Understanding ISO 9001 for Healthcare

Learn the concepts of ISO 9001 through the use of hands-on, interactive learning. This course covers an in-depth, clause by clause review of the Standard.

Length:  1 day     Prerequisites:  None

Learning Objectives

  • Demonstrate an understanding of the purpose and intent of the ISO 9001 Standard through a clause by clause review
  • Demonstrate an understanding of the process approach and relate how it impacts the use of ISO 9001
  • Apply of each of the standard’s clauses
  • Develop and utilize Turtle Diagrams

Plexus Learning Model

Learning is maximized through participation. That is why Plexus training avoids lecture-based teaching and focuses on group activities, case studies and hands-on applications. Learn by doing.

Who Should Attend

  • Any member of an ISO 9001 implementation team
  • New internal auditors and experienced auditors that have not attended training in over three years
  • Representatives from key functional groups involved in an organization’s quality management system

Instructors

Plexus Master Trainers. Plexus Master Trainers train and evaluate:

  • ISO 9001:2008, ISO/TS 16949:2009, AS9100, ISO 14001:2004 Environmental Management Systems, FSSC 22000:2005 Food Safety, ISO 9001:2008 for Healthcare and ISO 13485:2003 for Medical Devices.
  • Plexus trains 3rd party auditors and wrote the materials used to certify all of them

Agenda


Day 1

  • Purpose and Objectives
  • Process Approach and Impacts
  • Clause by clause review of ISO 9001

Day 2

  • Clause by clause review of ISO 9001
  • Quality Management Principles
  • Closure and Planning: Opportunities, roadblocks and implementation planning



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