VILAS Med
ACCREDITATION PROGRAM FOR MEDICAL LABORATORIES (VILAS Med)
The Medical Laboratory Accreditation Scheme (VILAS-MED) was established and implemented since 2008. This scheme is operated in compliance with the international standard ISO/IEC 17011. Over the years, the VILAS-MED scheme has built a strong foundation and continues to expand and improve.
Since 2012, the VILAS-MED scheme has been a signatory to Mutual Recognition Arrangements (MRAs) with both the Asia Pacific Accreditation Cooperation (APAC) and the International Laboratory Accreditation Cooperation (ILAC).
VILAS-MED boasts a team of lead assessors who are professionally trained and qualified in accordance with international standards, and who also serve as peer evaluators for APAC. In addition, VILAS-MED engages top-tier technical experts selected from leading universities, research institutes, and major hospitals across the country. To date, VILAS -MED scheme has accredited over 200 medical laboratories.
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Benefits of accreditation
- Enhances the management and technical competence of medical laboratories.
- Allows accredited laboratories to use the accreditation symbol directly on test/diagnostic reports.
- Increases confidence among service users in test and diagnostic results.
- Enhances domestic and international credibility.
- Provides a reliable basis for regulatory authorities, organizations, and individuals to select laboratories that meet the core criteria of diagnostic testing: independence, objectivity, and accuracy.
Target Clients
- Clinical laboratories
- Healthcare facilities performing laboratory testing
- Diagnostic imaging units
- Entities conducting Point-of-Care Testing (POCT)
Accreditation Standards
VILAS-MED applies the international standard ISO 15189 – Medical laboratories – Requirements for quality and competence, along with supplementary requirements for accreditation in the field of medical testing.
Scope of Accreditation
- Biochemistry
- Hematology
- Microbiology
- Pathology and Cytopathology
- Medical nuclear
- Imaging testing
- Point-of-Care Testing (POCT)
FAQs
Accreditation may be required by government or federal regulatory bodies, industry organizations, local government requirements, or individual customers.
What is the process to be accredited according to ISO/IEC 17011:2017?
Refer to "How to get accredited?" The key technical factors mentioned in the standard include:
- Validity and suitability of the method
- Technical competence of personnel
- Traceability of measurements to national and international standards
- Suitability, calibration, and maintenance of equipment
- Handling of testing/calibration items
- Quality control and assurance processes
- Reporting of results
The BOA (BAC) Accreditation Criteria packages include several documents available for download.
BOA's general documents include informational materials and do not serve as accreditation criteria.
There are General Accreditation Criteria applicable to all facilities and Specific Accreditation Criteria designed for specific fields and industry activities. These documents outline the mandatory accreditation criteria that must be met.
- General accreditation criteria
- Specific accreditation criteria
The General Accreditation Guidelines and Specific Accreditation Guidelines provide non-mandatory recommendations.
- General accreditation guidelines
- Specific accreditation guidelines
ISO/IEC 17011:2017 is the international standard that outlines the requirements for accreditation bodies assessing and recognizing conformity assessment bodies (CABs). This standard specifies the criteria for accreditation bodies to operate in a consistent, impartial, and transparent manner. It ensures that CABs—such as testing laboratories, certification bodies, and inspection bodies—are competent and produce reliable results.