{"product_id":"iso-13485-starter-kit","title":"ISO 13485 Starter Kit","description":"\u003cp\u003eThe six kits most organizations need first to build a certifiable ISO 13485 quality management system: the quality manual and management review, document control, CAPA, internal audit, training with eight ready modules, and a gap assessment to plan the work.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eBought separately these kits cost $504. The bundle is $249.\u003c\/strong\u003e\u003c\/p\u003e\u003ch2\u003eKits included\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-gap-assessment-workbook\"\u003eISO 13485 Gap Assessment Workbook\u003c\/a\u003e: Score your QMS against 71 ISO 13485 requirement areas with an automatic dashboard.\u003c\/li\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-quality-manual-management-system-kit\"\u003eISO 13485 Quality Manual \u0026amp; Management System Kit\u003c\/a\u003e: Quality manual, policy, objectives, management review and data analysis templates in one kit.\u003c\/li\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-document-control-records-kit\"\u003eISO 13485 Document Control \u0026amp; Records Kit\u003c\/a\u003e: Document and records control SOPs, master document list, retention schedule and two training modules.\u003c\/li\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-capa-nonconformance-kit\"\u003eISO 13485 CAPA \u0026amp; Nonconformance Kit\u003c\/a\u003e: NC and CAPA procedure, registers, root cause toolkit and a CAPA training module.\u003c\/li\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-internal-audit-kit\"\u003eISO 13485 Internal Audit Kit\u003c\/a\u003e: 71-row ISO 13485 audit checklist, audit SOP, programme, plan, report and auditor training.\u003c\/li\u003e\n\u003cli\u003e\n\u003ca href=\"\/products\/iso-13485-training-competence-kit\"\u003eISO 13485 Training \u0026amp; Competence Kit (8 Training Modules)\u003c\/a\u003e: Training SOP, matrix and records plus 8 ready-to-run ISO 13485 training modules.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow it's organized\u003c\/h2\u003e\u003cp\u003eEach kit sits in its own numbered folder, in a practical implementation order, with its own Start Here guide. A bundle Start Here guide gives you the roadmap and a realistic timeline to certification. Training modules are kept once, in the Training \u0026amp; Competence Kit folder.\u003c\/p\u003e\u003cp\u003eNeed design controls, risk management, production or post-market too? The \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eComplete QMS Kit\u003c\/a\u003e adds the other nine kits.\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\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":50498937651394,"sku":"ICC-13485-START","price":249.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-starter-kit.png?v=1790151025","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-starter-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}