Quality Audit 820.22 & ISO 13485 § 8.2.4 (Executive Series #7)

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Requirement name and location
Our requirement today is Quality Audit and it comes directly from 820.22 & ISO 13485 section 8.2.4

Requirement Explained in everyday language
Organization explained in 5 words:
Self-Scrutiny Find and Fix Problems
  1. Quality Systems Explained
  2. Quality Management System
  3. 820
  4. QSR
  5. 21 CFR 820
  6. Good Manufacturing Practices
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Initial Certification Audit: 0:15:18

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Document Control 820.40 0:03:36

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Effective Audits in 0:48:01

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