Organization 820.20b & ISO 13485 § 5.1 & 5.5 (Executive Series #2)

Описание к видео Organization 820.20b & ISO 13485 § 5.1 & 5.5 (Executive Series #2)

Links
21 CFR 820.20b: https://www.accessdata.fda.gov/script...
ISO 13485:2016: https://www.iso.org/standard/59752.html

Requirement name and location
Our requirement today is Organization and it comes directly from 820.20b and ISO 13485 Section 5.1 & 5.5.

Requirement Explained in everyday language
Organization explained in 5 words:
Adequate Organization for Product Quality

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