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
  • Managers
  • Engineers
  • Consultants

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

Prerequisite

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.

What's included?

Includes refreshments, lunch and delegate manual