QUBIX Management Services
ISO 13485:2003 - Medical devices Quality management systems

ISO 13485:2003 defines requirements for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. It basically consists of: 1) certain ISO 9001 requirements and 2) newly defined requirements catering specifically to the medical device industry. As such, ISO13485 differs from ISO 9001 in certain ways, modifying or even excluding some of the latter's requirements.

Benefits of ISO 13485:2003 Certification
  • Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements
  • Controlled consistency of manufactured products
  • Managed productivity and efficiency, controlling costs
  • Competitive advantage and increased marketing and sales opportunities.
  • Improved customer perception of the organization’s image, culture and performance
   Customer Quotes

"Thanks to your consultancy services, we were able to considerably reduce our manufacturing lead times"
- Pump Manufacturer
 

"We achieved Total Customer Satisfaction with your help. Best wishes to Qubix."
- Retail Industry Client
 

"Qubix Management Services provide their services in a timely and cost effective manner that suits the Small and Medium Scale Industries"
- Valve Manufacturer
 

"Our Hospital chain gained good trust from our patients after implementing Qubixs positive suggestions"
- Popular Hospital Chain

"Strong expertise and functional knowledge of Qubix Management services facilitated us to reach our ISO goals in time."
- Testing Laboratory
 

"Our long term dream of providing quality food to our customers was achieved thanks to your dedicated and continuous efforts. Thanks and best wishes."
- Food Chain
 
 

 

Qubix Management Services
350-A,Second Floor,D.B.Road, Adj.Karnataka Bank, R.S Puram,
Coimbatore 641002, Tamil Nadu, India. Ph: 0422 6571345
Email: info@qubixms.com Mobile: +91 98430 27974