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- (ISO 13485:2016) QMS.4.2.3.1.4 - Essential Requirements Checklist Template UKCA
- (ISO 13485:2016) QMS.4.2.3.1.1 - Declaration of Conformity Template UKCA
- (ISO 13485:2016) QMS.4.2.3.1 - Medical Device File Template UKCA Mark
- (ISO 13485:2016) QMS.7.4.1.1 - QR - Supplier Evaluation Form
- ISO 13485 Quality Management System Folder Structure
- Medical Device File (Technical File) Folder Structure
- (ISO 13485:2016) QMS.7.1.0.1 - QR - Risk Register Template
- (ISO 13485:2016) QMS.7.1.0 - QP - Risk Management
- (ISO 13485:2016) QMS.8.5.2.2 - QR - CAPA Report Form
- (ISO 13485:2016) QMS.8.5.2.1 - QR - CAPA Report Log
- (ISO 13485:2016) QMS.8.3.2.2 - QR - Non-conformance Report
- (ISO 13485:2016) QMS.8.3.2.1 - QR - Non-conformance Log
- (ISO 13485:2016) QMS.8.2.2.2 - QR - Complaint Investigation Form
- (ISO 13485:2016) QMS.8.2.2.1 - QR - Complaints Database
- (ISO 13485:2016) QMS.7.5.1 - QP - Device History Record
- (ISO 13485:2016) QMS.7.4.3 - QP - Receiving Inspection/Goods In
- (ISO 13485:2016) QMS.7.4.2 - QP - Purchasing Procedure
- (ISO 13485:2016) QMS.7.4.1.2 - QR - Approved Supplier List
- (ISO 13485:2016) QMS.7.4.1 - QP - Supplier Evaluation and Monitoring
- (ISO 13485:2016) QMS.6.2.0.4 - QR - Job Description Template
- (ISO 13485:2016) QMS.6.2.0.3 - QR - Training Record Template
- (ISO 13485:2016) QMS.6.2.0.2 - QR - Training Matrix Template
- (ISO 13485:2016) QMS.6.2.0.1 - QR - Employee Induction template
- (ISO 13485:2016) QMS.5.6.0.2 - QR - Management Review Meeting Minutes and Action Item Templates
- (ISO 13485:2016) QMS.5.6.0.1 - QR - Management Review Meeting Agenda Template
- (ISO 13485:2016) QMS.4.2.3.1.5c - Risk Evaluation and Risk-Benefit Template (EN ISO 14971:2019)
- (ISO 13485:2016) QMS.4.2.3.1.4 - GSPR Checklist Template IVDR 2017/746
- (ISO 13485:2016) QMS.4.2.3.1.1 - Declaration of Conformity Template IVDR 2017/746
- (ISO 13485:2016) QMS.4.2.3.1 - Medical Device File Template IVDR 2017/746
- (ISO 13485:2016) QMS.4.1.6.2 - QR - Software Acceptance Testing Template
- (ISO 13485:2016) QMS.4.1.6.1 - QR - Software Master List Template
- (ISO 13485:2016) QMS.4.2.3.1.5b - Device Risk Identification, Analysis and Control Template (EN ISO 14971:2019)
- (ISO 13485:2016) QMS.4.2.3.1.5a - Device Risk Management Plan Template (EN ISO 14971:2019)
- (ISO 13485:2016) QMS.4.2.3.1.7 - Device Post Market Surveillance Plan Template
- (ISO 13485:2016) QMS.4.2.3.1.1 - Declaration of Conformity Template MDR 2017/745
- (ISO 13485:2016) QMS.4.2.3.1.4 - GSPR Checklist Template MDR 2017/745
- (ISO 13485:2016) QMS.4.2.3.1 - Medical Device File Template MDR 2017/745
- (ISO 13485:2016) QMS.4.1.6 - QP - Software Validation and Re-validation Procedure
- (ISO 13485:2016) QMS.4.2.4.2 - QR - Master Document List
- (ISO 13485:2016) QMS.4.2.4.1 - QR - Change Control Log
- (ISO 13485:2016) QMS.8.5.2 - QP - Corrective Action and Preventative Action (CAPA) Procedure
- (ISO 13485:2016) QMS.8.4.0 - QP - Measurement and Analysis
- (ISO 13485:2016) QMS.8.3.4 - QP - Rework Procedure
- (ISO 13485:2016) QMS.8.3.2 - QP - Non-conformance Procedure
- (ISO 13485:2016) QMS.8.2.4.3 - QR - Audit Report Template
- (ISO 13485:2016) QMS.8.2.4.2 - QR - Audit Plan Template
- (ISO 13485:2016) QMS.8.2.4.1 - QR - Audit Schedule Template
- (ISO 13485:2016) QMS.8.2.4 - QP - Internal Audit Procedure
- (ISO 13485:2016) - All templates for EN ISO 13485:2016
- (ISO 13485:2016) QMS.8.2.3 - QP - Vigilance and Post-market Surveillance Procedure
- (ISO 13485:2016) QMS.8.2.2 - QP - Complaint Handling Procedure
- (ISO 13485:2016) QMS.8.2.1 - QP - Feedback Procedure
- (ISO 13485:2016) QMS.7.6.0 - QP - Control of Measuring and Monitoring Equipment Procedure
- (ISO 13485:2016) QMS.7.5.9 - QP - Traceability Procedure
- (ISO 13485:2016) QMS.7.5.8 - QP - Product Identification Procedure
- (ISO 13485:2016) QMS.5.4.1 - Quality Objectives
- (ISO 13485:2016) QMS.5.3.0 - Quality Policy
- (ISO 13485:2016) QMS.7.5.6 - QP - Process Validation Procedure
- (ISO 13485:2016) QMS.7.5.7 - QP - Validation of Process for Sterilisation and Sterile Barriers Systems Procedure
- (ISO 13485:2016) QMS.7.5.4 - QP - Servicing Activities Procedure
- (ISO 13485:2016) QMS.7.5.3 - QP - Requirements for Product Installation Procedure
- (ISO 13485:2016) QMS.7.5.2 - QP - Requirements for the Cleanliness of Product Procedure
- (ISO 13485:2016) QMS.7.3.0 - QP - Design and Development Procedure
- (ISO 13485:2016) QMS.7.2.0 - QP - Customer Related Process
- (ISO 13485:2016) QMS.7.0.0 - QP - Product Realisation Planning Procedure
- (ISO 13485:2016) QMS.6.3.0 - QP - Infrastructure, Work Environment and Contamination Control Procedure
- (ISO 13485:2016) QMS.6.2.0 - QP - Training and Qualification Procedure
- (ISO 13485:2016) QMS.5.6.0 - QP - Management Review Procedure
- (ISO 13485:2016) QMS.5.0.0 - QP - Management Responsibilities Procedure
- (ISO 13485:2016) QMS.5.4.2 - QP - Quality Management Planning Procedure
- (ISO 13485:2016) QMS.4.2.5 - QP - Control of Records Procedure
- (ISO 13485:2016) QMS.4.2.4 - QP - Document Control Procedure
- (ISO 13485:2016) QMS.4.2.2 - Quality Manual