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
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 laboratory program is mandated by three provinces in Canada (Ontario, New Brunswick, and Newfoundland & Labrador), and subscribed to voluntarily by other clients in the Laboratory and Diagnostic Imaging industry.
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 may 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.
One of the first documents you should consult is the “STEPS TO ISO 15189 PLUS™ ACCREDITATION”. Click on the link to access the document: STEPS TO ISO 15189 PLUS™ ACCREDITATION
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
The application cost is a non-refundable $200.00 preliminary fee which covers the costs associated with opening your file. Once the application is submitted, the information gathered in your application will facilitate determining the specifics related to your assessment process.
We strongly recommend that the Accreditation requirements, currently branded under IQMH, be purchased alongside of the application. The link to purchase the application is below. The cost of the Accreditation requirements is $650.00.
LINK TO PURCHASE REQUIREMENTS FOR LABORATORY ACCREDITATION
Following review of the information provided in the application form and discussion with the potential client, AC Diagnostics will provide an enrollment form for accreditation which will include a pricing estimate. Submission of a completed enrollment form indicates the accreditation client’s agreement with their rights and obligations. The Program Annual fees are due after the signing of the enrollment form.
In Ontario, any medical laboratory performing testing for the purposes of diagnosis, prevention, or treatment; or for COVID-19 testing is required to obtain a license from the Ontario Ministry of Health (MOH) as per Ontario Regulation. For this type of testing, licensing is required, and cannot be bypassed. If granted a license, accreditation through AC Diagnostics is mandatory; the MOH will notify us, and we will follow up with you. Please contact the MOH at email@example.com.
Additional costs associated to Accreditation:
- Direct costs and an administration fee associated with accreditation assessment and surveillance visits. Costs include staff and team travel, insurance, visas as well as labour associated with self-assessment, documentation review, coordination and preparation for the visit, on-site assessment, and follow-up activities. A price estimate will be provided once the application is received.
A maintenance fee is invoiced annually.
Purchase, complete and submit the accreditation application to start your journey.
We look forward to working with you in your path to accreditation.