(not required in case of initial certification request) Substantial changes When is this information required? You are transferring your certification from another certification body to DQS MED DQS MED asked you to update Basic Data In case of any planned substantial changes, without request If you are certified by DQS MED to Directive 93/42/EEC before or immediately on performing a recall, issuing an advisory notice, field safety action, incident – notification etc. (Section 5.3 of ). Changes in your organisation? Yes ☐ No e.g. company name, contact persons, activities, ☐ certifications granted by other certification bodies, If yes, please company size, ownership, consultant etc.? explain Changes to your QMS? Yes ☐ No e.g. products/services, essential processes, locations, ☐ suppliers/subcontractors etc.? If yes, please explain Regulatory information? Yes ☐ No ☐ Only for MDD N/A ☐ e.g. new or discontinued medical devices, etc.? If yes, please explain Regulatory actions? Yes Recalls, advisory notices, FSCA ☐ No ☐ Only for MDD Reportable incidents N/A ☐ Have you performed any of these regulatory actions If yes, please since your last audit? Any other reporting obligations explain Additional remarks
Substantial changes (not required in case of initial certification request) When is this information required? You are transferring your certification from another certification body to DQS MED DQS MED asked you to update Basic Data In case of any planned substantial changes, without request If you are certified by DQS MED to Directive 93/42/EEC – before or immediately on performing a recall, issuing an advisory notice, field safety action, incident notification etc. (Section 5.3 of ). Changes in your organisation? e.g. company name, contact persons, activities, certifications granted by other certification bodies, company size, ownership, consultant etc.? ☐ Yes ☐ No If yes, please explain Changes to your QMS? e.g. products/services, essential processes, locations, suppliers/subcontractors etc.? ☐ Yes ☐ No If yes, please explain Regulatory information? Only for MDD e.g. new or discontinued medical devices, etc.? ☐ Yes ☐ No ☐ N/A If yes, please explain Regulatory actions? Only for MDD Have you performed any of these regulatory actions since your last audit? ☐ Yes ☐ No ☐ N/A If yes, please explain Recalls, advisory notices, FSCA Reportable incidents Any other reporting obligations Additional remarks
410_14e_Basic_Data_Organisation_MD.docx