Tag: SOP for device design control

SOP for Documentation of CAPA in Quality Assurance

SOP for Documentation of CAPA in Quality Assurance Comprehensive Guide to Documentation of CAPA in Quality Assurance 1) Purpose The purpose of this SOP is to establish a standardized process for documenting Corrective and Preventive Actions (CAPA) in quality assurance. Proper documentation ensures traceability, regulatory compliance, and continuous improvement in manufacturing processes and quality systems….

Medical Devices

SOP for Handling Deviations in Manufacturing Processes

SOP for Handling Deviations in Manufacturing Processes Comprehensive Guide to Handling Deviations in Manufacturing Processes 1) Purpose The purpose of this SOP is to define a structured approach for identifying, documenting, evaluating, and resolving deviations in manufacturing processes. The goal is to ensure compliance with regulatory requirements, maintain product quality, and prevent recurrence of deviations….

Medical Devices

SOP for Calibration of Quality Testing Equipment

SOP for Calibration of Quality Testing Equipment Comprehensive Guide to Calibration of Quality Testing Equipment in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a systematic procedure for calibrating quality testing equipment used in medical device manufacturing. Proper calibration ensures accurate, reliable measurements, compliance with regulatory standards, and the production…

Medical Devices

SOP for Managing Device Master Records (DMR)

SOP for Managing Device Master Records (DMR) Comprehensive Guide to Managing Device Master Records (DMR) in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized approach to creating, maintaining, and managing Device Master Records (DMR) for medical devices. The DMR is a comprehensive document that defines the specifications, production…

Medical Devices

SOP for Final Quality Inspection of Medical Devices

SOP for Final Quality Inspection of Medical Devices Comprehensive Guide to Final Quality Inspection of Medical Devices 1) Purpose The purpose of this SOP is to define a standardized procedure for conducting final quality inspections on medical devices before their release for distribution. This ensures that the devices meet the required quality, safety, and performance…

Medical Devices

SOP for In-Process Quality Control Checks

SOP for In-Process Quality Control Checks Comprehensive Guide to In-Process Quality Control Checks in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a systematic procedure for performing in-process quality control (IPQC) checks during the manufacturing of medical devices. These checks ensure that products meet specified standards and regulatory requirements at…

Medical Devices

SOP for Quality Control Testing of Raw Materials

SOP for Quality Control Testing of Raw Materials Comprehensive Guide to Quality Control Testing of Raw Materials in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for testing raw materials used in medical device manufacturing. This ensures that all materials meet the required specifications, quality standards, and…

Medical Devices

SOP for Disposal of Rejected or Scrap Materials

SOP for Disposal of Rejected or Scrap Materials Comprehensive Guide to Disposal of Rejected or Scrap Materials in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to define the procedures for handling, documenting, and disposing of rejected or scrap materials in medical device manufacturing. This ensures compliance with environmental regulations, prevents unauthorized…

Medical Devices

SOP for Handling Non-Conforming Products in Manufacturing

SOP for Handling Non-Conforming Products in Manufacturing Comprehensive Guide to Handling Non-Conforming Products in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for identifying, documenting, and handling non-conforming products in the manufacturing process. This ensures that all non-conforming products are managed in a way that maintains compliance…

Medical Devices

SOP for Tool and Die Maintenance in Medical Device Manufacturing

SOP for Tool and Die Maintenance in Medical Device Manufacturing Comprehensive Guide to Tool and Die Maintenance in Medical Device Manufacturing 1) Purpose The purpose of this SOP is to define the procedures for maintaining tools and dies used in medical device manufacturing. Proper maintenance ensures precision, prolongs the lifespan of tools and dies, and…

Medical Devices