Monday 13 July 2015

Importance and benefits of ISO 13485 Certification


ISO 13485 standard is specifically introduced for the medical device manufactures and  It assists to provide guidelines to the organization how to improve the quality and safety of medical devices. Iso 13485 certification Helps in better knowing the role of design and development, production, purchasing, record keeping and customer communications. Organization who wish to adopt ISO 13485 Standard, the clause of the standard clearly define and require how the ISO 13485 regulatory and customer specific requirements are addressed.URS offers ISO 13485 Certification in all cities, India.

ISO 13485 Standard certification provides a comprehensive quality management guide for the manufacturing and maintenance of medical devices. ISO 13485:2003 Certification is an evidence to show buyers that the organization follows International Standard for improving and maintaining product quality for medical devices. URS is UKAS accredited ISO 13485 Certification Agency.

 Benefits of iso 13485 Certification:

  • Guarantees high quality of provided services and products
  • Reduces production loss rate
  • Reduces operational costs
  • Increases effectiveness across the whole organization
ISO 13485 certification represents certain requirements for a quality management system for medical devices and for the designing and manufacturing of medical instruments and equipment. Iso 13485 certification is just that organizations have to for the first time demonstrate that manufacture and maintenance of medical devices conform to the standard.URS is offering value added assessment and certification services in all India.

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