ISO 13485 Certification

About ISO 13485 Certification in Canada

The International Standard ISO 13485 establishes criteria for firms that provide medical devices and equipment to improve their quality management systems. It specifies control measures to reduce manufacturing process and system operating faults. This standard also assures that the quality of medical equipment continues to improve.

ISO 13485:2016 Version

This is the most recent version of the ISO 13485 standard, which was created using a process-oriented approach to eliminate operational mistakes and risks in the management system. ISO 13485:2016 is compatible with other ISO management system standards because it is proposed with a high-level framework and PDCA cycle. Furthermore, its risk-based thinking approach enables firms to constantly meet the needs of their consumers.

ISO 13485 in Canada – What is a Medical Device?

A medical device is a device that is used to diagnose, prevent, cure diseases or other medical conditions, such as an instrument, machine, implant, or in vitro reagent. The following are some examples of common medical devices:

  • pacemakers
  • medical thermometers
  • surgical tables/chairs
  • MRI scanners
  • EKG machines
  • Respiratory ventilators

What is ISO 13485 Certification?

The safety of professionals and patients in clinics, hospitals, and other medical facilities is ensured by companies that receive ISO 13485 certification. ISO 13485 certification focuses on the criteria for enterprises that design and produce medical devices and equipment to establish and maintain a quality management system. It is required by the United States Food and Drug Administration for medical device manufacturers who require ISO 13485 Certification before delivering products to the United States.

ISO 13485 Certification

Who Requires ISO 13485 Certification?

Medical device firms must have ISO 13485 certification for their quality management systems. ISO 13485 certification is required for companies that design, manufacture, install, and service medical equipment and related services. When performing compliance evaluations, regulatory bodies and certifying organizations can use ISO 13485 certification as a quality assurance baseline. Because it is an internationally recognized standard of quality and safety for medical device manufacture, ISO 13485 certification helps firms gain recognition as more respected, trustworthy providers.

What are the ISO 13485 Certification Requirements?

An enterprise must meet particular requirements of ISO 13485 standards in order to obtain ISO 13485 certification. There are various clauses in ISO that apply to medical devices and ISO procedures. ISO 13485 certification verifies that a medical device manufacturer is ISO compliant and that ISO procedures have been implemented. Organizations that implement ISO 13485 in Canada have to take care of many aspects including training, audits, documentation, and risk management. The following are some of the ISO 13485 certification requirements:

  • Design Controls Review
  • ISO-Compliance Documentation Development and Management
  • Risk Analysis
  • The Use of Peer Review to Demonstrate ISO 13485 Compliance
  • Identifying ISO-Required Documents
  • Plan for ISO 13485 Training
  • ISO 13485 Internal Audit

Once your organization implements ISO 13485 standards, IAS will review your documentation and processes. Following this procedure, IAS will conduct external audits to ensure your organization is properly implementing ISO 13485 standards. Upon successful completion of these audits, IAS will issue ISO 13485 certification to your company.

ISO 13485 Certification Audit Online

IAS now conducts ISO 13485 certification audits using an online web testing platform. After the audit is successfully conducted, IAS issues ISO 13485 certification stating that your business is ISO 13485 certified under various criteria, based on the online test scenarios for your system documentation, testing all policies, and other connected procedures.

Who Can Apply for ISO 13485 Certification?

The ISO 13485 certification standards apply to all companies/industries that manufacture and distribute medical devices and equipment, regardless of their size or location. Furthermore, ISO 13485 certification applies to those sectors that provide related services as well. Thus, ISO 13485 in Canada can be implemented by any organization involved in the medical device supply chain.

Benefits of ISO 13485 Certification

Companies certified to ISO 13485 in Canada enjoy a host of benefits, including the following:

  • Improvements in medical device quality and safety
  • Reduces waste and errors in operations
  • Demonstrates adherence to local laws and regulations
  • Encourages client trust and satisfaction
  • Relationships with stakeholders are strengthened
  • On a global scale, it creates new business prospects

Why choose IAS to Obtain ISO 13485 Certification?

Although the International Organization for Standardization (ISO) establishes and publishes the ISO 13485 standards, they do not perform certification. Therefore, organizations turn to third-party certification bodies to obtain ISO 13485 certification such as IAS. IAS is a leading ISO 13485 Certification body in Canada and assists companies in ensuring that their ISO 13485 quality management system is effective by conducting conformity assessments with certified experts who are experienced auditors. IAS audits your operations against the standard’s requirements to ensure you properly obtain ISO 13485 certification in a timely manner.

Once you successfully achieve ISO 13485 Certification, you can check the status of your certificate by visiting our ISO 13485 Certification search Page!

How to Contact us?

There are plenty of ways to reach us.

  • Visit our website –
  • Send us your inquiry through our website
  • Drop a mail to [email protected]
  • You can also fill out our ISO 13485 Certification application form and send it to us
  • Or contact us directly to have a free discussion about the auditing process specific to your organization

Click here to learn more about our ISO 13485 Certification process! Also, see the ISO 13485 certification frequently asked questions page to learn more!