On 1st November 2012 the standard ISO 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 15189:2012 Rev 3 replaces the standard ISO 15189:2007 Rev 2- Particular requirements for quality and competence.
According to the ILAC resolution, the transition period from ISO 15189:2007 to ISO 15189:2012 has to be completed by 29 February, 2016.
Clinical laboratories being already accredited according to the standard ISO 15189:2007 are required
to make the relevant changes to their management system and the
subsequent internal audit, in order to comply with the new requirements. The implementation of the changes will take place during the scheduled assessments or exceptional, if it is required. The assessment time is expected to increase.
Each accreditation body is expected to provide its accredited laboratories with more details concerning the transisiton plan.
According to the ILAC resolution, the transition period from ISO 15189:2007 to ISO 15189:2012 has to be completed by 29 February, 2016.
All accredited medical laboratories shall conclude their transition to the standard ISO 15189:2012 until 29.02.2016. After this date any accreditation against the standard ISO 15189:2007, will not be valid.
Each accreditation body is expected to provide its accredited laboratories with more details concerning the transisiton plan.
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ISO 15189 certification in UAE
Medical Laboratory Accreditation