ISO 13485 – Quality Management Systems for the design and manufacture of Medical Devices

ISO 13485: 2003 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, and system approach to management, continual improvement, fact-based decision-making and mutually beneficial supplier relationships. When fully adopted, these principles have been proven to enhance organizational performance.

ISO 13485:2003 Overview

ISO 13485: 2003 is an international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services. ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices and medical components.

By becoming certified in the ISO 13485 standard your company will:

  • Increase the probability of making safe and effective medical devices
  • Meet regulatory requirements
  • Meet customer expectations
  • Help monitor the effectiveness of your supply chain

This standard is recognized by most major markets around the world (United States of America, Europe, Canada, Japan, and Australia) and more major markets are likely to adopt this standard. With ISO 13485 certification you will be able to enter any major market around the world with one audit! By becoming ISO 13485 certified your company’s Quality Management System (QMS) will be in line with the Food and Drug Administration’s (FDA) QSR standards.

Additional Benefits of ISO 13485 certification:

  • Increased Efficiency
  • Cost Savings
  • More Effective Risk Management and Quality Assurance
  • Improved ability to respond to Customer Requirements

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