{"product_id":"fda-qmsr-transition-kit","title":"FDA QMSR Transition Kit (21 CFR Part 820 Gap Workbook, Records Procedure, Audit Checklist)","description":"\u003cp\u003eClose the gap between an ISO 13485 system and what FDA now inspects against. The QMSR (21 CFR Part 820, in force since 2 February 2026) incorporates ISO 13485:2016 by reference and adds record content, labeling controls and FDA-specific references that an ISO certificate alone does not cover. This kit gives you the gap workbook, the procedure and forms that plug those gaps, the transition plan for management review, and the audit checklist to prove it.\u003c\/p\u003e\n\u003ch2\u003eWhat's inside (5 files)\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eQMSR Gap Assessment Workbook (Excel):\u003c\/strong\u003e every section of Subparts A and B (820.1 to 820.45) with the ISO 13485 clause it builds on, an audit question, expected evidence and 0\/1\/2 scoring; a second sheet scoring each ISO 13485 clause the way FDA applies it (risk management, design controls, CAPA, complaints, purchasing, process and software validation); a crosswalk from every legacy QSR section (820.5 to 820.250) to its QMSR home; a terminology sheet (DMR, DHF, DHR, \"management with executive responsibility\" and ten more); an action plan with % readiness by area.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eQMSR Supplemental Records and Labeling Controls Procedure (Word):\u003c\/strong\u003e implements 820.35 and 820.45 inside an existing ISO 13485 system. Includes three forms: Complaint Record with all seven required data elements and the \"no investigation\" justification, Service Record with all six elements, and Labeling Inspection and Release Record covering the five accuracy checks, release signature, line clearance and label reconciliation.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eQMSR Transition Plan and Management Review Briefing (Word):\u003c\/strong\u003e twelve work packages with owners and dates, risks to the plan, and the management review inputs FDA expects top management to have seen.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eQMSR-Focused Internal Audit Checklist (Word):\u003c\/strong\u003e nineteen questions sampled the way an FDA investigator samples: ten complaints, five CAPAs, one lot traced from receiving to distribution, one device risk file.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStart Here guide\u003c\/strong\u003e with the order of use.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eWhy it matters now\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eRisk management under ISO 13485 clause 7.1 is the most-cited area in QMSR-era FDA warning letters and 483s. The gap workbook and audit checklist test the substance of your risk file, not just whether a procedure exists.\u003c\/li\u003e\n\u003cli\u003eComplaint and servicing records now have mandated content (820.35). Most ISO 13485 complaint forms miss at least two of the seven elements.\u003c\/li\u003e\n\u003cli\u003eLabeling must be inspected for UDI, expiry, storage, handling and processing instructions, released under signature, and protected against mix-ups with recorded line clearance (820.45).\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eHow to use it\u003c\/h2\u003e\n\u003col\u003e\n\u003cli\u003eScore the gap workbook (half a day for a certified ISO 13485 system).\u003c\/li\u003e\n\u003cli\u003eTake the transition plan to management review and assign the work packages.\u003c\/li\u003e\n\u003cli\u003eAdopt the supplemental procedure and switch to the three forms.\u003c\/li\u003e\n\u003cli\u003eSweep terminology using the crosswalk and terminology sheets.\u003c\/li\u003e\n\u003cli\u003eAudit with the checklist and close actions on the dashboard.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003ch2\u003eWho it's for\u003c\/h2\u003e\n\u003cp\u003eUS-market device manufacturers, contract manufacturers and sterilizers, specification developers and initial importers moving from the legacy QSR or from an ISO 13485-only system; consultants running QMSR readiness reviews.\u003c\/p\u003e\n\u003ch2\u003eGood to know\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eInstant download. Editable Word and Excel, no macros. Licensed for one organization including its sites; consultants can add the multi-client licence.\u003c\/li\u003e\n\u003cli\u003eRegulatory text is paraphrased for working use with eCFR references; verify wording against the current eCFR before using it in a submission or FDA response. The kit does not reproduce ISO 13485, which you need your own copy of.\u003c\/li\u003e\n\u003cli\u003ePairs with the \u003ca href=\"\/products\/iso-14971-risk-management-file-kit\"\u003eISO 14971:2019 Risk Management File Kit\u003c\/a\u003e (clause 7.1 evidence) and the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eISO 13485 Complete QMS Kit\u003c\/a\u003e.\u003c\/li\u003e\n\u003cli\u003e30-day money-back guarantee if it does not fit your system.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":68871840563394,"sku":"ICC-QMSR-KIT","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/fda-qmsr-transition-kit.png?v=1793963744","url":"https:\/\/isocloudconsulting.com\/products\/fda-qmsr-transition-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}