SP2.pdf

MOSTI

SKIM AKREDITASI MAKMAL MALAYSIA (SAMM) LABORATORY ACCREDITATION SCHEME OF MALAYSIA

SAMM POLICY 2 (SP2) – POLICY ON TRACEABILITY OF MEASUREMENT

RESULTS Issue 3, 30 January 2008

MS ISO/IEC 17025

JABATAN STANDARD MALAYSIA Department of Standards Malaysia

TABLE OF CONTENTS Section Page

1 Introduction 1

2 Purpose 1

3 Scope of application 1

4 References 1

5 Definitions 2

6 STANDARDS MALAYSIA policy on traceability of

measurement results 2

7 Measurement traceability situations in testing laboratories 3

8 Summary on general policy 5

Annex 1: Information on the National Metrology Institute in

Malaysia 6

Policy on Traceability of Measurement Results

SAMM Policy 2, Issue 3, 30 January 2008 Page 1 of 6

1 INTRODUCTION 1.1 The Department of Standards Malaysia (STANDARDS MALAYSIA) is a signatory to

Asia Pacific Laboratory Accreditation Cooperation (APLAC) and International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). To ensure confidence between APLAC and ILAC members, it is considered necessary to have appropriate harmony between key practices and policies of the accreditation bodies. Traceability of measurement results is a fundamental topic for development of a harmonised policy.

1.2 The criteria on traceability which laboratories have to meet are laid down in clause 5.6

of (MS ISO/IEC 17025:2005) – General requirements for the competence of testing and calibration laboratories.

2 PURPOSE This document details the general policy of the STANDARDS MALAYSIA with regard

to the acceptance of traceability of measurement results. 3 SCOPE OF APPLICATION This document is to provide a STANDARDS MALAYSIA policy on traceability of

measurement results which is to be implemented by SAMM applicant/accredited laboratories.

4 REFERENCES 4.1 MS ISO/IEC 17025:2005 “General requirements for the competence of testing and

calibration laboratories”. 4.2 ILAC-P10:2002 “ILAC Policy on Traceability of Measurement Results”. 4.3 ISO 10012:2003 Measurement management systems – Requirements for

measurement processes and measuring equipment. 4.4 VIM - 1993 “International Vocabulary of Basic and General Terms in Metrology”. 4.5 Guide to the Expression of Uncertainty in Measurement – BIPM, IEC, IFCC, ISO,

IUPAC, IUPAP, OIML (corrected and reprinted, 1995). 4.6 EURACHEM/CITAC Guide 2003 – Traceability in chemical measurement. 4.7 CIPM MRA – Mutual Recognition of national measurement standards and of

calibration and measurement certificate issued by national metrology institutes (14 October 1999)



5 DEFINITIONS 5.1 The formal definition of traceability is given in the International Vocabulary of Basic and General Terms in Metrology (VIM- 1993) as: ”6.10 traceability: property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties. 5.2 Traceability is characterised by:

(a) an unbroken chain of comparisons; going back to stated references acceptable to the parties, usually a national or international standard; (b) uncertainty of measurement; the uncertainty of measurement for each step in the traceability chain must be calculated or estimated according to agreed methods and must be stated so that an overall uncertainty for the whole chain may be calculated or estimated; (c) documentation; each step in the chain must be performed according to documented and generally acknowledged procedures, the results must be recorded; (d) competence; the laboratories or bodies performing one or more steps in the chain must supply evidence for their technical competence (e.g. by demonstrating that they are accredited); (e) reference to SI units; the chain of comparisons must, where possible, end at primary standards for the realization of the SI units; (f) calibration intervals; calibrations must be repeated at appropriate intervals; the length of these intervals will depend on a number of variables (e.g. uncertainty required, frequency of use, way of use, stability of the equipment).

6 STANDARDS MALAYSIA POLICY ON TRACEABILITY OF MEASUREMENT

RESULTS 6.1 Laboratories accredited by STANDARDS MALAYSIA shall be able to demonstrate

that calibration of critical equipment, and hence the measurement results generated by that equipment, relevant to their scopes of accreditation, are traceable to the International System of Units (SI units) (See Note 1).

Note 1: “Critical” equipment used by testing and calibration laboratories is considered by

STANDARDS MALAYSIA to be those items of equipment necessary to perform an accredited test or calibration and which have a significant effect on the measurement uncertainty of test or calibration results. STANDARDS MALAYSIA when necessary shall issue further guidelines to differentiate between calibrations that are critical and less critical and to indicate how in the latter case the traceability requirements may be less rigorous.

6.2 Where such traceability is not technically possible or reasonable, the laboratory and

the customer and other interested parties may agree to using certified reference materials provided by a competent supplier or using specified methods and/or consensus standards that are clearly described and agreed by all parties concerned; (See Note 2).



Note 2: It is recognised that, due to the nature of some tests, it is not possible, realistic or

relevant to expect traceability of measurement results to be demonstrated. Under such circumstances laboratories shall consult STANDARDS MALAYSIA for the resolution of measurement traceability issue(s).

6.3 Calibration laboratories, for equipment and calibrations relevant to their scopes of accreditation, shall in all cases, where possible, derive their traceability either:

• directly from an appropriate national metrology institute (see Note 3) , or • from a calibration laboratory that can demonstrate competence, measurement

capability and traceability with appropriate measurement uncertainty, e.g. an accredited calibration laboratory.

Note 3: STANDARDS MALAYSIA considers an “appropriate” national metrology institute to be one that participates regularly and successfully in relevant international interlaboratory comparisons performed by BIPM and/or by regional metrology bodies (such as APMP, COOMET, EUROMET, SADCMET and SIM). The national metrology institute may be the one in Malaysia or another country. Further the national metrology institute shall be a member of the CIPM MRA.

6.4 Where the concept of traceability is relevant and technically possible, testing

laboratories shall be required by STANDARDS MALAYSIA to ensure the traceability of their in-house calibration and/or accredited test results to:

a) an external calibration provider that is accredited for suitably small uncertainties or

that can otherwise demonstrate its competence, or b) a national metrology institute or national reference laboratory, or c) a certified reference material or consensus standard or agreed method.

6.5 Laboratories holding only quality management systems certification will be deemed to

have not demonstrated the necessary technical competence. 7 MEASUREMENT TRACEABILITY SITUATIONS IN TESTING LABORATORIES 7.1 Presently testing laboratories obtain calibration services from various sources which can be represented by 6 situations described below:- Note: Not all of these situations are acceptable under SAMM. Situation 1 The laboratory does not have its own calibration capability. All its measuring instruments are calibrated by an appropriate national metrology

institute that is a signatory to the CIPM MRA. . Situation 2 The laboratory does not have its own calibration capability. All its measuring instruments are calibrated by a calibration laboratory accredit under

SAMM or other Mutual Recognition Arrangement (MRA) partners.



Situation 3

The laboratory operates an accredited calibration facility that fully supports its accredited testing work. Situation 4 The laboratory operates an in-house calibration facility that fully supports its accredited testing work.

Situation 5 The laboratory does not have its own calibration capability and has its measuring

instruments calibrated by a local or foreign service company or manufacturer that does not operate a formalised quality system but possesses calibration standards that the service company claims or may claim to have been calibrated by an appropriate national metrology institute.

Situation 6 The laboratory does not have its own calibration capability and has its measurement

instruments calibrated by a service company whose calibration standards have no known history of calibration or traceability.

7.2 SAMM POLICY ON ACCEPTABILITY OF THE ABOVE SITUATIONS

(a) Situations 1, 2 and 3 fully meet SAMM requirements. However in Situation 2, SAMM assessors would have to examine carefully the calibration certificates issued by the accredited calibration laboratory.

(b) Situation 4, is acceptable provided all in-house calibrations shall be supported by

the following minimal set of elements: i. The in-house laboratory shall maintain documented procedures for the

in-house calibrations and the in-house calibrations shall be evidenced by a calibration report, certificate, or sticker, or other suitable method, and calibration records shall be retained for an appropriate, prescribe time;

ii. The in-house laboratory shall maintain training records for calibration personnel and these records shall demonstrate the technical competence of the personnel performing the calibrations: evidence of the competence includes, for example, documented training and the results of the measurement audits;

iii. The in-house laboratory shall be able to demonstrate traceability to national or international standards of measurement by procuring calibration services from the accredited calibration labs or national metrology institute;

iv. The in-house laboratory shall have and apply procedures for evaluating measurement uncertainty, Measurement uncertainty shall be calculated for each type of calibration and records of these calculations shall be maintained. Measurement of uncertainty shall be taken into account when statements of compliance with specifications are made;

v. Reference standards shall be recalibrated at appropriate intervals to ensure that the reference value is reliable. Policy and procedures for



establishing and changing calibration intervals shall be based on the historical behaviour of the reference standard.

(c) Situation 5, generally it is not acceptable. There is doubt on the competency of

staff, lack of information on adequacy of calibration procedures, staff training and their technical competence, equipment assurance, validity of calibration status of equipment, etc. However, if in doubt refer to STANDARDS MALAYSIA (See note 2.)

(d) Situation 6 is NOT accepted under the SAMM system as a matter of principle.

In situation 6, there is no formal assurance that the conditions in Clause 5.6 of

MS ISO/IEC 17025:2005, (namely that measurements are traceable to national standards or international standards of measurement through an unbroken chain of calibrations), are met.

8 SUMMARY ON GENERAL POLICY 8.1 If traceability is to achieve its purpose, not only must an unbroken chain of calibration

exist, but every calibration in the traceability chain must be carried out in a technically sound manner: the staff, equipment, environment and procedures, involved in the calibration must be adequate for the task involved. Therefore the best way to ensure the fulfilment of this requirement is to obtain calibration services from SAMM accredited laboratories or in special cases directly from an appropriate national metrology institute. (For information on the national metrology institute in Malaysia, see Annex 1).



Annex 1 Information on the national metrology institute in Malaysia The National Metrology Laboratory in SIRIM Berhad performs the functions of the

national metrology institute in Malaysia. It is responsible for the realisation, establishment and maintenance of the Malaysian national standards of measurement based on the SI units.

In September 2001, Malaysia became a signatory of the Metre Convention. This was

followed by the signing of the CIPM Global MRA in October 2001 by SIRIM Berhad. Further information on the National Metrology Laboratory and the national metrology

capabilities may be obtainable directly from: National Metrology Laboratory SIRIM Berhad Lot PT 4803 Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan Malaysia. Tel : +60-3-8778 1600 Fax : +60-3-8778 1616 Website : http://www.sirim.my

http://www.sirim.my/

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