Rework Procedure Template - ISO 13485

Rework Procedure Template - ISO 13485

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ISO 13485:2016 QMS Template - Rework Procedure (QMS.8.3.4 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Rework 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 an effective rework procedure, demonstrating robust quality management as required by ISO 13485:2016.

What is a Rework Procedure?

A Rework Procedure outlines the process of making changes to or reprocessing a product that does not meet specifications or is malfunctioning. This ensures the product meets current approved customer specifications and regulatory standards after rework. The procedure includes retesting and revaluation of the non-conforming product once rework is complete.

How Does the Rework Procedure Fit Into the QMS?

The Rework Procedure forms part of your evidence demonstrating compliance with ISO 13485, along with other documents such as:

  • The Non-Conformance Report
  • Corrective and Preventive Actions (CAPA)
  • Quality Control Procedures This template ensures that the Rework Procedure is relevant to your organization, aligns with your objectives, and fits within the scope of the QMS.

How Will Having a Rework Procedure Help My Organisation?

The Rework Procedure serves a critical role within your organization’s QMS and contributes to maintaining high-quality standards. It:

  • Defines the process for reworking non-conforming products, ensuring they meet specified requirements.
  • Provides a systematic approach to document and control rework activities.
  • Enhances traceability and accountability within the rework process.

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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