{"product_id":"qms-core-bundle-iso-13485-clauses-46-and-8","title":"QMS Core Bundle (ISO 13485 Clauses 4Ð6 \u0026 8)","description":"\u003cp\u003eMost organizations do not fail because one isolated document is missing; they fail because the core management, feedback, CAPA, audit, and document controls are fragmented. This bundle groups the operational backbone of ISO 13485 into one coherent build path so you can stand up the central system faster and with 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\u003eQuality Manual.docx\u003c\/li\u003e\n\u003cli\u003eDocument Control Registers.xlsx\u003c\/li\u003e\n\u003cli\u003eRoles and RACI Matrices.xlsx\u003c\/li\u003e\n\u003cli\u003eQuality Policy Pack.docx\u003c\/li\u003e\n\u003cli\u003eManagement Review SOP and Minutes.docx\u003c\/li\u003e\n\u003cli\u003eFeedback and Complaint SOP.docx\u003c\/li\u003e\n\u003cli\u003eCAPA Register Set.xlsx\u003c\/li\u003e\n\u003cli\u003eData Analysis Plan and Dashboard.xlsx\u003c\/li\u003e\n\u003cli\u003eInternal Audit SOP and Annual Plan.docx\u003c\/li\u003e\n\u003cli\u003eTraining and Competence Core Pack.xlsx\u003c\/li\u003e\n\u003cli\u003eChange Control Form.xlsx\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eBest suited to:\u003c\/strong\u003e Startup manufacturer, Distributor, Virtual manufacturer, and Quality manager.\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 QMS core controls 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 QMS core controls.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where QMS core controls records need to be complete, controlled, and consistent.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eUse this bundle to accelerate implementation, strengthen audit readiness, and avoid rebuilding your QMS backbone from scratch.\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":47258390495426,"sku":"QMS Core Bundle (ISO 13485 Clauses 4Ð6 \u0026 8)","price":699.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_Createasquarepremiumproductthumbnailfor_QMSCoreBundle_ISO13485Clauses4_674305.png?v=1773431582","url":"https:\/\/isocloudconsulting.com\/products\/qms-core-bundle-iso-13485-clauses-46-and-8","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}