Links
21 CFR 820.22: [ Ссылка ]
ISO 13485:2016: [ Ссылка ]
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
Quality Audit 820.22 & ISO 13485 § 8.2.4 (Executive Series #7)
Теги
Quality Management System820QSR21 CFR 820Good Manufacturing PracticescGMPGMPQuality System RequirementsISO 1348513485Top ManagementMedical DevicesManagement Controls820.22ISO 13485 Section 8.2.4Quality SystemsCorrective Action PlanQuality AuditMajor NonconformanceMinor NonconformanceCritical NonconformanceFindingOpportunities for ImprovementAudit ReportAudit AgendaStatus and ImportanceAuditorAuditeeComplianceMDSAPQSIT
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