{"product_id":"ims-medical-device-inspection-and-conformity-assessment-bodies-iso-13485-iso-iec","title":"IMS Medical Device Inspection \u0026 Conformity Assessment Bodies (ISO 13485, ISO\/IEC 17020, ISO 9001, ISO 31000)","description":"\u003cp\u003eThis Integrated Management System is designed for inspection and conformity-assessment bodies operating in the medical-device sector, where independence and technical rigor are paramount. It combines ISO\/IEC 17020 for inspection bodies, ISO 13485 medical-device quality management, ISO 9001, and ISO 31000 risk management into one authoritative framework. The documentation establishes the impartiality, competence, and consistency that accreditation bodies and regulators require of organizations judging product and system conformity. A master Quality Manual defines independence safeguards, inspection policy, and organizational structure, supported by procedures for inspection planning and execution, competence and authorization of inspectors, handling of complaints and appeals, reporting, and management of impartiality risks. Forms and records document inspection evidence, decisions, and traceability, while checklists convert ISO\/IEC 17020 and ISO 13485 requirements into repeatable inspection routines. Training modules build and evidence inspector competence — a decisive accreditation criterion. The ISO 31000 layer embeds structured risk thinking across impartiality, technical judgment, and operations. This kit is ideal for bodies seeking ISO\/IEC 17020 accreditation, notified-body activities, or contracts requiring demonstrable independence and device expertise. Every document is fully editable to your inspection scope, schemes, and structure, saving months of drafting effort. By systematizing impartiality management, competence control, and consistent decision-making, it strengthens the credibility of your inspection outcomes and accelerates accreditation. The result is a conformity-assessment body whose determinations are trusted by manufacturers, regulators, and the market — protecting your accreditation, your reputation, and the safety of the devices you assess.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eIncluded:\u003c\/strong\u003e 66 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eLicense:\u003c\/strong\u003e single-organization license; delivered electronically as a ZIP archive.\u003c\/p\u003e","brand":"Apex Global Solutions AGS","offers":[{"title":"Default Title","offer_id":56517064491348,"sku":"AGS-07-017","price":3800.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1052\/4996\/4372\/files\/IMS-Medical-Device-Inspection-Conformity-Assessment-Bodies-ISO-13485-ISO-IEC-170.png?v=1784574572","url":"https:\/\/agskits.com\/products\/ims-medical-device-inspection-and-conformity-assessment-bodies-iso-13485-iso-iec","provider":"apex global solutions","version":"1.0","type":"link"}