CQI and IRCA Medical Devices – Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016) (PR369)

Level Lead auditor Duration 5 days

Available to book: Public classroom View dates and Book now

Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques against the requirements of ISO13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of your quality system, leading to greater patient safety. You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”.

Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. You’ll acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.

How will I benefit?

Benefit from effective ISO 13485 audits and compliance
Maintain and improve quality standards with regular audits
Be confident that your organisation can rely on certified lead auditors
Increase credibility and competitive advantage
Motivate employees through CPD and build your customer base

Upon completion of this training, delegates will be able to:
- Describe the purpose of a quality management system, of quality management systems standards, of management system audit and of third-party certification
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
- Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011 (and ISO 17021 where appropriate)
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
- Consultants
Do you already have a good knowledge of ISO 13485?

If not, we highly recommend you take our ISO 13485 Clause by Clause training course first as there are particular requirements you need to understand before you can be an auditor.
The residential and non-residential courses both include refreshments, lunch and course notes. The residential option also includes 4 nights accommodation and evening meals from the first day of the course.

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​CQI and IRCA Medical Devices – Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016) (PR369)