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Designing an Effective Quality Management System

Quality Systems Documentation

Course Content:

  • Introduction & Course Objectives
  • The history of Quality Assurance
  • The process approach
  • System requirements of IS EN ISO 9001:2015 or ISO 13485:2016
  • Other standards based on ISO 9001:2015
  • Permissable exclusions
  • Certification process & costs
  • Quality Management System Documents
  • Process Mapping & Metrics
  • Introduction to Quality Management System Auditing
  • Audit checklists
  • Q&A
  • Conclude & Follow Up Process