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قوالب الامتثال في منصة Notion | إدارة السياسات وعمليات التدقيق

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Practical templates, starter systems, and documentation support for regulated teams - from SaMD and ISO 13485 to AI governance and structured compliance workflows.

ISO 27001 Free Sample Pack - Build your information security management system with editable templates. Includes ISMS scope, risk assessment, SoA, and audit checklist — ISO 27001 aligned and certification-ready.

ISO 27001 ISMS Sample Pack

ISO 14971 Medical Device Risk Management Free Sample Pack - Tackle risk management with clear, structured templates. Includes risk management plan, hazard analysis, FMEA, and risk report — ISO 14971 aligned and ready to edit.

ISO 14971 Risk Management Sample Pack

ISO 13485 Medical Device QM - Build your medical device quality management system from a solid foundation. Includes QMS overview, document control, CAPA, and audit templates — ISO 13485 aligned and ready to tailor.

ISO 13485 Medical Device QMS Sample Pack

The 23 mandatory documents required to demonstrate IEC 62304 compliance across the full medical device software lifecycle — from planning through release.

IEC 62304 Medical Device Software - 23 Docs Kit

All 77 mandatory documents required to build an ISO 13485:2016 Quality Management System — the most complete mandatory-only medical device QMS template set available.

ISO 13485 Medical Device QMS - 77 Docs Kit

The 26 mandatory documents required to build and certify an ISO/IEC 27001:2022 ISMS — nothing you don't need, nothing missing.

ISO 27001 ISMS - 26 Mandatory Docs Kit

The 18 mandatory documents required to establish and certify an ISO/IEC 42001:2023 AI Management System — structured, editable, and audit-ready.

ISO 42001 AIMS - 18 Mandatory Docs Kit

21 editable ISO 14971:2019 templates covering the full risk management lifecycle — from hazards, FMEA/FTA, controls, and traceability through post-market review and CAPA. Top-tier, audit-ready file for NB and FDA submissions.

ISO 14971 Risk Management Full Compliance Kit

Complete ISO 13485 QMS in a box: 157 editable Notion templates across 21 process areas, aligned with IEC 62304, IEC 62366-1, and ISO 14971 — build a fully audit-ready medical device QMS.

ISO 13485 Medical Device QMS Full Compliance Kit

IEC 62366-1 usability engineering toolkit with 15 editable templates covering use specification, task analysis, use-related risk, formative and summative evaluations, and a complete validation dossier. Top-tier, audit-ready HF file for MDR/IVDR and FDA submissions.

IEC 62366-1 Usability Full Compliance Kit

35 editable IEC 62304 templates covering the full SaMD lifecycle — from planning and architecture through V&V, risk, and post-market. Audit-ready for NB review, FDA submission, and ISO 13485 quality audits. Class A, B & C coverage.

IEC 62304 Medical Software Full Compliance Kit

The 9 mandatory documents required to implement and document a complete IEC 62366-1:2015 usability engineering process for medical devices.

IEC 62366-1 Usability Engineering - 9 Docs Kit

The 12 mandatory documents required to implement and document a complete ISO 14971:2019 risk management process for medical devices.

ISO 14971 Risk Management - 12 Mandatory Docs Kit

IEC 62304 Medical Device Software - Jump-start your regulatory documentation with this curated set of IEC 62304-aligned templates. Includes safety classification, requirements, traceability matrix, and test planning — ready to duplicate and tailor to your device.

IEC 62304 Medical Device Software Sample Pack

ISO 42001 Free Sample Pack - Navigate AI governance with confidence. Includes AI management plan, impact assessment, risk register, and transparency template — ISO 42001 aligned and ready to customize.

ISO 42001 AIMS Sample Pack

32 editable ISO/IEC 42001:2023 templates covering full AIMS - governance, risk treatment, operations, incident management & data governance. The most complete kit on the market. Built for organizations serious about AI governance, not just a policy doc.

ISO 42001 Full Compliance Kit

IEC 62366-1 Usability Engineering - Jump-start usability documentation for medical devices. Includes UE plan, use specification, UI characteristics, and summative test protocol — all editable and IEC 62366-1 aligned.

IEC 62366-1 Usability Engineering Sample Pack

Complete ISO/IEC 27001:2022 ISMS in a box: 98 editable Notion templates covering governance, risk, all 93 Annex A controls, audits, and implementation tools — everything needed for a certification-ready information security management system.

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