Advanced Course on Medical Laboratory Quality Management System (2 Days)
Time | Activities |
---|---|
Day 1 | |
0830 – 0900 | Registration |
0900 – 0930 | Introduction to the training course |
0930 – 0950 | Laboratory Accreditation : International Scenario |
0950 - 1000 | Group Photo |
1000 – 1015 | Tea Break |
1015 – 1300 | ISO 15189:2012 – Clause 4: Management Requirements |
1300 – 1330 | Lunch Break |
1330 – 1530 | ISO 15189:2012 – Clause 4: Management Requirements |
1530 – 1545 | Tea Break |
1545 – 1700 | Exercise No. 1: Clause identification (reference clause 4) |
1700 – 1730 | Outline of Case Study 1: Policy, Procedure, Process, Document & Record |
Outline of Case Study 2: Evaluation of Quality Manual for Clause 4 |
|
Day 2 | |
0830 – 0900 | Review of Day 1 |
0900 – 1100 | ISO 15189:2012 – Clause 5: Technical Requirements |
1100 – 1145 | Tea Break |
1145 – 1300 | ISO 15189:2012 – Clause 5: Technical Requirements |
1300 - 1330 | Lunch Break |
1330 – 1530 | Exercise No. 2: Clause identification (reference clause 5) |
1530 – 1545 | Tea Break |
1545 – 1630 | Discussion on Case Study 1: Policy, Procedure, Process, Document & Record |
1630 - 1730 | Discussion on Case Study 2: Evaluation of Quality Manual for Clause 4 |
1730 - 1800 | Feedback & Close |
What is covered in the course for Quality Management System for Medical Laboratory as per ISO 15189?
Understanding of the requirements of ISO 15189 on the following heads:
Management Requirements | Technical Requirements |
---|---|
Organisation and Management responsibility | Personnel |
Quality management system | Accommodation and environmental conditions |
Document control | Laboratory equipment, reagents and consumables |
Service agreements | Pre-examination, examination and post-examination processes |
Examination by referral laboratories | Ensuring quality of examination results |
External services and supplies | Reporting of results |
Advisory services | Release of results |
Resolution of complaints | Laboratory information management. |
Identification and control of nonconformities | |
Corrective action | |
Preventive action | |
Continual improvement | |
Control of records | |
Evaluation and audits | |
Management review | |