MOSTI

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

SAMM POLICY 1 (SP1) TERMS AND CONDITIONS GOVERNING THE LABORATORY ACCREDITATION SCHEME OF MALAYSIA
Issue 3, 28 February 2007

MS ISO/IEC 17025

JABATAN STANDARD MALAYSIA Department of Standards Malaysia

TABLE OF CONTENTS
1 2 3 Introduction and scope Definition Authority for the granting of SAMM accreditation Page 1 1

3.1 3.2

General Criteria of competence, procedure and amendment of conditions Processing and granting of accreditation Monitoring, Surveillance and Reassessment of Accredited Laboratory Suspension, withdrawal of accreditation and appeal Inoperative accreditation Confidentiality

2 3

3.3 3.4 3.5 3.6 3.7 4

3 4 4 5 5

Obligations of the calibration/testing laboratories

4.1 4.2 4.3 4.4 4.5 4.6 5

General Impartiality, independence and integrity SAMM endorsed test reports and calibration certificates Cooperation with STANDARDS MALAYSIA Liabilities Notification of change

6 6 7 8 8 9 10

Miscellaneous

Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia

1
1.1

Introduction and scope

The Terms and Conditions Governing SAMM (hereinafter referred to as "SAMM Conditions" in short) are applicable to accredited calibration / testing laboratories and are also to be met by laboratories applying to SAMM for accreditation. These regulations should be read in conjunction with the following document(s): i) ii) iii) MS ISO/IEC 17025 General Requirements for the Competence of Calibration and Testing Laboratories; or MS ISO 15189 - Medical Laboratories Particulars and Requirements for Quality and Competence; and Other additional rules or specific requirements that may be issued / endorsed as SAMM requirements relating to specific testing, measurement and quality assurance activities in calibration / testing laboratories.

1.2

2
2.1

Definition
For the purpose of this document as define in MS ISO/IEC 17025 & MS ISO 15189, the following definitions shall apply: (a) Accreditation criteria: A set of requirements which a calibration / testing laboratory must meet for it to be accredited under SAMM. (b) Accredited laboratory: A calibration / testing laboratory to which SAMM accreditation certificate has been granted. (c) Approved signatory: A person recognised under the SAMM system to sign SAMM endorsed calibration certificates or test reports issued by an accredited laboratory for specific activities and to whom Department of Standards Malaysia (STANDARDS MALAYSIA) has given approval for signing endorsed report for certificate for such activities. (d) Key personnel Laboratory staff who perform the scientific and technical work of the laboratory. Approvals for providing interpretations and signing SAMM endorsed reports will be granted to those personnel who are found to fulfill the relevant requirements. (e) Department of Standards Malaysia : A governmental accreditation body established under the Standards of Malaysia Act 1996 (Act 549). (f) Certificate of accreditation: A certificate issued by the Director General of STANDARDS MALAYSIA under Section 16, Part V of Act 549 to a calibration / testing laboratory attesting that the laboratory is recognized as competent to perform specific calibrations / tests or types of measurements / tests under the SAMM system.

(g) Inoperative accreditation: Accreditation status held in abeyance until remedial action has been taken. While accreditation is held inoperative, no SAMM endorsed calibration certificates / test reports shall be issued. (h) Withdrawal: Withdrawal requested in writing by an accredited organisation.

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Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia (i) Suspension: Accreditation held in abeyance by STANDARDS MALAYSIA. This term applies to all or part of the activities under the scope of accreditation of an accredited organisation. No endorsed reports or certificates may be issued by an accredited organisation for the activities which are in the state of suspension, termination, voluntary suspension or voluntary termination. Revocation: Withdrawal of accreditation of STANDARDS MALAYSIA.

(j)

(k) Laboratory accreditation: A formal recognition that a calibration / testing laboratory is competent to carry out specific calibration / tests or specific types of calibration / tests. (l) Schedule of accreditation: A schedule issued with a Certificate of Accreditation listing those accredited scopes of calibration, tests and/or measurements that STANDARDS MALAYSIA recognizes a calibration / testing laboratory is competent to perform.

(m) SAMM endorsed calibration certificate or test report: A calibration certificate or test report that includes a SAMM symbol / mark or a statement that a calibration / testing laboratory is accredited for the calibration / test reported and that the calibration, measurement or test has been performed in accordance with SAMM requirements and conditions. (n) Calibration certificate/report: A document that presents the calibration or measurement results and other information relevant to the calibration or measurement. (o) Test report / certificate: A document that presents the test or measurement results and other information relevant to the test or measurement. (p) Laboratory: A body or organisation that calibrates and/or tests. (q) SAMM (Skim Akreditasi Makmal Malaysia): The Laboratory Accreditation Scheme of Malaysia is a national unified laboratory accreditation scheme and administered by STANDARDS MALAYSIA. For any other terms not listed above, the relevant definitions in ISO/IEC 17000:2004 and the International Vocabulary of Basic and General Terms in Metrology apply.

3
3.1

Authority for the granting of SAMM accreditation

General Under Skim Akreditasi Makmal Malaysia (SAMM), the Director General of STANDARDS MALAYSIA is responsible for all policies and decisions affecting the accreditation of calibration / testing laboratories, including the granting, maintenance, renewal, extension, reduction, suspension or withdrawal of accreditation. The granting, maintenance and renewal of accreditation will be afforded only to a calibration / testing laboratory which:a) b) c) d) is legally identifiable, complies with these conditions and the relevant SAMM accreditation criteria, pays such fees as are due to STANDARDS MALAYSIA, gives such undertakings as STANDARDS MALAYSIA may require.

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Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia 3.2 Criteria of competence, procedure and amendment of conditions a) STANDARDS MALAYSIA shall have the right to prescribe the relevant criteria of competence against which a calibration / testing laboratory shall be assessed. b) The accreditation standard set out in document MS ISO/IEC 17025 General Requirements for the Competence of Calibration and Testing Laboratories or MS ISO 15189 Medical Laboratories Particular and Requirements for Quality and Competence, will be taken as the basis for assessing the competence of a calibration / testing laboratory, and additional criteria prescribed at the discretion of STANDARDS MALAYSIA. c) STANDARDS MALAYSIA will specify the procedures by which application for accreditation should be made, the conditions for granting, maintenance, extension, reduction and renewal of accreditation, and the conditions under which SAMM accreditation may be refused, reduced, suspended, withdrawn or reinstated. d) STANDARDS MALAYSIA reserves the right to amend, alter, add or delete any part of these regulations if in the opinion of STANDARDS MALAYSIA such alterations, amendments, additions are reasonable and necessary to maintain the credibility or smooth operation of SAMM. e) In the event of such alterations, reasonable time shall be given to laboratories to carry out the necessary adjustments to their procedures in order to comply with the altered terms and conditions. Unless otherwise specified, a period of six (6) months from the date of notification of change by STANDARDS MALAYSIA will be given for testing / calibration laboratories to carry out the necessary adjustments to their procedures. The accredited laboratory shall notify STANDARDS MALAYSIA when such adjustments have been completed. 3.3 Processing and granting of accreditation a) An application for accreditation shall be valid for two (2) years from the date of receipt of application and shall lapse at the end of the two-year period if accreditation has not been successful. STANDARDS MALAYSIA reserves the right to extend this period, as it deems appropriate. b) STANDARDS MALAYSIA will assess the applicant laboratory by performing: (i) (ii) Adequacy audit a review of its quality manual and associated documents Pre-assessment a preliminary assessment of the laboratorys quality system and operation to determine its readiness for the compliance assessment Compliance an assessment to establish whether a laboratory can competently perform the calibration/test for which it seeks accreditation

(iii)

c) STANDARDS MALAYSIA will only consider the granting of accreditation upon satisfactory discharge of all non-compliances raised during the assessments d) STANDARDS MALAYSIA will grant a SAMM Certificate of Accreditation and a Schedule of Accredited Calibrations or Tests to a laboratory after it is satisfied that the laboratory complies with these conditions and all the SAMM criteria. e) The Certificate of Accreditation shall be valid for three years from the date of approval by the Director General of STANDARDS MALAYSIA. Thereafter the

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Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia certificate is renewable at every three-year interval subject to the requirements of these conditions. f) The Certificate of Accreditation shall not be transferable.

g) Subject to such limitations as laid down in these conditions, changes to the certificate of accreditation such as; (i) (ii) (iii) (iv) (v) change of name of a laboratory or its organisation structure; change in its legal status; change of address or premises; change(s) in approved signatories of test/calibration reports or key personnel; or other editorial changes.

may be considered by STANDARDS MALAYSIA if in the opinion of STANDARDS MALAYSIA or its authorized representatives, these changes do not constitute significant changes to the laboratory quality system or do not affect its technical competence. STANDARDS MALAYSIA reserves the right to conduct an assessment or other forms of evaluation to confirm its continued compliance with the SAMM accreditation criteria. h) All accredited laboratory will be listed in a directory of accredited laboratories or other suitable publications or records, published or maintained by the STANDARDS MALAYSIA.

3.4

Monitoring, surveillance and re-assessment of accredited laboratory a) STANDARDS MALAYSIA will indicate, as it deems fit, how monitoring of compliance with these conditions and the relevant SAMM accreditation criteria will be carried out. b) STANDARDS MALAYSIA will schedule assessments of the accredited laboratories according to the following table: Surveillance 1 Surveillance 2 Reassessment Approximately 9 months from date of granting/renewal Approximately 12 months from date of surveillance Approximately 3 months before date of expiry

Laboratories are strongly advised to adhere to the assessment schedule as fixed by STANDARDS MALAYSIA. c) In addition to or as part of its programme of surveillance, STANDARDS MALAYSIA or its authorized agent(s) reserve(s) the right to carry out unscheduled assessment to accredited laboratories if there are reasons to suspect that accredited calibration / testing laboratories have failed in their obligations to meet the SAMM accreditation criteria or conditions. 3.5 Suspension, Withdrawal of Accreditation and Appeal a) STANDARDS MALAYSIA accreditation in the light of: i) ii) may at its discretion, suspend or withdraw

violation of the terms and conditions of accreditation; failure to provide reasonable cooperation or facilities for STANDARDS MALAYSIA, its assessors and/or its authorized agents to discharge their official duties; Page 4 of 10

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Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia iii) where, in the reasonable view of STANDARDS MALAYSIA an accredited laboratory has made unreasonable or irresponsible use of sub-contract testing; an accredited laboratory being owned by an individual, such individual is declared bankrupt or enter into a composition with his creditors; or accredited laboratory, being a company, enters into liquidation, whether compulsory or voluntary (but not including liquidation for the purposes of reconstruction) or enters into receivership.

iv) v)

b) STANDARDS MALAYSIA reserves the right to determine the period of suspension for accreditation depending on the severity of nonconformity or nonconformities against STANDARDS MALAYSIA accreditation criteria and conditions. At any time during the period of suspension, STANDARDS MALAYSIA may withdraw the Certificate of Accreditation if in its opinion, the accredited laboratory is found to be unable to fulfill its obligations to comply with these criteria and conditions. c) Before STANDARDS MALAYSIA suspends or withdraws a Certificate of Accreditation it shall issue a notice to the accredited laboratory requiring it within 14 working days from the date the laboratory is informed, to show cause why the Certificate of Accreditation should not be suspended or withdrawn. d) If a written appeal has been received, STANDARDS MALAYSIA shall consider the explanations given, and accord the accredited laboratory an opportunity to be heard by the Appeal Panel as soon as possible. e) If no appeal has been received by STANDARDS MALAYSIA against the notice of suspension or withdrawal, STANDARDS MALAYSIA shall on expiry of the notice, suspend or withdraw the accreditation and inform the laboratory in writing. f) A laboratory whose accreditation has been withdrawn shall return the Certificate of Accreditation to STANDARDS MALAYSIA immediately.

g) A laboratory that has been suspended shall not issue SAMM endorsed calibration certificates or test reports for the suspended scope. 3.6 Inoperative accreditation If an accredited laboratory is unable to comply with any of SAMM requirements, and in the opinion of STANDARDS MALAYSIA, such failure to comply is of a temporary nature and does not warrant suspension of accreditation, STANDARDS MALAYSIA retains the right to hold the accreditation on an inoperative basis for part or all of the tests covered in the schedule of accreditation of that laboratory. A laboratory whose accreditation has been made inoperative shall not issue SAMM endorsed calibration certificates or test reports for the incorporative scope. 3.7 Confidentiality All information gained by STANDARDS MALAYSIA, its assessors and authorized agents in the processing, granting, maintenance, renewal, extension, reduction, suspension or withdrawal of accreditation will be treated as confidential between STANDARDS MALAYSIA and the accredited laboratory. Such information will be handled on a strict "need to know" basis and will not, subject to the law of Malaysia, be divulged without the written instructions of the calibration / testing laboratory.

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Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia MSAC and Committee members, STANDARDS MALAYSIA staff members, members of Laboratory Accreditation Evaluation Panels, Technical Committees and Subcommittees, STANDARDS MALAYSIA authorized agents and assessors shall be made aware of and abide by this requirement for confidentiality.

4
4.1

Obligations of the calibration / testing laboratories

General Participation in SAMM does not in any way exempt organisations / laboratories from or diminish their responsibilities in observing / complying with existing laws and regulations currently enforced in the country. The calibration / testing laboratory shall: (a) at all times maintain its laboratory practices to a standard complying with SAMM condition, accreditation criteria and other requirements prescribed by STANDARDS MALAYSIA; (b) pay such fees for application, assessment, surveillance and other services as shall be from time to time determined by STANDARDS MALAYSIA to be fair and appropriate, having regard to the costs involved; (c) offer all clients a standard of service consistent with SAMM conditions, accreditation criteria and requirements, and maintain credibility and commercial integrity in all its operations; (d) claim that it is recognized or accredited only in respect of calibration / testing services for which it has been granted accreditation and which are carried out in accordance with SAMM ,requirements and criteria; (e) not vary the terms or conditions under which the certificate of accreditation is issued during the period of accreditation unless it has given notice in writing to STANDARDS MALAYSIA of its intention to do so and has received confirmation in writing from STANDARDS MALAYSIA. It is the responsibility of the laboratory to demonstrate such variation does not render invalid the Certificate of Accreditation; (f) not use the Certificate of Accreditation in such a manner as to bring the SAMM scheme into disrepute, and shall not make any statement pertaining to its accreditation which STANDARDS MALAYSIA may reasonably consider to be misleading;

(g) make it clear in all contracts with its clients that the laboratory's accreditation or any of its accredited test / calibration report by itself does not constitute or imply product certification/ product process or system so tested is approved or certified by STANDARDS MALAYSIA or any other body; (h) endeavour to ensure that no SAMM endorsed test report / calibration certificate nor any part thereof shall be used by a client, or be authorized for use by a client, for promotional or publicity purposes, if STANDARDS MALAYSIA considers such use to be misleading. (i) in making reference to its accreditation status in communication media such as documents, brochures or advertisement, shall use the following phrase as appropriate: "STANDARDS MALAYSIA or SAMM Accredited testing /

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Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia calibration laboratory for specific tests / calibrations described herein and identified by SAMM Accreditation number(s) ....."; (j) require that its clients who make reference to the use of the accredited laboratory shall use the following phrase as appropriate: "Tested/Calibrated by STANDARDS MALAYSIA or SAMM accredited laboratory for the calibration / testing services described herein and identified by SAMM Accreditation number(s) ....";

(k) retain on record all calibration certificates and/or test reports, original observations, calculations and derived data for at least 6 years or as required by law, organisational or contractual arrangement. 4.2 Impartiality, independence and integrity a) The laboratory and its personnel shall be free from any commercial, financial and other pressures or inducement which might influence their technical judgment. b) The laboratory shall not allow persons or organisations external to the laboratory to influence the results of tests or calibrations performed by the laboratory. c) The laboratory shall not engage in any activity that may endanger the trust in its independence of judgment and integrity in relation to its testing or calibration activities. d) The remuneration of the personnel engaged in testing or calibration activities shall not depend on the number of tests or calibrations carried out nor on the results of such tests or calibrations e) When products are tested by bodies, (e.g. manufacturers) who have been concerned with their design, manufacture or sale, a clear separation of different responsibilities shall be made known in the laboratory quality manual and an appropriate policy statement on fulfilling the above requirements shall also be made.

4.3

SAMM endorsed test reports and calibration certificates a) All SAMM endorsed test reports or calibration certificates shall be signed by a signatory approved by STANDARDS MALAYSIA or the key personnel for medical laboratory for the tests or calibrations that are covered by the scope of SAMM accreditation. In the case of medical laboratory, the key personnel approved by STANDARDS MALAYSIA shall sign the results or reports. b) SAMM endorsed test report / calibration certificate shall not be reproduced except in full without approval of the accredited laboratory. c) An accredited laboratory shall use the SAMM endorsement on test reports or calibration certificates that contain accredited tests and/or calibration, unless otherwise determined by STANDARDS MALAYSIA. d) All SAMM endorsed test reports or calibration certificates shall use the SAMM endorsement in the form of SAMM symbol and the identification of accreditation certificate number. Alternatively, they shall use the endorsement in the form of a statement that the laboratory is accredited under SAMM and identified by its accreditation certificate number.

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Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia

e)

The accredited laboratory may issue a SAMM endorsed test report or calibration certificate that includes test or calibration sub-contracted to another laboratory (sub-contractor laboratory) provided that i. A test report or calibration certificate has been issued to the accredited laboratory by the subcontractor laboratory; and The sub-contracted result(s) is identified with appropriate disclaimer(s) in the SAMM endorsed test report or calibration certificate issued by the accredited laboratory.

ii.

f)

A SAMM endorsed test report or calibration certificate shall not contain any expression of expert opinion as to serviceability of the sample, batch or consignment or its suitability for a specific purpose. Any such expression of expert opinion must be provided in a separate unendorsed document. Alternatively, any expression of expert opinion shall be qualified by a disclaimer that it is not under the scope of accreditation under SAMM.

4.4

Cooperation with STANDARDS MALAYSIA The calibration / testing laboratory shall afford STANDARDS MALAYSIA, its assessors and its authorized agents such reasonable accommodation and cooperation as necessary, to enable STANDARDS MALAYSIA to monitor compliance with the regulations and relevant accreditation criteria. This cooperation shall include: (a) affording STANDARDS MALAYSIA or its agents reasonable access to relevant areas of the calibration / testing laboratory, for the witnessing of calibration or tests; (b) undertaking any reasonable check test or measurement audits to enable STANDARDS MALAYSIA or its agents to verify the testing / calibration capability of the laboratory; (c) preparation, packaging and dispatch, at the expense of the calibration / testing laboratory of test pieces, artifacts, samples or other items needed by STANDARDS MALAYSIA or its agents for verification purposes such as for the conduct of interlaboratory comparison testing or proficiency testing; (d) participation in any appropriate programme of proficiency testing / measurement or comparison testing that STANDARDS MALAYSIA may reasonably deem to be necessary; (e) permitting scrutiny by STANDARDS MALAYSIA or its agents of the results of the calibration / testing laboratory's own internal audits, the performance results of measurement audits or proficiency tests; (f) assist STANDARDS MALAYSIA or its authorised agents in the investigation and resolution of any properly authenticated complaints made by third parties or outside parties about the laboratorys accredited calibrations or tests.

4.5

Liabilities a) An accredited laboratory shall have full control of the issue of accredited calibration certificates or test reports subject to these regulations. It shall therefore assume full liability on the issue of all calibration / test results and reports. Page 8 of 10

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Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia

b)

The laboratory is hereby advised to take out professional indemnity insurance against risks that may arise from the use of the results of calibration / tests performed.

4.6

Notification of Change a) An accredited laboratory shall inform the STANDARDS MALAYSIA immediately any changes bearing on its compliance with these regulations and other requirements affecting the calibration / testing laboratory's capability, competence, integrity, independence or scope of activity. Such significant change in an accredited laboratory includes: i. changes in personnel, equipment, or scope of activity of an accredited laboratory.

ii. any change in the laboratory's organisation and management, e.g. Head of laboratory, Technical Manager or Quality Manager, iii. any change, transfer, redesignation of duties, resignation of laboratory key personnel, approved signatory, authorised representative and other senior laboratory staff, iv. changes of duties of approved signatories, v. significant changes in address, premises, laboratory calibration / testing environment, facilities, equipment or other resources, vi. any change in the laboratory's legal, commercial or organisational status, vii. changes in the laboratory's policy and procedures. b) Under circumstances where an accredited laboratorys capability or competence is affected by one or more of the above significant changes that reduced the confidence of SAMM accredited test / calibration reports, the laboratory, at its discretion may make voluntarily request to STANDARDS MALAYSIA for the laboratory to be placed under inoperative accreditation. After the necessary adjustments and appropriate actions have been instituted to comply fully with STANDARDS MALAYSIA accreditation criteria and requirements, it should notify STANDARDS MALAYSIA for a verification visit to restore accreditation. c) A certificate of accreditation may be relinquished by an accredited laboratory upon giving one month's notice (or other time period agreed upon between the parties) in writing to the STANDARDS MALAYSIA.

d) Any notice or other communication required to be given or sent under these regulations by STANDARDS MALAYSIA and its authorised agents shall be deemed to be duly given or sent if sent by registered post, telex or telefax to the address, telex or telefax number of the accredited laboratory last known to the STANDARDS MALAYSIA and shall be deemed to be given at the time when the same would have been delivered in any of these means.

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Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia

Miscellaneous
a) Accreditation should not be regarded in any way diminishing the normal contractual responsibilities between the laboratory and the users of its test or calibration data. While SAMM accreditation will normally be a sound indicator of the quality of calibration / testing service offered by the laboratory, it cannot be taken to constitute a guarantee by STANDARDS MALAYSIA that the laboratory always maintains a particular level of performance. b) Accreditation does not, of itself, qualify the laboratory to approve any particular product, process or system, although accreditation may be a relevant factor enabling approval and certification authorities to decide whether to use a given laboratory in connection with their own activities, or whether to delegate approval or certification authority to a particular laboratory. c) Charging arrangements between the laboratory and its clients are not under the purview of SAMM accreditation and of these regulations.

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