Certificate Program: Quality Auditor Course on ISO 15189:2012 (3 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 |
| 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 - 1715 | Discussion on Case Study 1 |
| 1715 - 1730 | Outline of Case Study 2: Evaluation of Quality Manual |
| Day 3 | |
| 0830 - 0900 | Review of Day 2 |
| 0900 - 1100 | Discussion on the case study -2 |
| 1100 – 1115 | Tea Break |
| 1115 – 1215 | Case Study 3: Writing of Standard Operating Procedure (SOP) |
| 1215 – 1315 | Audit and its associated activities (what is audit? why audit is done? How audit is done?) |
| 1315 – 1345 | Lunch Break |
| 1345 - 1530 | Group Exercise: Conduct of mock audit |
| 1530 – 1545 | Tea Break |
| 1545 - 1600 | Process of Accreditation |
| 1600 - 1700 | Written Test |
| 1700- 1715 | Feedback & Close |
What is covered in the course for Quality Auditor for Medical Laboratory as per ISO 15189?
(a) Quality Management System and (b) Internal Auditing
(a) What is covered in Quality Management System as per ISO 15189?
| 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 | |
What is covered in Internal Audit?
- What is audit
- Types of audits
- What is Internal Audit
- Process of Internal Audit including planning and execution
- Internal Audit Report writing
- Follow-up and Closing the loop
