Changelog Summary Document: Quality Management System Route Map to Documents and Procedures – Viamed Ltd ISO 13485:2016 Compared versions: 2 April 2026 and 23 July 2026. Overall change The Route Map has been substantially expanded and updated. The document increased from 50 pages to 103 pages, primarily because additional documents, management-review processes, controller reviews and operational processes have now been linked against the relevant ISO 13485 clauses. The Route Map itself has also been reissued under Document ID 215763, with a revision and review date of 2 April 2026. The previous version showed Document ID 211643 with a revision date of 23 February 2026. New or revised controlled documents The principal document changes identified are: Viamed AI LLM Usage Policy, Document ID 221508, issued and reviewed 29 May 2026. This has been linked into several clauses covering document control, management responsibility, training, production controls, feedback, data analysis and improvement. Viamed Ltd Cyber Security Policy, Document ID 224582, issued and reviewed 29 June 2026. VOP 18 – Maintenance of Buildings, Fabric and Infrastructure, Document ID 221536, revised and reviewed 29 May 2026. Audit 22 – Post Market Surveillance Viamed, Document ID 220899, revised and reviewed 22 May 2026. VM3COP20.31 – Export Order Processing, Document ID 218916, revised and reviewed 5 May 2026. VM3COP20.30 – UK Order Processing, Document ID 215965, revised and reviewed 7 April 2026. These documents have been cross-referenced across the relevant parts of the Route Map rather than appearing as isolated document-index updates. New management and controller review processes A significant change is the introduction of a structured set of senior-management, controller and departmental review processes: Process 8103 – Managing Director Responsibilities Review Process 8104 – Accounts Controller Responsibilities Review Process 8105 – Documentation and Records Controller Review Process 8106 – Health and Safety Controller Review Process 8107 – ISO and Compliance Controller Review Process 8108 – IT Controller Review Process 8109 – Maintenance Controller Review Process 8110 – Marketing Controller Review Process 8111 – Product Controller Review Process 8112 – Sales Controller Review Process 8113 – Warehouse Controller Review Process 8114 – Accounts Processes Review Process 8115 – Audits Review Process 8116 – Data Protection Officer Review Process 8117 – Goods In Review Process 8118 – Goods Out Review Process 8119 – Human Resources Review Process 8120 – Marketing Processes Review Process 8121 – Office Processes Review Process 8122 – Production Processes Review Most of these were reviewed on 16 July 2026, with the Accounts Processes and IT Controller reviews dated 14 May 2026. These processes have been linked particularly to clauses concerning management responsibility, resource management, process monitoring, data analysis, improvement and corrective action. Other new or updated processes Additional operational and administrative processes added to the Route Map include: Process 5895 – Responsibility Allocation: Completing Office Job List Process 5948 – Adding New Accounts to Opera Process 7792 – Shipped Order Success Report Process 7798 – Operational Throughput, Fulfilment and Dispatch Performance Review Process 7987 – Sync External Telephone Logs Process 8102 – Add the Bank Holidays to the Phone System Process 8123 – Insurance Renewal Process 8124 – Inter-company transfer from sales in one company to purchasing in another Process 5863 – Responsibility Allocation: Sales Meetings UK Process 5864 – Responsibility Allocation: Sales Meeting Export The new version therefore gives greater visibility to everyday operational controls, rather than limiting the Route Map mainly to formal ISO audits and older procedures. Main effect on the QMS The changes strengthen the Route Map in four main areas: Management accountability Responsibilities are now more clearly divided between the Managing Director, functional controllers and departmental process owners. Management-review evidence Departmental and controller reviews are directly linked to applicable clauses, providing clearer evidence that management review is carried out across the business rather than through one annual meeting alone. Modern system controls AI usage, cyber security, data protection, software-related activities and electronic communications are now more visibly incorporated into the documented QMS. Operational process monitoring Office processing, accounts, sales, warehouse throughput, goods in/out, production and marketing activities now have more direct links into monitoring, analysis and improvement clauses.