Course Description

Quality Manual Development

This course describes the purpose and key elements of a quality manual that meets ISO 9001 and ISO 15189 requirements. The course will provide examples drawn from quality manuals that meet these requirements. It will also explain the development process for such a manual.

Learning Objectives

After completing this course, participants will be able to:

  • Identify the audiences and purposes of a quality manual
  • Identify the necessary elements of a quality manual
  • Describe possible structures of quality manuals
  • Develop a quality manual
  • Align quality policy, quality objectives, and quality metrics

Course Length: Approximately 1-2 hours

Allowable CE Credit: 2 hours

Price: $350 for 365-day license