CIB Ballot: Input for position on ISO/TC 304 proposal for blood banking

* 3. We hereby inform you that ISO/TC 304 Healthcare organization management is currently circulating ISO/NP 24015, Blood Banks ─ General requirements for the quality and competence of blood bank activities for the approval as a new work item to its work programme. 

However, with ISO 20387:2018, Biotechnology — Biobanking — General requirements for biobanking there already exists an applicable standard that can also be used by blood biobanks in the medical field. ISO 20387 was developed by ISO/TC 276 Biotechnology with the approval of ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems to share its scope for the inclusion of biobanks in the medical field even before the establishment of ISO/TC 304. 

There are additional blood biobank specific requirements in the technical part of ISO/NP 24015, but these can be addressed within a normal ISO Standard that does not follow the Annex SL of the ISO Directives for accreditation enabling documents. This is to avoid the problem that some biobanks would have to use two standards (accreditations) for the same samples as both competence assessment standards are covering blood samples and the market might demand one or the other or both - especially for biobanks holding multiple sample types including blood samples. This is neither customer friendly nor convenient for accreditation schemes.

Thus, to avoid duplication and customer confusion wherever possible, ISO/TC 276 proposes to change the content of ISO/NP 24015 as follows:

1.     to follow ISO 20387 as a whole;
2.    add blood bank specific requirements; and
3.    delete all management-related text and those text passages required by Annex SL.


Do you agree to propose to ISO/TC 304 that the content of ISO/NP 24015 needs to be changed to follow ISO 20387, exclude other management and Annex SL requirements, and include only technical details specific to blood biobanks?