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ISO 9001:2015 Certification
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ISO 22000:2005 Certification
ISO 13485:2012 Certification
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ISO 10002:2014 Certification
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ISO 13485 Certification
    Medical Devices - Quality Management System
Our ISO 13485:2012 Certification is a quality management system that helps a business to produce or supply medical related devices and services while taking care of the health problems. The key objective here is to facilitate the conformance to medical device regulatory requirements for quality assurance. This quality management system inherits some of the particular requirements of medical devices and excludes some requirements that belong to ISO 9001 as they are not appropriate in the medical industry. ISO 13485 Medical Device Certification specifies equipments a Quality Management system which an Organization needs to demonstrate ability. Though Some of medical devices excludes the requirements of ISO 9001 Regularity.

Procedure of ISO 13485 Certification
1 Application & Quotation to PSA
2 Review The Application
3 Contact Agreement PSA and Client.
4 Audit Program
5 Audit Schedulem
6 Stage 1 Audit
7 Stage 2 Audit
8 Surveillance Audit
9 Special Audit
10 Extension Audit


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