Laboratory accreditation based on ISO/IEC 17025 (formerly ISO/IEC Guide 25) was first introduced in Malaysia on 1 July 1987. This was followed by the introduction on 15 August 1990 of a national unified laboratory accreditation scheme, known as Skim Akreditasi Makmal Malaysia (SAMM). The SAMM scheme was initially administered by SAMM National Council that currently come under the authority of the Ministry of International Trade and Industry (MITI).
Following the establishment of the Department of Standards Malaysia (Standards Malaysia) on 28 August 1996 under the Standards of Malaysia Act, 1996, all accreditation activities of the former Malaysia Accreditation Council were transferred to and come directly under the responsibility of Standards Malaysia. The laboratory accreditation scheme, however, retains its original name Skim Akreditasi Makmal Malaysia (SAMM).
The primary objective of SAMM is to provide a credible accreditation service to testing and calibration laboratories including medical testing laboratories such that ultimately SAMM endorsed test reports and calibration certificates are accepted internationally. The accepted mechanism for recognition is by means of the Mutual Recognition Arrangements framework of the International Laboratory Accreditation Co-operation (ILAC) and the Asia Pacific Accreditation Cooperation (APAC).
Scope of Activities
SAMM is a unified national laboratory accreditation scheme and is multi-disciplinary in its scope of accreditation activities. It covers both calibration and testing including medical testing.
Reference to SAMM Accreditation
Accredited laboratories may use Accreditation Symbol and combined ILAC MRA Mark or make reference to SAMM accreditation.
Standards Malaysia is staffed by full-time technical officers and supporting staff to carry out daily operations. It is operated in accordance with ISO/IEC 17011.
General criteria as published in MS ISO/IEC 17025 / MS ISO 15189, SAMM Policies (SP), Specific Criteria (SC), and Specific Technical Requirements (STR) are used in assessments and the accreditation process.
Policy on Cross Frontier Accreditation
It is the policy of Standards Malaysia not to accept any CAB application from abroad. This policy is consistent with the Act 549, Standards of Malaysia Act 1996, clause 10 (2)(h).
All existing standard methods from both national and international standard bodies as well as reputable technical organizations are acceptable. Non-standard/in-house methods are also acceptable provide that they are validated and documented.
|Figure 1: Accreditation Processes
Valid for three (3) years and renewable subject to terms and conditions of the SAMM scheme.
Surveillance and Re-assessment
Standards Malaysia shall schedule assessments of the accredited laboratories according to the following table:
Table 1: First cycle of accreditation
Approximately 9 months from the date of granting/ renewal
Approximately 12 months from the date of Surveillance 1
Approximately 3 months before the date of expiry
Table 2: Subsequent cycle of accreditation
Approximately 12 months from the date of the last expiry
Approximately 6 months before the date of expiry
However, Standards Malaysia reserves the right to revert the cycle of accreditation depending on the performance of the laboratory arising from the results of the assessment.
Assessors are drawn from technical agencies, such as MRB, MPOB, Chemistry Department, Ministry of Health, universities, and government laboratories. Other competent individuals are also employed as part-time assessors. Assessors are trained by competent training organizations. The criteria for the acceptability of laboratory assessors are prescribed in SAMM documentation.
Accredited laboratories are required to participate in available interlaboratory comparison programs or other forms of comparison testing such as the proficiency testing programs by APAC (Asia Pacific Accreditation Cooperation).
Appeals procedure which maintained the independence, and impartiality in the process of appeal, has been established for the handling and resolution of any appeal that may arise from the accreditation process.