{"product_id":"iso-13485-capa-nonconformance-kit","title":"ISO 13485 CAPA \u0026 Nonconformance Kit","description":"\u003cp\u003eCAPA is where most ISO 13485 audits find problems: weak root causes and no proof that actions worked. This kit covers nonconforming product, concessions, corrective and preventive action, root cause analysis and effectiveness checks.\u003c\/p\u003e\u003ch2\u003eWhat's inside (11 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProcedure:\u003c\/strong\u003e Nonconformance, Concession and CAPA SOP.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegisters and Tools:\u003c\/strong\u003e CAPA Effectiveness Follow-Up Register; CAPA Initiation Checklist; CAPA Register; Nonconformance and Incident Register; Root Cause Analysis Toolkit.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTraining:\u003c\/strong\u003e CAPA 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 SOP: who can raise a nonconformance, who decides on concessions, and CAPA timescales by risk.\u003c\/li\u003e\n\u003cli\u003eLog every nonconformance in the register, and decide with the checklist whether it needs a CAPA.\u003c\/li\u003e\n\u003cli\u003eUse the root cause toolkit (5 whys, fishbone) and record the evidence for the cause.\u003c\/li\u003e\n\u003cli\u003eTrack each CAPA to closure and check effectiveness with data after a set period.\u003c\/li\u003e\n\u003cli\u003eTrain CAPA owners with the training module.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eQuality teams who need a working NC and CAPA process, or who have CAPA findings to close.\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":50498905473218,"sku":"ICC-13485-CAPA","price":79.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-capa-nonconformance-kit.png?v=1790150803","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-capa-nonconformance-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}