ISO 13485:2016 Internal Auditor
“ISO 13485:2016 Internal Quality Systems Auditor” competency-based 3-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of effective internal audits in accordance with ISO 19011, “Guidelines on Auditing Management Systems”. Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through internal audits that are required for a quality management system based on ISO 13485:2016. Students gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.
This course comprises the following two Exemplar Global Competency Units whose outcomes are certified by Exemplar Global:
- MD –Medical Device Systems
- AU – Management Systems Auditing
Attendees successfully completing this course receive a Certificate of Attainment for each of Exemplar Global Competency Units listed above.
- Understand quality management definitions, concepts, and guidelines
- Understand the purpose of the ISO 9000 series
- Understand the requirements of the ISO 13485:2016 standard
- Understand the roles and responsibilities of the auditor
Course Materials: Students receive comprehensive course manuals with reference materials.
Who Should Attend: Individuals interested in conducting, managing, or participating in first-party (internal) audits
Prerequisite: A prior review of the ISO 13485:2016 standard is required and an understanding of auditing principles is suggested for this course. Additionally, it is highly recommended that inexperienced students take the e-learning class “Essentials of ISO 13485:2003″ prior to attending the classroom training.
Class Logistics: There are written tests on each of the competency units in turn on Days 2 and 3. Detailed exam instructions will be provided. Certificates of Attainment in each competency unit will be provided for students who are deemed “Competent” for each competency unit. Certificates of attendance are provided to those who do not pass the competency test(s), and students will be given the opportunity to retake the test(s).
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