Six steps to ISO 13485:2016 Certification and MDSAP Certification скачать в хорошем качестве

Six steps to ISO 13485:2016 Certification and MDSAP Certification

This webinar explains the six steps to achieve ISO 13485:2016 certification or MDSAP certification: 1. create a quality plan (which you then implement) 2. conduct an internal audit 3. initiate corrective actions 4. conduct a management review 5. Stage 1 certification audit 6. Stage 2 certification audit The webinar also explains the 9 steps for creating a procedure. This is a process you will repeat for each of the 28 procedures required in ISO 13485:2016. We also explain which procedures you should be implementing first and why. We provide an overview of the design control process and how that integrates with the processes of risk management, usability testing, and software development. There also other links provided in the webinar to additional training resources from Medical Device Academy.