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Process

AC Diagnostics accreditation is a four year cycle with an assessment every two years and a certificate that is valid for four years.

New AC Diagnostics applicants must submit a self-assessment within a year of application. An initial assessment visit can occur in as little as four months after completion of the self-assessment. It will take about five months after the initial assessment to correct any non-conformances identified and for AC Diagnostics to issue an accreditation certificate. New applicants will receive a surveillance visit about one year after the issuance of their certificate. A surveillance visit will occur two years after the initial visit. Full reassessment will occur in another two years. Thereafter, assessment visits and surveillance visits will alternate every two years. Additional focused surveillance visits for cause may be required during the four-year accreditation cycle.

Application

ISO 15189 Plus™ Accreditation

Become a world-class facility. Demonstrate your commitment to patient safety when you become ISO 15189 Plus™-accredited. Organizations that achieve ISO 15189 Plus™ accreditation standardize their processes, set up document control and implement a quality management system in order to address latent errors and improve patient safety. With ISO 15189 Plus™, you will:

  • Achieve certification to the internationally-recognized ISO 15189 standard
  • Engage all staff through collaboration
  • Build a quality culture
  • Implement best practices
  • Address diminishing resources
  • Reduce risk

Requirements

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.

Start Your Accreditation Journey


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Accreditation Canada Diagnostics

1500–393 University Avenue
Toronto, Ontario
M5G 1E6 Canada

Phone: 416-323-9540 
Toll-free: 1-877-323-9540 
Fax: 416-323-9324 

Email: accreditation@acdiagnostics.ca

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AC Diagnostics is a group of diagnostics assessment programs offered byAccreditation Canada.