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This course also features a 30-minute session with our star instructors, Frankie Breedlove who will share insights on the standard and key industry updates.
This course also features a 30-minute session with our star instructors, Frankie Breedlove who will share insights on the standard and key industry updates.
Course Duration: 5 Days - 8 Hours/day
Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD, Exemplar Global-AU and Exemplar Global-TL Competency Units. This 5-Day ISO 13485 training course 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(FDA QMSR) 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 following competency units:
This training 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.
Each participant will receive a seminar manual and a breakout workbook that includes auditing case studies.
Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.
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.
ISO 13485 Lead Auditor Training for Medical Devices Program is available in multiple locations globally, including the USA, Canada, Mexico, India, Europe, Thailand, Singapore, Middle East and China.