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Standardisation

BBMRI-ERIC Quality Policy

 

All Partners should commit themselves to implement quality management/assurance procedures compliant with applicable European and International standards, OECD best practice guidelines for Global Biological Resource Centres Networks and WHO/IARC Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research.

SOPs should be established and made publicly available for all processes related to sample collection, processing, storage, retrieval and dispatch. It is recommended that SOPs should follow the procedures as specified in the WHO/IARC guidelines for biological resource centres for cancer research whenever feasible.

A biobank (collection) shall be provided a unique persistent identifier as a part of registering the biobank (collection) in the BBMRI-ERIC Directory. Partners are also encouraged to participate and benefit from the quality services of BBMRI-ERIC.

 

International Biobanking Standard

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.

This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.

Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.This International Standard can be used by internal and external parties, including certification bodies, to assess the organisation’s ability to meet customer, statutory and regulatory requirements applicable to the product, and the organisation’s own requirements.

 

WHO/IARC Common Minimum Technical Standards

 

OECD best practice guidelines

Image Map

Recommended European and International Standards

 

BBMRI-ERIC recommends the implementation of International Standards and supports, whenever applicable, the implementation of certification and/or accreditation processes.

 

ISO

 

ISO Standards

Molecular in vitro diagnostic examinations

Specifications for pre-examination processes for frozen tissue

 

Part 1: Isolated RNA (ISO 20184-1:2018)

This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate RNA extracted from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.

 

Part 2: Isolated proteins (ISO 20184-2:2018)

This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.

 


 

Molecular in vitro diagnostic examinations

Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue

 

Part 1: Isolated RNA (ISO 20166-1:2018)

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

 

Part 2: Isolated proteins (ISO 20166-2:2018)

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable for protein examination by immunohistochemistry.

 

Part 3: Isolated DNA (ISO 20166-3:2018)

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
 


 

Molecular in vitro diagnostic examinations

Specifications for pre-examinations processes for venous whole blood

 

Part 1: Isolated cellular RNA (ISO 20186-1:2019)

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood. These are not described in this document. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom. RNA in pathogens present in blood is not covered by this document.

 

Part 2: Isolated genomic DNA (ISO 20186-2:2019)

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for stabilizing blood cell free circulating DNA, which are not described in this document. NOTE Circulating cell free DNA in blood is covered in ISO 20186-3. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom. DNA in pathogens present in blood is not covered by this document.

 

Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2. Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document. NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes. DNA in pathogens present in blood is not covered by this document.

 


 

Laboratories for testing and calibration

Medical laboratories

 

General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)

ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. It is applicable to all organisations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.

 

Medical laboratories – Requirements for quality and competence (ISO 15189:2012)

specifies requirements for quality and competence in medical laboratories. This International Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognising the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

 

Medical laboratories – Requirements for safety (ISO 15190:2003)

While this International Standard is intended for use throughout the currently recognised disciplines of medical laboratory services, other services and disciplines may find it useful and appropriate. However, medical laboratories handling human pathogens requiring containment levels 3 and 4 will need to meet additional requirements to ensure safety.
 


 

Auditing

 

Guidelines for auditing management systems (ISO 19011:2018)

This document provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit programme, auditors and audit teams. It is applicable to all organizations that need to plan and conduct internal or external audits of management systems or manage an audit programme. The application of this document to other types of audits is possible, provided that special consideration is given to the specific competence needed.

 

CEN_541C

 

CEN Standards

 

CEN the European Committee for Standardisation finalised their effort and published standards for molecular in vitro diagnostic examinations – Specifications for pre-examination processes:

 

Metabolomics in urine, serum and plasma

This Technical Specification covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. This Technical Specification is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis.

 


The website was co-funded within ADOPT BBMRI-ERIC, a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 676550.
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