P-07 : Corrective and Preventive Actions (CAPA) Procedure Procedure for Corrective & Preventive Actions P-027 : Procedure for Management of Field Actions/Advisory Notices Procedure for Control of Nonconforming Product P-018 – Production and Post-Production Feedback P-026 – Validation of Ionizing Sterilization Procedure Procedure for the Validation of Processes for Sterilization Procedure for Servicing Activities of Medical Device P-024 – Production and Service Provision Procedure Procedure and methods for the control of production Procedure for Purchasing and Evaluation of Suppliers Processes for risk management in product realization P-04 : Human Resources and Training Management Procedure Procedure for Competence, Training and Awareness P-06 : Computer System Validation Procedure In this list, we will mainly focus on mandatory SOPs: Title of the procedure ISO 13485 mandatory documents can be summarised in the table below. In this short article we will go through the requirements related to mandatory documents for ISO 1348 5, especially in relation to procedure, and we provide evidence of how QualityMedDev can help on this topic.
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