Program requirements are based on the following International Organization for Standardization (ISO) standards:
- ISO 15189:2012 Medical laboratories — Particular 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 Statues 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.