ISO 13485:2016 Medical Certification Services is required to establish a Quality Management System (QMS), which is directed towards the development, design, production, and installation of medical devices and services related to it. ISO 13485 is important if you are dealing in medical devices and its related services. It ensures that the supplier can be trusted as he is registered and the products delivered are of top-quality. Get in touch with us now if you seek to attain this certification.
Use ISO 13485 :
ISO 13485 Vs ISO 9001 :
When ISO 9001 wants you to document a procedure, it also wants you to implement and maintain it. Section 4.2.1 of ISO 13485 expands on this idea by including requirements, activities, and special arrangements. More precisely :