BSI’s “ISO 13485:2016 Lead Auditor” competency-based 4-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of leading management systems and process 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 the entire audit process, from managing an audit program to reporting on audit results. Students gain necessary auditing skills through a balance of formal classroom tutorials, role playing, group workshops, and open forum discussions.
This course comprises the following three Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:
- MD – Medical Device Systems
- AU – Management Systems Auditing
- TL – Leading Management Systems Audit Teams
Attendees successfully completing this course receive a Certificate of Attainment for each of Exemplar Global Competency Units listed above.
New to TPECS? For more information, please see ourUnderstanding the TPECS Course Structure page.
- 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
- Apply ISO 19011 definitions, concepts, and guidelines
- Recognize the principles, practices, and types of audits
- Conduct all phases of an internal audit
- Prepare and present effective reports
- Understand Exemplar Global’s certification scheme
- Understand the role of objectives, scope and criteria in the audit process
- How to plan audits
- Conduct audit team selection
- Initiate the audit and conducting opening meetings
- Understand audit team leader responsibilities
- Communicate effectively during the audit
- Conduct on-site activities
- Prepare audit conclusions
- Conduct closing meetings
- Report audit results
Students receive comprehensive course manuals with reference materials.
Who Should Attend
- Individuals interested in conducting first-party, second-party, and third-party audits
- Management Representatives
- Quality Directors in Medical Device
A prior review of the ISO 13485:2016 standard is required and internal audit experience is suggested for this course. Additionally, it is highly recommended that inexperienced students take the BSI e-learning class “Essentials of 13485:2003″ prior to attending the classroom training.
There are written tests on each of the competency units in turn on Days 2, 3 and 4. 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).
Location: Littleton, MA