Device History Record Procedure - ISO 13485

Device History Record Procedure - ISO 13485

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ISO 13485:2016 QMS Template - Device History Record (QMS.7.5.1 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Device History Record template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
  • Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
  • Compliance Assurance: Utilizing our template helps you maintain effective Device History Records, demonstrating robust quality management as required by ISO 13485:2016.

What is a Device History Record?

A Device History Record (DHR) is a comprehensive record that contains all documentation related to the manufacture and monitoring of a specified device. It ensures the device has been manufactured according to the specifications laid out in applicable product design documents such as:

  • QMS.7.0.0 - QP - Product Realisation Planning
  • QMS.7.3.0 - QP - Design and Development Procedure

A DHR is required for each manufactured product and includes, but is not limited to, the following information:

  • Product identification, including part/reference number or model/version number
  • Traceable control numbers, including serial number or lot number
  • Unique Device Identification (UDI) on the product label and/or direct marking
  • Dates of manufacture
  • Quantity manufactured

How Will Keeping a Device History Record Help My Organisation?

The ISO 13485 standard mandates that organizations establish and maintain records for each medical device (or batch of devices) to provide traceability and identify the quantity manufactured and approved for distribution. This template will help you:

  • Establish and Maintain DHRs: Determine your method for establishing and maintaining Device History Records.
  • Ensure Verification and Approval: Ensure these records are verified and approved according to ISO 13485 requirements.

Why Patient Guard?

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