Includes a fully-customizable (MS Word) ISO 13485 Quality Manual, complete set of 26 QMS Procedures and 30 related forms all connected with a logical numbering system for easy document control. Features/Benefits: Provides the processes and documents needed to design and build an ISO 13485 compliant Quality Management System. Includes text to addresseach requirementof the ISO 13485 Standard. Document numbering system ensures solid Document Control. Master Document List is completed and ready for Work Instructions. All documents are writtenin MS WordorExcel for ease of use and editing. Contents: 40 page customizable ISO 13485 Quality Manual(26) Quality System Procedures (41) related Forms