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ISO 13485

Home ISO 13485 Procedures Template

ISO 13485 Procedures and Templates

Get latest ISO 13485 Procedures Template for medical device from i3cglobal. Below you can check the complete list of documentation templates. Let us know if you have any query or question.


Cl # 4.1.5,
Procedure

Outsourcing Process

Record Templates
  • List of Outsourced Vendors
  • Vendor NC Report

Outsourcing Process



Cl # 4.1.6
Procedure

Validation of Software used in QMS


Validation of Software used in QMS



Cl # 4.2.4,
Procedure

Control of Documents

Record Templates
  • 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

Control of Documents



Cl # 4.2.5,
Procedure

Control of Records

Record Templates
  • Master List of Records

Control of Records



Cl # 5.6
Procedure

Management Review

Record Templates
  • 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

Management Review Process



Cl # 6.2
Procedure

Training Process

Record Templates
  • Induction and Orientation
  • Employee Master List
  • Competence Chart
  • Training Needs Identification
  • Annual Training Plan
  • Training Intimation Memo
  • Training Record
  • Training Evaluation

Training Process



Cl # 6.3
Procedure

Infrastructure

Record Templates
  • Nil

Infrastructure



Cl # 6.3
Procedure

Maintenance Activities

Record Templates
  • Maintenance Log
  • Master List of Equipment
  • Preventive Maintenance Schedule
  • List of Equipment under Preventive Maintenance
  • Preventive Maintenance Register
  • Breakdown Maintenance Memo

Maintenance Activities



Cl # 6.4.1
Procedure

Control of  Work Environment

Record Templates
  • Environmental Monitoring
  • Housekeeping Register

Control of Work Environment



Cl # 6.4.1 a
Procedure

Health, Cleanliness and Clothing

Record Templates
  • Environmental Monitoring
  • Housekeeping Register

Health, Cleanliness and Clothing



Cl # 6.4.2
Procedure

Control of Contaminated or Potentially Contaminated Product

Record Templates
  • Nil

Contaminated or Potentially Contaminated Product



Cl # 6.4.2
Procedure

Contamination Control for Sterile Medical Devices

Record Templates
  • Nil

Control of Contaminated or Potentially Contaminated Product



Cl # 7.1
Procedure

Risk Management

Record Templates
  • Nil
Cl # 7.3
Procedure

Design and Development

Record Templates
  • Nil
Cl # 7.4
Procedure

Purchase Process

Record Templates
  • 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

Purchase Process



Cl # 7.5.2
Procedure

Cleanliness of the Product

Record Templates
  • Nil

Cleanliness of the Product



Cl # 7.5.3
Procedure

Installation and Acceptance Criteria

Record Templates
  • Nil

Installation and Acceptance Criteria



Cl # 7.5.4
Procedure

Servicing Activities

Record Templates
  • Nil

Servicing Activities



Cl # 7.5.6
Procedure

Validation of Processes for Production and Service Provision

Record Templates
  • Nil

Validation of Processes for Production and Service Provision



Cl # 7.5.6
Procedure

Validation of the Software used in Production.

Record Templates
  • Nil

Validation of the Software used in Production



Cl # 7.5.7
Procedure

Validation of Processes for Sterilization and Sterile Barrier Systems

Record Templates
  • Nil

Validation of Processes for Sterilization and Sterile Barrier Sy



Cl # 7.5.8
Procedure

Product Identification

Record Templates
  • Nil

Product Identification



Cl # 7.5.8
Procedure

Identification of returned Medical Device

Record Templates
  • Returned Product Register & Analysis Report
  • Status Identification of Returned Goods

Identification of returned Medical Device



Cl # 7.5.9
Procedure

Traceability

Record Templates
  • Nil

Traceability



Cl # 7.5.11
Procedure

Product Preservation

Record Templates
  • Nil

Product Preservation



Cl # 7.6
Procedure

Monitoring and Measuring

Record Templates
  • Nil

Monitoring and Measuring



Cl # 7.5.6
Procedure

Calibration

Record Templates
  • Calibration Register
  • Calibration Master List
  • List of Calibration Equipment

Calibration Process



Cl # 7.5.6
Procedure

Validation of Software used for Monitoring and Measurement

Record Templates
  • Nil

Validation of Software used for Monitoring and Measurement



Cl # 8.2.1
Procedure

Feedback process

Record Templates
  • Customer Feedback Form

Feedback Process



Cl # 8.2.1
Procedure

Post Market Surveillance

Record Templates
  • Nil
Cl # 8.2.1
Procedure

Post Market Clinical Follow up

Record Templates
  • Nil
Cl # 8.2.2
Procedure

Handling of Customer Complaints

Record Templates
  • Market Complaint Register
  • Customer Complaint Form
  • Complaint Notification Register

Handling of Customer Complaints



Cl # 8.2.3
Procedure

Notifying the Regulatory Authorities

Record Templates
  • Nil
Cl # 8.2.4
Procedure

Internal Audit

Record Templates
  • 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

Internal Audit Process



Cl # 8.2.6
Procedure

Monitoring & Measurement of Product

Record Templates
  • Nil

Monitoring & Measurement of Product



Cl # 8.3
Procedure

Nonconforming Product

Record Templates
  • Non-Conforming Product Register
  • Deviation Note
  • Quarantine Register

Nonconforming Product



Cl # 8.3.3
Procedure

Advisory Notice

Record Templates
  • Advisory Notice

Advisory Notice



Cl # 8.3.4
Procedure

Rework

Record Templates
  • Nil

Rework



Cl # 8.4
Procedure

Analysis of Data

Record Templates
  • Analysis of Data

Analysis of Data



Cl # 8.5.2
Procedure

Corrective and Preventive Action

Record Templates

Corrective and Preventive Action