GIGC is an IDA Certified training body. This seminar fully covers the ISO 13485:2016 requirements. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report and evaluating corrective actions. Auditing case studies will be used to develop the required auditing skills based on ISO 19011.
This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector. Attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the competency.
Who Should Attend
This seminar is designed for Management Representatives, ISO 13485:2016 Implementation Teams, Auditors and others who would like to learn the widely-used international management systems auditing process.
Recommended Training and/or Experience
An understanding of the ISO 13485:2016 requirements and a minimum 12 months of work experience in applying or auditing quality management systems is recommended. The first 1.5 or 3 days of this class are offered separately for those new to auditing or quality management.
Each participant will receive a seminar manual and a breakout workbook that includes auditing case studies.