Quality Policy 820.20a & ISO 13485 § 5.3 (Executive Series #1)

Описание к видео Quality Policy 820.20a & ISO 13485 § 5.3 (Executive Series #1)

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

Requirement name and location
Our requirement today is Quality Policy and it comes directly from 820.20a and ISO 13485 Section 5.3.

Requirement Explained in everyday language
Quality Policy explained in 5 words:
Companywide commitment to Quality

Bonus – This is where you over deliver
Now for the bonus: three questions to ask about quality policy are:
1) How has the quality policy been communicated to everyone in the company?
2) How is my training to the QP documented?
3) Do we need to update the quality policy or Is the quality policy still relevant for our business?

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