{"product_id":"capa-toolkit-iso-13485-corrective-and-preventive-action-pack","title":"CAPA Toolkit ISO 13485 Corrective \u0026 Preventive Action Pack","description":"\u003cp\u003eCAPA is one of the most scrutinized processes in medical-device audits, yet many teams still handle investigations, root cause, and verification in inconsistent formats. This toolkit gives you a structured CAPA process with forms, logs, and closure controls so nonconformities can be investigated and verified with far less rework. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.\u003c\/p\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eCAPA Procedure Template.docx\u003c\/li\u003e\n\u003cli\u003eCAPA Form Template.docx\u003c\/li\u003e\n\u003cli\u003eCAPA Log.xlsx\u003c\/li\u003e\n\u003cli\u003eCAPA Follow-Up Register.xlsx\u003c\/li\u003e\n\u003cli\u003eRoot Cause Analysis Toolkit.xlsx\u003c\/li\u003e\n\u003cli\u003eEffectiveness Check Template.docx\u003c\/li\u003e\n\u003cli\u003eImplementation Guide.pdf\u003c\/li\u003e\n\u003cli\u003eKPI Dashboard.xlsx\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eBest suited to:\u003c\/strong\u003e Quality manager, Internal auditor, Regulatory consultant, and Startup manufacturer.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eUseful in audit situations where you need to:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eShow a structured CAPA process during ISO 13485 certification, surveillance, supplier, or internal audits.\u003c\/li\u003e\n\u003cli\u003eSupport FDA inspections with controlled records, traceability, and process evidence related to CAPA.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where CAPA records need to be complete, controlled, and consistent.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eUse this pack to tighten execution, strengthen evidence, and make this part of your ISO 13485 system easier to defend under audit.\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":47258390757570,"sku":"CAPA Toolkit ISO 13485 Corrective \u0026 Preventive Action Pack","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_GeminiFlash_Createasquarepremiumproductthumbnailfor_CAPAToolkit_ISO13485Corrective_74305.png?v=1773429155","url":"https:\/\/isocloudconsulting.com\/products\/capa-toolkit-iso-13485-corrective-and-preventive-action-pack","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}