ISO 15189 2022 course on 2 to 3 September 2024

SINGAPORE ACCREDITATION COUNCIL

CHANGES IN ISO15189:2022 4TH EDITION

Workshop for medical laboratory professionals

2 and 3 September 2024

COURSE OUTLINE

Day 1 

Morning

Some ISO background information

Overview of differences in ISO15189:2022

Section 3 Definitions

Section 4 General requirements

Afternoon

Section 5 Structural and governance requirements

Risk management

Section 6 Resource requirements: Personnel, Facilities, Equipment & reagents etc

Section 7 Process requirements 

Day 2 

Morning

Section 7.2  Pre-examination processes

Section 7.3 Examination processes

Section 7.4 Post-examination processes

Section 7.5 Non-conforming work

Afternoon

Section 7.6 Control of data and information management

Section 7.8 Continuity and emergency preparedness planning

Section 8 Management system requirements

Annex A POCT