• ISO certification consultants Delhi, India, IT Consultancy Services –  ICPL

    ISO 9001:2008

    Quality Management System

  • ISO 14001:2004 Certification - Environmental Management System –  ICPL

    ISO 14001:2004

    Environment Management System

  • OHSAS 18001:2007 Certification, Occupational Health and Safety -  ICPL

    OHSAS 18001:2007

    Occupational Health and Safety

  • ISO 27001:2005 Certification, ITSMS Certification –  ICPL

    ISO 20000-1:2011

    Information Technology Service Management System

  • ISO 22000:2005 Certification, food safety management system –  ICPL

    ISO 22000:2005

    Food Safety Management System

  • Network Penetration Testing, IT Security Services –  ICPL

    ISO 27001:2005

    Information Technology Security Management System

  • ISO 13485:2003 Certification, Quality Management System for Medical Devices – ICPL

    ISO 13485:2003

    Medical Devices

ISO 13485:2003 Certification

ISO 13485:2003 defines the Quality Management System for Medical Devices. It is specifically introduced for the medical device manufactures. Its helps to improve the quality management system of medical devices which ensures the safety of medical devices and also helps to improve the services of organization.

Benefits Of ISO 13485:2003

  • Improves the manufacturing procedure that ensures for safety of medical devices.
  • Improves Risk Management
  • Achievement of goals
  • Improves the business
  • Customer satisfaction
  • Mutual understanding between customers and manufactures
  • Improves quality of medical devices
  • Improves market value and brand value of the organization

Indicum Consultancy Road Map Of ISO 13485:2003

  • Assessment of Existing Resources including infrastructures
  • Assessment of existing System & Identification of processes
  • Identification of Task Group & Management Representative
  • ISO 13485:2003 Awareness Training Program in batches
  • Development of  Process Flow Charts, Policy, Objectives, Formats & other supporting documents (Work Instructions etc)
  • Finalization of above documents & release for implementation
  • Preliminary Audit (Gap Analysis) & revisions to documents
  • Design & Development of Quality Manual & issue draft for review
  • Finalization of Manual  & issue documents for implementation
  • Implementation of Quality Management System
  • Provision of Identified Resources
  • Qualification of processes & personnel for special processes
  • Calibration of Monitoring & Measuring Instruments
  • Selection & Finalization of Certification Body
  • Training of Internal auditors in two batches if > 20
  • Audit by ICPL Auditor and Management Review Meeting – I
  • Implementation of Corrective & Preventive Actions
  • Submission of Quality Manual to Certification Body for review
  • Corrective & Preventive Action on review comments
  • Audit by ICPL  and Management Review–II
  • Corrective Action on Internal Audit
  • Preparation for Certification Audit
  • Final Audit by Certification Body
  • Implementation of Corrective & Preventive Actions
  • Award of certificate by certification body



Indicium deployed most competent resource to provide us with the network security assessment through VAPT and the assessment report was found very professional with in-depth analysis and gap closure consultation which helped HCL Services Ltd to secure it’s networks and servers from intrusions.

Mr. G.G. Rao (CIO)
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