Standards Malaysia has established the accreditation activities since 1996, many schemes and programmes for accreditation were launched since then. In 2016, there were another demand to enhance the quality of services for Primary Healthcare Laboratories. Technical Working Group (TWG) was established to develop the accreditation requirements. In 2020 the draft was proposed as draft Malaysia Standards and, the MS 2702 : Primary healthcare laboratories - Requirements for quality and competence was approved by Minister of International Trade and Industries (MITI) on 4th October 2020.
Total of 26 expert from various organisation both government and private were involved in the drafting of the document including closed cooperation from the Bahagian Pembangunan Kesihatan Keluarga/Family Health Development Division (BPKK), Ministry of Health. The PHLAS has been launched on 4th January 2021.
The accreditation scheme is voluntary scheme open to any primary healthcare laboratories that provides conformity assessment services for medical testing such as Haematology, Chemical Pathology, Medical Microbiology and others.
A manual is established to describes the management system for the accreditation of primary healthcare laboratories or Primary Healthcare Laboratory Accreditation Scheme (PHLAS) including the related procedures. This manual also describes the organisation of Department of Standards Malaysia (hereafter known as Standards Malaysia) with respect to this accreditation scheme.
The structure, policies and procedures under which Standards Malaysia operates are documented to ensure implementation of these policies and procedures are administered in an independent and impartial manner to ensure the smooth operation of all compliance activities. Standards Malaysia quality system has been established, documented, implemented and maintained to give confidence in its ability to operate the compliance process in an effective manner.
Standards Malaysia is directly responsible for an adequate team of assessor having the necessary expertise or is ultimately responsible for such a "team". Details are described in the PHLAS Manual.
Standards Malaysia will maintain records of laboratory assessed including the compliance status in the website.
PHLAS Manual and procedure : Manual PHLAS
The Director General of Standards Malaysia is responsible for PHLAS and its Accreditation Division carries out the daily operations.
The process for assessment generally includes the following stages:
Registration / Assessment Process
The general criteria used for accreditation of PHL are those set out in MS 2702 (Primary healthcare laboratories- Requirements for quality and competence) requirements and PHLAS accreditation criteria.
The accreditation process includes Preliminary Visit, Compliance Assessment, Surveillance Assessment and Extra Ordinary Assessment (where applicable).
|1||Pn. Fariza Wan Abdullah||03 8008 email@example.com|
|2||Pn. Rohasmizah Ismail||03 8008 firstname.lastname@example.org|
|3||Cik Aminin Sadida Anwar||03 8008 email@example.com|