{"product_id":"iso-14971-risk-management-file-kit","title":"ISO 14971 Risk Management File Kit","description":"\u003cp\u003eBuild an ISO 14971:2019 risk management file that reviewers can follow from plan to report, with the registers and workbooks for hazard analysis, risk evaluation and control, and the link to production and post-production information.\u003c\/p\u003e\u003ch2\u003eWhat's inside (15 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003ePolicy and Plan:\u003c\/strong\u003e Risk Management Plan; Risk Management Policy.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAnalysis, Evaluation and Control:\u003c\/strong\u003e Benefit-Risk Analysis Worksheet; Hazard Identification and Risk Analysis Registers; Overall Residual Risk Evaluation; Risk Evaluation and Control Workbook.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFile, Report and Production Information:\u003c\/strong\u003e Optional - Quality (Process) Risk Assessment; Production and Post-Production Information Review; Risk Management File Index and Traceability; Risk Management Report.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTraining:\u003c\/strong\u003e Risk 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\u003eApprove the risk management policy with your acceptability criteria.\u003c\/li\u003e\n\u003cli\u003eWrite the risk management plan for each device family.\u003c\/li\u003e\n\u003cli\u003eIdentify hazards and hazardous situations, estimate and evaluate risks, and record controls in the workbooks.\u003c\/li\u003e\n\u003cli\u003eVerify each control, evaluate overall residual risk and document benefit-risk where needed.\u003c\/li\u003e\n\u003cli\u003eComplete the report and keep reviewing production and post-production information.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eManufacturers building or repairing an ISO 14971 risk management file.\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-complete-qms-kit\"\u003eISO 13485 Complete QMS Kit\u003c\/a\u003e, which costs less than buying kits separately.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":50498912157890,"sku":"ICC-14971-RMF","price":129.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-14971-risk-management-file-kit.png?v=1790150870","url":"https:\/\/isocloudconsulting.com\/products\/iso-14971-risk-management-file-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}