ISO 15189 Revision Update

Media Releases June 29, 2020
NATA team

The revision of ISO 15189 Medical laboratories – Requirements for quality and competence commenced in 2019 under the direction of the ISO technical committee TC 212 Clinical laboratory testing and in vitro diagnostic test systems

Standards Australia is the nominating Australian body on TC 212 and NATA has representation on this committee.

The first Committee Draft (CD) was released by ISO for ballot recently and has been considered by the Australian ISO mirror committee HE-029 Clinical Laboratory Testing and In Vitro Diagnostic Test Systems

It should be noted that the guiding principles for this revision include:

  • AS ISO/IEC 17025 is the normative reference to ISO 15189, the common structure of ISO CASCO standards (ISO CASCO PROC 33) has been implemented in the new draft of ISO 15189. Therefore ISO 15189 will be similar in structure to ISO/IEC 17025;
  • Mandatory language from PROC 33 has been integrated into the draft
    document and will continue to be highlighted throughout the relevant parts of the
    Mandatory language is not subject to revision or change and must be
    kept as written;
  • TC 212 have agreed that the new revised ISO 15189 should be less prescriptive,
    more risk based and linked to patient care;
  • The revised ISO 15189 will include relevant aspects of POCT performed under the control of the laboratory.

According to ISO rules wider consultation for a CD is not allowed. However this can occur at the next stage – Draft International Standard – which should be released in late 2020 or early 2021.

Further updates will be provided in due course.