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ISO 13485:2016

Unizen Certification Services is one of the largest and leading ISO 13485 consultants in India. We are a transnational ISO certification consultants with clients in India

The ISO 13485 standard was designed in 2016 to respond the latest quality management system practices to be used by organization engaged in designing process, production and supply of medical devices and related services .ISO 13485:2016 standard was established by ISO Organization with greater emphasis on risk based decision making and continual improvement in process with using best practices to fulfill the regulatory requirement for medical devices and ensure safe usage of medical devices. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations of customers.ISO 13485:2016 specifies requirements for a quality management system where an organization needs to achieve their safety objective for medical devices that consistently meet customer and applicable regulatory requirements. ISO 13485 certification in India provides a crucial advantage for medical device manufacturing organization to assure stakeholder that the organization is committed to comply the regulatory requirement of MDQMS standard with Organizations have adopted the process approach which follows PDCA (Plan–Do–Check–Act) for continuous perfection in the process of organization. It’s emphasizing on managing foreseeing risk and control plan to resolve problem before they occur. The most recent update to the standard was published in February of 2016, migrating previously published versions from 2003 and 1996. To avail the standard benefit, organization required ISO 13485 certification process consultant for design the framework of MDQMS standard and he also assist to management department for design and implementation of standard with amended principles that help organization in sustainable development of quality product to face the competitive market and lead in international market.

What is ISO 13485:2016:-

ISO 13485:2016 is a quality management system requirements for medical devices and related services.

The organization should meet with customer and legal requirements the related to manufacturing medical devices and related services.

Recently, this standard was revised and released in the year 2016.

How to upgrade to new standard:

If you are already certified with old revision, just update the requirements/documents and implement 2016 new revision and get certified during surveillance or recertification audit.

Major reasons for revision:

  1. Adapt to new global changes
  2. To provide consistent basement in future
  3. To improve customer satisfaction
  4. To identify context and interested parties needs
  5. To integrate with other management system.

Requirements for ISO 13485

ISO 13485 requirements are based on ISO 9001:2015 standards.

  1. Systematic requirements
  2. Management requirements
  3. Resource requirements
  4. Realization Requirements
  5. Remedial Requirements

What we offer for ISO 13485 Certification for your organization?

With a team of highly qualified consultants and trainers having vast industrial experience, Unizen Certification Services partners organizations across the world to implement and achieve ISO 13485 certification. Our consulting approach is highly professional, time bound and effective resulting in ease of implementation and adds value to the business processes of the client organization.

We offer ISO 13485 training, implementation, consulting, gap analysis, documentation, internal audits, preassessment audits, certification audit through best of the certification bodies and post certification enhancement / maintenance services to enable your organization get the best out of ISO 13485 quality management system. Our services are globally accepted, authoritative and benchmarked in the field of ISO 13485 QMS:

Contact us at to get your organization ISO 13485 certified.

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