Medical Devices – Quality Management Systems Auditor/Lead Auditor IRCA Certified (A18190)

BSI’s “Medical Devices – Quality Management Systems Auditor/Lead Auditor Course (ISO 13485 & EN ISO 13485)” course teaches the principles and practices of effective quality management system audits in accordance with ISO 13485 and ISO 19011, “Guidelines for auditing management systems”.  Experienced BSI tutors will guide delegates through the entire audit process, from initiating the audit through to conducting audit follow-up. 

By attending this course delegates will gain necessary auditing skills developed 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 this training, delegates will be able to:

  • Describe the purpose of a quality management system, of quality management systems standards, of management system audit and of third-party certificatio
  • Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
  • Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011 (and ISO 17021 where appropriate)

Prerequisites

It is essential that you have knowledge of ISO 13485 in the context of internal auditing before you complete this course.

How will I benefit?

Successful completion of this IRCA certified training course by passing the relevant IRCA examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management systems audit.