ISO 13485 SOP Templates and Procedures
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Cl # 4.1.5,
Outsourcing Process
- List of Outsourced Vendors
- Vendor NC Report
Cl # 4.1.6
Validation of Software used in QMS
Cl # 4.2.4,
Control of Documents
- Master List of Internal or External Documents
- Master List of SOP and Work Instructions
- Document Revision Request
- Document Approval Record
- Master List of Formats
- Document Issue Record
- Obsolete Documents Register
Cl # 4.2.5,
Control of Records
- Master List of Records
Cl # 5.6
Management Review
- Quality System Committee Members
- MRC Members Notice
- Minutes of Meeting
- MRM Action Plan and Follow Up
- Quality Objective Planning
- Annual MRM Plan
- Risk Identification & Control
Cl # 6.2
Training Process
- Induction and Orientation
- Employee Master List
- Competence Chart
- Training Needs Identification
- Annual Training Plan
- Training Intimation Memo
- Training Record
- Training Evaluation
Cl # 6.3
Infrastructure
- Nil
Cl # 6.3
Maintenance Activities
- Maintenance Log
- Master List of Equipment
- Preventive Maintenance Schedule
- List of Equipment under Preventive Maintenance
- Preventive Maintenance Register
- Breakdown Maintenance Memo
Cl # 6.4.1
Control of Work Environment
- Environmental Monitoring
- Housekeeping Register
Cl # 6.4.1 a
Health, Cleanliness and Clothing
- Environmental Monitoring
- Housekeeping Register
Cl # 6.4.2
Control of Contaminated or Potentially Contaminated Product
- Nil
Cl # 6.4.2
Contamination Control for Sterile Medical Devices
- Nil
Cl # 7.3
Design and Development
- Nil
Cl # 7.3.7
Cl # 7.4
Purchase Process
- Supplier Registration & Approval Form
- List of Approved Vendor Supplier or Service Provider
- Purchase Order
- Material Request & Issue Details
- Vendor Rating and Re-evaluation Form
- Goods Received Note
- Vendor Audit Checklist
- Vendor Agreement
Cl # 7.5.2
Cleanliness of the Product
- Nil
Cl # 7.5.3
Installation and Acceptance Criteria
- Nil
Cl # 7.5.4
Servicing Activities
- Nil
Cl # 7.5.6
Validation of Processes for Production and Service Provision
- Nil
Cl # 7.5.6
Validation of the Software used in Production.
- Nil
Cl # 7.5.7
Validation of Processes for Sterilization and Sterile Barrier Systems
- Nil
Cl # 7.5.8
Product Identification
- Nil
Cl # 7.5.8
Identification of returned Medical Device
- Returned Product Register & Analysis Report
- Status Identification of Returned Goods
Cl # 7.5.9
Traceability
- Nil
Cl # 7.5.11
Product Preservation
- Nil
Cl # 7.6
Monitoring and Measuring
- Nil
Cl # 7.5.6
Calibration
- Calibration Register
- Calibration Master List
- List of Calibration Equipment
Cl # 7.5.6
Validation of Software used for Monitoring and Measurement
- Nil
Cl # 8.2.1
Feedback process
- Customer Feedback Form
Cl # 8.2.1
Post Market Clinical Follow up
- Nil
Cl # 8.2.2
Handling of Customer Complaints
- Market Complaint Register
- Customer Complaint Form
- Complaint Notification Register
Cl # 8.2.3
Notifying the Regulatory Authorities
- Nil
Cl # 8.2.4
Internal Audit
- Annual Internal Audit Plan
- Internal Audit Schedule
- List of Internal Auditors
- Internal Audit Summary
- IQA Non-Conformity Report
- IQA Non Conformity Report Follow Up
- Internal Audit Checklist
Cl # 8.2.6
Monitoring & Measurement of Product
- Nil
Cl # 8.3
Nonconforming Product
- Non-Conforming Product Register
- Deviation Note
- Quarantine Register
Cl # 8.3.3
Advisory Notice
- Advisory Notice
Cl # 8.3.4
Rework
- Nil
Cl # 8.4
Analysis of Data
- Analysis of Data