General Criteria of competence, procedure and amendment of conditions

Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia SAMM Policy 1, Issue 4, 8 April 2014 Page 3 of 14 iv Laboratory: A body or organisation that performs test andor calibration. v SAMM Skim Akreditasi Makmal Malaysia: The Laboratory Accreditation Scheme of Malaysia is a national laboratory accreditation scheme administered by Standards Malaysia. vi SAMM Accreditation criteria: Includes the appropriate accreditation standard, and all Standards Malaysia approved policies and procedures at the time of application, and those approved from time to time subsequent to accreditation, that are applicable to the respective accreditation programmes. For other terms not listed, the relevant definitions in ISOIEC 17000 and the International Vocabulary of Basic and General Terms in Metrology shall apply. 3 Authority for the granting of SAMM accreditation

3.1 General

Under Skim Akreditasi Makmal Malaysia SAMM, the Director General of Standards Malaysia is responsible for all policies and decisions affecting the accreditation of testingcalibration laboratories, including the granting, maintaining, extending, renewal, reducing, suspending, withdrawing or reinstatement of accreditation. The granting, maintaining and renewal of accreditation shall be granted only to a testingcalibration laboratory which; a is legally identifiable and operational, b complies with SAMM conditions and the relevant SAMM accreditation criteria, c pays such fees as prescribed in the Fee Schedule as are due to Standards Malaysia, and d gives such undertakings as Standards Malaysia may require.

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 testingcalibration laboratory shall be assessed. b The accreditation requirements set out in MS ISOIEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories or MS ISO 15189: Medical Laboratories –Requirements for Quality and Competence and any applicable criteria prescribed at the discretion of Standards Malaysia, shall be taken as the criteria for assessing the competence of a testingcalibration laboratory. Terms and Conditions Governing the Laboratory Accreditation Scheme of Malaysia SAMM Policy 1, Issue 4, 8 April 2014 Page 4 of 14 c Standards Malaysia shall specify the procedures by which application for accreditation shall be made, the conditions for maintaining, extending, renewal, reducing, suspending or withdrawing of accreditation, and the conditions under which SAMM accreditation may be refused, reduced, put under suspension, withdrawal, or reinstatement. d Standards Malaysia reserves the right to amend any part of SAMM conditions, if in the opinion of Standards Malaysia such amendments are necessary to maintain the credibility of SAMM. e In the event of such amendments, reasonable time shall be given to laboratories to carry out the necessary adjustments to their management system 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 shall be given for testingcalibration laboratories to carry out the necessary adjustments to their system.

3.3 Processing and granting of accreditation