ISO 13485 Internal Quality Auditor Training

This two day course is targete and focused on delivering competent, ready-for-auditing Internal Auditors for your company with an emphasis on Federal Quality System requirement Part 820. This course includes hands-on practice process-auditing exercises designed by professional auditors.

Participants will learn:

An ISO 13485 internal system with an emphasis on Federal Quality System requirement Part 820, How to interpret ISO standards from an auditor’s point-of-view, How to plan and prepare for your interal audits, How to construct effective audit checklists--what to look for in the company's documentation, How to conduct opening and closing meetings, How to perform the audit report and ask the right questions, How to write the audit report and effective corrective actions. In addtion to the coverage of ISO 13485 standards, participants will have opportunities for: Small-group and class case studies as classes are divided into "departments". Hands-on auditing utilizing prepared document binders, complete with 4 levels of systems documentation. You will have the opportunity to interact with professionals from other organizations, enhancing both the course and their opportunities to learn. 

Instuctor: Russ Ziebell is a RABQSA Certified Lead Auditor (#Q1807) and an ASQ Certified Qualtity Auditor. Russ has designed and delievered internationally recognized ISO 9001 Certified Lead ISO 9001 certification since 1992. Russ has audtied for the certified body KEMA Registered Quality, Inc.