ISO 13485 Certification describes requirements for a Quality Management System where an organization must demonstrate its capability to provide Medical Devices and services that constantly meet customer and applicable regulatory requirements. Such organizations is worried in a or even more quantity of a life-cycle, including design and development, storage and distribution, production, installation, or servicing of a medical unit and design and development or provision of corresponding activities (e.g. technical support). ISO 13485 may also be used by suppliers or external parties that provide product related services to such organizations like the Quality Management System.
ISO 13485 Certification requirements are applicable regardless of height and width of the organizations and no matter their type except where clearly stated. Wherever requirements applying to medical products are specified, the requirements apply equally to related services as supplied by the business.
The ISO 13485 required processes which can be applicable towards the organization, but aren’t executed by the organization, will be the role from the organization and so are accounting for in the organization’s quality management system keeping, controlling and monitoring of the processes.
If applicable regulatory requirements permit eliminating design and development controls, this can be as being a justification for their removal from your quality management system. These managing requirements can offer alternative approaches that are being addressed inside the quality management system. Oahu is the role with the organization to ensure that claims of conformity to iso 13485 consulting reflect any elimination of design and development controls.
Advantages of being certified to ISO 13485 Standard
Regardless if you are seeking to operate internationally or expand locally, ISO 13485 Certification may help you improve overall operations, eliminate uncertainty, and widen market opportunities. Companies with this certification dedicated 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, spend less and control logistics operations
• Show you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations
For you to use ISO 13485 to demonstrate that you’ve resolve for quality with an internationally recognized standard.
By using ISO 13485 you’ll be able to:
• Demonstrate compliance with regulatory and legal requirements
• Assure investing in quality management system practices that consistently yield effective and safe medical devices
• Manage risk adequately
• Enhance processes and efficiencies
• Gain a competitive advantage
• Design and development
• Manage Storage and distribution
• Maintain Production
• Installation or servicing
• Final decommissioning
• Design, development or provision of related activities (like support)
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