Please see important message from ILAC with regards to the proposed revision of the ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence

Dear ILAC Members,


As many of you will be aware ILAC maintains A Liaison status with ISO/TC 212 WG 1, which is the working group responsible for the standard ISO 15189:2012 Medical Laboratories - Requirements for Quality and Competence. ISO 15189:2012 is due for Systematic Review in October 2017 and ISO/TC 212 WG 1 is conducting a survey amongst users of the standard to seek information that will be used, in conjunction with the results of the Systematic Review, to determine the extent of any revisions that may be considered necessary.


ILAC members who use this standard are invited to complete survey that can be accessed via the following link:


ILAC Stakeholder members are further invited to distribute this survey invitation to their members where relevant.


ISO/TC WG 1 has provided the following infomration on the survey:


Later this year ISO 15189:2012 is due for Systematic Review. At meetings of WG1 we have discussed the changes proposed to ISO/IEC 17025, the normative reference for ISO 15189, as well as changes in ISO 9001:2015. Prior to the ballot taking place for the review, we would like to obtain information from users of ISO 15189:2012.


A survey has been developed and we ask that you share this link with as many people as possible and encourage them to do the same. We need to hear from users in laboratories, accreditation bodies/agencies, accreditation assessors and any others who may have reason to use the standard, whether it is voluntary or mandatory use. This feedback will be shared with members of ISO/TC 212 WG1 and used together with the results of the upcoming systematic review, to determine the extent of revisions that need to be made to the standard.


Thank you, Sheila Woodcock, Convenor ISO/TC 212 WG1.


Sheffield Teaching Hospitals NHS Foundation Trust, a UKAS proficiency testing provider No. 7804, operating UK NEQAS for Leucocyte Immunophenotyping.

You can find our schedule of accreditation here.

Also a link to the UKAS website is here.

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