Technical Assessor Training (T.A.T): PHASE 2
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 Assessors Phase 2 Training Programme in compliance with the ISO 15189 2022 Standard.
Assessments to be conducted in Caribbean Medical Laboratories will be based on the requirements of the ISO 15189 Standard, to be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory 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 laboratory assessments will depend on an Assessor’s knowledge, understanding and application of the ISO 15189 requirements. Your Phase 2 continued training as an assessor 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.