Proud to Announce: We are ISO 13485:2016 Certified

In the process establishing & sustaining world class Quality management systems, we Ami Polymer Pvt. Ltd. proudly announcing that we are ISO 13485:2016 Certified, an internationally recognized Quality Management System for medical devices manufacturing, that ensures that our products and services build considering needs of our clients and National/International regulations.

THE “ISO 13485” STORY

The ISO 13485 standard was published by the International Standards Organization to provide medical device companies with requirements for establishing and maintaining quality systems.

ISO 13485 was first published in 1996 as a quality management standard for medical device companies based on?ISO 9001. It was published in two versions: ISO 13485 for manufacturers (original equipment manufacturers (OEM), and ISO 13488 for contract manufacturers (suppliers). In a 2003 revision, the documents were combined into one quality standard that could be universally applied to medical device manufacturers.

A final revision to ISO 13485 was released in 2016 (current version), just in advance of the new European Union Medical Devices Regulations (EU MDR).

ISO 13485 is a stand-alone MD-QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.

?We have developed and implemented our quality management system in order to improve the overall performance, maintain a high-level of quality, strong customer service and to provide a medical basis for sustainable development initiatives. Our decision to work towards ISO 13485 certification demonstrates the commitment to provide a high-quality consistent products, services to our clients and our ongoing investment in medical devices segment.

To become ISO 13485 compliant, Integrated Optics underwent an evaluation process that included quality management system development, a management system documentation review, audit and initial assessment which was very successful as no non-conformances were identified.?

In achieving compliance with the standard requirements we chose a reliable partner – TUV India Pvt. Ltd– a global leader in?Testing, Inspection and Certification, delivering high quality services to help companies to meet the growing challenges of quality, safety, environmental protection and social responsibility.?TUV India Pvt. Ltd reviewed our management system and provided certification to the standard as an independent third party specialist. It provides our clients with independent assurance that our commitment to quality permeates everything we do.????

Therefore, we can proudly and safely state that we Ami Polymer Pvt Ltd "Sealing Expert in Silicone" are now entering into the new segment of medical devices and already we had already announced the IMASAFE- Reusable Menstrual Cup and it’s specially designed for women, a small step taken by us towards the society. We integrate the attitude of quality in our daily work and continuously challenge ourselves to improve the quality management system to provide products that meet or exceed the needs and expectations of our customers, always complying with the specifications and regulations.?

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