Medical Laboratory Accreditation Requirements
Requirements
Purpose
Accreditation Canada (AC) Diagnostics is a signatory to the Mutual Recognition Arrangement with the International Laboratory Accreditation Cooperation (ILAC). These achievements set our services apart from others by demonstrating that we meet international standards for operating an accreditation body. We undergo a rigorous peer evaluation by an international team every four years.
Our role is to elevate confidence in the healthcare system by providing recognition of quality and competence. Our program is mandated by three provinces in Canada (Ontario, New Brunswick and Newfoundland & Labrador) for laboratories, and subscribed to voluntarily by other clients, including diagnostic imaging services.
The principle international standard on which our programs are based is ISO 15189: Medical laboratories —Requirements for quality and competence.
For each program, AC Diagnostics has defined the applicable requirements necessary to issue an accreditation certificate and has provided extensive guidance for each requirement. The AC Diagnostics Accreditation Requirements include not only the applicable clauses of the appropriate international standards but also:
- Additional Canadian Statutes and Regulations (for services located outside Canada, local regulations apply)
- Provincial Statutes and Regulations
- Health Canada Guidelines
- Standards and guidelines are achieved through consensus by international, North American, Canadian, and provincial associations, federations, organizations, and regulatory bodies.
Because of the extra rigour of our requirements, our programs are brand named ISO 15189 Plus™.
One of the first steps is for you to carefully review our requirements and determine if you are ready for our program. It is important for you to purchase these checklists prior to committing to an assessment to gain a better understanding of the ISO 15189 Plus™ program and its requirements. The requirements give insight into the rigorous standards facilities are required to meet along with valuable guidance information
Each accreditation requirement has an accompanying reference source. Accompanying each requirement is “What To Look For” guidance information that explains the intent of the requirement and provides insight into its application. Usually, this guidance information is phrased as a question and may include an indication of documents and records required to meet the requirements.
To review additional information about our program, please review the AC Diagnostics Program Information Guide. Click on the link to access the document: AC DIAGNOSTICS PROGRAM INFORMATION GUIDE
Applicability
These requirements are intended to apply to Medical Laboratory Services. Requirements purchased online are delivered as printable PDF downloads.
Once your facility is onboarded as a new client you will receive additional enhanced access to the requirements and guidance information through QView™, our password-protected web portal. This will include automatic updates of new versions of the requirements.