ISO 13485:2016 Refresher Training - Stage 2

This live-streaming video is the second of a two-part series on ISO 13485:2016. The second part is specific to the scope of a Stage 2 certification audit for ISO 13485:2016 certification. The two-stage format is mandated as part of the ISO 17021-1 Standard, Conformity assessment — Requirements for bodies providing audit and certification of management systems. Stage 1 is a preparatory review, whereas Stage 2 is the in-depth validation for actual certification. Stage 1 is usually 1 to 1.5 days in duration, and it may be conducted remotely. Stage 2 is usually 3 or more days in duration. The Stage 2 certification audit training focuses on the clauses of the ISO 13485:2016 Standard that were not covered in the Stage 1 readiness audit: 1 - Lead Auditor Course Poll -    • Запись   2 - Required procedures 3 - What is a controlled document? 4- Human Resources/Training (6.2) 5- Infrastructure (6.3) 6- Contamination Control (6.4) 7- Planning of Product Realization (7.1) 8- Customer-Related Processes (7.2) 9- Design Controls (7.3) 10- Medical Device File (4.2.3) 11 - DHF vs. DMR 12- Purchasing (7.4) 11- Production Process Controls (7.5.1) 12- Cleanliness (7.5.2) 13- Installation (7.5.3) 14- Servicing (7.5.4) 15- Sterile Product Requirements (7.5.5) 16- Process Validation (7.5.6) 17- Sterilization Validation & Sterile Barrier Validation (7.5.7) 18- Identification (7.5.8) 19- Traceability (7.5.9) 20- Customer Property (7.5.10) 21- Preservation of Product (7.5.11) 22- Control of Monitoring & Measurement Devices (7.6) 23 - Lead Auditor Course Poll -    • Запись   24- Complaint Handling (8.2.2) 25- Reporting to Regulatory Authorities (8.2.3) 26- Control of Nonconforming Product (8.3) If you are interested in a training certificate, please sign-up for our training quizzes and you will automatically receive a training certificate for each part of the ISO 13485 refresher training . The sign-up page is: https://medicaldeviceacademy.com/iso-... If you are interested in trying Streamyard for developing your own video content, please check out StreamYard: https://streamyard.com/