ISO 13485 Lead Auditor Training Course (CQI & IRCA Course ID: 2495)

Level Lead auditor Duration 5 days

Available to book: Public classroom HK$24990 Book your place

This course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011, “Guidelines for Quality and/or Environmental Management Systems Auditing.” Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

Benefits

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

- Interpret the requirements of ISO 13485 in the context of an audit
- Describe the purpose of a quality management system and explain the 8 principles of quality management
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
- Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485
- Manage the duties of a lead auditor in their organization or for a third-party
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
- Consultants
This course teaches auditing principles using ISO 13485, therefore a knowledge of ISO 13485 and its application within a Medical Device organization is strongly recommended together with internal audit experience.
- You will gain 40 CPD hours on completing the course
- Lunch
- Refreshments
- Course notes
- An internationally recognized BSI Training Academy certificate

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