Accreditation Scheme>Medical Testing Laboratories
Medical Testing LaboratoriesAccreditation Scheme
The goal of the accreditation scheme for a medical testing laboratory is to officially approve the competence of a medical testing laboratory in the medical
testing field by an accreditation body conforming to relevant laws or international standards through assessment of its management systems and technical
competency by qualified assessors
Overview
| KOLAS | Has been established accreditation scheme in accordance with the requirements of ISO/IEC 17011 |
| Medical Testing Laboratories | Accredited by KOLAS in accordance with KS P ISO 15189 and the requirements announced by the Head of KOLAS |
| Customers | Receive accredited testing (inspection) reports provided by accredited testing laboratories and inspection bodies within the accredited scope, in accordance with relevant standards and technical requirements |
If your organization is preparing to apply for KOLAS medical testing laboratory accreditation, please review the latest criteria including KOLAS
Regulations on the Accreditation of Medical Testing Laboratories (KS P ISO 15189:2013) and KOLAS Regulations on the Accreditation and Assessment of
Conformity Assessment Bodies (CABs), and inquire to the KOLAS Secretariat about relevant procedures and requirements.
(☏ 043-870-5496, kolast@korea.kr)
Applicable Documents and Laws
-Framework Act on National Standards
-Enforcement Decree of the Framework Act on National Standards
-KOLAS Regulations on the Accreditation of Medical Testing Laboratories
-KOLAS Regulations on the Accreditation and Assessment of Conformity Assessment Bodies (CABs)
Supplementary Requirements in each Accreditation Field
-Guidance on Traceability of Measurement Results
-Guidance on the Estimation and Expression of Measurement Uncertainty
Regulations on Proficiency Testing Schemes
-Guidance on the Use of Accreditation Marks and Claims for Accredited Status
-KOLAS Regulations on Qualifications and Registration of Assessors and Technical Experts
-KS Q ISO/IEC 17011 (ISO/IEC 17011): Conformity Assessment—Requirements for Accreditation Bodies accrediting Conformity Assessment Bodies
-JCGM 100:2008 (GUM 1995 with Minor Corrections), Guide to the Expression of Uncertainty in Measurement (BIPM, IEC, IFCC, ILAC, ISO, IUPAC, IUPAP and OIML)
