Corrective Action and Preventative Action Procedure - ISO 9001

Corrective Action and Preventative Action Procedure - ISO 9001

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ISO 9001:2015 QMS Template - Corrective & Preventative Action Procedure (QMS.10.2.3 - QP)

Enhance your Quality Management System with our ISO 9001:2015 compliant Corrective & Preventative Action (CAPA) Procedure 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 CAPA Procedure 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.
  • Compliance Assurance: Using our CAPA procedure helps you maintain an effective process for managing non-conformances, demonstrating robust quality management as required by ISO 9001:2015.

What is a CAPA Procedure and Why Do You Need It?

A CAPA procedure is essential for detailing the steps to raise and implement corrective and preventative actions when a non-conformance is identified within your Quality Management System. This template allows you to:

  • Detail the Process: Outline how a CAPA is raised, including responsibilities and how it integrates with other QMS requirements.
  • Ensure Accountability: Assign clear responsibilities for each step in the CAPA process, ensuring thorough and effective implementation.
  • Maintain Compliance: Document each stage of the corrective and preventative action process, providing a clear trail of actions and decisions.

Benefits of the CAPA Procedure Template

  • Detailed Process Documentation: Maintain comprehensive records of the CAPA process, including steps taken, responsibilities, and outcomes.
  • Enhanced Accountability: Clearly outline roles and responsibilities, ensuring effective implementation of corrective and preventative actions.
  • Audit Facilitation: Enable auditors to review your CAPA procedure, demonstrating compliance and best practices.

Invest in Excellence

Optimize your Quality Management System with our expertly crafted CAPA procedure template. Tailored to meet ISO 9001:2015 requirements, this tool ensures your organization effectively manages non-conformances and continuously improves its processes. Purchase our CAPA procedure 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 qmsregs@patientguard.com.

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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