ISO 13485:2016 - MDQMS


ISO 13485 defines the Quality management systems — Requirements for regulatory purposes of an organization to Design, Manufacture and Deliver products and services to meet customer as well as applicable statutory & regulatory requirements. The standard also specifies framework to assess the customer perception and the continual improvements 

ISO 13485 certification results into good management practices. The certification aims at providing a global standard that spells out quality and trust. To meet the requirements for the ISO 13485 certification, an organisation should demonstrate its ability to consistently provide products that meet applicable statutory & regulatory requirements and continue to meet changing expectations of customers

ISO 13485

The purpose of ISO 13485 is a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

ISO 13485  is internationally well accepted. It is recognized and is the obvious choice for any organisation involved in international business or committed to quality



  • Legal Compliance
  • Enhanced Risk Management
  • Reduced Operating Costs
  • Improved Customer Satisfaction
  • Better Access To Information
  • Improved Business Reputation
  • Ability To Win More Business.
  • International Expansion Opportunities

Certification Process

The certification process is a multiple-step process. The certification cycle is described briefly:

  • Application for certification from client
  • Offer from TUV India
  • Offer acceptance from client and order confirmation by TUV India
  • Pre audit (optional)
  • Certification audit - (Stage 1 + Stage 2)
  • Issue of certificate on successful completion of certification audit
  • Surveillance audits 1 & 2
  • Recertification audit after 3 year

Highlights of ISO 13485:2016

The current version is ISO 13485:2016. This new version takes account of the increasing complexity of the environment within which organisations have to work and also focus more strongly on the special features and needs of service providers. Further, the responsibility and autonomy of organisations will be much more strongly emphasised; the same applies to the importance of the process approach and handling of risks. This standard continues to be the only Medical device sector specific certification standard for quality management systems and maintains its most important quality objectives, such as customer satisfaction and generation of compliant products and services.

TUV India's services

Our team will work with your organisation to facilitate the process of achieving the certification. TUV India's audits certify your organisation as being committed to continual improvement and customer satisfaction. Our team of competent auditors ensures your organization’s fulfillment of customer as well as statutory & regulatory requirements.

We are looking forward to your enquiry