In September 2007 the CPA standards were revised to incorporate the ISO Standard for Medical Laboratories (ISO 15189)
Statement from CPA website http://www.cpa-uk.co.uk:
As the joint audit of the CPA UKAS partnership draws nearer, the issue of the CPA standards and their relationship to ISO 15189 has been an important discussion topic for both the CPA Board and its shareholding bodies.
It is recognised that for the joint audit to be successful, CPA standards should incorporate all the requirements of the international standard (ISO 15189) and therefore the CPA Standards, Training and Education Group were asked to undertake a full gap analysis. The other main issue to highlight was the wording and interpretation of standards B1 and B2.
The resulting revised standards has now been issued and this April sees the first audits against the new standards commence.
The new standards introduce a number of changes and they range from simple changes to non-conformity terms and definitions for example the introduction of the term Remedial Action, to more significant changes like the introduction of new procedures for Identification and Control of Non-conformity and Establishment and review of Laboratory Service Agreement.
With the introduction of a significant number of amendments and new requirements in the standards, how long will it take to get back up to speed?
Have these changes generated lots of work to ensure organisations are complying to the new requirements or has it been a walk in the park?
Discuss this further in the related forum post in the healthcare forums.