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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
  • IVD 79/98/EC
  • 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 / 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)
LIEFERANTENBEWERTUNG / SUPPLY CHAIN / 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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