bodies of products/services (UNI CEI EN ISO 17065) Example 1 The certificate of accreditation issued by ACCREDIA-DC contains: Typology of systems and components for solar heating UNI EN : - solar collectors: for this typology ACCREDIA-DC has approved the scope of flexible accreditation. The details concerning the products/professional persons/accredited inspection activities and standards/reference documents are reported in the specific list available on the website. of the CAB. The CAB s controlled list makes reference to the typology solar collectors and it lists all the certified components with the relative standard/specific and certification scheme adopted. Example 2 Typology of product of animal and vegetable origin: for this typology ACCREDIA-DC has approved the scope of flexible accreditation. The details concerning the products/professional persons/accredited inspection activities and standards/reference documents are reported in the specific list on the website. of the CAB. The CAB s controlled list makes reference to the typology as above and lists, for example, Hams without certain additives and pork products produced in with the relative specific and the certification scheme For Certification Bodies of persons (UNI CEI EN ISO 17024) The flexible scope for persons is applicable only for professionals referring to the same standard or certification scheme. Example 3 The certificate of accreditation issued by ACCREDIA-DC reports: Typology: management system auditor: for this typology ACCREDIA-DC has approved the scope of flexible accreditation. The details concerning the products/professional persons/accredited inspection activities and standards/reference documents are reported in the specific list available on the website. of the CAB. The CAB s controlled list makes reference to the typology - management system auditor, and lists: - QMS auditor - QMS lead auditor standard. scheme. - EMS auditor - EMS lead auditor standard. scheme. - OHSAS auditor - OHSAS lead auditor standard. scheme. N.B. This description of the flexible scope is approved by ACCREDIA-DC only if the CAB has shown that it possesses procedures and competences (e.g. examiners) which cover the three sectors QMS, EMS and OHSAS. TECHNICAL REGULATION RT-37 rev.00 pag. 9/10

10 Example 4 The certificate of accreditation issued by ACCREDIA-DC reports: Typology: professional persons operating in the sector ICT - UNI 11506: for this typology ACCREDIA-DC has approved the scope of flexible accreditation. The details concerning the professional persons are reported in the specific list available on the website. of the CAB. The CAB s controlled list makes reference, for example, to some professional profiles indicated in the normative references and the certification scheme. N.B. This description of the flexible scope is approved by ACCREDIA-DC only if the CAB has shown that it possesses procedures and competences which cover all the responsibilities reported in the controlled list. Example 5 The certificate of accreditation issued by ACCREDIA-DC reports: Typology: professional persons operating in translation and interpreting against UNI 11591:2015 for this typology ACCREDIA-DC has approved the scope of flexible accreditation. The details concerning the professional persons are reported in the specific list available on the website. of the CAB. The CAB s controlled list makes reference, for example, to some professional profiles indicated in the normative references and the certification scheme. N.B. This description of the flexible scope is approved by ACCREDIA-DC only if the CAB has shown that it possesses procedures and competences which cover all the professions reported in the controlled list For Inspection Bodies (UNI CEI EN ISO 17020) Example 6 The certificate of accreditation issued by ACCREDIA-DC reports: Typology: inspections of welded components and structures in accordance with international standards: for this typology ACCREDIA-DC has approved the scope of flexible accreditation. The details concerning the products/professional persons/accredited inspection activities and standards/reference documents are reported in the specific list available on the website. of the CAB. The IB s controlled list makes reference to the various typologies of welded structures with the applicable standards/specifics and inspection procedures. Notes: in some cases the flexible scope may be limited to the management of the year of issue (or revision index) of the standards or technical documents used for the accredited certification activities; as set out in 5.1 above, in cases where the IB operates according to client specifics it is sufficient that it reports the typology/category of inspection activities, indicating that these are performed according to the client s specifications. TECHNICAL REGULATION RT-37 rev.00 pag. 10/10