BELAC 1-03 Rev 4-2016 BELAC ACTIVITIES : DESCRIPTION AND CRITERIA FOR SELECTION The only valid versions of the documents of the BELAC management system are those available from the internet website (www.belac.fgov.be). English translation for information only French and Dutch version remain the authoritative documents Date of implementation : 15.11.2016 BELAC 1-03 Rev 4-2016 - 1/11
BELAC 1-03 Rev 4-2016 - 2/11
Revision and date of approval 0 CC 27.01.2011 1 CC 26.10.2012 and consultation by correspondence 17.12.2012 2 Secr. 10.06.2014 3 CC 03.05.2016 4 CC 27.10.2016 New document HISTORY OF THE DOCUMENT Reason for the revision Principles with respect to the accreditation of testing and medical laboratories for activities that are systematically subcontracted. Extension of BELAC scope for the accreditation of validation and verification bodies according to ISO 14065: - Adding reference to the series of BELAC documents 2-405 in case of specific accreditation requirements for a specific conformity assessment activity. - Explicit mention of GHG validation and verification bodies as a new type of conformity assessment bodies. Update of reference to accreditation standards Suppression of the possibility of accreditation according to ISO/IEC 17025 for activities that can be covered by EN ISO 15189 Update of reference to accreditation standards Subcontracting by laboratories: specific provisions Conformity assessment activities within the framework of product certification Scope of the revision New points 4.2.2 and 4.3.2 Point 3.2 New point 4.11 Chapter 4 Point 4.2.1 Chapter 4 Points 4.2.2 and 4.2.3 Point 4.2.1, 4.6 and 4.9 BELAC 1-03 Rev 4-2016 - 3/11
BELAC ACTIVITIES: DESCRIPTION AND SELECTION CRITERIA 1. AIM OF THE DOCUMENT AND REFERENCES TO STANDARDS This document aims to provide a general description of the scope of activities of BELAC and of the criteria to be complied with for the selection of an activity under the BELAC scope. This document refers to and complies with the relevant sections of the EC Regulation 765/2008, the standard NBN EN ISO/IEC 17011 and the relevant EA / IAF / ILAC guidelines and complementary requirements. A list (document BELAC 6-017) identifies, for each type of conformity assessment activity, the main technical fields in which BELAC is currently active. The list complements the present document and is regularly updated; it has a strictly informative character and does not presume of the ability of BELAC to extend its activities to other domains. 2. RECIPIENTS. With follow-up of modifications: the members of the Co-ordination Commission the members of the Accreditation Board the BELAC secretariat the assessors the accredited bodies Without follow-up of modifications: Any external request BELAC 1-03 Rev 4-2016 - 4/11
3. GENERAL PROVISIONS 3.1. The scope of BELAC and its limits As the sole national accreditation body, BELAC is entitled - to grant accreditation according to requirements that are fixed in normative documents, published by Ministerial Decree and listed in document BELAC 0-06, i.e. for all types of conformity assessment bodies mentioned under point 4; - to cover all potential fields of activity of conformity assessment bodies, in both the regulated and non-regulated sectors. 3.2. Extension of the scope The extension of the BELAC scope of activities to a new accreditation field (i.e. an accreditation standard not yet recognised by BELAC) will only be decided subject to - a positive advice of the National Council of Accreditation; the interest expressed by the concerned sector, the expectations of the stakeholders, the position of the regulatory authorities when relevant and the situation at the international level will be considered; - endorsement by the Minister of Economy. In case of extension of the scope of activities of BELAC to significantly new types of conformity assessment activities (including related new conformity assessment schemes) within an already active accreditation field, the endorsement by the Coordination Commission is solely required. In both cases, a documented review of feasibility is performed by the BELAC permanent secretariat; the specific aspects described under point 4 are taken into consideration. In case of extension of the BELAC scope, the implementation includes all or part of the following elements, depending on the specific situation: - the identification and training, when relevant, of assessors and experts with the necessary technical competence ; - the development of specific guidance documents in order to allow for a consistent implementation of the accreditation requirements and for a standardised lay-out of the accreditation documents ; - the setting up of a specific sector committee or task force; - the information of the concerned parties. In case the feasibility review leads to the identification of specific accreditation requirements (either applicable to the conformity assessment body or to BELAC itself), these requirements are documented and made publicly available under the form of a document of the BELAC 2-405 series (BELAC 2-405 NAME ACTIVITY). BELAC 1-03 Rev 4-2016 - 5/11
4. SPECIFIC PROVISIONS FOR EACH TYPE OF CONFORMITY ASSESSMENT BODY 4.1. Calibration laboratories (EN ISO/IEC 17025) 4.1.1 As far as calibration laboratories are concerned, accreditation may cover: - all types of laboratories; - all physical quantities and types of instruments, provided traceability may be achieved; - the performance of reference measurements in laboratory medicine, provided that the requirements of EN ISO/IEC 17025 are complemented with those of EN ISO 15195. 4.2. Testing laboratories (EN ISO/IEC 17025) 4.2.1 As far as testing laboratories are concerned, accreditation may cover: - all types of laboratories; - all technical sectors, with the exception of the activities of medical laboratories that can be covered by EN ISO 15189; - all types of tests, performed according standardised or published methods or national or European regulatory provisions or according to self-developed methods; in each case, an appropriate validation of the test method and of the results is required; - sampling activities when coupled to testing performed at least in part by the laboratory itself ; - test performed within the framework of national or international conformity assessment schemes, in the regulated or in the private fields (see also under point 5); - testing activities performed within the framework of activities as notified body - testing activities performed within the framework of inspection or product certification activities (provided the conditions documented under 4.9 are respected). 4.2.2 Accreditation can only be granted for activities that the laboratory itself is able to perform as a whole. However, systematic subcontracting of the whole or of part of a testing process: - is accepted in case it is explicitly allowed by a national or European regulation or has been agreed by the concerned regulatory authority; - may be accepted by the Accreditation Board, on a case by case basis, in order to allow an accredited laboratory or a defined sector to cope with a specific situation; the following conditions need to be complied with: - the laboratory shall provide motivation for systematic subcontracting of the whole or of part of a testing process and the associated risks will be identified; - the testing processes or part thereof that will be systematically subcontracted will represent only a limited part of the accredited activities; - the activities shall be subcontracted to a laboratory accredited for the concerned activities; BELAC 1-03 Rev 4-2016 - 6/11
- the accredited laboratory shall be able to demonstrate its technical competence with respect to the subcontracted activities and shall keep due control on them; - the accredited laboratory remains solely responsible for the whole testing process, starting with the acceptance of the test object up to issuing the final test report; - the accredited laboratory shall inform its customer in advance about the conditions of performance of the test. The activities that are systematically subcontracted shall be explicitly mentioned in the accreditation documents. 4.2.3 The accreditation of part of a testing process is not allowed. 4.3. Laboratories of biological medicine (EN ISO 15189) 4.3.1 As far as laboratories for biological medicine are concerned, accreditation may cover: - all types of laboratories ; - all types of samples, sectors and techniques provided they fall under the scope of the EN ISO 15189 standard; - the activities of Point of Care Testing, provided that the requirements of EN ISO 15189 are complemented with those of EN ISO 22870. 4.3.2 The provisions documented under 4.2.2 and 4.2.3 are applicable to the laboratories of biological medicine. 4.4. Proficiency Testing Organisers (EN ISO/IEC 17043) As far as the organisation of proficiency testing is concerned, accreditation may cover: - all potential technical sectors; - punctual exercises or campaigns with a repetitive character ; - organisers that prepare themselves the objects to be circulated and that perform the necessary calibration /testing activities ; - organisers who rely on subcontracting bodies / laboratories for the preparation of the objects to be circulated and the performance of part or all of the necessary calibration / testing activities ; the organisers are required to provide evidence of their technical competence for the critical evaluation of the subcontracted results. 4.5. Reference Materials Producers (Guide ISO 34) As far as the production of reference materials is concerned, accreditation may cover: - all potential technical sectors ; - punctual productions or with a repetitive character; - organisers that prepare themselves the material to be certified and that perform the necessary testing activities ; - organisers who rely on subcontracting bodies / laboratories for the preparation of the material to be certified and the performance of part or all of the necessary testing activities ; the organisers are required to provide evidence of their technical competence for the critical evaluation of the subcontracted results. BELAC 1-03 Rev 4-2016 - 7/11
4.6. Inspection bodies (EN ISO/IEC 17020) As far as inspection bodies are concerned, accreditation may cover: - all types of inspection bodies; - inspections of product design, product, service, process, plant or premises, performed according to normative provisions, national or European regulations, or national or international conformity assessment schemes in the regulated or in the private fields (see also under point 5); - inspection activities performed within the framework of activities as notified body - inspection activities performed within the framework of product certification activities (provided the conditions documented under 4.9 are respected). 4.7. Certification bodies for management systems (EN ISO/IEC 17021 (until 14.06.2017) or ISO/IEC 17021-1) As far as the certification of management is concerned, accreditation may cover: - certification according to international standards for management systems, provided that the requirements of EN ISO/IEC 17021 (until 14.06.2017) or ISO/IEC 17021-1 are complemented with the requirements of: - ISO/IEC TS 17021-2 for the certification bodies providing audit and certification of environmental management systems; - ISO/IEC TS 17021-3 for the certification bodies providing audit and certification of quality management systems; - ISO/IEC TS 17021-5 for the certification bodies providing audit and certification of asset management systems; - ISO TS 22003 for the certification bodies providing audit and certification of food safety management systems; - ISO/IEC 27006 for the certification bodies providing audit and certification of information security management systems ISMS); - ISO 50003 for the certification bodies providing audit and certification of energy management systems. - certification according to national or international conformity assessment schemes, in the regulated or in the private fields (see also under point 5); - certification activities performed within the framework of activities as notified body. 4.8. Environmental verifiers (EN ISO/IEC 17021 (until 14.06.2017) or ISO/IEC 17021-1 and EMAS Regulation) As far as environmental verification is concerned, accreditation may cover: - a conformity assessment body as defined by Regulation 765/2008 but not a physical or moral person; - all relevant sectors of activity as defined by the nomenclature of economic activities set up by the EC Regulation 1893/2006. 4.9. Certification bodies for products (EN ISO/IEC 17065) As far as the certification of products is concerned, accreditation may cover: - certification of any type of product ; BELAC 1-03 Rev 4-2016 - 8/11
- certification according to standards, normative documents or certification national or international schemes, in the regulated or in the private fields (see also under point 5); - certification activities performed within the framework of activities as notified body; - certification of trust services for electronic identification and electronic transactions under the Regulation (EU) No 910/2014 on condition of fulfilling the requirements of the ETSI EN 319 403 in addition to the ISO / IEC 17065 requirements. The conformity assessment activities (testing or inspection) performed by the product certification body itself are part of the product certification process and are covered by the accreditation according to ISO/IEC 17065. A specific accreditation certificate and technical appendix according to ISO/IEC 17020 and/or ISO/IEC 17025 will not be granted. This is however possible provided the certification body has formally applied for accreditation according to ISO/IEC 17020 and/or ISO/IEC 17025 and on condition that these activities are also performed for external customers, as a testing laboratory or inspection body. All requirements of the concerned accreditation standard need to be complied with. (see also 4.2; and 4.6) 4.10. Certification bodies for personnel (EN ISO/IEC 17024) As far as the certification of persons is concerned, accreditation may cover: - each type of certification scheme for persons provided it complies with the requirements of the standard EN ISO/IEC 17024 and in particular annex A; - certification activities performed within the framework of activities as notified body. 4.11 Greenhouse gas validation and verification bodies (EN ISO 14065) As far as the activities of greenhouse gas validation and verification bodies are concerned, accreditation may cover all activities performed within the framework of a national or European legislation. BELAC 1-03 Rev 4-2016 - 9/11
5. POLICY FOR CONFORMITY ASSESSMENT SCHEMES 5.1. Definitions 5.1.1. Conformity assessment scheme With conformity assessment scheme is meant a set of documents that fix: 1) the requirements or reference documents to be used by the conformity assessment bodies (e.g.: test methods, regulatory requirements to which inspection or certification needs to be performed ); 2) the requirements placed on conformity assessment bodies that fix provisions for their organisation, working, staff, equipments, content of reports.; 3) the requirements placed on accreditation bodies that assess the conformity assessment bodies. 5.1.2. Owner of a conformity assessment scheme Body that establishes a conformity assessment scheme 5.2. International conformity assessment schemes Conformity assessment activities performed within the framework of an international conformity assessment scheme may be covered by accreditation provided the following conditions are complied with: - the conformity assessment scheme has been formally endorsed by EA, ILAC or IAF; - EA, ILAC or IAF have not taken a negative position with respect to the scheme. In all other cases, accreditation will only be possible based on the following conditions: - The scheme owner will be invited to contact EA with the view to get formal endorsement of the scheme; - The scheme will: o be formally documented and publicly available; o be developed, approved and maintained under the responsibility of a formally identified public or private scheme owner; o demonstrate a clear market support, which may also include governmental initiatives or regulatory needs; o rely on a conformity assessment process that fall into the scope of internationally agreed accreditation requirements; o not include scheme specific requirements placed on conformity assessment bodies that contradict or exclude any of the accreditation requirements; o not include scheme specific requirements placed on BELAC that contradict or exclude any of the requirements of the standard EN ISO/IEC 17011, the EC Regulation 765/2008 and the relevant EA, ILAC and IAF provisions; - the applicant for accreditation will be established in Belgium and shall have a Belgian legal identity; - BELAC commits itself to respect the EA, ILAC or IAF decisions with respect to the scheme as soon as the scheme gets formally endorsed or refused by these organisations. BELAC 1-03 Rev 4-2016 - 10/11
5.3. National conformity assessment schemes Accreditation is possible provided that the conformity assessment scheme complies with the requirements for the international conformity assessment schemes and brings added value with respect to existing federal, regional or community regulatory requirements. BELAC 1-03 Rev 4-2016 - 11/11