ISO 13485 Medical Devices

About ISO 13485 for medical devices

ISO 13485 is an international standard for manufacturers and certifiers of medical devices. When a device is described as meeting ISO 13485, it means it has been made following the requirements of the standard. ISO 13485:2016 specifies the requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and applicable regulatory requirements and, where relevant, patient safety goals.

The ISO 13485:2016 version

The most recent revision of ISO 13485 was published in March 2016. ISO 13485:2016 is a major update from ISO 13485:2003, published to reflect changes in regulation and technology, improve clarity, and align with ISO 9001 and other requirements.

What is a medical device?

ISO 13485 defines a medical device as an instrument, apparatus, appliance, software, material, or other article intended by the manufacturer to be used on humans for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Examples include:

• Spectacle lenses for correcting defective vision
• Pacemakers
• Dialysis machines
• Bone plates and screws for fractures
• Intravenous infusion pumps

What is ISO 13485 certification?

ISO 13485 certification verifies that your organization’s medical device quality management system conforms to the standard. Medical device regulators around the world – such as the EU (under its Medical Devices Regulation), Health Canada, and the US FDA – require or reference an ISO 13485-based QMS, so certification helps ensure your devices meet high quality requirements and are safe for patients.  

Once your processes and procedures are in place, you operate the QMS for a period of time to gather the records needed for the audit, review, and certification. The steps that follow your documentation include:

• Internal audit – to confirm your QMS procedures work properly, keep records that demonstrate compliance, and identify any flaws or vulnerabilities.
• Management review – a formal evaluation by management of key facts about the management system, to make decisions and assign resources.
• Corrective actions – addressing the root cause of any issues found and documenting how they were resolved.

The certification audit, conducted by a certification body, has two stages:

• Stage 1 (preliminary audit): auditors check that your documentation complies with the standard and conduct a preliminary review to confirm the QMS is properly implemented.
• Stage 2 (implementation audit): auditors examine your records and practices to confirm your actual activities comply with both the standard and your own documentation, and check that any non-conformities from Stage 1 are resolved. On passing, certification is issued.

ISO 13485 training

The ISO 13485 training courses give you the knowledge to understand the standard, start building your QMS, and complete certification audits. ISO 13485 is a complex standard, and structured training is an efficient way to learn it. Completing a course also provides a certificate that shows employers you have the skills for medical device QMS auditing. The courses available include:

• Lead Auditor Course (5 days): helps participants understand the ISO 13485 QMS standard and how to audit management systems against it. It includes an exam, and completing an accredited course is generally required before you can audit for a certification body.
• Internal Auditor Training (2 days): based on the lead auditor course but without the detail on conducting external third-party audits – ideal for those starting out with internal audits.
• Awareness and Implementation Courses (1-2 days): general information about ISO 13485 and how to put it into practice – useful for all employees involved in a QMS.

Benefits of ISO 13485 certification

ISO 13485 certification shows that your products are made in line with internationally recognized standards, helping you win global business. Benefits include:

• New business relationships
• A competitive edge
• Greater efficiency and lower costs
• Safer, more effective medical devices
• More knowledgeable, empowered employees
• Higher customer satisfaction and retention

Contact IAS today to learn more about ISO 13485 for medical devices, 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
• ISO 13485 in Canada – including the Health Canada.