BIOBANKS

DANAK accredit companies for biobanking in accordance with DS/ISO 20387:2018, General requirements for biobanking based on ILAC Resolution GA 22.19 “The General Assembly resolves that the standard applicable to biobanks for the purposes of accreditation will be ISO 20387 Biobanking – General requirements for biobanking, to be used as a standalone standard.”

Accreditation to biobanking is as of yet not included by reciprocated agreements in EA or ILAC.
If a company is running both an accredited biobank and an accredited laboratory it will be possible to make an overall assessment based on these activities.

DANAK determines a scope of accreditation which describes the services the biobank provide. This will then be published in DANAK’s register (see in “Database of accredited companies”).

RULES AND REGULATIONS:

Below are links or references to documents for the specific scheme.

EXECUTIVE ORDERS

• Executive order No. 913 of 25 September 2009 on accreditation of companies.
  
  

ACCREDITATION STANDARD

• DS/ISO 20387, General requirements for biobanking
  
  

ACCREDITATION REGULATIONSR

• AB 1: General regulation for accreditation of companies
• AB 2: DANAK’s accreditation mark and reference to accreditation
  
  

GUIDELINES

In addition to the requirements documents above that biobanks must adhere to, there are a number of international guidelines which are relevant, and which are implemented through the accreditation provisions:

• EA-4/14:2003: The Selection and Use of Reference Materials.
• ILAC G-24:2022: ILAC Guidelines for the determination of calibration intervals of measuring instruments
  
  

ACCREDITATION MESSAGES (ONLY IN DANISH)

Various accreditation messages have also been published to guide and describe the assessment practice and issues relevant to providers for biobanks:

• AML 02: Extend of accreditation scope
• AML 03: Use of computer systems in accredited laboratories
• AML 04: Processing of non-conformities
• AML 07: Securing independence and impartiality
• AML 10: Surveillance of the general management system of multiple accreditations
• AML 17:Internal audit and management evaluation
• AML 22: Submitting electronic management systems
• AML 23: Reference to DANAK and accreditation and specification of traceability
• AML 28: Calibration and control of measuring equipment
• AML 29: Change of location