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ISO 13485:2016

Unizen Certification: is one of the top ISO 13485 consultants in Lucknow providing ISO 13485 certification process and training in lucknow and other location of 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 consultant 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.

Process of ISO 13485:2016:

ISO 13485 Certification process in India means define prerequisite procedure for ISO 13485 certification that enable the organization to apply additional control in exiting process to make process more efficient and valuable. ISO 13485 certification process in India improve their work efficiency and maintain the regulatory requirement of ISO standard to lead in market in term of quality & client satisfaction. ISO 13485 certification process contain several methodology of standard that emphasize on consistent improvement in performance and productivity to achieve quality objective of product and services. ISO certification enables Organization to improve performance of an organization with internal audit, assessment, gap analysis, and risk based decision making which ensure products and services consistently meet customer requirements along with consistent improvement in quality as well customer satisfaction. ISO certification system provide the best business process module to optimize exiting process with effective and globally accepted ISO system. ISO principles are foundation for any business looking for continuous growth in (3P Model) process, performance and productivity.

  • planning and document review
  • Gap analsysis
  • tarining and implementation
  • Audit and resprt submiission
  • Final Certification
  • Benefit of ISO 13485 :

  • enhance customer satisfaction
  • trust among stakeholder
  • continuous improvement
  • Global market opportunities
  • reduce process cost and time

  • 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 [email protected] to get your organization ISO 13485 certified.

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