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 | |