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Samm Policy 6 (SP 6) - Requirements For Samm Approved Signatory

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SKIM AKREDITASI MAKMAL MALAYSIA (SAMM)

LABORATORY ACCREDITATION SCHEME OF MALAYSIA

SAMM POLICY 6 (SP 6) – REQUIREMENTS FOR


SAMM APPROVED SIGNATORY
Issue 4, 30 August 2008
(Amd. 2, 13 February 2019)

MS ISO/IEC 17025

JABATAN STANDARD MALAYSIA


Department of Standards Malaysia
TABLE OF CONTENTS

Page

1 Introduction 1

2 Scope 1

3 Requirements of MS ISO/IEC 17025 1

4 SAMM policy on approved signatory 2

5 Requirements for signatory approval 3

6 Liabilities 5
Requirements for SAMM Approved Signatory

1 Introduction

1.1 The approved signatory under Skim Akreditasi Makmal Malaysia


(SAMM) is as defined in SAMM Policy 1 (SP 1) – Terms and Conditions
Governing the Laboratory Accreditation Scheme of Malaysia.

1.2 The presence of SAMM symbol or reference to SAMM accreditation in


the test reports or calibration certificates is a formal recognition of the
technical competence of the laboratory and the evidence of its
compliance with MS ISO/IEC 17025 and SAMM requirements.

1.3 This policy document should be read in conjunction with other SAMM
requirements.

2 Scope

2.1 This document specifies the policy and requirements for SAMM
signatory approval for use by SAMM laboratories, assessors and other
interested parties.

2.2 This policy is applicable to SAMM accredited and applicant laboratories


under MS ISO/IEC 17025.

3 Requirements of MS ISO/IEC 17025

3.1 Clause 6.2.2 of MS ISO/IEC 17025 requires,


“The laboratory shall document the competence requirements for each
function influencing the results of laboratory activities, including
requirements for education, qualification, training, technical knowledge,
skills and experience.”

NOTE: The laboratory shall document competence requirements for the


signatory(ies).

3.2 Clause 6.2.5 of MS ISO/IEC 17025 requires,


“The laboratory shall have procedure(s) and retain records for:
a) determining the competence requirements;”

NOTE: Records for all technical personnel including approved


signatory(ies) shall be maintained.

3.3 Clause 6.2.6 of MS ISO/IES 17025 requires,


“The laboratory shall authorise personnel to perform specific laboratory
activities, including but not limited to, the following:
a) development, modification, verification and validation of methods;
b) analysis of results, including statements of conformity or opinions and
interpretations;
c) report, review and authorisation of results.’’

SAMM Policy 6, Issue 4, 30 August 2008 (Amd. 2, 13 February 2019) Page 1 of 5


Requirements for SAMM Approved Signatory

NOTE: Such personnel as in Clause 6.2.6 c) shall be SAMM approved


signatory for SAMM endorsed test reports or calibration certificates.

3.4 Clause 7.8.1.1 of MS ISO/IEC requires,


“The results shall be reviewed and authorised prior to release”

NOTE: The results shall be reviewed and authorised by approved


signatory(ies).

3.5 Clause 7.8.2.1 (o) of MS ISO/IEC 17025 requires that each report shall
bear the identification of the person(s) authorising the report.

NOTE: Referring to the Clause 7.8.1.2 of MS ISO/IEC 17025, report


means a test report or a calibration certificate or report of sampling.

4 SAMM Policy on approved signatory

4.1 A report issued by SAMM accredited laboratories for accredited test or


calibration shall be reviewed and authorised by signatory(ies) approved
by Standards Malaysia. An approved signatory is responsible for the
technical validity and accuracy of all information contained in the report.

4.2 The nominated signatory shall be assessed on-site by the assessment


team for compliance with Clause 5 of this document.

4.3 The signatory shall hold a position within the organisation, which
provides authority over the testing or calibration activities and to reject
results when he/she considers them to be inadequate.

4.4 Signatory approval by Standards Malaysia is granted to personnel for


specific scopes for which he/she has been assessed to be technically
qualified and competent.

4.5 Signatory approval under Standards Malaysia is not a personal


qualification and is not transferable from one laboratory to another. The
approved signatory status is deemed to be terminated when the
personnel leaves the organisation.

4.6 Signatory approval by Standards Malaysia may also be granted to


personnel registered under the regulatory authorities/organisations
providing recognition. Such personnel may be employed or contracted
full-time or part-time, provided that the requirements of Clause 4 of this
document are met.

NOTE 1 Resident signatory means a signatory working full-time in the


accredited laboratory or in another section/department within the
same organisation at the same location.

SAMM Policy 6, Issue 4, 30 August 2008 (Amd. 2, 13 February 2019) Page 2 of 5


Requirements for SAMM Approved Signatory

NOTE 2 Non-resident signatory means a signatory who is a part-time


employee of the accredited laboratory or a signatory from another
branch providing covering duties to the accredited laboratory.

4.7 Non-resident signatory

4.7.1 A non-resident signatory can only be approved if the accredited


laboratory has a permanent resident signatory.

4.7.2 Should the accredited laboratory lose the service of the permanent
resident signatory the laboratory shall apply to Standards Malaysia to
continue its use of the non-resident signatory. Standards Malaysia at its
discretion may grant approval on the continual use of the non-resident
signatory for a specified period.

4.7.3 It is the responsibility of the laboratory to ensure that the laboratory has
a replacement for the permanent resident signatory.

4.7.4 A non-resident signatory shall have direct interaction with the laboratory
on-site at least once a month.

4.7.5 Formal agreement between the laboratory and the non-resident


signatory shall be established. The agreement shall ensure that:

i) the functions, responsibilities and authority in particular those of


an approved signatory shall be clearly defined.

ii) records of input including dates and duration of on-site visits,


topics and issues discussed, interaction with on-site staff and
recommendations, advice or instruction given are kept.

iii) the non-resident signatory shall attend:

a) the management review meeting; and

b) SAMM assessments unless specific exemption is


granted by Standards Malaysia.

iv) the non-resident signatory shall:

a) review and authorise report; and

b) review quality control records and relevant technical records.

4.8 Continual professional development

4.8.1 The SAMM approved signatory shall maintain his/her technical


competence to ensure his/her ability to evaluate the report results.

SAMM Policy 6, Issue 4, 30 August 2008 (Amd. 2, 13 February 2019) Page 3 of 5


Requirements for SAMM Approved Signatory

4.8.2 The SAMM approved signatory shall participate in continual professional


development through in-house and external activities e.g.: method
development and validation, review and update of test procedure,
training, presentation of papers, attending seminars and lectures etc.

5 Requirements for signatory approval

5.1 Legal requirements

5.1.1 These requirements shall be read in conjunction with any other legal
requirements relating to the signatory of report. Granting of SAMM
signatory does not absolve the signatory and laboratory from complying
with legal requirements relating to the signatory of report. Compliance
with legal requirements shall be the sole responsibility of the signatory
and laboratory.

5.1.2 The laboratories shall provide necessary information and documentary


evidence to Standards Malaysia for compliance with the necessary legal
requirements.

5.2 Qualification and experience

5.2.1 Education qualification and working experience:

i) SPM or equivalent in science or technical stream, with at least


eight (8) years of experience working in the relevant fields; or

ii) STPM or diploma in science or equivalent discipline, with at least


three (3) years working experience in relevant fields; or

iii) Degree holders in science or equivalent discipline with at least six


(6) months relevant working experience in relevant fields; and

iv) Other requirements as stipulated in the relevant specific technical


requirements.

5.3 Technical and operational requirements

5.3.1 Knowledge and understanding of the technical and laboratory


operational requirements:

i) Requirements of MS ISO/IEC 17025 and all related SAMM


requirements (e.g.: SP series, SC and STR) and relevant
regulatory requirements.

ii) The principles of testing, calibration or measurement.

SAMM Policy 6, Issue 4, 30 August 2008 (Amd. 2, 13 February 2019) Page 4 of 5


Requirements for SAMM Approved Signatory

iii) The standards, methods and specifications for accreditation


sought or held.

iv) The estimation of measurement uncertainties for the


accreditation sought or held.

5.3.2 Working at least three (3) months in the current laboratory and be
knowledgeable of its management system.

5.4 Specific Exceptions

5.4.1 The Director of Accreditation, at his discretion, may grant specific


exceptions to the requirements for approved signatory or impose other
requirements upon consultation with relevant parties.

6 Liabilities

6.1 An accredited laboratory shall assume full liability on all reports issued.

Abbreviations:

1) SAMM – Skim Akreditasi Makmal Malaysia

2) SC – Specific Criteria

3) SP – SAMM Policy

4) STR – Specific Technical Requirements

SAMM Policy 6, Issue 4, 30 August 2008 (Amd. 2, 13 February 2019) Page 5 of 5

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