QMS 1 - MANAGEMENT RESPONSIBILITY

1.3.1-3 Model Overview

SLMTA 3 E-Learning Course Download Video
  • Overview
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PURPOSE:

To achieve a quality management system (QMS) that is repeatable, measurable, and constantly improving, ISO 15189 requires laboratories to take a process-based approach towards quality management.

In this session, participants will integrate and align ISO 15189’s management and technical requirements into a process-based model, thus allowing participants to design a high-level outline for an effective and efficient QMS.

KEY MESSAGES:

  • The process-based model can be used as a roadmap towards designing and implementing a more effective and efficient QMS.

  • Organizational leadership and management commitment and responsibility for designing and implementing a QMS are essential to assuring the quality of laboratory services.

  • An effective and efficient QMS is repeatable, measurable, and constantly improving.

SELF ASSESSMENT:

Can you:

  • Map a process-based QMS given the 25 ISO 15189 management and technical requirements?

  • Recognize management’s responsibility for designing and implementing a QMS?

  • Recognize that the QMS design must be customer -focused and continuously improving?

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.


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