In this short article we will go through the requirements related to mandatory documents for ISO 13485, especially in relation to procedure, and we provide evidence of how QualityMedDev can help on this topic.
ISO 13485 mandatory documents can be summarised in the table below. In this list, we will mainly focus on mandatory SOPs:
| Title of the procedure | Section of the standard | QualityMedDev Document |
|---|---|---|
| Software Validation Procedure | 4.1.6, 7.5.6, 7.6 | P-06 : Computer System Validation Procedure |
| Quality Manual | 4.2.1 | Quality Manual (Template) |
| Documents and Records Control Procedure | 4.2.4, 4.2.5 | P-012 : Document Control Procedure |
| Procedure for Management Review | 5.6.1 | P-01 : Management Review Procedure |
| Procedure for Competence, Training and Awareness | 6.2 | P-04 : Human Resources and Training Management Procedure |
| Processes for risk management in product realization | 7.1 | P-02 : Risk Management Procedure |
| Procedure for Design and Development | 7.3 | P-015 : Design Control Procedure |
| Procedure for Purchasing and Evaluation of Suppliers | 7.4.1 | P-022 – Supplier Management Procedure |
| Procedure and methods for the control of production | 7.5.1 | P-024 – Production and Service Provision Procedure |
| Procedure for Servicing Activities of Medical Device | 7.5.4 | P-024 – Production and Service Provision Procedure |
| Procedures for Validation of Processes | 7.5.6 | P-016 : Process Validation Procedure |
| Procedure for the Validation of Processes for Sterilization | 7.5.7 | P-026 – Validation of Ionizing Sterilization Procedure |
| Procedure for Product Identification | 7.5.8 | P-014 : UDI Management Procedure |
| Procedure for Product Preservation | 7.5.11 | P-024 – Production and Service Provision Procedure |
| Procedure for Customer Feedback | 8.2.1 | P-018 – Production and Post-Production Feedback |
| Procedure for Complaint Handling | 8.2.2 | P-013 : Complaint Handling Procedure |
| Procedure for Internal Audit | 8.2.4 | P-03 : Internal Audit Procedure |
| Procedure for Control of Nonconforming Product | 8.3.1 | P-08 : Non-Conforming Products Procedure |
| Procedure for Issuing Advisory Notices | 8.3.3 | P-027 : Procedure for Management of Field Actions/Advisory Notices |
| Procedure for Rework | 8.3.4 | P-08 : Non-Conforming Products Procedure |
| Procedure for Analysis of Data | 8.4 | P-05 : Data Analysis Procedure |
| Procedure for Corrective & Preventive Actions | 8.5.2, 8.5.3 | P-07 : Corrective and Preventive Actions (CAPA) Procedure |
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