Quality Management Systems
QM 062
Zenith Quality Assessors Pvt. Ltd.
Address 01A, B-Wing, SIDDHESH OPTIMUS, S.No.211, Viman Nagar, Pune - 411 014, Maharashtra, India.
Contact Person Mr. Pradyut Bera
Designation Director
Tel +91 9607006692 / 9607006823 / 9607006973 / 9607006945 / 9607004749
Fax +91-20-41314107
Email ID pradyut@zenith-worldwide.com
Website www.zenith-worldwide.com
Valid From July 15, 2019
Valid Upto July 14, 2022
Accreditation Standard ISO/IEC 17021-1:2015 and IAF MD 9
 
Scopes of accreditation
ISO 13485:2016 - Medical Devices Quality Management Systems
Main Technical Areas (as per IAF MD 8) Description (Main Technical Areas) Technical Areas
A1.1 Non-Active Medical Devices General non-active, non-implantable medical devices
Non-active implants
Devices for wound care
Non-active dental devices and accessories
Non-active medical devices other than specified above
A1.2 Active Medical Devices (Non-Implantable) General active medical devices
Devices for imaging
Monitoring devices
Devices for radiation therapy and thermo therapy
Active (non-implantable) medical devices other than specified above
A1.4 In Vitro Diagnostic Medical Devices (IVD) Reagents and reagent products, calibrators and control materials for:
  • Clinical Chemistry
  • Immunochemistry (Immunology)
  • Haematology / Haemostasis / Immunohematology
  • Microbiology
  • Infectious Immunology
  • Histology/Cytology
  • Genetic Testing
In Vitro Diagnostic Instruments and software
IVD medical devices other than specified above
A1.5 Sterilization Methods for Medical Devices Ethylene oxide gas sterilization (EOG)
Moist heat
Aseptic processing
Radiation sterilization (e.g. gamma, x-ray, electron beam)
Sterilization method other than specified above
A1.6 Devices Incorporating / Utilizing Specific Substances/ Technologies Medical devices incorporating medicinal substances
A1.7 Parts or services Raw materials
Components
Subassemblies
Calibration services*
Distribution services
Maintenance services
Transportation services
Other services
* Organizations providing calibration services should be accredited to ISO/IEC 17025
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