3 modules9 lessons~7 h

Laboratory Quality Management and ISO 15189

QC statistics, Levey–Jennings and Westgard rules, EQA, the total testing process, ISO 15189 and NABL, method verification, documents, CAPA and safety.

What you'll be able to do

✓ Calculate and use mean, SD, CV, bias and total error
✓ Apply Westgard rules and choose QC by sigma
✓ Run EQA and investigate unsatisfactory results
✓ Control pre- and post-analytical quality with indicators
✓ Explain ISO 15189 requirements and the NABL process
✓ Plan method verification studies
✓ Manage documents, records, nonconformities and safety

Syllabus

MODULE 1Statistical QCStatistics, charts and rules.
- QC statistics you will use every dayFree preview
- Levey–Jennings charts and Westgard rulesFree preview
- External quality assessment
MODULE 2The quality systemTotal testing process, ISO 15189 and verification.
- The total testing process: pre- and post-analytical quality
- ISO 15189 and NABL accreditation
- Method verification and validation
MODULE 3Documents and safetyRecords, CAPA and safety.
- Documents, records and nonconformities
- Laboratory safety and biosafety
- Final exam (25 questions)

Questions

Who is this course for?

Laboratory staff and quality managers in medical laboratories.

Is there a certificate?

Yes, an educational certificate of completion after the lessons and a 25-question final test (pass mark 70 %), verifiable online. It is not a professional licence, registration or accreditation.

Does it give NABL accreditation?

No. It explains the requirements; accreditation is granted only by NABL after assessment of a laboratory.