I mean no disrespect if this is your method. The best way to describe this approach to a QMS is ad hoc. How do you manage your Quality Management System? If you are like the majority of the medical device industry, chances are you have a QMS that is a combination of paper-based processes and general purpose tools, loosely held together by a group of people within your company-usually document control. What is ISO 13485 Quality management system How Greenlight Guru Streamlines ISO 13485 Certification Allowing You to Focus on True Quality Validation of Processes for Production and Service ProvisionĬontrol of Monitoring and Measuring Equipment ISO 13485 Design and Development ProcessesĬontrol of Design and Development ChangesĬontrol of Production and Service Provision Responsibility, Authority & Communication
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