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logologologologo
  • Products
    • Patient monitoring and connectivity
      • Patient monitoring
        • Xprezzon bedside monitor
        • Qube compact bedside monitor
        • Qube Mini transport monitor
        • Clinical parameters
          • Bispectral Index (BISx)
          • Capnography
          • Multigas analysis
          • Multi-parameter Command Module
          • SvO₂/ScvO₂
        • C50 bedside monitor
        • Elance vital signs monitor
        • DM4 dual-mode monitor
      • Surveillance
        • Xhibit XC48 central surveillance
        • Xhibit XC4 satellite surveillance
      • Telemetry and ambulatory
        • AriaTele patient-worn telemetry
        • LifeSync patient-worn BlueTooth
      • Clinical tools
        • Clinical Access
        • Custom Trends
        • Print Manager
        • SafeNSound
          • SafeNSound Mobile
        • Smart Disclosure
        • Vital Signs Viewer
      • Secondary Alarm Notifications
      • Networking and integration
        • XprezzNet
        • Flexport interfaces
    • Cardiology and remote monitoring
      • Data management
        • Sentinel
      • Holter analyzers and recorders
        • Eclipse Pro extended Holter recorder
        • Eclipse Mini diagnostic patch recorder
        • Lifecard CF
        • Evo
        • Pathfinder SL
        • LifeScreen Pro event screening system
      • Sentinel mobile workstation
      • Resting ECG
        • CardioExpress SL18A
        • CardioExpress SL12A
        • CardioExpress SL6A
      • Stress Testing
      • ABP monitoring
        • OnTrak
        • 90217A
    • Cybersecurity
      • Security advisories and archives
      • Patch Test Reports
      • MDS2 Forms
    • Factory Certified
    • Supplies and accessories
      • Curve Blood Pressure Cuffs
      • Supplies and accessories to reduce healthcare-associated infections
  • Care areas
    • Keeping caregivers safe
    • Cardiology
    • Emergency department
    • Intensive care unit
    • Neonatal intensive care unit
    • Perioperative care
  • Education
    • Clinical education
    • eLearning
    • Technical training
  • Support
    • Feedback submission
    • Product manuals
    • Service contract
    • Supplier change request
    • Cleaning instructions
  • News and Events
  • About us
    • Contact us
    • Our heritage
    • Patents and trademarks
    • Quality and ISO certificates
    • Regional contacts
    • Senior management
    • Terms and policies
    • Careers
  • EnglishEnglish
    • EnglishEnglish
    • EspañolEspañol
    • FrançaisFrançais
    • DeutschDeutsch
    • ItalianoItaliano
    • PortuguêsPortuguês
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Quality & ISO Certificates

Home » About us » Quality & ISO Certificates

QUALITY POLICY
Spacelabs Healthcare is committed to:
  • Striving to deliver innovative, high quality products and services that save lives
  • Patient-centric products that exceed our customers’ expectations
  • Achieving our quality objectives with an effective quality system in compliance with worldwide regulatory requirements
  • Continuous improvement because there’s always a better way
  • Fostering a diverse, inclusive and equitable workforce to participate in the efficiency and effectiveness of the quality system

Spacelabs Healthcare’s Quality Management System is certified to ISO 13485. Copies of the certificates issued to the three Spacelabs Healthcare companies are linked below:

  • Spacelabs Healthcare, Inc., Snoqualmie, WA USA
    ISO 13485 Certificate (PDF)
    Current EC Certificate (PDF)
    MDSAP Certificate (PDF)
  • Spacelabs Healthcare Ltd, Hertford, UK
    ISO 13485 Certificate (PDF)
    EC Certificate
    (PDF)
    MDSAP Certificate (PDF)
  • Statcorp Medical, Snoqualmie, WA USA
    ISO 13485 Certificate (PDF)
    EC Certificate (PDF)
    MDSAP Certificate (PDF)


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Spacelabs Healthcare is a wholly owned subsidiary of OSI Systems, Inc.

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