BIOBANKS

DANAK accredit companies for biobanking in accordance with DS/ISO 20387:2017, 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

ACCREDITATION STANDARD

  • DS/ISO 20387, General requirements for biobanking

ACCREDITATION REGULATIONSR

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:

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:

Download application form (in Danish) here.

Contact person: Head of section Kirsten M. Rosenberg. Tel: +45 77 33 95 83. E-mail: kmr@danak.dk