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
Who is it for?
- 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 be able to
- 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
What's included?
- You will gain 40 CPD hours on completing the course
- Lunch
- Refreshments
- Course notes
- An internationally recognized BSI Training Academy certificate
