{"product_id":"iso-13485-internal-audit-kit","title":"ISO 13485 Internal Audit Kit","description":"\u003cp\u003eEverything to plan, run and report internal audits under clause 8.2.4, including a clause-by-clause ISO 13485 audit checklist in Excel with the evidence to sample for each requirement.\u003c\/p\u003e\u003ch2\u003eWhat's inside (11 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProcedure:\u003c\/strong\u003e Internal Audit SOP.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAudit Programme and Records:\u003c\/strong\u003e Annual Audit Programme; Audit Plan Template; Audit Report Template; Auditor Qualification Log.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eChecklist:\u003c\/strong\u003e ISO 13485 Internal Audit Checklist (71 requirement areas, findings log).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTraining:\u003c\/strong\u003e Internal Auditing 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 Internal Audit SOP and set audit frequency by process risk and past results.\u003c\/li\u003e\n\u003cli\u003eBuild the year's programme in the Annual Audit Programme.\u003c\/li\u003e\n\u003cli\u003eFor each audit, prepare an audit plan, filter the checklist to the clauses in scope, and record evidence.\u003c\/li\u003e\n\u003cli\u003eWrite the report, raise findings as CAPAs and verify them.\u003c\/li\u003e\n\u003cli\u003eQualify auditors with the log and the training module; nobody audits their own work.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eQuality managers and internal auditors planning an audit programme or preparing for certification.\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":50498905800898,"sku":"ICC-13485-IA","price":79.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-internal-audit-kit.png?v=1790150813","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-internal-audit-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}