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BiobanksAccreditation Scheme

Overview
The goal of the accreditation scheme for biobanks is to officially approve the competence of a biobank in certain fields by an accreditation body conforming to relevant laws or international standards through assessment of its management systems and technical competency by qualified assessors

KOLAS Has been established accreditation schemes in accordance with the requirements of ISO/IEC 17011
Biobanks Accredited by KOLAS in accordance with KS J ISO 20387 and the requirements announced by the Head of KOLAS
Customers Receive accredited certification reports provided by accredited biobanks within the accredited scope, in accordance with relevant standards and technical requirements

If your organization is preparing to apply for KOLAS biobanks accreditation, please review the latest criteria including KOLAS Regulations on the Accreditation of Biobanks (KS J ISO 20387:2018) 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)


Applicable Documents and Laws
-Framework Act on National Standards
-Enforcement Decree of the Framework Act on National Standards
-KOLAS Regulations on the Accreditation of Biobanks
-KOLAS Regulations on the Accreditation and Assessment of Conformity Assessment Bodies (CABs)
-Supplementary Requirements for Each Field of Accreditation

-KS Q ISO/IEC 17011 (ISO/IEC 17011): Conformity Assessment—Requirements for Accreditation Bodies accrediting Conformity Assessment Bodies
-KS J ISO 20387 (ISO 20387): Biotechnology—Biobanking—General Requirements For Biobanking
-KS Q ISO/IEC 17067 (ISO/IEC 17067): Conformity Assessment—Fundamentals Of Product Certification And Guidelines For Product Certification Schemes