Internal Auditor Course Lead Auditor: ISO 13485” course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485:2003 and ISO 19011:2002, “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.
Important to delegates
This examination is 'closed book'.
Training course objectivesLearning objectives
Participants may use their copy of the requirement standard and a dictionary - these are the only items permitted for reference.
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.