» Application & Assessment Process

Application & Assessment Process: ISO 15189:2012

Summary of the key stages:

UKAS Application forms to be submitted: Online application form (including UKAS agreement). These ALL need to be completed and submitted, approximately 6 months before the 6 month period in which the main visit is due. You will be sent electronic copies of these documents at the appropriate time.

UKAS ONLY requires the Quality Manual to be submitted with the application forms.

Laboratories will need to have completed their 'own' GAP analysis to identify any areas for development against ISO 15189 requirements. This analysis should be completed 3 months before the planned visit.

To read the key differences between ISO 15189:2012 and the CPA standards, and the difference in the assessment approach, see below.

Summary of Differences between ISO 15189 2012 and CPA

Summary of Differences between ISO 15189 2012 and CPA

Assessment Focus - Differences

Assessment Focus - Differences (pdf)

 The Assessment - key areas to be aware of:

  • It's important that the Laboratory maintains CPA accreditation during the transition process. The visit will therefore be an assessment against CPA standards and ISO 15189.
  • There is no requirement to organise a user group meeting.
  • 5 - 8 weeks prior to the visit, you will be required to submit information e.g. method documentation including validation/verification.
  • The action to be taken to close out any non conformities is agreed and documented on the day with the Assessment Team.
  • UKAS does not categorise non conformities into 'critical' or 'non critical'. Where there is non conformance against the standard, leading to the need for an improvement action to be recorded, this action is then mandatory in order for accreditation to be granted.
  • The overall structure of the visit will be similar to that of a CPA main visit.

For information about the UKAS reporting and assessment process, please refer to these UKAS publications.