ISO 13485 lead auditor training
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ISO 13485 lead auditor training: ISO 13485:2016 is a quality system management standard. It’s similar to ISO 9001 but has a few more stipulations to help companies meet the more specialized demands that come with making medical components and healthcare related products.
Next Schedule:
November 2023
11, 18, 19, 25 & 26 November | 9am - 6pm
November 2023
11, 18, 19, 25 & 26 November | 9am - 6pm
December 2023
2, 3, 9, 10 & 16 December | 9am - 6pm
2, 3, 9, 10 & 16 December | 9am - 6pm
ISO 13485 lead auditor training
- Explain the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.
- Explain the role and responsibilities of an auditor to plan, conduct, report, and follow- up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021.
- Plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.
This course is specially designed for:
- A Third-Party Assessor or Lead Assessor of ISO 13485:2016
- Responsible for undertaking audits of suppliers/subcontractors as per ISO 13485:2016
- Responsible for implementing internal audits and audit programs as per ISO 13485:2016
- Responsible for implementing the ISO 13485 series of standards
