ISO 13485 in Canada
About ISO 13485
ISO 13485:2016 sets out the requirements for a quality management system (QMS) that demonstrates an organization’s ability to supply medical devices that consistently meet customer and applicable regulatory requirements. It applies to all organizations involved in the design and manufacture of medical devices, including device manufacturers and service providers.
What does it mean to be ISO 13485 certified?
The ISO 13485 standard is a stand-alone specification. It is based on the structure of ISO 9001:2015, but adds medical device-specific requirements such as risk analysis, sterile production, rework, and traceability. An organization that has established an ISO 13485 QMS and successfully met all applicable requirements, as assessed by a certification body, is referred to as an “ISO 13485-certified company.”
How to prepare your organization for ISO 13485 certification?
Documentation: a Quality Manual is central to most quality systems. Alongside it, define your commitment to creating a culture that prioritizes quality across all activities, often expressed through a policy or objective statement. The standard has specific requirements for operations and records, including a device file containing product details and instructions for use, a document-control plan, and a records-control plan.
Management responsibility: management must show they are accountable for the organization’s operations, keep focus on the needs of the end customer, and follow all applicable regulations. They are responsible for supporting the quality policy, ensuring it complies with local regulations, communicating objectives to staff, planning ahead, delegating authority, and leading the periodic Management Review.
Resource management: top management must ensure the QMS meets ISO 13485 and local regulatory requirements, and that appropriate resources – personnel, infrastructure, materials, equipment, succession planning, and risk avoidance – are available to deliver the work.
Product realization: plan the journey from concept to finished device, with documented processes for how ideas are generated, validated, planned, and developed. Strong communication supports design and development – transferring ideas, controlling the design, documenting required changes, and keeping records of all files. Define and track suppliers, link key information to each product, and validate products. Cleaning, installation, servicing, equipment monitoring and maintenance, device identification, traceability, customer property, and product preservation all form part of this stage.
Measuring, analyzing, and improving: once a device is in use, you must ensure customers get what they need. That means gathering feedback and building a system to monitor and measure product performance, including:
- Handling complaints
- Reporting to regulatory authorities
- Internal auditing and continuous process and product evaluation
- Identifying and controlling nonconforming product
- Analyzing data and continually improving the process
The ISO 13485 certification audit
Once your QMS is implemented, a certification body assesses your compliance through two external audits:
- Stage 1 (preliminary audit): auditors check that your documentation meets the requirements and that the QMS is effectively implemented.
- Stage 2 (implementation audit): auditors examine your records and processes to confirm your actual activities comply with the standard, and review whether any non-conformities from Stage 1 have been addressed. On passing, ISO 13485 certification is awarded.
Advantages of ISO 13485
ISO 13485 certification shows the world that your products are made in line with internationally recognized standards, opening up commercial opportunities. Benefits include:
- A competitive advantage and new business relationships
- Greater efficiency and lower costs
- Safer, more effective medical devices
- More knowledgeable and empowered staff
- Increased customer satisfaction
Contact IAS today to learn more about ISO 13485, or visit our frequently asked questions page.
Explore more
- ISO 13485 Certification in Canada – medical device QMS certification
- ISO 13485 Training in Canada – auditor training for medical device QMS
- 510k Submission in Canada – US market access for medical devices
Frequently Asked Questions
What is ISO 13485?
ISO 13485:2016 is the international quality management standard for organizations involved in the design, manufacture, and servicing of medical devices.
Which edition is current?
ISO 13485:2016.
Who should implement ISO 13485?
Any organization involved in the design, manufacture, servicing, or supply of medical devices.
How does the certification audit work?
A two-stage audit - a documentation/readiness review (Stage 1) and an implementation audit (Stage 2) - after which certification is awarded, with surveillance audits to maintain it.
