Accreditation according to ISO/IEC 17025 in Europe Historic EA Europeing Accreditation Assessment Experience from Technical assessment 1
In year 1803 the foots in Europe had a big differences, depending not only in which country, also every town had its own size of the foot. The biggest was in Roma, 551 mm, and the smallest in Florence, 221 mm. 2
The relation between a cubicfoot in Florence and Roma
• The first step to solve this problem was taken in 1875 when BIPM and the Convention of the Meter was established. • However it took until 1989 before we got the first international standard for calibration laboratories (ISO 45001 which later was replaced by ISO 17025). • DID THIS HAVE ANY EFFECT??
Intercomparison between national laboratories in Europe 1995 k-factor for screw meter - different calibration conditions 16.805
Plo t S-A,B,C ,D ,E,F,G,H,I,J,K
16.800 16.795 16.790 ± 0 .1 %
16.785 A (19.5°C, 2.16 cSt) B (20.0°C, 2.13 cSt) C (19.9°C, 2.1 4cSt) D (24.9°C, 1.9 3cSt) E (15.3°C, 2.34cSt) F (23.3°C, 2,0 cSt)
G (14.8°C, 1.4 cSt) H (19.8°C, 1.3 1 cSt) I (25.1°C, 1.12 cSt) J (20.3°C, 2.12 cSt) K (20.0°C, 2.13cSt)
flow rate [l/min] 6
In the regulation 765/2008 the EU parliament decided that all EU countries...
•must have a Board of Accreditation which have to follow the standard ISO 17011. •must be a member of EA and follow their requirements. 7
The European co-operation for Accreditation Serving the European Economy and Society
Contents What is EA? EA organizational structure MLA Signatories Standards for Accreditation The Development of European Accreditation EA in the global network
Purpose of EA (1) • The European co-operation for Accreditation (EA) is the Association of the national accreditation bodies that provide accreditation for the following conformity assessment activities: – – – – – – –
Calibration Testing Inspection Certification of quality, environmental management systems Certification of products Certification of persons EMAS verifiers
Purpose of EA (2) • Provide Europe with an effective, reliable accreditation infrastructure • Develop accreditation criteria and guidelines supporting harmonisation of practices • Operate a sound, robust, reliable peer evaluation process • Ensure equivalence of accreditation and equal reliability of accredited results • Cooperate with the European Commission and other European, international stakeholders
The European co-operation for Accreditation (1) • A not-for-profit association registered in the Netherlands in June 2000. • 33 Full Members representing 33 European economies • 19 Contracts of Cooperation signed with non EU / EFTA AB’s (6 ABs covered by the ENP, 5 ABs located in Europe, Russia and 7 ABs located outside Europe) • Out of these contracts, 9 have turned into a bilateral agreement with EA.
EA & MLA Members April 2011 Calibration ; testing ; products, management systems certification and persons certification ; inspection Calibration ; testing ; products and management systems certification; inspection
Calibration; testing; products and management systems certification
Products, Persons and management system certification, Inspection
Testing ; products, management systems certification ; inspection Testing
Full members non signatories Contracts of Cooperation (European countries)
New Legislative Framework ‐ result of a review of New Approach European Commission initiated a review of the “New Approach” in 2003 Main aims: – Improve Member States’ market surveillance practice – More distinct requirements on Notified bodies – More distinct responsibilities for importers and distributers – Strengthen role of accreditation – Recognition of European Cooperation for Accreditation, EA 2nd of February 2012
Technical barriers to trade - EU Tools
Global Vision •
A single worldwide programme of conformity assessment which reduces risk for business, regulators and the consumer, by ensuring that accredited services can be relied upon.
Government and Regulators relying on the IAF and ILAC Arrangements to further develop or enhance trade agreements.
To support the freedom of world trade by eliminating technical barriers, realising the free‐trade goal of ‘tested, inspected or certified once and accepted everywhere' .
Coverage of the ILAC MRA
ILAC MRA Signatories ILAC Associate Members ILAC Affiliate Members
INTERNATIONAL KEY COMPARISON OF LIQUID HYDROCARBON FLOW FACILITIES CCM‐FF‐K2 Draft A REPORT NO: 2008/18
PROJECT NO: FFIN56
DATE: 5 February 2008
Force 1 CMS NMIJ NEL 1 NMi Force 2 SP NEL 2
Assessment The assessment consist of 2 parts •Assessment of the quality system. This is made by the national board of accreditation. •Technical assessment. This is made by an assessor with technical experience. The technical assessor is checking methods of calibration, inspect the calibration rigs and measuring equipment, examine the uncertainty budget and intercomparison results.
Assessment of the competence of the staff who is performing calibration • This is made by interviewing operators of testrigs and technical leaders. • Sometimes also written examination are in use. • Finally one or two of the operators are witnessed by the assessor during a calibration. This can be made together with an intercomparison 19
In ISO 17011, documented test‐ and calibration intercomparisons are required, as evidence for accreditation. • The accredistion body also shall check that the accredited lab regurlary takes part in intercomparisons, when such are avaliable. • No choice! 20
www.intercomparison.org • Interlaboratory comparisons (ILC) or proficiency testing (PT) are common means of determining the testing performance of a laboratory. Proficiency testing is used by accreditation bodies to assess the technical competence of a laboratory and also by companies to ascertain the quality of measurement equipment and performance. • CFI, Centre for Intercomparison, covers a wide range of measurement quantities, such as: • Electrical ‐ Flow ‐ Force ‐ Length ‐ Mass ‐ Optical – • Pressure ‐ Temperature ‐ Torque ‐ Vacuum ‐ Volume 21
Youdenplot for spread analysis
sa: spread in meter sb: spread from meter including test equipment Spread in test equipment: sb- sa
En ≤ +/-1 approved En >+/- 1 not approved
The common way of assessment
My way of assessment
Some example of non comformaty which often are repeated • • • •
Flowrate stability Puls collection Pipework Temperature stability
Schematic drawing of test rig
Thank you for listening • [email protected]
• [email protected]
Works as technical assessor for the National Board of Accreditation in Sweden, Norway, Ireland, Slovenia and United Kingdom.