The principle international standards on which our programs are based are:
- ISO 15189:2012 Medical laboratories - Requirements for quality and competence
- ISO 15190:2020 Medical laboratories - Requirements for safety
- ISO 22870:2016 Point-of-care testing (POCT) - 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 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.
Because of the extra rigour of our requirements, our programs are brand named ISO 15189 Plus™.
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.
AC Diagnostics Accreditation Requirements and Guidance Information are available for purchase. Click here to read the product description and how to order. Once an application for accreditation is submitted, that facility 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.