{"product_id":"iso-13485-quality-manual-management-system-kit","title":"ISO 13485 Quality Manual \u0026 Management System Kit","description":"\u003cp\u003eThe documents that hold an ISO 13485 quality management system together: the quality manual, policy and objectives, responsibilities, change control, and a management review and data analysis cycle that covers every input the standard asks for.\u003c\/p\u003e\u003ch2\u003eWhat's inside (21 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eQuality Manual and Policy:\u003c\/strong\u003e Management Representative Appointment Letter; Management Representative Terms of Reference; Organizational Chart; Quality Manual; Quality Policy; RACI Matrix; Roles and Responsibility Matrix.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eObjectives, Planning and Change:\u003c\/strong\u003e Change Control Form; Customer Contract Review Checklist; Customer Focus SOP; KPI Dashboard; Planning and Change Control SOP; Quality Objective Register and Tracker.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eManagement Review and Data Analysis:\u003c\/strong\u003e Data Analysis Dashboard; Data Analysis Plan; Data Analysis SOP; Management Review Action Plans; Management Review Meeting Minutes Template; Management Review SOP; Monthly Quality Data Review Deck.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eAdapt the quality manual first: scope, regulatory role, and justified exclusions and non-applications.\u003c\/li\u003e\n\u003cli\u003eApprove the quality policy and set measurable objectives in the Quality Objective Register.\u003c\/li\u003e\n\u003cli\u003eFill in the organization chart, responsibility matrix and RACI, and appoint the management representative.\u003c\/li\u003e\n\u003cli\u003eRun monthly data reviews with the dashboard and slide deck; carry actions into the management review.\u003c\/li\u003e\n\u003cli\u003eHold management review using the SOP and minutes template, which cover every required input and output.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eNew and growing medical device companies writing their quality system, and quality managers rebuilding a manual and management review that auditors keep questioning.\u003c\/p\u003e\u003ch2\u003eGood to know\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003eInstant download. Editable Microsoft Office files, no macros.\u003c\/li\u003e\n\u003cli\u003eIncludes a Start Here guide with the contents and how to use them.\u003c\/li\u003e\n\u003cli\u003eLicensed for one organization, including its sites.\u003c\/li\u003e\n\u003cli\u003eTemplates don't reproduce ISO standards. You need your own licensed copies.\u003c\/li\u003e\n\u003cli\u003eAlso in the \u003ca href=\"\/products\/iso-13485-starter-kit\"\u003eISO 13485 Starter Kit\u003c\/a\u003e and the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eComplete QMS Kit\u003c\/a\u003e, which cost less than buying kits separately.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":50498901835970,"sku":"ICC-13485-QMS","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-quality-manual-management-system-kit.png?v=1790150761","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-quality-manual-management-system-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}