This intensive two day course is intended for medical device quality professionals aiming to build on their current knowledge of ISO 13485 and evaluate the effectiveness of the quality management system in their organization.
Learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485 and ISO 19011.
An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.
What are the benefits?
- Be better able to continue compliance with ISO 13485
- Maintain and improve a global benchmark in quality standards
- Be confident that your organization can rely on competent internal auditors
- Motivate colleagues through CPD and build customer confidence.
Who should attend?
- Medical device quality professionals with knowledge of quality management systems and ISO 13485
- Individuals interested in conducting first-party or second-party audits
- Management representatives
- Internal auditors
- Managers
- Consultants
This course does not detail the requirements of ISO 13485 so some previous knowledge is required
What will I learn?
On completion of this training, participants will be able to:
- Explain the structure and scope of ISO 13485 management system standard and how it applies to the organization aiming for regulatory compliance worldwide
- Identify the principles of auditing and auditor responsibilities
- Plan an internal audit
- Conduct informal opening and closing meetings
- Conduct an audit based on process identification, sampling and questioning
- Provide verbal and written feedback
- Document concise nonconformities
- Effectively report on an audit
- Follow-up on corrective actions
What is included?
- Training course notes
- Lunch
- Refreshmensts
- Pen
