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Role of Metrology in Conformity Assessment

Andy Henson Director of International Liaison and Communications of the BIPM Metrology, the science of … and its applications “When you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind”

William Thompson (Lord ): Lecture on "Electrical Units of Measurement" (3 May 1883)

Conformity assessment

Overall umbrella of measures taken by : ‐manufacturers ‐customers ‐regulatory authorities ‐independent third parties To assess that a product/service meets standards or technical regulations

2 Metrology is a part of our lives from birth

Best regulation Safe food

Technical evidence Safe treatment

Safe baby food Manufacturing

Safe traveling

Globalization weighing of baby Healthcare Innovation Climate change Without metrology, you can’t discover, design, build, test, manufacture, maintain, prove, buy or operate anything safely and reliably. From filling your car with petrol to having an X‐ray at a hospital, your life is surrounded by . In industry, from the thread of a nut and bolt and the precision machined parts on engines down to tiny structures on micro and nano components, all require an accurate measurement that is recognized around the world. Good measurement allows country to remain competitive, trade throughout the world and improve quality of life. www.bipm.org 3 Metrology, the science of measurement

As we have seen, measurement science is not purely the preserve of scientists. It is something of vital importance to us all. The intricate but invisible network of services, suppliers and communications upon which we are all dependent rely on metrology for their efficient and reliable operation.

Metrology is often divided into three subfields: Scientific or fundamental metrology Applied or industrial metrology Legal metrology

The BIPM, established in 1875 by the Convention (a diplomatic The OIML, established in 1955, is an intergovernmental organization treaty between 56 nations), ensures worldwide uniformity of whose principal aim is to harmonize the regulations and metrological measurements and their traceability to the International System of Units controls applied by the national metrology services of its national (SI). members. www.bipm.org www.oiml.org

www.bipm.org 4 Scientific or fundamental metrology

Scientific or fundamental metrology concerns the establishment of measurement units, unit systems, the development of new measurement methods, realization of measurement units and the transfer of metrological traceability from these standards to users in society. Base units Consultative Committees Comparisons CCAUV CCEM CCL CCM CCPR CCQM CCRI CCT CCTF

There are also many derived units! & Measurement Capabilities in See the SI brochure for recommended units. the KCDB

www.bipm.org 5 2014 AFRIMETS Legal MetrologyA traceability School chain for measurements of increasing

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Slide courtesy Dr S Davidson, NPL, UK 6 Applied or industrial metrology

Applied or industrial metrology concerns the application of measurement science to manufacturing and other processes and their use in society, ensuring the suitability of measurement instruments, their calibration and quality control of measurements.

Science Innovation Advanced manufacturing & process industries Complex service industries

Quality and Competition Trade Economic well being National well being www.bipm.org 7 Legal metrology

Legal metrology concerns regulatory requirements of measurements and measuring instruments for the protection of health, public safety, the environment, enabling taxation, protection of consumers and fair trade.

Science Health Safety Environment

Legislation and Regulation Security & Trade Social well being National well being www.bipm.org 8 Worldwide recognized competence through equivalent technical infrastructure

RCABs RMOs RLMOs (RSBs) Tools that deliver common understanding and application of metrology worldwide ISO/IEC 17025 ISO/IEC 17011 NMI ISO Guide 34 NAB NSB ILAC‐CIPM document on accreditation of NMIS ISO standards JCGM: International organizations working together, creating an ‐BIPM international Agreements on mutual recognition in their own ‐ILAC Accredited ISO/IEC 17025 VIM ‐ISO fields,calibration linked together to create the technicalISO infrastructurestandards that ISO Guide 34 ‐IFCC underpinsand conformityILAC P10; assessmentP14 documents… consider that GUM testing laboratories ‐IUPAC ISO/IEC 17025 ‐IUPAP Calibration and testing ‐OIML laboratories ISO 9001, etc… ISO 14000 Sectors of economy ISO 22000 etc… Measurement instruments www.bipm.org 9 Importance of metrology in context of trade

WTO –TBT Agreement, Article 6: Recognition of Conformity Assessment by Central Government Bodies – Article 6.1.1: “adequate and enduring technical competence of the relevant conformity assessment bodies in the exporting Member, so that confidence in the continued reliability of their conformity assessment results can exist; in this regard, verified compliance, for instance through accreditation, with relevant guides or recommendations issued by international standardizing bodies shall be taken into account as an indication of adequate technical competence;” By calling on the use of international standards & accreditation, regulators automatically tap into the underpinning metrology base. As ISO standards and ILAC policy ensures linkage to the International System of Units. However adequate metrology infrastructure and adequate engagement with the international organizations is needed for the system to work effectively.

10 Joint BIPM, OIML, ILAC and ISO declaration on measurement traceability

The BIPM, OIML, ILAC, and ISO endorse the following recommendations: • in order to be able to rely on their international acceptability, should be performed • in National Metrology Institutes who should normally be signatories to the CIPM MRA and have CMCs published in the relevant areas of the KCDB or • in laboratories accredited by accreditation bodies which are signatories to the ILAC Arrangement; • should follow the principles established in the GUM; • the results of the measurements made in accredited laboratories should be traceable to the SI; • NMIs providing traceability for accredited laboratories should normally be signatories to the CIPM MRA and have CMCs published in the relevant areas of the KCDB; • within the OIML’s MAA, accreditation should be provided by bodies which are signatories to the ILAC Arrangement and the above policies on traceability to the SI should be followed; The above principles should be used whenever there is a need to demonstrate metrological traceability for international acceptability. www.bipm.org 11 Joint BIPM, OIML, ILAC and ISO declaration on measurement traceability

Use of this Declaration These principles underpin a world measurement system which provides a robust, internationally accepted framework within which users can have confidence in the validity and acceptability of measurements results. BIPM, OIML, ILAC and ISO strongly urge legislators and regulators to refer to the Arrangements described earlier in this Declaration and also to accept measurement results made within this system, thereby helping avoid technical barriers to trade. We also invite interested parties to endorse these principles and to make use of them in their own work.

www.bipm.org 12 Uncertainty information in compliance assessment

In order to utilise a result to decide whether it indicates compliance or non‐compliance with a specification, it is necessary to take into account the measurement uncertainty.

See also OIML (draft) "The role of measurement uncertainty in conformity assessment decisions in legal metrology" and

JCGM Guide JCGM 106: 2012 “Evaluation of measurement data –The role of measurement uncertainty in conformity assessment”

Figure courtesy www.bipm.org EURACHEM/CITAC 13 Guide Uncertainty information in compliance assessment

Figure courtesy www.bipm.orgEURACHEM/CITAC Guide 14 Uncertainty information in compliance assessment

Figure courtesy www.bipm.orgEURACHEM/CITAC Guide 15 Uncertainty information

Regulatory requirements

Legally controlled Regulated measurements Unregulated measurements measurement instruments (customer quality/price expectations/specifications) Performance requirements Dedicated Dedicated Options to achieve measurement for measurement instruments application

Measurement Measurement Knowledge uncertainty uncertainty partly of measurement uncertainty “bespoke” “bespoke” “built in” Increasingly easy to innovate www.bipm.org 16 2014 AFRIMETS Legal Metrology School

Concepts of measurement (in the context of legal metrology)

Metre convention CIPM MRA Comparisons CMCs calibration verification NMI Measuring

Verification requires an application based

specification ‐ MPE Trade

calibration verification NMI Measuring CIPM MRA Comparisons CMCs “Traceability” ‐ the property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty 17 The objectives of Metrology

Metrology is the “science and practice of measurement”, its objectives are Measurements that are stable Long‐term trends can be used for decision making Measurements that are comparable Results from different laboratories can be brought together Measurements that are coherent Results for different compounds and from different methods can be brought together

To meet the evolving needs of the economy, society and citizens

www.bipm.org 18 The CIPM MRA –an international tool providing evidence of SI traceable measurements

From the text: “…thereby to provide governments and other parties with a secure technical foundation for wider agreements related to international trade, commerce and regulatory affairs.”

19 The CIPM Mutual Recognition Arrangement

Metrology is a key part of the global “quality infrastructure” that underpins world trade.

The work of the NMIs is made visible and transparent through the CIPM MRA signed in 1999.

TheaimoftheCIPMMRAistoprovide the technical basis for the worldwide acceptance of national measurement standards and calibration and measurement certificates from NMIs.

The work of the CIPM MRA now goes far beyond matters of trade to cover climate change, healthcare etc.

20 CIPM MRA

The objectives of the CIPM MRA are stated as: to establish the degree of equivalence of national measurement standards maintained by NMIs to provide for the mutual recognition of calibration and measurement certificates issued by NMIs thereby to provide governments and other parties with a secure technical foundation for wider agreements related to international trade, commerce and regulatory affairs

The objectives of the CIPM MRA are to be achieved through: International comparisons of measurements (technical evidence of competence) Peer reviewed Quality systems Peer reviewed calibrations & measurement capabilities (CMCs)

21 CIPM MRA: Outcome

TheoutcomeoftheCIPMMRAprocessesarestatementsofthe internationally recognized calibration and measurement capabilities (CMCs) of each NMI published in the database maintained by the BIPM and publicly available online.

http://kcdb.bipm.org/

22 CIPM MRA Participation

TheCIPMMRAhasbeensignedbytherepresentativesof96 institutes –from53 Member States, 39 Associates of the CGPM,and4 international organizations –andcoversafurther152 institutes designated by the signatory bodies.

Member participating in the CIPM MRA Associate participating in the CIPM MRA www.bipm.org Members/Associates not yet signed the CIPM MRA 23 Thank you.

[email protected]

www.bipm.org