Understand the elements that constitute a quality system, and the audit evidence necessary to comply with ISO 13485 requirements. The course includes hands-on workshops that allow you to replicate the working environment of the medical device industry. The curriculum will reinforce key topics critical to your success in this field.
This training course is an Exemplar Global-certified course and meets the training requirements for certification of individual QMS auditors, QMS senior auditors, and QMS lead auditors. Successful completion satisfies the training requirements for individual auditor certification by accrediting bodies such as IRCA and Exemplar Global. With an emphasis on hands-on training, this course features workshops tailored to the working environment of the medical device industry. You will discuss a range of topics including ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes, as well as ISO 9001:2008. Workshops reinforce key topics including documentation of audits, opening and closing meetings, auditor interpretations, listening and questioning techniques, checklists, and nonconformance reports.
This course is offered in cooperation with AQS Management Systems, an Exemplar Global Certified course provider and meets the training requirements for individual auditor certification.
Professionals involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier QA effort should attend this training.
All attendees are required to bring their own copy of the ISO 13485:2003 standard to this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (item T13485).