Quality Management Systems
QM 030
BSCIC Certifications Pvt. Ltd.
Address 1st Floor, & work Offices, 5B/Sector 15A, Crown Plaza Mall, Faridabad - 121 007 (Haryana), India
Contact Person Sanjay Seth
Designation Managing Director
Tel +91 129 4162505 / +91 129 4175513 / +91 9910502709 / +91 8130791908
Fax +91 129 4012505
Email ID bd@bsc-icc.com, sanjay.seth@bsc-icc.com
Website www.bsc-icc.com
Valid From 22 Nov 2018
Valid Upto 14 July 2026
ISO/IEC 17021-1:2015 and IAF MD 9
Scopes of accreditation
ISO 13485:2016 - Medical Devices Quality Management Systems
Main Technical Area as per IAF MD 8 Description Technical Areas
A 1.1 Non-Active Medical Devices General non-active, nonimplantable medical devices
Devices for wound care
Non-active dental devices and accessories
Non-active medical devices other than specified above
A 1.2 Active Medical Devices (Non-Implantable) General active medical devices
Monitoring devices
Active (non-implantable) medical devices other than specified above
A 1.4 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
In Vitro Diagnostic Instruments and software
IVD medical devices other than specified above
A 1.7 Parts or services Distribution services (Distributors providing storage and delivery of Medical Devices, not acting as a ‘legal manufacturer’ for Medical Devices.)
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