ISO 15189:2012 and CLIA Clinical Laboratory Accreditation



This two-day course will use lecture, discussion and interactive exercises to assist you in understanding the benefit of the newly revised and recently published ISO 15189:2012 standard. Through the implementation of 'best in class' guidance contained in ISO 15189, you will be able to: Use a systems view of quality management to better design and implement 'best in class' laboratory functions; Design a 'best in class' total laboratory process that addresses the principles of quality medical laboratory services; and Implement pre-examination, examination and post-examination processes essential to 'best in class' patient care, specific to your laboratory.

The CLIA portion of the seminar will focus on a new risk-based initiative recently introduced by CMS: The IQCP or Individualized Quality Control Plan. You will:

  • Gain an understanding of risk assessment and risk management concepts and tools;
  • Be able to list the five areas of risk identified by CMS; and
  • Understand how ISO 15189 and the CLIA regulations complement one another.


The course content includes a comprehensive look at the ISO 15189 clauses, risk concepts and tools and IQCP requirements allowing you to better:

  • Design, control and implement documents and information;
  • Manage arrangements with clients, referral laboratories and consultants, suppliers and advisory services;
  • Identify, manage, monitor and learn from complaints and non-conformances;
  • Use corrective and preventive action processes, internal audits and management reviews for continual improvement;
  • Engage your human resource function;
  • Effectively implement the key process inputs to the critical laboratory systems of pre-analytic, analytic, post-analytic and reporting phases;
  • Compete and fully participate in the domestic and international laboratory marketplace;
  • Effectively use robust tools to assess and manage laboratory risk;
  • Know when and how to implement an IQCP;
  • Meet ethical and professional obligations to the patients and laboratory users you serve; and
  • Surpass minimal quality requirements set by many governments and regulatory agencies.


There is no pre-requisite for this course.


Clinical laboratory management personnel


There is no exam for this course.


After successful completion of this course, attendees will be able to:

  • Continuously be prepared for the on-going regulatory visits that are integral to the clinical laboratory business;
  • Find yourself moving from reactionary management to more proactive management in order to ensure best practices for patient health and care; and
  • Better understand the intricacies of your business to facilitate continual improvement.


1.2 CEUs Awarded*


This course will use lecture, discussion and interactive exercises.

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