QMS 4 - EVALUATION & CONTINUAL IMPROVEMENT
4.1.5-2 ISO review 2024
Illuminating the Path to ISO 15189 (SLMTA 3) e-Learning Course Download Video
- Overview
- Resources
PURPOSE:
Beneath every problem lies a cause for that problem. If the cause is reduced or eliminated, the risk is also reduced.
In this session, participants solve a complex problem, which entered the corrective action process, using the Root Cause Analysis (RCA) methodology, a structured problem-solving approach.
KEY MESSAGES:
- Prioritization is the key so that laboratories apply their problem-solving resources where they are needed the most.
- Root cause analysis is a consistent and disciplined problem-solving process that focuses on systems and processes and not individual performance.
- Understand the process, and then ask WHY.
SELF ASSESSMENT:
Can you:
- Understand the importance of selecting the right problem for RCA?
- Perform RCA given a nonconformity?
- Relate the ISO15189 4.10 Corrective Action standards with the RCA model?
Instructor(s)
Janet Scholtz
Ms. Scholtz helped redesign the classroom-based SLMTA 3 curriculum for on-line delivery and will serve as an instructor and facilitator of the e-learning course. Ms. Scholtz is a Quality Manager, Regional Western and Northern Cape, at National Health Laboratory Services (NHLS), South Africa. She is a certified auditor for The South African National Accreditation System (SANAS). Ms. Scholtz has a Medical diploma in Biomedical Technology. She is a SLMTA master trainer and has trained numerous laboratorians in the past decade.