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QUALITÄTSMANAGEMENT / QUALITY MANAGEMENT
  • ISO 9001:2015 4.3
  • ISO 13485 (Medical Device)
  • 820.3 Definitions
  • 820.5 Quality system
  • 820.180 General requirements
  • 820.186 Quality system record

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PROZESSMANAGEMENT / PROCESS MANAGEMENT
  • ISO 9001:2015 4.4
  • ISO 13485
  • QSR
  • Kernprozesse / Core Process
  • 820.40 Document controls
  • 820.60 Identification
  • 820.65 Traceability
  • 820.70 Production and Process controls
  • 820.72 Inspection, measuring, and testequipment
  • 820.75 Process validation
  • IQ / OQ / PQ
  • 820.181 Device master record
  • 820.184 Device history record
ZULASSUNG / REGULATORY AFFAIRS
  • MDD 93/42/EWG and MDR
  • IVD 79/98/EC and IVDR
  • Technical File according STED

RISKMANAGEMENT / RISC MANAGEMENT
  • ISO 9001:2015 6.1
  • ISO 14971 (Medical Devices)
  • ISO 31000

REKLAMATIONEN / COMPLAINT HANDLING
  • ISO 9001:2015
  • 820.198 Complaint files
KORREKTUR UND VORBEUGEMASSNAHMEN (CAPA / NCR) / CORRECTION AND PREVENTION ACTIONS (CAPA / NCR)
  • ISO 9001:2015 10.2
  • 820.90 Nonconforming product
  • 820.100 Corrective and preventive action
  • Root Cause Analysis (RCA)
  • CAPA Triggers
LIEFERANTENBEWERTUNG / SUPPLIER QUALITY
  • ISO 9001:2015 8.4
  • ISO 13485
  • 820.50 Purchasing controls
  • Approved Supplier List (ASL)
  • SCAR (Supplier Corrective Action Request)

PRÜFMITTELÜBERWACHUNG / MEASURING DEVICE
  • ISO 9001:2015 8.23
  • ISO 13485
  • QSR

WARENEINGANGSKONTROLLE / INCOMING INSPECTION
  • ISO 2859
  • AQL / ANSI
  • 820.80 Receiving, in-process, and finished device acceptance
  • 820.86 Acceptance status
  • 820.250 Statistical techniques
KENNZEICHNUNG UND VERPACKUNG / LABELING AND PACKAGING
  • UDI
  • 820.120 Device labeling
  • 820.130 Device packaging
  • 820.140 Handling
  • 820.150 Storage
  • 820.160 Distribution
  • 820.170 Installation
  • 820.200 Servicing
INTERNE AUDITS / INTERNAL AUDIT
  • ISO 9001:2015 9.2
  • ISO 13485

Weitere qualitätsrelevanten Informationen werden hier in Zukunft veröffentlicht.
Further quality relevant Informations will be published here in future.


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