Скачать или смотреть 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 -
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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-...

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