ISO 13485, published in 1996, requires a comprehensive quality management system for medical device design and manufacturing. To achieve ISO 13485 certification, organizations must implement a Quality Management System and prepare the necessary documents. The ISO 13485:2016 Documentation Toolkit provides a complete set of mandatory and supporting documents, along with ISO 13485 Documentation Consultancy. The toolkit includes a Quality Manual, Procedures, Exhibits, Blank Formats/Templates, Standard Operating Procedures, Process Flow Charts, Audit Checklist, and Medical Device File. The toolkit is developed under the guidance of experienced ISO consultants, making it easy to use and understand. The key feature of using these readymade ISO 13485 documents is that they save time and cost in the documentation process, ultimately achieving ISO 13485 certification.

Source Link: https://www.documentationconsultancy.com/iso-13485-documents.html