ISO 15189 Medical Laboratory
TAF accreditation program in the medicine is developed based on the ISO 15189, the Asia Pacific Accreditation Cooperation Mutual Recognition Arrangement (APAC MRA), and the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA), to meet the need for impartial, objective, and independent third-party medical laboratory accreditation. The accreditation program covers medical (clinical) laboratories that exercise routine inspection/ professional examination, anatomical pathology, and imaging medicine.
The scope of medical laboratory accreditation program covers the following categories (See "Medical Field Accreditation Item Code Table (TAF-CNLA-D02)" for details)
Accreditation services of different technical categories include anatomical pathology (HA), clinical biochemistry (HB), blood transfusion medicine (HC), hematology (HD), clinical immunoserology (HE), clinical microbiology (HF), clinical toxicology (HG), clinical microscopy (HH), cytogenetics (HI), genetics and molecular pathology (HJ), imaging medicine (HR), etc.
Note: Application items in the medical domain should also meet the accreditation notification of “Essential Application Items for the Corresponding Professional Fields of Medical Laboratories Applying for Accreditation (TAF-CNLA-J09)”.
Regardless of the size, all legally registered domestic medical (clinical) laboratories with operation license issued by the health government authorities of Taiwan, can file in applications for laboratory accreditation by the person in charge. The laboratory and affiliated could be military, public, private, and academic research institutions and has designated technical personnel, use specific equipment in appropriate space, perform medical examination work based on the established management system, and issue the reports.
In addition, accredited medical laboratories can also apply to join " Accreditation Program for the Criteria of Health Examination Procedures for Employed Alien after Entry (TAF-CNLA-A07)”. Hospital, upon the accreditation of medical laboratory, can apply to the Taiwan Centers for Disease Control of the Ministry of Health and Welfare to be included in the “designated hospitals practicing health examination of employed aliens after entry" regulated in “Regulations Governing the Designation and Management of Hospitals for the Health Examination of Employed Aliens after Entry”.(Please refer to the accreditation instructions in health examination division)
Applicants are advised to read the “Accreditation Service Manual for Laboratories and Inspection Bodies (TAF-CNLA-A01)” to understand the relevant regulations and application procedures, so as to facilitate the accreditation.
For the application procedures, please refer to the general instructions. The relevant documents in the medical domain can be obtained from the TAF website.
For any further questions, please contact the service personnel for the medicine division in TAF Laboratory Accreditation Department II.