QMS Certification EN ISO 13485
- M.FR.07.01 - Application Form
- M.FR.07.03 – ISO 13485 Certification Flowchart
- M.FR.08.15 - Planned Change Notification Form
- M.FR.09.01 - Planned Change Control Form Before Surveillance Audit
- M.FR.19.01 - Confidentiality Declaration
- M.FR.20.01 - Impartiality Declaration
- M.FR.23.02 - Certification Rules and General Conditions
- M.FR.23.03 - Product Information Receipt Form
- M.FR.24.01 - Customer Complaint Objection and Advice Form
- ISO 17021 Accreditaion Certificate
- M.PR.07 - Receiving & Evaluating Certification Pre-Applications Procedure
- M.PR.10 - Suspension, Scope Reduction & Withdrawal of Certificates and their Notification Procedure
- M.PR.11 - Change of Certification Body-Notified Body Procedure
- M.PR.21 - Certificate and Brand Usage Procedure
- M.PR.24 - Appeals and Complaints Evaluation Procedure
- M.PR.27 - Control of Subcontractors Activities Procedure
- M.PR.31 - Remote Audit Procedure
- M.PR.32 - Safety Procedure for Pandemic
- M.PR.38 - ISO 13485 Audit Duration Determination and Planning Procedure
- M.PR.39 - ISO 13485 Audit Fee Determination Procedure
- M.TL.07.01 - Pre-Application Instructions
