1 / 24

Requirements for potential accreditation providers

This document provides an overview of the Finnish legislation on accreditation of conformity assessment services, including the purpose, scope, definitions, application process, prerequisites, and monitoring of accredited bodies.

rancourt
Download Presentation

Requirements for potential accreditation providers

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Metrology & Conformity Assessment Team Technical Department of Technical Directorate • Dmitry Starkov Requirements for potential accreditation providers

  2. No CONTENTS 1 FINNISH Legislationon Accreditation of Conformity Assessment Services • FINAS TERMS OF ACCREDITATION DECISION ON 22.03.2016 2 3 • FINAS Requirements applied to accreditation activities 4 • FINAS Rules for Reference to Accreditation 5 • FINAS multilateral recognition arrangements (MLA, MRA) 6 • STUK Requirements applied to the accredited testing organisations 7 • STUK Requirements applied to the NON-accredited testing organisations

  3. 1. FINNISH Legislation on the Accreditation of Conformity Assessment Services Act of the Accreditation of Conformity Assessment Services 920/2005 dated 25.11.2005 Content Section 8Monitoring the assessment body’s competence Section 9Withdrawal of accreditation Section 10Appeals Section 11Registers Section 12Entry into force Section 13Transitional provisions Section 1Purpose of the Act Section 2Scope of application Section 3Relationship with other acts Section 4Definitions Section 5Applying for accreditation Section 6Prerequisites for accreditation Section 7Accreditation decision

  4. 1. FINNISH Legislation on the Accreditation of Conformity Assessment Services Act on the Accreditation of Conformity Assessment Services ON 25.11.2005 № 920 (920/2005) Section 1 Purpose of the Act This Act contains provisions on the national accreditation system, the purpose of which is to ensure that conformity assessment services are reliable and meet international requirements. Section 2 Scope of application This Act is applied when conformity assessment services are subject to accreditation or to other assessment of competence comparable to accreditation. Section 4 Definitions For the purposes of this Act, the following definitions are used: 1) Conformity assessment means accreditation, testing, calibration, certification, inspection or other comparable activities. 2) Conformity assessment service means testing, calibration, certification and inspection and other comparable activities. 3) An assessment body means a corporation, institute or some other body providing conformityassessment services. 4) Accreditation means verification of the competence of an assessment body in accordance withuniform international or European assessment criteria. … 11) The accreditation unit means the accreditation unit of the Finnish Safety and Chemicals Agency(19.09.2014/764). Section 5Applying for accreditation An assessment body may apply for accreditation or for assessment of competence comparable toaccreditation by sending an application to the accreditation unit. Section 6Prerequisites for accreditation A prerequisite for accreditation is that the assessment body has the type of organisation,personnel, management and quality systems, internal control and conformity assessment servicethat are appropriate taking into consideration the adoptedassessment criteria.

  5. 1. FINNISH Legislation on the Accreditation of Conformity Assessment Services Act on the Accreditation of Conformity Assessment Services ON 25.11.2005 № 920 (920/2005) Section 7Accreditation decision The assessment body must show that it meets the prerequisites referred…The accreditation decision defines the scope of accreditation and confirms the procedures thatare followed for maintaining and monitoring the assessment body’s competence. The decisioncan be given for a certain fixed period… Section 8Monitoring the assessment body’s competence Following the procedures determined in the decision …theaccreditation unit monitors the competence of the assessment bodies it has accredited… Section 9Withdrawal of accreditation If, during the monitoring …the accreditation unit finds that the accreditedassessment body does not meet the prerequisites …,the accreditation unit shall determine a reasonable time within which the situation must becorrected… The accreditation unit may withdraw the accreditation if the assessment body has not correctedthe situation within the time specified …. Section 10Appeals An administrative decision made by the accreditation unit by virtue of this Act may be appealedas stipulated in the Act on the Application of Administrative Law (586/1996)… Section 11Registers The accreditation unit keeps a register of the assessment bodies that it has accredited and of theirscopes of accreditation… UNOFFICIAL TRANSLATION Legally binding only in Finnish and Swedish

  6. 2. FINAS TERMS OF THE ACCREDITATION DECISION ON 22.03.2016 1. The accredited client shall comply with the requirements confirmed by the Finnish Accreditation Service (FINAS) for accreditation activities. However, if major changes are made to the accreditation requirements, the recipient of the accreditation decision shall, within a given grace period, show that the revised requirements are met. Otherwise, the validity of accreditation will expire at the end of the grace period. 2. The accredited client agrees to be subject to the periodic surveillance that the Finnish Accreditation Service considers necessary for accreditation activities. When the accredited client operates in another country it gives its consent for the cooperation and exchange of information between Finnish Accreditation Service and the accreditation body in the country concerned. 3. The accredited client’s competence is monitored by means of periodic surveillance at intervals no longer than 18 months. The results of interlaboratory comparisons are also part of the assessment. 4. The accredited client shall inform the Finnish Accreditation Service without delay of any changes that have taken place in its legal, commercial or organisational status or in the management of its organisation, as well as of any changes important in terms of accreditation, especially as concerns personnel, equipment, premises, scope of accreditation, or procedures. 5. The accredited client shall pay the fees incurred in accreditation and shall co-operate with the Finnish Accreditation Service so that it can be ensured that the accredited client constantly meets the requirements confirmed for accreditation activities. 6. The accredited client shall not offer the same service as the accreditation body. If the accredited client uses accreditation standards for the assessment of subcontractors, it should become clear from the assessment documents that it is an assessment of a subcontractor and it must not give the impression that the subcontractor fulfils the accreditation requirements.

  7. 3. FINAS Requirements applied to the accreditation activities FINAS Decision ON 17.11.2015 (Р1/2015) According to the Act of theAccreditation of ConformityAssessment Services 920/2005,FINAS decides on the adoption of assessment criteria. The accreditation system is based on voluntary participation. At their discretion, bodies engaged in testing, inspection, certification and calibration, bodies providing proficiency testing, EMAS verifiers and green house gas verifiers may apply for accreditation. The requirements confirmed in this decision are applied when the competence of these bodies is assessed. Before a body is accredited, it must demonstrate that it meets the requirements confirmed in this decision for the activities in question.

  8. 3. FINAS Requirements applied to the accreditation activities FINAS Decision ON 17.11.2015 (Р1/2015) • For an accredited body, it is mandatory to continuously meet the relevant accreditation requirements. • During the accreditation procedure, assessors approved by the FINAS evaluate the competence of the body. • The assessors shall meet accreditation requirements sections which are applicable to them. • Requirements applied to the accreditation activities: • Testing and calibration laboratories • Certification bodies • Inspection Bodies • EMASverifiers • Verification organisations • Providers of proficiency testing • Requirement applied to assessment of competence. • This decision came into force 17.11.2015, and it shall be valid until further notice.

  9. 3. FINAS Requirements applied to the accreditation activities FINAS Decision ON 17.11.2015 (Р1/2015) Testing and calibration laboratories The following requirements are applied to the accreditation of testing and calibration laboratories: - standard ISO/IEC 17025:2005 “General requirements for the competence of testing and calibration laboratories” In the Russian Federation, the standard GOSTISO/IEC17025-2009 “General requirements for the competence of testing and calibration laboratories” applies to the same. This standard is identical to the international standard ISO/IEC 17025:2005. IDT - isidentical to the international standard

  10. 3. FINAS Requirements applied to the accreditation activities • FINAS Decision ON 17.11.2015 (Р1/2015) • Inspection Bodies • The following requirements are applied to the accreditation of inspection bodies: • - standardISO/IEC 17020:2012 “Conformity assessment.Requirements for the operation of various types of bodies performing inspection”. • In the Russian Federation, the standard GOST RISO/IEC 17020-2012 “Conformity assessment. Requirements for the operation of various types of bodies performing inspection” applies to the same. • This standard is identical to the international standard ISO/IEC 17020:2012. • IDT - is identical to the international standard

  11. 3. FINAS Requirements applied to the accreditation activities • FINAS Decision ON 17.11.2015 (Р1/2015) • Certification bodies • The following requirements are applied to the accreditation of certification bodies engaged in product certification: • - standardISO/IEC 17065:2012 “Conformity assessment.Requirements for bodies certifying products, processes and services”. • In the Russian Federation, the standard GOST RISO/IEC 17065-2012 “Conformity assessment. Requirements for bodies certifying products, processes and services” applies to the same. • This standard is identical to the international standard ISO/IEC 17065:2012. • IDT - is identical to the international standard

  12. 3. FINAS Requirements applied to the accreditation activities • FINAS Decision ON 17.11.2015 (Р1/2015) • Certification bodies • The following requirements are applied to the accreditation of bodies engaged in the certification of management systems: • - standardISO/IEC 17021-1:2015 “Conformity assessment. Requirements for bodies providing audit and certification of management systems. Part 1: Requirements”. • In the Russian Federation, the standard GOST RISO/IEC 17021-1-2017 “Conformity assessment. Requirements for bodies providing audit and certification of management systems. Part 1. Requirements” applies to the same. • This standard is identical to the international standard ISO/IEC 17021-1:2015. • IDT - is identical to the international standard

  13. 3. FINAS Requirements applied to the accreditation activities • FINAS Decision ON 17.11.2015 (Р1/2015) • Certification bodies • The following requirements are applied to the accreditation of bodies engaged in the certification of personnel: • - standardISO/IEC 17024:2012“Conformity assessment. General requirements for bodies operating certification of persons”. • In the Russian Federation, the standard GOST RISO/IEC17024-2017 “Conformity assessment. General requirements for bodies operating certification of persons” applies to the same. • This standard is identical to the international standard ISO/IEC17024:2012. • IDT - is identical to the international standard

  14. 3. FINAS Requirements applied to the accreditation activities • FINAS Decision ON 17.11.2015 (Р1/2015) • Providers of proficiency testing • The following requirements are applied to the accreditation of bodies providing proficiency testing: • - standardISO/IEC 17043:2010“Conformity assessment. General requirements for proficiency testing”. • In the Russian Federation, the standard GOSTISO/IEC 17043-2013“Conformity assessment. General requirements for proficiency testing” applies to the same. • This standard is identical to the international standard ISO/IEC 17043:2010. • IDT - is identical to the international standard

  15. 3. FINAS Requirements applied to the accreditation activities • FINAS Decision ON 17.11.2015 (Р1/2015) • Requirement applied to assessment of competence • The following requirements are applied to assessing the competence: • - standardISO/IEC 17011:2004“Conformity assessment. General requirements for accreditation bodies accrediting conformity assessment bodies”. • In the Russian Federation, the standard GOSTISO/IEC 17011-2009“Conformity assessment. General requirements for accreditation bodies accrediting conformity assessment bodies” applies to the same. • This standard is identical to the international standard ISO/IEC17011:2004. • IDT - is identical to the international standard

  16. 4. FINAS Rules for Reference to Accreditation The national accreditation body, FINAS, is responsible for accreditation in Finland and grants accreditation to applicants determined to be competent. Accredited activities are identified by the accreditation symbol used by the body. Reference to accreditation is recommended always when reporting on activities falling within the scope of accreditation. FINAS has drawn up national rules for reference to accreditation; these are based on the requirements published by the international cooperation bodies such as EA(European cooperation for Accreditation), ILAC (International Laboratory Accreditation Cooperation) and IAF (International Accreditation Forum Inc.) and on the Regulation of the European Parliament and of the Council on environmental verifiers.

  17. 4. FINAS Rules for Reference to Accreditation type of registration number The accreditation symbol of an accredited body consists of the FINAS logo with the body’s registration number centredunder it. These are followed, in parentheses, by the abbreviated name of the standard or another requirement underlying the accreditation. Calibration laboratories KXXX Testing laboratories TXXX Testing laboratories TXXX Inspection bodies IXXX Inspection bodies IXXX

  18. 4. FINAS Rules for Reference to Accreditation • Examples of calibration labels • Calibration labels show the following information: name of the laboratory number of the calibration certificate accreditation symbol date of calibration measuring equipment • The identification data of the measuringequipment and the name of the laboratory are optional. • The date of re-calibration is entered by the client, or if so agreed between the client and the calibration laboratory, by aperson performing the calibration. • The date of re-calibration can be entered after the date of calibration

  19. 5. FINAS multilateral recognition arrangements (MLA, MRA) Agreements with international organisations: European co-operation for Accreditation (EA), International Laboratory Accreditation Cooperation (ILAC), International Accreditation Forum Inc. (IAF)

  20. 6. STUK Requirements applied to the accredited testing organisations Guide YVL-E.12 Testing organisations for mechanical components and structures of a nuclear facilityon 20.05.2014 This Guide sets forth requirements for organizations and personnel performing non-destructive testing (NDT) and for organisationsperforming destructive testing (DT) at nuclear facilities in order to verify the integrity of the components and structures of nuclear facilities in accordance with the requirements of safety classes 1, 2, and 3.

  21. 6. STUK Requirements applied to the accredited testing organisations • General requirements for testing organisations The testing organization shall have a valid accreditation from the FINAS or an equivalent foreign organization pursuant to standard ISO/IEC 17025 or ISO/IEC 17020. An accreditation decision by an organization equivalent to FINAS may be approved if the accreditation in question is covered by the Multilateral Agreements (MLA) or Mutual Recognition Arrangements (MRA) signed by FINAS. In safety classes 1 and 2, an accredited testing organization shall be a third party independent of the parties involved in the activities. In safety class 3, and in safety class 2 whenever justified, an accredited testing organization may be part of the licensee's organization, the organization manufacturing the item tested, or the inspection organization performing the conformity assessment of the item tested, provided that it is a separate part of the organization. Destructive testing of concrete and reinforcement steel may also be performed by a testing organization approved by the Ministry of the Environment. If a testing organisation subcontracts tests, subcontractors shall be approved by STUK.

  22. 6. STUK Requirements applied to accredited testing organisations • Accredited testing organisations • STUK'sapproval for the following organizations: • NDT organizations for pressure equipment, mechanical components, and steel structures in safety classes 1 and 2 • Organizations performing non-destructive testing related to the manufacturing of materials for pressure vessels, internals of main components, piping, valves and pumps in safety classes 1 and 2 in accordance with the component-specific division of group 1 of Annex A • Organisationsperforming indirect visual testing in safety class 3 if the testers have not been qualified under standard ISO 9712 or an equivalent qualification system • Organizations and personnel that perform DT on steel structures and the steel components of composite structures in safety class 2 • NDT testers shall have at least a level 2 qualification under standard ISO 9712 or an equivalent qualification system for the method used in testing.

  23. 7. STUK Requirements appliEDto NON-accredited testing organizations • NON-Accredited testing organizations The requirements for the manufacturers’ own non-accredited NDT organizations are presented in Subsection 4.2, and the requirements for manufacturers’ own non-accredited DT organizations are presented in Subsection 5.2.

More Related