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INAB Transition to ISO/IEC 15189:2012 Third edition

10 Apr 2013

On 1^st November 2012 the standard ISO/IEC 15189: 2012 Rev 3 Medical Laboratories –Requirements for quality and competence was published by ISO.

Based on the resolutions of the International Laboratory Accreditation Co-Operation (ILAC) ISO/IEC

15189:2012 Rev 3 replaces the standard ISO/IEC 15189:2007 Rev 2- Particular requirements for quality and competence.

This document applies to the accreditation of medical testing laboratories that are currently accredited by INAB based on the ISO/IEC 15189:2007 standard and those intending to apply for medical laboratory testing accreditation.

From the 1^st November 2015, accreditation to ISO/IEC 15189:2007 2^nd edition will no longer be available and accreditation certificates to ISO 15189:2007 no longer valid.

A resolution passed by the ILAC General Assembly endorsed a 3 year transition period to ISO/IEC 15189:2012.

In order to facilitate a smooth transfer to the new standard, INAB have decided upon the following transition programme:

INAB requests that accredited medical laboratories submit a transition action plan to their INAB accreditation officer. The plan shall be sent to INAB before 1^st November 2013.

As a minimum the plan shall include:

All specific actions to be taken to implement the changes,
The timeframe for completion of such actions,
The persons responsible for the actions,
Process in place to monitor progress and completion of the actions.

The action plan will need to demonstrate an analysis of the new standard and effective implementation such that the medical laboratory confirms it is operating to ISO/IEC 15189:2012 by the 1^st May 2014.
All INAB surveillance / reassessments from 1^st May 2014 will be carried out to ISO/IEC 15189:2012.
From November 2013 all new applicants will be assessed against ISO/IEC 15189: 2012.
From November 2013 to May 2014 all existing accredited laboratories will be assessed against the current ISO/IEC 15189:2007 standard.
From 1 May 2014 all medical laboratories will be assessed against ISO/IEC 15189: 2012.
The 2014 / 2015 schedule of visits may be altered to ensure that all medical laboratories are verified for compliance by 1^stNovember 2015.

The Accreditation Certificate and Schedule of Accreditation will be adapted to reflect accreditation against ISO/IEC 15189:2012 after the surveillance/re-assessment against the new standard has been successfully completed and a decision for renewal of accreditation has been granted. The accreditation number will remain the same. The date on the certificate will be the date of the decision to grant accreditation for the new standard.

Please note, that it is the responsibility of the medical laboratory to familiarise itself with the new revision of the standard and implement the changes necessary to comply with ISO/IEC 15189:2012 3^rd edition.

After 1^stMay 2014, at the next scheduled visit, INAB will carry out surveillance/re-assessments to the new standard ISO/IEC 15189:2012 that will include an assessment of the changes in the documented management system and the implementation of the action plan. As part of this assessment the medical laboratory will be required to have performed an internal audit to assess the effectiveness of the changes and its implementation in compliance with ISO/IEC 15189: 2012.

During the surveillance/re-assessment INAB will review records concerning the implementation of the new standard and at a minimum these records shall include:

Analysis of impact on system and action plan;
Internal audit of changes; ISO/IEC 15189:2012;
The implementation at all sites if the medical laboratory has multiple sites, as appropriate;
Communication of changes in the system to interested parties, as appropriate.

Organisations may obtain a copy of this standard from:

ILI, 42-44 Northumberland Road, Dublin 4..

Tel: (01) 8576730, Fax: (01) 8576729

www.standards.ie

INAB looks forward to implementing the new standard and working with you to ensure a smooth transition to ISO/IEC 15189:2012.

Any queries should be directed to your INAB accreditation officer.

Summary of changes in ISO 15189:2012 compared to the 2007 version (DOC, 2 pages, 34KB)