ISO 13485 Quality Management System

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ISO 13485 quality management system It is an International (ISO) standard for Quality management system (QMS) of medical devices. It is the world’s most popular medical devices standard designed specifically for medical device -manufacturers. This standard is derived from ISO 9000 quality management standard series. It is a standard developed for the Medical Device Industry. The ISO 13485 - standalone Standard, company can apply it without the support of any other quality system standard. Although ISO 13485 certification is voluntary, obtaining certification allows to meet the quality system requirements of the European MDD(93/42/EEC), In Vitro Medical Device Directive (98/79/EC) and AIMD (90/835/EEC) with less difficulty. The main purpose…show more content…
The key sections of ISO 13485 set out a range of documents requirements for developing, implementing and maintaining a quality management system tailored to the design and production of medical devices. • ISO 13485 Quality manual It is a mandatory documents for ISO 13485 certification, which maintain QMS in medical devices. This quality manual included in total documentation kit Global Manager group is given with ready to use templates for creating company profile, control and distribution, organization structure, Management responsibility and more. The ISO 13485 quality manual shall outline the structure of the documentation used in the quality management your organization • ISO 13485 procedures The ISO 13485 procedures are designed to help the organization in developing effective QMS procedures for medical devices as per ISO 13485:2012 requirements which accelerates the process of certification. • Exhibitors The ISO 13485 exhibits are very helpful tool to teach us employees and staff about how to implement and employees and staff about how to implement and improvement of QMS that helps organization to continues improvements and get number of…show more content…
What are ISO 13485 Procedures Requirements ISO 13485 procedures are documents designed and developed for best Quality Management System (QMS) in Medical Devises as per standard requirements ISO 13485 standards. This procedures documents standard requirements implementation QMS system as well as ISO 13485 certification. The ISO 13485 procedures documents describes documents, control, audit and how to improve Quality management system their
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