ISO 13485:2016 – Quality management systems — Requirements for regulatory purposes
Clause 4.2.2: Quality Manual
Clause 4.3.3 Medical Device File
Clause 4.2.4 Control of Documents
Clause 4.2.5 Control of Records
Clause 5.3 Quality Policy
Clause 5.4.1 Quality Objectives and Quality Plan
Clause 5.5.1 Responsibility and Authority
Clause 5.5.2 Management Representative
Clause 5.5.3 Communication
Clause 5.6: Management Review
Clause 6.2: Human Resources Templates
Clause 6.3 Infrastructure
Clause 6.4 Work Environment and Contamination Control
Clause 7.1 Planning for Product Realisation
Clause 7.2 Communication
Clause 7.3 Design and Development
Clause 7.4: Purchasing Templates
Clause 7.4.3 Verification of Purchased Product
Clause 7.5 Production and Service Provision
Clause 7.5.1 Control of Production and Service Provision
Clause 7.5.2 Cleanliness of Product
Clause 7.5.3 Installation Activities
Clause 7.5.4 Servicing Activities
Clause 7.5.5 Particular Requirements for Sterile Medical Devices
Clause 7.5.6 Validation of Processes for Production and Service Provision
Clause 7.5.7 Particular Requirements for Validation of Processes for Sterilisation and Sterile Barrier Systems
Clause 7.5.8 Identification
Clause 7.5.9 Traceability
Clause 7.5.10 Customer Property
Clause 7.5.11 Control of Monitoring and Measuring Equipment
Clause 7.6 Control of Measuring and Monitoring Equipment
Clause 8: Measurement, Analysis and Improvement
Clause 8.2.1 Feedback
Clause 8.2.2 Complaint Handling
Clause 8.2.3 Reporting to Regulatory Authorities
Clause 8.2.4 Internal Audits
Clause 8.2.5 Monitoring and Measurement of Processes
Clause 8.2.6 Monitoring and Measurement of Product
Clause 8.3 Control of Non-conforming Product
Clause 8.3.2 Actions in Response to Non-conforming Product Detected Before Delivery
Clause 8.3.3 Actions in Response to Non-conforming Product Detected After Delivery
Clause 8.3.4 Rework
Clause 8.4 Analysis of Data
Clause 8.5 Improvement
Clause 8.5.2 Corrective Action
Clause 8.5.3 Preventive Action
PNS MED HEALTH 