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ISO 13485-2016 for Medical Device
Exemplar Global TPECS Certified Lead auditor
Days: 4 • CEU’s: 3.6
Time: Days 1-4 8:30 a.m. – 6:00 p.m.
Date: August 18, 19, 20 & 21, 2025
This training course is Exemplar Global’s, ISO 13485:2016 Lead Auditor Certification Scheme (TPECS) that focuses on the assessment outcomes of competency-based training. This training program has been designed to reflect contemporary and innovative learning and assessment practices, industry expectations, and demonstrate that applicants have achieved the level of knowledge and competence required for Exemplar Global personnel certification. Successful graduates are able to apply for Exemplar Global personnel certification.
This is a four-day, virtual, instructor-led classroom course. There are written tests on each of the competency units on days 2, 3, and 4. Days 1 and 2 will cover medical device auditing along with a corresponding competency exam (MD). Day 3 will cover management systems auditing (AU) along with a corresponding competency exam. Day 4 will cover lead auditor requirements with a competency exam (TL).
There is 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 13485-2016 Medical devices—Quality management systems—Requirements for regulatory purposes. Workshops reinforce key topics including documentation of audits, opening and closing meetings, auditor interpretations, listening and questioning techniques, checklists, and nonconformance reports.
Course Objectives:
- Fully understand and interpret the requirements of ISO 13485
- Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction.
- Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
- Understand how to apply the requirements of ISO 13485 Standard during 5 practical audit exercises conducted during the class.
- Understand the terminology of the ISO 9000 and ISO 13485 and how these apply in a Medical Device Environment
- Learn how to develop an ISO 13485 auditing system based on the ISO 19011 auditing requirements.
- Learn how to ask audit questions that get results.
- Learn how to conduct opening and closing meetings that have impact.
- Learn how to construct effective audit checklists.
- Learn how to generate effective corrective and preventive actions
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Puedes contactarnos al tel. +1-787-705-7272 o por email at training@calidadpr.com
Pepe Rodriguez-Perez, PhD
President BEC Inc & BEC GLOBAL
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