Date:  16 September, 2014


Accreditation Requirements and Guidance Information

Program requirements are based on the following International Organization for Standardization (ISO) standards:

  • ISO 15189:2012 Medical laboratories — Requirements for quality and competence
  • ISO 15190:2003 Medical laboratories – Requirements for safety
  • ISO 22870:2006 Point-of-care testing (POCT) – Requirements for quality and competence

In addition, these Canadian national standards are also fully addressed:

  • CAN/CSA-Z15190-05 Medical Laboratories – Requirements for Safety
  • CSA Z902-10 Blood and Blood Components February 2010

Requirement development was aided by cross-referencing these standards to generally accepted principles of good practice in Ontario. As a result, additional documents are also referenced:

  • Canadian Statutes and Regulations (for laboratories located outside Canada, local regulations apply)
  • Provincial Statutes and Regulations
  • Health Canada Guidelines

Standards and guidelines achieved through consensus by international, North American, Canadian and provincial associations, federations, organizations and regulatory bodies.

Each accreditation requirement has an accompanying reference source. Additional good practice recommendations are included with the requirements.

Accompanying each requirement and good practice recommendation is “What To Look For” guidance information that explains the intent of the requirement and provides insight into its application.

Download OLA Program Information OLA Program Information

Decoding ISO 15189 Interactive Online Education

Become OLA 15189PLUS™ Accredited
Demonstrate your commitment to excellence through accreditation to OLA 15189PLUS™. Labs interested in undergoing accreditation by the program that has accredited over 250 labs can apply through our distributor, IQMH. Learn more>>
Accreditation Requirements
OLA’s Accreditation Requirements translate complex ISO and Canada Standards Association (CSA) requirements into explicit criteria that your lab can use to prepare for accreditation. The Accreditation Requirements are available through our distributor, IQMH. Learn more>>
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