ISO 13485:2012 Certification
The standard ISO 13485:2012 was created exactly for medical devices and supplies and is based on ISO 9001. The standard has been made into a tool for the manufacturer to use in creating preconditions through which to cater for the regulatory safety and performance requirements as well as client requirements at various stages of product life.
ISO 13485: 2012 is an international standard that characterizes the necessities for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry's quality system expectations and regulatory necessities, an organization does not essential to be actively manufacturing medical devices or their components to seek certification to this standard. ISO 13485: 2012 applies to the design, development, production, installation and servicing of medical devices. Compliance is a measure of your ability to meet client and legal requirements.
ISO 13485 is an internationally recognized standard of quality, which articulates the stringent requirements of the Quality Management System (QMS) for the design and manufacture of medical devices. Based on better-known ISO 9001 standards, ISO 13485 requires heightened attention to the regulatory requirements associated with the design, development and manufacture of medical devices. Proven Process first earned its ISO 13485 certification in 2002.
Medical Device component manufactures, finished good manufactures, Medical Software developers, Medical Device designers and Developers and pharmaceutical dealers interested in enjoying international presence has to prove their plans are manufactured under certain auditable standards which means it’s safe and effective. ISO 13485:2012 Certification is a solution for this problem.
Benefits of ISO 13485
Ability to win more business – particularly where procurement specifications need certification as a condition to supply in a highly regulated sector.
Proven business credentials – through independent confirmation against documented standards.
Reduced operating costs – through continual development of procedures and resulting operational efficiencies.
Improved risk management – through greater consistency and traceability of products and use of risk management techniques.
Legal compliance – by understanding how statutory and regulatory necessities impression the organization and its clients.
Improved stakeholder relationships – including staff, clients and suppliers.
Customer satisfaction – through delivery of products that consistently meet customer necessities as well as quality, safety and legal necessities.