ended4월 28일· 1 sources
Authenticity Over Presentation: How Inspectors Spot 'Quality Theatre'
'보여주기식'은 통하지 않는다… MDR 실사관이 주목하는 품질 문화의 실체
Why it matters
Regulatory compliance is shifting from mere 'tick-box' exercises to evaluating the tangible effectiveness of a Quality Management System (QMS). Companies must prioritize genuine operational culture over superficial documentation to ensure long-term safety and successfully navigate rigorous inspections like MDR.
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Quality CultureQuality TheatreQMSMDR ComplianceCAPAAudit Readiness