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ISO 13485

Home ISO 13485 Procedures and Templates

ISO 13485 Procedures and Templates

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 ofย  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