ISO9001 System Introduction & Standard Review

(1 days)

Course Summary:

This course provides the history for development of the ISO9001 family of standards. A thorough review of the ISO9001 standard including specific points for the application to healthcare and specific exercises to emphasize relevance to healthcare. Finally this course includes a basic review of the documentation system for ISO9001 in healthcare and review of the key NIAHOSM integration points of the quality management system.

This Course also includes:

  • On-site instruction at your location or preferred site.
  • One day of full access to highly trained, knowledgeable ISO accredited consultants.

Course Outcome:

  • Onsite consultation support
  • Development the business application of ISO9001.
  • Identify the common requirements for implementation of ISO9001 in hospitals.
  • Participants keep useful course materials for valuable future reference.
  • Review of the workshop assignment form.
  • Providing a foundation for leadership.
   Topics  Key Objectives
  • Simplicity of ISO9001
  • Foundation of ISO9001
  • Differences between Management Systems as it relates to Healthcare
  • ISO9001 Clauses 1–6
  • Exercise Clauses 4–6
  • ISO9001 Clauses 7–8
  • ISO9001 Clauses 7–8
  • Exercise Clauses 7–8
  • Healthcare document as related to ISO9001 system design
  • ISO9001 and NIAHOSM 
  • Integration of the requirements
  • Assignment for review
  • Develop the business application of ISO9001
  • Identify the required documents of an ISO9001 system
  • Identify the application of clauses 1 – 6 to healthcare
  • Identify the application of clauses 7 – 8 to healthcare
  • Identify common areas of ISO and NIAHOSM and their relationship.
  • Provide the relationship between ISO9001,NIAHOSM  and regulatory requirements
  • Apply ISO9001 to healthcare activities.