ISO 13485 Certification describes requirements to get a Quality Management System where an organization should demonstrate its capacity to provide Medical Devices and services that constantly meet customer and applicable regulatory requirements. Such organizations can be involved in a single or maybe more levels of the life-cycle, including design and development, storage and distribution, production, installation, or servicing of the medical tool and design and development or provision of corresponding activities (e.g. support). ISO 13485 may also be used by suppliers or external parties that provide product related services to such organizations such as the Quality Management System.
ISO 13485 Certification requirements are applicable whatever the size the organizations and irrespective of their type except where clearly stated. Wherever requirements applying to medical products are specified, certain requirements apply equally to related services as furnished by the corporation.
The ISO 13485 required processes that are applicable towards the organization, but are not executed with the organization, will be the role from the organization and they are accounting for from the organization’s quality management system by preserve, controlling and monitoring of the processes.
If applicable regulatory requirements permit removing design and development controls, this can be being a justification for his or her removal from the quality management system. These managing requirements can provide alternative approaches which might be to get addressed within the quality management system. It’s the role in the organization to ensure claims of conformity to iso 13485 consulting reflect any elimination of design and development controls.
Benefits of being certified to ISO 13485 Standard
Whether you’re seeking to operate internationally or expand locally, ISO 13485 Certification may help you improve overall operations, eliminate uncertainty, and widen market opportunities. Companies using this certification devoted to quality to both customers and regulators.
• Increase access to more markets worldwide with certification
• Framework how you can review and improve processes across your company
• Increase efficiency, reduce costs and control supply chain operations
• Show that you have produced safer and more effective medical devices
• Meet regulatory requirements and customer expectations
Why you should use ISO 13485 to show that you’ve resolve for quality using an internationally recognized standard.
Through the use of ISO 13485 you are able to:
• Demonstrate compliance with regulatory and law
• Assure installing quality management system practices that consistently yield effective and safe medical devices
• Manage risk adequately
• Enhance processes and efficiencies
• Obtain a competitive advantage
• Design and development
• Manage Storage and distribution
• Maintain Production
• Installation or servicing
• Final decommissioning
• Design, development or provision of related activities (for example tech support team)
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