{"product_id":"traceability-and-udi-essentials-kit","title":"Traceability \u0026 UDI Essentials Kit","description":"\u003cp\u003eTraceability is frequently underbuilt until a complaint, recall, or audit exposes missing product identity records, weak status labelling, or poor distribution linkage. This kit gives you the core controls for clause 7.5.9, including product identity, warehousing, UDI logic, and traceability records that can scale with the business. 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\u003eIdentification and Traceability SOP.docx\u003c\/li\u003e\n\u003cli\u003eUDI and Distribution Register.xlsx\u003c\/li\u003e\n\u003cli\u003eSample Identification Labels.pdf\u003c\/li\u003e\n\u003cli\u003eTraceability Warehousing Registers.xlsx\u003c\/li\u003e\n\u003cli\u003eStatus Labelling Guide.pdf\u003c\/li\u003e\n\u003cli\u003eImplementation Guide.pdf\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eBest suited to:\u003c\/strong\u003e Distributor, Startup manufacturer, Warehouse lead, 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 traceability and UDI 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 traceability and UDI.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where traceability and UDI records need to be complete, controlled, and consistent.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eUse this toolkit to move faster, create cleaner evidence, and reduce the time it takes to stand up or repair this part of your ISO 13485 system.\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":47258390298818,"sku":"Traceability \u0026 UDI Essentials Kit","price":199.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_GeminiFlash_Createasquarepremiumproductthumbnailfor_Traceability_UDIEssentialsKit_.Sh74305.png?v=1773431915","url":"https:\/\/isocloudconsulting.com\/products\/traceability-and-udi-essentials-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}