ISO 13485:2016
ISO 13485
Need of ISO 13485:2016 (MDQMS)
The objective of MDQMS i.e. ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems. Medical Equipment are prone to any defect which causes injury to the public health and it is very dangerous. Therefore ISO 13485:2016 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.
This standard is accredited by CAI.
Role of QSI-CERT in ISO 13485 Certification
QSI-CERT having the team of Auditor and Technical Experts who can conduct a value added Audit and contribute in the continual improvement of your organization.
QSI-CERT team can provide the two step audit and you are entitled for the certification of ISO 13485:2016 which is required by your customer or in tender purpose.
WHY QSI-CERT is best for ISO 13485 Certification?
There are several Reasons to choose QSI-CERT as
Value added two step certification process
Timely delivery of certificate as committed
24 X 7 support as executive team is always available
Online processing from Application to certification decision.
Economical and Competitive Prices of Certification
Benefits of ISO 13485:2016 Certification
Increase efficiency, cut costs and monitor supply chain performance
Increase access to more markets worldwide with certification
Demonstrate that you produce safer and more effective medical devices
Outline how to review and improve processes across your organization
Meet regulatory requirements and customer expectations