People, Education & Healthcare
ISO 13485:2016 Medical Devices QMS – Lead Auditor
Overview
A professional programme for those who plan, lead and report management-system audits against ISO 13485:2016. It follows the audit principles of ISO 19011 and covers the full audit cycle — from planning and opening meeting to findings, nonconformity grading, reporting and follow-up — through realistic case work and role play.
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
- Interpret the requirements of ISO 13485:2016 in an audit context
- Plan an audit programme and an individual audit, including scope, criteria and sampling
- Lead an audit team and conduct opening and closing meetings
- Collect and evaluate objective evidence through interview, observation and document review
- Grade nonconformities and write clear, defensible audit findings
- Prepare the audit report and follow up corrective actions
Who should attend
Auditors, consultants, management representatives and professionals who want to lead first-, second- or third-party audits.
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