New edition of ISO 15189

Current events

New edition of ISO 15189, ISO 15189:2012 Medical laboratories - Requirements for quality and competence, was published at the end of 2012.

Hence the International Laboratory Accreditation Cooperation (ILAC) made a decision that a transitional period for the application of the new edition of ISO 15189 should be over by 1st March 2016.

This edition of the standard (third one) repeals and replaces the second edition (ISO 15189:2007) the technical review of which was carried out. Furthermore, this edition provides a basis for continuous approximation to the requirements of ISO/IEC 17025. The relationship between these two editions is presented in Annex B, ISO 15189:2012.

Management system requirements in Chapter 4, ISO 15189:2012, were explained in the language that is of importance to the operation of medical laboratories and that fulfils the principles of ISO 9001:2008, Quality management systems – Requirements, and that are in keeping with relevant requirements of this standard. The relationship between the clauses and sub-clauses of this edition of ISO 15189 and those of ISO 9001:2008 and ISO/IEC 17025:2005 is presented in Annex A of this international standard.

It is important to emphasise that this edition of ISO 15189 provides general explanation of environmental protection issues related to the activities of medical laboratories.

By the end of 2013 the Institute for Standardization of Serbia (ISS) will publish the Serbian (SRPS) version of ISO 15189, whereas this edition of the standard will repeal and replace SRPS ISO 15189:2008.

The Accreditation Body of Serbia (ATS) will plan all activities and carry out all of them (change in the management system documents, training of assessors and persons participating in decision-making) in order to harmonise the accreditation procedure of medical laboratories to mirror the new edition of the standard, whereas ATS will consider the date of issuance of the Serbian version of the standard.

Assessments of accredited medical laboratories in terms of transition/approximation to/harmonisation with the new edition of the standard will be carried out during regular surveillance assessments or reassessments. Hence ATS will harmonise its assessment activities in case of all accredited medical laboratories.

After 1st March 2016 accreditations granted as per SRPS ISO/IEC 15189:2008 shall no longer be valid.