QMS Tier 2-3
REVIEW OBJECTIVES FOR TRAINEE ASSESSORS:
- To undertake a review of the contents of the ISO 15189:2012 Standard prior to moving to the ISO 15189:2022
- To assess the level of your knowledge of the ISO 15189:2012 Standard requirements
- To be better prepared to participate fully in the QMS Tiers 2-3 Programme in compliance with the ISO 15189 2022 Standard.
Implementation of quality management systems (QMS) in Caribbean Medical Laboratories will be based on the requirements of the ISO 15189 Standard that is acknowledged to be the benchmark standard for the Caribbean region. The ISO 15189 Standard is to be used by medical laboratories, not only to develop their QMS, but to assess the competence of laboratory staff. Compliance with this Standard is also recognised as a sign of the laboratory’s competence by customers, regulating authorities and accreditation bodies.
The previous version of this Standard was the ISO 15189:2012. A revision of this standard has been completed and the new approved version is now the ISO 15189:2022. While the new version of the ISO Standard:2022 has significant changes, the essentials of the Standard are very similar and relatable. Thus, a review of and re-familiarisation with the Standard used in your previous Phase 1 training (ISO 15189:2012) will benefit the start-up of your Phase 2 experience.
Successful QMS implementation will depend on your knowledge, understanding and application of the ISO 15189 requirements. The first step in your training in QMS Tier 2 & 3 will thus begin with a thorough review of the 2012 Standard. We have developed a pre-assessment exercise that will require you to have ready access to a copy of the ISO 15189:2012 Standard and/or the CMLF LQMS-SIP tool (attached).
Reminder: You will need a copy of the ISO 15189:2022 Standard in order to fully participate in the Assessor’s Phase 2 training programme.