QMS 1 - MANAGEMENT RESPONSIBILITY
1.4.4-2 Records Process Map
Illuminating the Path to ISO 15189 (SLMTA 3) e-Learning Course Download Video
- Overview
- Resources
PURPOSE:
Through process mapping, the activity steps and their linkages will be discussed so that participants will better understand the ISO 15189 sub-clause and how to achieve the intended quality output and minimizes the risks of unintended (e.g. defective, nonconforming) outputs. Gaining clarity, the participants will be better able to effectively lead the quality planning at their site.
In this activity, participants will explore the numerous interrelated or interacting processes of ISO 15189 8.4 Control of Records, a QMS sub-system
KEY MESSAGES:
-
By taking a process-based approach, ISO 15189 standard can be transformed into a practical tool.
-
A process map can bring clarity and better understanding.
-
Connections to other sub-clauses in the standard can easily be seen.
SELF ASSESSMENT:
Can you:
- Map the process?
- Describe what happens at each step?
- Identify where other sub-clauses interconnect?
Instructor(s)
Elde Mel Paladar
Mr. Paladar led the redesign of the classroom-based SLMTA 3 curriculum for on-line delivery and will serve as an instructor and facilitator of the e-learning course. Based in Malawi, he is a Project Manager at Adventist Health International, as well as Assistant Professor at the Department of Clinical Laboratory Science, Loma Linda University. Mr. Paladar has a Master of Science in Biochemistry and Molecular Biology. He is a SLMTA master trainer and has trained numerous laboratorians in the past decade.