ISO 13485:2016


ISO 13485 standard is a Quality Management System for the medical device industry where an organization needs to demonstrate its ability to manufacture, procure, store and well medical devices and related services that consistently meet customer and applicable regulatory requirements.
Organizations can have multiple stages of lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and other associated activities (e.g. technical support).
In simple words, ISO 13485 standard is a combination of ISO 9001 requirements with an additional set of medical device requirements.

ISO 13485 Certification


  • Credibility – Increase access to bigger market worldwide with the certification 
  • Process Approach – Increase efficiency, cut costs and monitor supply chain effectiveness
  • Quality Compliance – Demonstrate that you produce safer and more effective medical devices
  • Customer Satisfaction – Meet regulatory requirements and customer expectations 
  • Employee Engagement – Better people involvement to identify best solutions for improving processes
  • Business Excellence – Shorter lead times and better services through quality and process improvement initiatives 


  • Provides management with a defined & efficient management process
  • Responsibility across the organization to achieve the objective
  • One of the criteria of a tender to qualify for some public sector work
  • Positive atmosphere & builds confidence in internal staff & customers
  • Identifies areas to improve & reduce iterations
  • Metrics to reduce resources (Men, Money, Machine, Material & Method)
  • Provides continuous assessment and improvement
  • Marketing opportunities
  • Improved customer retention and acquisition
  • Globally recognized standard inviting for international opportunities

Who can get ISO 13485 certification?

ISO 13485:2016 standard is applicable to organizations regardless of their size and their type. Requirements that are specified as applicable to medical devices shall also be applicable equally to associated services. 

Therefore, the standard is not only applicable to medical device manufacturers but also to supporting firms like subcontractors, stockists, suppliers and European Authorized Representatives.

What are the requirements of ISO 13485:2016?

General Requirements – This includes required documents like Quality Manual, documented procedures and records

Management Responsibilities – Resource identification for MR and planning of QMS (Resource Management)

Product Realization – Major concepts of planning and creation of the product like Design Controls, Risk Management, Document Control and Records Management & Supplier Management will be addressed as part of requirements

Culture of Evaluation & Continual Improvement – These requirements include customer satisfaction, internal audits, dealing with non-conformities and corrective actions

These concepts are based on Plan-Do-Check-Act cycle, which use the above-mentioned elements to implement, drive and maintain improvements within the processes.

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