This training is designed to give you the relevant skills and knowledge to carry out audits of Quality Management Systems for Medical Devices (QMS). The principles of ISO 13485 set out an explicit management system so that you can audit, examine and continually improve systems for a QMS.
On training completion you will be able to:
- Understand the requirements of ISO 13485:2003
- Understand the role of internal audit in the maintenance and improvement of management systems
- Possess in-depth knowledge of the ISO 13485:2003 audit and certification process
- Have the skills and knowledge needed to plan and conduct third party audits against the requirements of the ISO 13485:2003 and report the compliance of the management systems against the standard requirements so that any corrective action can be undertaken.
Please note: Participants should have some prior knowledge of ISO 13485:2003 before attending this training.
This course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485. 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.
Who should attend?
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
What will I learn?
On completion of this training, participants 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 13485
- Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 13485
- Manage the duties of a lead auditor in their organization or for a third-party
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 ISO certified lead auditors
- Increase credibility and competitive advantage
- Motivate employees and build your customer base