ISO 13485 Template Pack

The ISO 13485 Template Pack provides a comprehensive collection of Procedures, Steps, and Standard Operating Procedures (SOPs) essential for achieving and maintaining compliance with ISO 13485:2016 standards. This pack is designed to streamline the development, implementation, and management of quality management systems (QMS) for medical device manufacturers and related industries.

It includes clear, ready-to-use documentation covering all mandatory and recommended processes, ensuring regulatory compliance and reducing the time and effort required to establish a compliant QMS. Each template is fully customisable to align with your organisation's specific needs and includes detailed guidance on implementation.

Key Areas Covered in the Template Pack:

• Document Control
  Procedures for creating, approving, distributing, and maintaining controlled documents.
• Risk Management
  Templates for risk assessment, mitigation, and management throughout the product lifecycle.
• Design and Development
  Documentation to support compliant product design, verification, and validation processes.
• Supplier Management
  SOPs for qualifying, auditing, and monitoring suppliers and vendors.
• Production and Process Control
  Guidelines for process validation, production monitoring, and quality assurance.
• Non-Conformance and CAPA
  Forms and workflows for managing non-conformities, root cause analysis, and corrective and preventive actions.
• Complaint Handling and Post-Market Surveillance
  Tools for logging, investigating, and resolving complaints, and ensuring effective post-market activities.
• Internal Audits
  Comprehensive internal audit checklists and reporting templates to assess compliance and identify areas for improvement.
• Training and Competency
  Documentation to track staff training, qualifications, and competency assessments.
• Equipment and Calibration
  Procedures for equipment maintenance, calibration, and validation.
• Traceability and Labelling
  Guidelines for product identification, labelling, and traceability throughout the supply chain.
• Emergency Procedures
  SOPs for handling emergencies, incidents, and recalls.

This ISO 13485 Template Pack in Seal is key for organisations aiming to simplify the complexities of ISO 13485 compliance while ensuring robust quality management practices are in place.