ISO 13485 Medical Devices Lead Auditor Training
BSI’s “Lead Auditor: ISO 13485” 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.
Who should attend?
- Medical Device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management Representatives
- Quality Directors
What will I learn?
Upon completion of the training, participants will be able to:
- Interpret the requirements of ISO 13485 in the context of an audit
- Explain the relationship with ISO/TR 14969 and the ISO 9000 series
- 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
This course teaches auditing principles using ISO 13485, therefore a basic knowledge of ISO 13485:2003 and its application within a Medical Device organization is strongly recommended together with internal audit experience.
Includes refreshments, lunch and delegate manual