ISO 13485 2003 in Bangalore

ISO 13485 is an international standard that specifies the quality management system necessities for organizations committed medical devices at any stage of the product lifecycle. This is able to embrace the planning, development, production, storage, distribution, installation, service and technical support of the device. The ISO 13485:2016 revision is the third edition of the standard and supersedes the previous ISO 13485:2013. This latest revision of the standard contains substantial updates relating to risk-based quality processes, supplier management, and strict adherence to regulative necessities. This standard is also applied to parties that offer material, product or services to the organization and is applicable to organizations of all sizes massive and little. Additionally, any processes needed to get or maintain compliance with the ISO 13485:2016 standard that’s not performed inside the organization, remain the responsibility of the organization and should be enclosed among the quality management system. The organization should monitor, management and guarantee correct maintenance of the external processes.

Iso 13485 standard is a quality management system for the medical device industry where an organization needs to demonstrate its ability to manufacture, procure, store and well medical devices and related services that consistently meet customer and applicable regulatory requirements. Organizations can have multiple stages of lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and other associated activities (e.g. Technical support). In simple words, iso 13485 standard is a combination of iso 9001 requirements with an additional set of medical device requirements. Benefits of iso 13485 certification to your organization credibility – increase access to bigger market worldwide with the certification process approach – increase efficiency, cut costs and monitor supply chain effectiveness quality compliance – demonstrate that you produce safer and more effective medical devices customer satisfaction – meet regulatory requirements and customer expectations employee engagement – better people involvement to identify best solutions for improving processes business excellence – shorter lead times and better services through quality and process improvement initiatives benefits of iso 13485 certification to your customers? provides management with a defined & efficient management process responsibility across the organization to achieve the objective one of the criteria of a tender to qualify for some public sector work positive atmosphere & builds confidence in internal staff & customers identifies areas to improve & reduce iterations metrics to reduce resources (men, money, machine, material & method) provides continuous assessment and improvement marketing opportunities improved customer retention and acquisition globally recognized standard inviting for international opportunities

Iso 13485 Certification Services, ISO 9001 2015 Certification Service