ISO 15189 Certification
ISO 15189 Certification in Canada
ISO 15189 is the international standard developed specifically for the quality management system of medical laboratories. It specifies requirements to establish, monitor, maintain, and continually improve the quality and competence of laboratories, and it supports accreditation bodies and regulatory authorities in evaluating medical laboratory performance. The current edition is ISO 15189:2022.
Who can apply?
Regardless of size or reputation, the requirements of ISO 15189 apply to all medical laboratories.
Benefits of certifying to ISO 15189
- Demonstrates the quality and competence of a medical laboratory
- Enhances the confidence of laboratory customers
- Supports accurate, reliable clinical results
- Promotes the laboratory’s reputation
ISO 15189 for medical laboratories in Canada
ISO 15189 is an accreditation standard for medical laboratory quality and competence. In Canada, medical laboratory accreditation to ISO 15189 is recognized through bodies such as IQMH (now Accreditation Canada Diagnostics) and provincial programs in provinces including Ontario, Newfoundland and Labrador, and New Brunswick. Accreditation bodies worldwide also participate in the International Laboratory Accreditation Cooperation (ILAC) arrangement, which supports mutual recognition of ISO 15189 results across borders.
Meeting ISO 15189 gives a Canadian medical laboratory a structured, internationally recognized way to demonstrate the reliability of its testing. IAS supports laboratories in understanding and implementing the ISO 15189 requirements and preparing for assessment.
A trusted ISO 15189 certification body in Canada – IAS
With more than 15 years of experience, IAS is a trusted ISO 15189 certification body serving medical laboratories across Canada. We provide ISO 15189 services to organizations with well-developed operational processes and management systems, and we support our clients with clear guidance through implementation of the ISO 15189 requirements and achievement of certification.
Experienced auditors
Our auditors are professional experts with years of experience in management system audits and broad knowledge of ISO standards. They guide laboratories to improve against the standard’s requirements quickly and accurately. IAS also acts as an ISO 15189 certification consultant to support organizations through the preparation process.
Global presence
IAS is a globally recognized certification body serving clients in Canada and worldwide, with branches and representatives in many countries. Alongside Canada, IAS offers ISO 15189 certification services across the Americas, Europe, the Gulf, Asia, and Africa.
Once you successfully achieve ISO 15189 certification, you can check the status of your certificate on our certificate search page.
How to contact us?
- Visit our website – ias-certification.com/ca
- Send us your enquiry through our website
- Email us at enquiry@iascertification.com
- Fill out our ISO 15189 Certification application form and send it to us
- Or contact us directly for a free discussion about the certification process specific to your organization
Visit our ISO 15189 Certification frequently asked questions page, or review the ISO 15189 audit procedure.
Related Certification and Training
- ISO 13485 Certification in Canada – quality management for medical devices
- ISO 17025 Training in Canada – testing and calibration laboratories
- ISO Certification in Canada – all IAS management system schemes
Frequently Asked Questions about ISO 15189 Certification
What is ISO 15189?
ISO 15189:2022 is the international standard for quality and competence in medical laboratories, covering both management and technical requirements.
Is ISO 15189 a certification or an accreditation?
ISO 15189 is, in practice, an accreditation standard for medical laboratory competence. IAS provides certification of conformity to the standard and supports laboratories in meeting its requirements.
How is ISO 15189 recognized in Canada?
Medical laboratory accreditation to ISO 15189 in Canada is recognized through bodies such as IQMH (now Accreditation Canada Diagnostics) and provincial programs, with international recognition through the ILAC arrangement.
Which laboratories can apply?
Any medical laboratory - clinical, hospital, research, or commercial diagnostics - of any size.
Which edition of the standard is current?
ISO 15189:2022, the fourth edition, which aligns with ISO/IEC 17025:2017 and now includes point-of-care testing requirements.
How long does the process take?
It depends on the size of the laboratory and the maturity of its existing quality system. A gap analysis at the start gives you a realistic timeline.
How long is the certificate valid?
Certification typically runs on a multi-year cycle with periodic surveillance assessments to confirm ongoing conformity.
Why does ISO 15189 matter for a medical laboratory?
It provides independent, internationally recognized assurance that the laboratory produces accurate, reliable results - building trust with clinicians, patients, and partners.