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For quick Quality Management System Certification, all QMS documents are must required. To know how to structure QMS documentation read this blog.

ISO 13485:2016 standard for QMS Medical Devices. ISO 13485:2016 Documentation kit is used for solution of quick documentation process for easy certification.

It must required ISO 9001:2015 documents like manual, procedures, SOPs, audit checklist for certification. Do you know why SOPs documents are required? know here.

ISO 9001:2015 specifies the requirement of Quality Management system. Presentation which describes an overview of QMS - ISO 9001:2015.