10 Year Anniversary of the CIPM MRAParis, 8 October 2009

How the effectiveness of the International Laboratory Accreditation System depends on the CIPM MRA

ByDaniel PierreILAC Chair

Introduction Summary of Presentation

What is ILAC and the ILAC (Mutual Recognition) Arrangement Brief overview of BIPM/ILAC Cooperation Links between the CIPM MRA and ILAC Arrangement Conclusions and Questions

What is ILAC ?International Laboratory Accreditation Cooperation

Established in 1977 to promote communication among laboratory accreditation bodies of the world

Formalized as a cooperation in 1996 with 44 Accreditation Bodies (ABs) signing a Memorandum of Understanding (MOU)

On 2 November 2000, a mutual recognition arrangement was signed,among those members which had successfully completed a peer evaluation

As at September 2009, there were 65 Signatories (Full Members) to the Arrangement, representing 50 economies

ILAC was incorporated in the Netherlands on 20 January 2003

Approx. 33,000 laboratories & over 6,000 inspection bodies have been accredited by the 65 ILAC Full Member ABs

ILACs Global Role

Principal international forum for:

Recognition of competent test and calibration labs world-wide through its Mutual Recognition Arrangement

Development and appropriate harmonization of laboratory accreditation practice

Promotion of laboratory accreditation as a trade facilitation tool and also to provide socio-economic benefits at national level

Assisting with in the development of laboratory accreditation systems

ILAC Goals Strengthen/deepen the existing ILAC MRA, promote the

use of accredited labs & appropriately link this activity to the CIPM MRA to facilitate inter-governmental trade activity

Continually promote the clear distinction between certification & accreditation to help reduce the confusion in the marketplace

Provide assistance (in Metrology, Accreditation and Standardisation) to developing countries by providing appropriate pre-MRA support to new accreditation systems

Increase cooperation with all relevant stakeholders, i.e. labs, CIPM/BIPM, regulators, industry groups, standard writing bodies and governments

The International Picture

ILAC International Laboratory Accreditation Cooperation

EA European Cooperation for AccreditationAPLAC Asia Pacific Laboratory Accreditation Cooperation

IAAC Inter-American Accreditation CooperationSADCA Southern African Development Community Accreditation

Unaffiliated Bodies Peer evaluated ABs who are not geographically located in one of theestablished regions

ILAC

EA APLAC IAAC

SADCA

Status of ILAC MRA The MRAs of the recognised regions underpin the ILAC Arrangement (MRA)

Currently, the MRAs of 3 of the 4 Regional Cooperation Accreditation Body (RCAB) members in ILAC are recognised by ILAC (EA, APLAC and IAAC)

Recognition of a region is achieved after successful peer evaluation by ILAC (every 4 years)

ILAC relies on the evaluations undertaken by the recognised regions (against requirements based on ISO-IEC 17011 to grant and maintain ILAC signatory status for the ILAC Accreditation Body (AB) members in their respective regions

ILAC itself undertakes the evaluations of the regions, the unaffiliated bodies (those ABs who do not have a region in their geographical area) and those ABs who are part of a developing region, that has not yet obtained recognition (e.g. SADCA)

ILAC draws its peer evaluators from the regions and unaffiliated bodies

ILAC Arrangement for Accreditation Bodies

A laboratory accredited by one partner has equivalent competence to a

Laboratory accredited by the other partner(s) and thus calibration certificates and

test reports from laboratories accredited by an AB which is a signatory to the ILAC

Arrangement is accepted by others.

Note: This is very similar to the mutual acceptance of certificates issued by

National Measurement Institutes (NMIs) which are signatories to the CIPM-MRA.

In both cases, the use of the MRA Marks is promoted so that customers have a

transparent and identifiable link to the strength and benefits of the two interlinking

MRAs.

The Fundamental Purpose -

BIPM and ILAC Cooperation

Our cooperation is undertaken under the following frameworks: BIPM / ILAC MoU signed in 2001 Regular meetings of the BIPM / ILAC working group and other meetings,

teleconferences and frequent email communication

Outputs include: Joint statements (e.g. CMC, role of NMIs and ABs), website links and cross

references in ILAC / BIPM documents (in MRAs texts etc) Harmonised feedback to other international organisations (e.g. ISO,

WADA, IFCC, UNIDO, OIML, WHO etc.)

CIPM/BIPM and ILAC Cooperation

Close cooperation and progress is essential to:

Meet our primary objective of strengthening the links between accreditation (ILAC Arrangement) and metrology (CIPM MRA)

Disseminate metrological traceability from NMIs to accredited laboratories

Provide confidence that laboratory outputs calibration and measurement results - are fit for their intended use

Provide benefits for trade (e.g. minimize technical barriers to trade and unnecessary re-testing thereby save billions of dollars) and other socio-economic issues (e.g. food safety, health, environment)

Regional Metrology Organisations (RMOs) / Regional Cooperations of Accreditation Bodies (RCABs) (meetings and workshops)

BIPM / ILAC / OIML tripartite group BIPM / ILAC working group CITAC and Eurachem CCQM (chemistry) JCRB (RMOs) JCTLM (medicine) JCDCMAS (Developing Countries) JCGM (guides to metrology)

WGMM (Materials Testing) CGPM and ILAC GA ILAC Technical Committee (AIC) and BIPM

joint task groups (JTC-CMC; JTC-RAP) ISO CASCO (Proficiency Testing, laboratory

requirements etc.) ISO REMCO (Reference Materials) Various symposia and workshops

Metrology issues are dealt with by the representatives of both organisations in the following fora:

BIPM and ILAC Cooperation

Accreditation & Peer Review processes - National Measurement Institutes RMOs and NABs perform a lot of activity e.g. onsite assessments, desk top reviews and

verification of supplied data (eg CMCs)

Both organisations are working hard to: Minimise duplication (and costs) for accredited NMIs Make timely and objective decision based on ALL available information Provide the mechanism for increased cooperation / communication between all relevant

parties (e.g. NMIs/Labs/RMOs/RCABs/ABs/ILAC/BIPM)

Produce guidance documents on harmonised assessment process for those NMIs that choose accreditation, taking RMO process appropriately into account

Take into account the results of recent surveys conducted by ILAC and APMP

Attempt to coordinate NAB assessments and other activity with RMO on-site and off-site peer reviews (e.g.. publishing an annual time table)

The MRAs are mutually supportive and together they provide a sound framework for the delivery of traceable and reliable measurements results across the globe

Links between the CIPM-MRA andILAC Arrangement

ILAC-MRA

CIPM-MRA

Traceable measurements, fit for intended use

CIPM-MRA NMIs RMOs

RCABs ORAccreditationBodies

Accredited Labs

ILAC-MRA

Accredited Labs

NMIs

CIPM-MRA/ILAC Arrangement

It is essential that there is good cooperation and understandingbetween the AB and NMI at national level e.g.

Use of assessors/technical experts Scope of accreditation (CMCs) Participation in AB Technical Committees Characterisation of measurement artifacts for measurement audits (PT)

During evaluations of ABs for MRA purposes (against ISO/IEC 17011 and other ILAC documents) this cooperation is fully investigated in terms of the national capability for calibration and measurement services and the mechanism to disseminate this to theusers of measurement results.

Note: If the local NMI is a signatory to the CIPM-MRA, their competence to deliver calibration and measurement services (for a specified scope) is ACCEPTED. If thelocal NMI is not a signatory, further investigations are required and in many casesthis will lead to the NAB and national laboratories having to rely on calibration andmeasurement services from a foreign NMI (signatory).

CIPM-MRA/ILAC ArrangementBoth MRAs are based on similar criteria and toolsFor NMIs and Accredited Laboratories we need to provide confidence in the validity of the calibration and measurementresults produced.

To do this, we use

On-site (peer) assessments (based on general requirements of ISO-IEC 17025 and where appropriate, ISO Guide 34 for the competence of Reference Material Producers) to ascertain technical competence and the effectiveness of supporting management systems

Use Interlaboratory comparisons (Proficiency Testing/Key Comparisons to complement on-site assessment activity to verify laboratory capability for specified calibrations and measurements

In all cases, a focus on metrological issues (e.g. traceability, measurement uncertainty) is essential so that the links from NMIs to field laboratories are strong.This is important for all technical areas, not just traditional calibration activity

Note: Much progress has been made in relation to metrology in chemical and microbiological fields which cover the majority of the millions of measurements conducted each day (e.g. clinical chemistry, bioassays, greenhouse gases).

CIPM-MRA/ILAC ArrangementTangible Benefits(These will be presented by other speakers later)

ILAC Surveys and Input from members Good News stories on ILAC website

CIPM Surveys and Input from members Good News stories on CIPM website

But we still have more work to do, particularly in promoting benefits of both MRAs to regulators and gaining acceptance by all parties.

Conclusions

The CIPM-MRA and ILAC Arrangement are mutually supportive and provide tangiblebenefits for the welfare of the planet and its citizens (with the former providing the anchor and the latter the chain).

The close cooperation that exists between ILAC and CIPM BIPM has already produced some very positive and tangible results for the benefit for both memberships and their related stakeholders

ILAC appreciates the opportunities for open and frank exchanges that focus on the issues that confront both organisations in promoting the need for, and usefulness of their respective recognition agreements and arrangements.

On behalf of all ILAC members, I would like to congratulate the CIPM on this 10thAnniversary of the CIPM-MRA and look forward to some celebrations for the ILAC Arrangements 10th Anniversary next year!

Any Questions please?

10 Year Anniversary of the CIPM MRAParis, 8 October 2009How the effectiveness of the International Laboratory AccreditationIntroduction Summary of PresentationWhat is ILAC ?International Laboratory Accreditation CooperationILACs Global RoleILAC GoalsThe International PictureStatus of ILAC MRAILAC Arrangement for Accreditation BodiesBIPM and ILAC CooperationCIPM/BIPM and ILAC CooperationBIPM and ILAC CooperationAccreditation & Peer Review processes - National Measurement InstitutesLinks between the CIPM-MRA andILAC ArrangementCIPM-MRA/ILAC ArrangementCIPM-MRA/ILAC ArrangementBoth MRAs are based on similar criteria and toolsCIPM-MRA/ILAC ArrangementTangible Benefits(These will be presented by other speakers later)Conclusions