Internal Auditor Certification Achieved

EnPak Strengthens Expertise with Certification

We’re excited to announce that our Project Manager, Myriam Viviana Cabrera, has successfully achieved Internal Auditor Certification. Cabrera earned the BSI Certificate of Competency for ISO 13485:2016 Internal Auditor (TPECS). 

Through this advanced training, Viviana gained a deeper understanding of ISO 13485:2016 standards. She also learned the practices of effective internal auditing, guided by ISO 19011:2018 Guidelines on Auditing Management Systems. Additionally, the course included the most recent updates to the ISO 19011 standard. This ensures her expertise reflects the latest best practices.

The certification confirms her competency in:

• MD – Medical Devices Quality Management Systems ISO 13485:2016
• AU – Management Systems Auditing ISO 19011:2018

BSI is an Exemplar Global certified training provider for modules listed above.

This training program is designed to equip participants with a comprehensive understanding of quality management principles. It covers key definitions, concepts, and guidelines. Learners explore the purpose and structure of the ISO 9000 series. They also gain in-depth knowledge of the ISO 13485:2016 standard, which governs quality management systems for medical devices. Furthermore, the course introduces ISO 19011:2018, highlighting its updated terminology and auditing guidelines. Participants learn to identify and assess risks and opportunities associated with auditing. They also understand the roles and responsibilities of internal auditors and conduct all phases of an internal audit using a risk-based approach.

“This accomplishment not only strengthens Viviana’s expertise in auditing but further enhances the value she brings to our partners,” said Marlene Mulero Betances, President of EnPak LLC.  “We are proud to celebrate her accomplishment”