ISO 13485 Certification

ISO 13485 certification

ISO 13485 Certification for Medical Device

ISO 13485 is an international standard for the design, manufacture and distribution of medical devices. ISO 13485:2016 is the latest version by ISO.  This standard is based on the ISO 9001:2015 process model approach.

ISO 13485 is process based approach which define, implement, and improve effectives of quality management system that they expected by customers and regulatory requirements. The main aim of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems.

ISO 13485:2016 Certification  is closely aligned to other management standards such as ISO 9001, ISO 14001 and OHSAS 18001 providing a great opportunity for integration and synergy with other quality systems.

Benefits of Implementing ISO 13485 standards

The main internal benefits of 13485 standard is that it indicate a preventive approach to assuring medical device quality which the process inspection and rejection are done at the end of the manufacturing line

  • Its provides a systematic framework for to define, implement, measure and analyze the process of business operation and customer opinion.
  • It provides a systematic framework on monitored base that resulting in less waste and fewer complaints.
  • Reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources saving.
  • This standard focused to improve the performance in areas such as sales, product delivery, and process efficiency.
  • Its reduce costs as a result of minimizing product failures.
  • Through ISO 13485 standard organization access to the competitive edge with our independently

How to get ISO 13485:2016 Certification?

As a leading ISO 13485 Certification body in India, IAS helps organizations to ensure the effectiveness of the ISO 13485 quality management by performing the conformity assessment with standard experts who are experienced auditors in performing audits and providing the certification.

Apart from management system certification, IAS also offers product certifications against numerous certification schemes such as CE Marking, GOST-R, Green, and more.

Click here to know more about the ISO audit procedure and our Certification process! Also, refer to the frequently asked questions to get more details about the IATF 16949 certification!

Kindly contact us to have a free discussion about the certification for your organization! Request a quote now!

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