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For laboratories considering implementation of an ISO 15189 program, this course summarizes each of the main clauses of the ISO standard, clarifying the intent of the clause and the key requirements.

See video recordings of the CAP’s ISO 15189 assessors who offer context and examples of how technical problems relate to more fundamental deficiencies in the quality management system.

The course is updated for the ISO 15189:2022 edition.

As a result of completing this activity, participants should be able to:

  • Identify the intent and key requirements of each of the main sections of the ISO 15189:2022 standard.
  • Identify how CAP 15189 assessors determine whether a laboratory meets the key ISO 15189 requirements.
  • Describe the benefits of a complete quality management system (QMS) for the laboratory.
  • Recognize links between technical problems and more fundamental deficiencies in the quality management system.

Laboratory quality managers, medical and administrative directors, and executive decision makers who are considering implementing the ISO 15189 program in their laboratories

Duration: 2 hours

Availability: January 1, 2024 - December 31, 2025

  • After purchase, there is one year to log in / register into this activity.
  • To ensure you receive continuing education (CE) credit, the activity must be completed and credits claimed by the posted activity expiration date.
  • More than one year after the purchase date, participants will no longer be able to register.

Course Features

  • Delivered online via interface that allows participants to learn at their own pace.
  • Device-responsive – learners can access the courses with device-responsive software that works for smart phones, tablets, or laptops.
  • Individual learners can use their own login and will have their own bookmarking when they leave and return to the course.

Sample Course Content (PDF)

Non-Member Price:   $395.00  
Member Price:  $395.00