{"product_id":"iso-13485-gap-assessment-workbook","title":"ISO 13485 Gap Assessment Workbook","description":"\u003cp\u003eFind out exactly where your quality management system stands against ISO 13485:2016, clause by clause, and turn the gaps into an action plan. Each requirement is summarised in plain words with an audit question and the evidence to look for.\u003c\/p\u003e\u003ch2\u003eWhat's inside (2 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eGap Assessment Workbook (Excel):\u003c\/strong\u003e instructions, 71-row assessment with audit questions and evidence prompts, clause dashboard and action plan.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eStart Here guide (PDF).\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eWork down the Gap Assessment tab and look for the evidence listed in each row.\u003c\/li\u003e\n\u003cli\u003eChoose a status for every requirement and note what you found.\u003c\/li\u003e\n\u003cli\u003eRead the dashboard to see which clauses need the most work.\u003c\/li\u003e\n\u003cli\u003eGive each gap an action, owner, priority and due date.\u003c\/li\u003e\n\u003cli\u003eRe-run the assessment before your certification or surveillance audit.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eAnyone starting ISO 13485, preparing for a certification audit, or checking an existing system.\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":50498897084610,"sku":"ICC-13485-GAP","price":49.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-gap-assessment-workbook.png?v=1790150719","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-gap-assessment-workbook","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}