ISO 13485 Certification : 2016 Medical Devices - Quality Management Systems
ISO 13485 : 2016 Medical Devices - Quality Management Systems
What Is ISO 13485 Certification?
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
It is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.
An organization can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
ISO 13485 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.
Benefits of ISO 13485 Certification
Take a Deep Dive Into ISO 13485 Certification
Looking to implement an ISO 13485 Medical Devices – Quality Management Systems but not sure where to start? Take a look at our ISO 13485 guide here. The free guide will give you a great insight into this certification.
Steps to ISO 13485 Certification
Want to Transfer Your ISO 13485 Certification?
You can transfer your ISO Certification from one Certification Body to another at any stage you wish, you are not tied into any contract. You need a trusted certification body and we’ll help you transfer to us quickly and easily.
If you would like a free quotation for the transfer of your certification then please complete the form and we will be able to provide you with a quotation.
ISO 13485 Remote Audits - Online
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Remote auditing is the only option to circumvent the challenges we are facing due to the pandemic.
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Client Case Study
Implementing ISO 13485:2016 can help ensure that your customers get high-quality products and services consistently. The following ISO 13485 case studies offer a look at the difference ISO 13485 made for organizations in terms of customer satisfaction, overall process efficiency and revenue.
Related ISO 13485 Contents
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