Chapter 4 · Implementation pathway and accreditation

The pathway to ISO 15189 accreditation: gap analysis against the standard, documentation development, staff training, a period of implementation and evidence collection, internal audit, management review, and then application to an accreditation body. In Georgia, accreditation is granted by the Georgian Accreditation Centre (GEAC). The laboratory must be able to present objective evidence for every clause.

Practical example

A laboratory director asks how long ISO 15189 accreditation takes. Good practice: The QM presents a 12-month timeline: months 1–3 gap analysis and documentation, months 4–6 implementation and training, months 7–9 evidence collection and internal audit, months 10–12 management review and application. Poor practice: The director submits an accreditation application after two months, before any internal audit or management review — the application will fail at assessment.

What this means for your practice: ISO 15189 accreditation is a journey, not an event. The accreditation body is looking for evidence of a functioning quality system, which takes time to build and demonstrate.