ISO 13485 Template Pack
The ISO 13485 Template Pack provides a comprehensive collection of procedures, templates, 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.
Entities
- PROCEDURECAPA Creationv2Github
- PROCEDUREChange Control Formsv3Github
- PROCEDURECleaning Procedurev1Github
- PROCEDURECOSHH Regulationv5Github
- PROCEDURECustomer Complaints Formv2Github
- PROCEDUREEquipment Calibration Formv3Github
- PROCEDUREEquipment Installation Procedurev3Github
- PROCEDUREEquipment Maintenance Formv2Github
- PROCEDUREEquipment Registration Formv2Github
- PROCEDUREFire Incident Reporting Formv1Github
- PROCEDUREGoods Receipt Formv2Github
- PROCEDUREGoods Release Formv5Github
- PROCEDUREIncident Reporting Formv2Github
- PROCEDUREInternal Audit Formsv2Github
- PROCEDURENon-Conformance Reportv2Github
- v2Github
- PROCEDUREPurchasing Formv1Github
- PROCEDUREReagent Preparation and Storage Formv20Github
- v1Github
- DOCUMENTSOP - Aseptic Techniquesv1Github
- v1Github
- DOCUMENTSOP - Calibration Proceduresv1Github
- v1Github
- DOCUMENTSOP - Complaint Handlingv1Github
- DOCUMENTSOP - Conducting Change Controlv1Github
- v1Github
- v1Github
- v1Github
- DOCUMENTSOP - Document Controlv1Github
- v1Github
- v1Github
- DOCUMENTSOP - Electrical Safetyv1Github
- v1Github
- DOCUMENTSOP - Environmental Monitoringv1Github
- DOCUMENTSOP - First Aid and Fire Safetyv1Github
- DOCUMENTSOP - General Laboratory Safetyv1Github
- v1Github
- v1Github
- DOCUMENTSOP - Internal Auditsv1Github
- v1Github
- v1Github
- DOCUMENTSOP - Management Reviewv1Github
- v1Github
- DOCUMENTSOP - Patient Confidentialityv1Github
- v1Github
- v1Github
- v1Github
- v1Github
- DOCUMENTSOP - Purchasingv1Github
- DOCUMENTSOP - Quality Manualv1Github
- v2Github
- v1Github
- DOCUMENTSOP - Referral Testingv1Github
- v1Github
- DOCUMENTSOP - Risk Managementv1Github
- v1Github
- v1Github
- v1Github
- DOCUMENTSOP - Test Methods SOPsv1Github
- DOCUMENTSOP - Test Result Reportingv1Github
- DOCUMENTSOP - Traceability Proceduresv1Github
- v1Github
- DOCUMENTSOP - Validation of Softwarev1Github
- PROCEDURESupplier Audit Evaluationv5Github
- PROCEDURESupplier Performance Evaluationv3Github
- v5Github
- PROCEDUREToxicological Risk Assessmentv3Github
- PROCEDUREVerification of Effectiveness Formv2Github
- PROCEDURERisk Assessment Formv2Github
- STEPCAPA Informationv2Github
- v2Github
- v2Github
- v2Github
- v2Github
- STEPChange Detailsv2Github
- v2Github
- v2Github
- v2Github
- v2Github
- v1Github
- v1Github
- STEPCOSHH Assessmentv4Github
- v3Github
- v3Github
- v3Github
- v3Github
- v2Github
- v1Github
- STEPQuality Reviewv3Github
- v2Github
- v1Github
- v1Github
- v1Github
- v2Github
- v1Github
- v1Github
- v1Github
- STEPIssue Reportingv1Github
- v1Github
- v1Github
- v1Github
- STEPGoods Receiptv4Github
- v3Github
- v4Github
- STEPProduct Releasev3Github
- v1Github
- v1Github
- v1Github
- v1Github
- v1Github
- v2Github
- STEPReview Scopev1Github
- STEPData Collectionv1Github
- v1Github
- STEPReview Summaryv1Github
- STEPPurchase Requestv1Github
- v3Github
- v12Github
- v7Github
- STEPStoragev7Github
- STEPSupplier Detailsv3Github
- v2Github
- v3Github
- v2Github
- STEPTesting Planv2Github
- v2Github
- v2Github
- STEPRisk Assessmentv1Github