Product Identification & Traceability Template - ISO 13485

Product Identification & Traceability Template - ISO 13485

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ISO 13485:2016 QMS Template - Product Identification & Traceability Procedure (QMS.7.5.8 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Product Identification & Traceability Procedure 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 product identification and traceability procedures, demonstrating robust quality management as required by ISO 13485:2016.

What Are the Requirements of ISO 13485 Relating to Product Identification & Traceability?

The ISO 13485 standard requires that organizations:

  • Document Procedures: Establish and document procedures for product identification throughout the product realization process.
  • Maintain Identification: Ensure medical devices are identified by suitable means throughout production, storage, installation, and servicing.
  • Status Tracking: Maintain the identification of your medical device’s status to ensure only products that have passed required inspections and tests are dispatched, used, or installed.
  • Assign UDIs: Assign unique device identification numbers (UDIs) if selling into the EU.
  • Identify Returns: Document procedures to distinguish returned medical devices from conforming products.
  • Ensure Traceability: Define the extent of traceability in accordance with applicable regulatory requirements.

How Will the Template Help Me Meet the Requirements of the Standard?

The Product Identification & Traceability Procedure template helps your organization:

  • Establish Controls: Create procedures for establishing and maintaining product identification and traceability throughout product realization.
  • Track Product Status: Ensure the finished product is traceable to the customer and Device History Records.
  • Comply with Contract Manufacturing: Include requirements for contract manufacturers where applicable.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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