IQMH participates in the work of the International Organization for Standardization as a member of the ISO/TC212 WG1, the working group responsible for the review of the ISO 15189:2012 standard. IQMH’s accreditation requirements are based on ISO 15189:2012 Medical laboratories — Requirements for quality and competence and facilities accredited by IQMH may have valuable feedback to share with this ISO Working Group.
Later this year ISO 15189:2012 is due for Systematic Review. At meetings of WG1 the changes proposed to ISO 17025, the normative reference for ISO 15189, as well as changes in ISO 9001:2015 have been discussed. Prior to the ballot taking place for the review, the Working Group 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/TC212 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.
Please note that this is feedback to ISO 15189:2012, not to the IQMH Accreditation Requirements and Guidance Information. Feedback pertaining to specific clauses will need to refer to the ISO 15189:2012 clause number.