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The IQMH Requirements and Guidance Information for Medical Laboratories

Demonstrate compliance to ISO 15189 and more. Available in English or French, our program requirements are based on multiple international standards conveniently displayed in a single document with guidance information.

 

  • ISO 15189:2012 Medical laboratories — Requirements for quality and competence
  • ISO 15190:2003 Medical laboratories — Requirements for safety
  • ISO 22870:2016 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. 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.

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Management in Healthcare

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