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Advanced Course on Medical Laboratory Quality Management System (2 Days)

Event
TimeActivities
Day 1
0830 – 0900Registration
0900 – 0930Introduction to the training course
0930 – 0950Laboratory Accreditation : International Scenario
0950 - 1000Group Photo
1000 – 1015Tea Break
1015 – 1300ISO 15189:2012 – Clause 4: Management Requirements
1300 – 1330Lunch Break
1330 – 1530ISO 15189:2012 – Clause 4: Management Requirements
1530 – 1545Tea Break
1545 – 1700Exercise No. 1: Clause identification (reference clause 4)
1700 – 1730Outline of Case Study 1: Policy, Procedure, Process, Document & Record
Outline of Case Study 2: Evaluation of Quality Manual for Clause 4
Day 2
0830 – 0900Review of Day 1
0900 – 1100ISO 15189:2012 – Clause 5: Technical Requirements
1100 – 1145Tea Break
1145 – 1300ISO 15189:2012 – Clause 5: Technical Requirements
1300 - 1330Lunch Break
1330 – 1530Exercise No. 2: Clause identification (reference clause 5)
1530 – 1545Tea Break
1545 – 1630Discussion on Case Study 1: Policy, Procedure, Process, Document & Record
1630 - 1730Discussion on Case Study 2: Evaluation of Quality Manual for Clause 4
1730 - 1800Feedback & 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 RequirementsTechnical Requirements
Organisation and Management responsibilityPersonnel
Quality management systemAccommodation and environmental conditions
Document controlLaboratory equipment, reagents and consumables
Service agreementsPre-examination, examination and post-examination processes
Examination by referral laboratoriesEnsuring quality of examination results
External services and suppliesReporting of results
Advisory servicesRelease of results
Resolution of complaintsLaboratory information management.
Identification and control of nonconformities
Corrective action
Preventive action
Continual improvement
Control of records
Evaluation and audits
Management review

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