Certification, accreditation, quality label
Quality is a key success factor for every biobank. Strategic and process-orientated quality management ensures consistently high quality and user satisfaction in the long term. Certification or accreditation of biobanks in accordance with applicable standards will continue to gain in importance and contribute to enhancing the reputation of these biobanks. With a "Quality Label" from BBMRI-ERIC, biobanks can receive proof of quality in preparation for or in addition to certification or accreditation.
Certification according to DIN EN ISO 9001
In a certification procedure, an external certification body (e.g. TÜV Nord/Süd) checks in a system audit whether a biobank fulfils certain requirements. Currently, certification of the management system of biobanks is possible in accordance with DIN EN ISO 9001. The current revision from 2015 is already being applied by many biobanks. The QM manual developed as part of the first GBN funding phase is based on this, among other things.
Accreditation
Accreditation in accordance with DIN EN ISO 20387
Accreditation verifies the conformity of processes with standards and the specific expertise of the employees concerned. Since 2020, DIN EN ISO 20387 Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018, German version: DIN EN ISO 20387:2020) has been available as an accreditation standard.
GBN biobanks have been prepared for accreditation with internal audits since 2019. Prior to an assessment by the DAkkS, the GBN offers biobanks an additional in-depth audit as a "dress rehearsal".
Application for accreditation
The accreditation process comprises four phases. It begins with the application for initial accreditation (FO-Antrag_Erstakkreditierung) at the DAkkS Central Application Processing Centre. The scope of accreditation, which includes process steps, sample types as well as tests and analyses, is specified in the annex to the application (FO application GB_Biobanks). DAkkS prepares a fee estimate based on the application and its fee regulation. After the application has been reviewed and an optional preliminary meeting has been held, all documents to be submitted (LI-EU_BB) must be sent to DAkkS by the biobank.
The second phase of the accreditation process is the assessment. Among other things, the assessors carry out a document review. The subsequent inspection of the biobank takes place at best three months after the application has been submitted. After the inspection, the assessors write a report and set a deadline for correcting the deviations. The assessors or DAkkS procedure managers evaluate the corrective measures and prepare the accreditation committee.
In the third phase, the committee examines and decides on the accreditation. In the event of a positive decision, DAkkS issues the accreditation notice and certificate and grants permission to use the accreditation symbol. In addition, it includes the biobank in question in the list of accredited bodies.
In the fourth phase, the DAkkS carries out a surveillance assessment of the biobank in question approximately every 18 months. For re-accreditation, a re-assessment by DAkkS is also required after a maximum of five years.
"Quality Label" from BBMRI-ERIC
Since 2017, the European biobank network BBMRI-ERIC has been awarding "Quality Labels" as proof of quality to biobanks in its member states. For biobanks, this is an opportunity to obtain proof of quality in preparation for or in addition to certification or accreditation, which also appears in the directory. As GBN has a proven audit programme that prepares for accreditation in accordance with DIN EN ISO 20387, GBN and BBMRI-ERIC have agreed on a separate procedure for GBN biobanks that have already been audited:
1. complete audit along DIN EN ISO 20387: In order to receive a Quality Label from BBMRI-ERIC, the biobanks must fully comply with the requirements of DIN EN ISO 20387. At least two internal audits are necessary for a corresponding audit of the GBN biobanks. The prerequisite for receiving a quality label is that no critical or a maximum of ten per cent non-critical deviations were identified during the audits.
2. completion of the BBMRI-ERIC audit checklist: GBN provides general information about the biobank and the responsible auditors, as well as the findings identified during the internal audits (such as possible deviations) and the biobank documents inspected (with title, date and version). The BBMRI-ERIC QM team does not require the documents themselves. The information is then checked by the responsible GBN auditor.
3. sending the audit checklist: If the GBN auditors recommend the award of a quality label, the completed audit checklist is sent to the BBMRI-ERIC QM team by the GBN. The documents are treated confidentially.
4. award of the Quality Label: After reviewing the submitted documents and a final discussion between the GBN lead auditor and the BBMRI-ERIC QM team, BBMRI-ERIC awards the Quality Label following a positive evaluation and makes this visible in the directory. As soon as a new version of DIN EN ISO 20387 is published, the Quality Label loses its validity.
This procedure is used for quality labels in accordance with DIN EN ISO 20387. In accordance with the regular procedure, biobanks can also receive quality labels from BBMRI-ERIC for other norms and standards. Depending on the scope of the audit, BBMRI-ERIC distinguishes between quality labels at biobank and collection level. Quality labels can also be awarded on the basis of valid certification or accreditation certificates from the relevant awarding bodies. Nhutuyen Nguyen (Tel. +49. 30. 450 536 374, e-mail:nhutuyen.nguyen@charite.de), GBN Coordinator for Quality Management, is available to answer any questions.