Abstract
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ISO International Standards will be of benefit because they ensure that products and services are safe, reliable, and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. Overall, they help companies to access new markets, level the playing field for developing countries, and facilitate free and fair global trade.
The task force (TF) was initially established in 2008 to consider the preparation of an international standard in the field of biotechnology. Germany then proposed setting up a new technical committee (TC) in July 2012. Based on these proposals, ISO/TC276 was established in February 2012. The first plenary meeting was held in Berlin in December 2013. TC276 at first developed four working groups (WG) including WG1: Terms & Definitions, chaired by Germany, WG2: Biobanks/BioResource Centers, chaired by France, WG3: Analytical Methods, chaired by USA, and WG4: Bioprocessing, chaired by Japan. Recently, WG5 was added to consider bioinformatics standards and is chaired by Germany. So far five meetings have been held at various locations; #1 (Berlin 2013 December), #2 (Berlin 2014 May), #3 (Berlin 2014 December), #4 (Shenzhen 2015 April), and #5 (Paris 2015 July, limited to WG2). A sixth general meeting was held in Tokyo in October 2015.
About 22 countries with P member status and about 13 countries with O member status are participating in TC276. P member countries can vote on all questions submitted within the TC; O member countries are observers who receive committee documents and have the right to submit comments but cannot vote.
Current Status
The participants found that there are already a large number of guidelines and best practices1–7 focused on the biobanking field, and also determined that these guidelines overlapped each other. For this reason the participants decided to extract essential parts of international standards from various official documents, including in particular ISBER Best Practices for Repositories, 8 OECD Best Practice Guidelines for Biological Resource Centres, 9 and some others. The participants then prepared a synthesis draft utilizing portions of the documents mentioned above. The participants then merged these synthesized documents into one prototype standards document.
The current version of the draft encompasses the following subcategories; 1. Non-conforming products, 2. Premises/equipment, 3. Staff competence and training, 4. Validation of methods, 5. Quality control of biological resources, 6. Compliance with regulations, including confidentiality issues, 7. Ethical issues, 8. Sample traceability/labeling, 9. Sample collection and processing, 10. Sample preservation and storage, 11. Sample transport/shipping, 12. Access procedures for samples and data, 13. IT (clinical and sample data management, interoperability, authenticity of data…), 14. Financial Sustainability, 15. Stability of collection, 16. Biological risk management.
Future Plans
With regard to WG2, the drafting members will distribute the draft document not only to each domestic ISO mirror committee but also to domestic stakeholders (depending on each country's mandate). After ample discussion, each country was requested to provide comments on the draft to the WG2. There are 114 pages of comments that have been accrued for further discussion. At its Tokyo meeting, October 29–30, 2015, there was detailed discussion of the draft with extensive modification for improvement. Further refinement of the Standards document will occur prior to eventual final approval, distribution, dissemination, and adoption over the course of the next few years.
WG2 will need at least one or two years to finalize the document. After agreement is reached on the finalized document, voting will occur. There are a number of steps in this process that must occur before the final ISO standards document will be finalized, distributed, and diffused.