Tag: SOP for traceability in medical device manufacturing

SOP for Risk Management Documentation in Medical Devices (ISO 14971)

SOP for Risk Management Documentation in Medical Devices (ISO 14971) Comprehensive Guide to Risk Management Documentation in Medical Devices (ISO 14971) 1) Purpose The purpose of this SOP is to establish a standardized procedure for documenting risk management activities for medical devices in compliance with ISO 14971. Proper documentation ensures systematic identification, assessment, control, and…

Medical Devices

SOP for Conducting Internal Quality Audits

SOP for Conducting Internal Quality Audits Comprehensive Guide to Conducting Internal Quality Audits 1) Purpose The purpose of this SOP is to establish a systematic approach to planning, conducting, and documenting internal quality audits. These audits ensure that processes comply with established quality management system standards, regulatory requirements, and organizational policies, and that opportunities for…

Medical Devices

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