{"product_id":"iso-13485-document-control-records-kit","title":"ISO 13485 Document Control \u0026 Records Kit","description":"\u003cp\u003eDocument control is the first thing an auditor samples. This kit gives you the procedures, the master list and the registers to prove every document in use is current and approved, and every record is retrievable for as long as you need it.\u003c\/p\u003e\u003ch2\u003eWhat's inside (18 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProcedures:\u003c\/strong\u003e Document Control SOP; Records Control SOP.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegisters and Logs:\u003c\/strong\u003e Archived Document Review Log; Backup Verification Log; Document Control Register; External Document Register; Master Document List; Records Destruction Log; Records Retention Schedule.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTraining:\u003c\/strong\u003e Document Control training module (slides, trainer guide, workbook, assessment); Records Management training module (slides, trainer guide, workbook, assessment).\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eAdapt the Document Control SOP: numbering scheme, approval levels and how obsolete documents are handled.\u003c\/li\u003e\n\u003cli\u003eLoad every controlled document into the Master Document List with owner, revision and review date.\u003c\/li\u003e\n\u003cli\u003eRecord standards and regulations in the External Document Register.\u003c\/li\u003e\n\u003cli\u003eSet retention periods in the Records Retention Schedule (at least device lifetime and not less than two years from release).\u003c\/li\u003e\n\u003cli\u003eRun the two training modules with everyone who writes, approves or uses controlled documents.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eAny medical device organization setting up document control, or fixing document control findings.\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":50498903376066,"sku":"ICC-13485-DOC","price":79.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-document-control-records-kit.png?v=1790150779","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-document-control-records-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}