People, Education & Healthcare
ISO 13485:2016 Medical Devices QMS – Internal Auditor
Overview
A practical programme that equips staff to audit their own organisation against ISO 13485:2016. Participants learn to plan an internal audit, gather objective evidence, write clear findings and support corrective action, in line with ISO 19011.
The standard
About the standard
ISO 13485:2016
Medical Devices Quality Management System
Specifies requirements for a quality management system used by organizations involved in one or more stages of a medical device life cycle, including design, production, installation and servicing. It places particular weight on meeting regulatory obligations, controlling risk, and validating processes so devices are consistently safe and effective for their intended use. It can be applied by manufacturers as well as suppliers and other parties providing related services.
Key objectives
- Ensure medical devices are consistently designed, produced and delivered safely
- Support compliance with regulatory requirements across different jurisdictions
- Embed risk management throughout the medical device life cycle
- Validate and control processes critical to device safety and performance
- Provide a QMS framework usable by manufacturers and their suppliers alike
Who uses it
Manufacturers and suppliers involved in the medical device lifecycle.
Learning outcomes
What you will be able to do
- Explain the intent and key requirements of ISO 13485:2016
- Prepare an internal audit plan and checklist
- Gather objective evidence and record findings
- Write nonconformity statements and support root-cause analysis
- Report audit results to management
Who should attend
Staff joining an internal audit team, process owners and quality, safety or compliance coordinators.
More in People, Education & Healthcare
All People, Education & HealthcareInternal AuditorEDU-01People, Education & Healthcare
ISO 21001:2025 Educational Organization Management – Internal Auditor
Lead AuditorEDU-02People, Education & Healthcare
ISO 21001:2025 Educational Organization Management – Lead Auditor
Lead AuditorEDU-02-00People, Education & Healthcare
ISO 21001:2025 Educational Organization Management – Lead Auditor
AXIOS · Certification body
Looking for management-system certification?
AXIOS certification is a separate, impartial certification body: audits, certification decisions and the public register of ISO certificates.