Lead Auditor ISO 13485 Training Course

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.

Further Information

Fee: Five-day course including refreshments, lunch and course notes £2675 + VAT non-residential; £3095 + VAT including accommodation.
Attendance on this course will provide delegates with 40 CPD points.