Course Description
BSI’s “Lead Auditor: ISO 13485” course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485:2003 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 program 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.
Learning Objectives
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
Who Should Attend?
• Medical Device quality professionals interested in conducting first-party, second-party, and/or third-party audits
• Management Representatives
• Quality Directors
• Managers
• Engineers
• Consultants
Prerequisites
A prior review of the ISO 13485:2003 standard and internal audit experience are strongly recommended for this course.
Next steps
View our Medical Devices training course schedule. For more information, please contact us or complete our enquiry form.
