American Association for Laboratory Accreditation

ISO 15189 and Medical Laboratory Accreditation



This 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 course content includes a comprehensive look at the ISO 15189 clauses, 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;
  • 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.

When you effectively apply this knowledge you will:

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



Lisa Walters, Greg Cooper or other A2LA-approved instructor.

PLEASE NOTE: A2LA can offer on-site training at your facility. For additional information about this option, please contact Julie Collins, A2LA Training and Membership Administrator, at 301 644 3235 or