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Non-conformance Report Template - ISO 9001

Non-conformance Report Template - ISO 9001

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ISO 9001:2015 QMS Template - Non-Conformance Report (QMS.10.2.1 - QR)

Enhance your Quality Management System with our ISO 9001:2015 compliant Non-Conformance Report template. Created by the fully qualified and experienced professionals at Patient Guard, this template meets the specific requirements of each clause and section of the ISO 9001:2015 standard.

Why Choose Our Non-Conformance Report Template?

  • Expertly Designed: Our seasoned Quality Assurance and Regulatory Affairs specialists crafted this template to ensure full compliance with ISO 9001:2015 standards.
  • Easy Customization: Fully editable in Microsoft Word, our template allows you to modify and tailor it to your specific business needs and branding.
  • Comprehensive Coverage: This template helps you document and manage non-conformities effectively within your QMS.

What is a Non-Conformance Report and Why Do You Need It?

A Non-Conformance Report details instances where the Quality Management System does not align with the organization’s policies, procedures, or work instructions. Raising non-conformances allows for effective monitoring and management of the QMS. Our Non-Conformance Report template helps you:

  • Detail Non-Conformances: Record what the non-conformance is and which part of the QMS is affected.
  • Escalate Issues: Ensure the right people evaluate the non-conformity as part of risk management.
  • Decide on Actions: Determine if an investigation is needed and if it leads to Corrective and Preventative Actions.

Benefits of the Non-Conformance Report Template

  • Structured Documentation: Maintain a clear and organized report for handling non-conformances.
  • Enhanced Compliance: Ensure your non-conformance reports meet ISO 9001:2015 standards.
  • Improved Monitoring: Keep track of all non-conformities to facilitate timely resolution and continuous improvement.

Invest in Excellence

Optimize your Quality Management System with our expertly crafted Non-Conformance Report template. Tailored to meet ISO 9001:2015 requirements, this tool ensures your organization effectively documents and manages non-conformities. Purchase our Non-Conformance Report template today and take the first step towards a more efficient and compliant Quality Management System.

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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