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ISO 15189: CPA transition gap analysis

Since the introduction of ISO 15189:2012 to replace the older Clinical Pathology Accreditation, medical laboratories have been making the necessary updates to their quality management systems to demonstrate compliance to the new standard. 

The September 2018 deadline for CPA-compliant laboratories to make the jump to UKAS ISO 15189 accreditation is fast-approaching.

In October, any laboratories without 15189 accreditation will find themselves without certification as their CPA accreditation is withdrawn.

Not quite prepared for the jump? Our ISO 15189 gap analysis is designed to enable simple clause-by-clause pinpointing of potential non-conformances, and help identify all the necessary amendments needed by September.

 

laboratory 15189 quality

 

The changes

If your laboratory is CPA-compliant, you have until September 2018 to complete UKAS accreditation to ISO 15189. The additional requirements as compared to the CPA include:

  • New emphasis on ethical conduct regarding disposal of remains
  • Changes to the role of laboratory directors
  • Deepened emphasis on record-keeping, from instrumentation maintenance records to supplier selections
  • New actions regarding reagents and consumables 
  • Greater emphasis on staff competence and information management

ISO 15189 is designed to encourage laboratories to operate in an increasingly quality-centric manner and to continuously improve their processes, products and services.

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Next steps

Download our free gap analysis here.iso 15189 gap analysis

Tags: Quality Management Software, GRC Resources, FDA, GxP Pharmaceutical Regulation, ISO 15189, GRC, GXP