Design and Development Procedure - ISO 9001

Design and Development Procedure - ISO 9001

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ISO 9001:2015 QMS Template - Design and Development Procedure (QMS.8.3.2 - QP)

Enhance your Quality Management System with our ISO 9001:2015 compliant Design and Development 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 Design and Development 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 template helps you manage design and development processes effectively, demonstrating robust quality management as required by ISO 9001:2015.

Why Do You Need a Design and Development Procedure?

ISO 9001:2015 requires organizations to document procedures for design and development. This includes:

  • Design and Development Planning: Outline activities, stages, and controls.
  • Design and Development Inputs and Outputs: Specify requirements and results.
  • Design Changes and Reviews: Detail actions taken to reduce risks to the end user.

Our template provides a comprehensive framework for creating your procedure and ensuring compliance with the standard.

What Are Design and Development Inputs and Outputs?

Design inputs define the physical and performance requirements for product design. These inputs include:

  • Statutory and Regulatory Requirements: Ensure compliance with laws and regulations.
  • Risk Assessment: Identify potential risks to end users if a product fails.

Design outputs are the results of the design effort at each phase and at the end of the total design effort. Outputs should:

  • Contain Product Acceptance Criteria: Ensure the product meets design input requirements.
  • Meet Specified Requirements: Align with the criteria set out in the design and development inputs.

Our template helps your organization document design and development inputs and outputs clearly, demonstrating compliance with ISO 9001:2015.

Benefits of the Design and Development Procedure Template

  • Detailed Process Documentation: Maintain comprehensive records of design and development activities.
  • Enhanced Compliance: Ensure all design and development steps meet ISO 9001:2015 standards.
  • Audit Facilitation: Enable auditors to review your procedures, demonstrating best practices.

Quality Management Support

If you seek support with your QMS, Patient Guard’s consultancy services offer a cost-effective solution for your organization. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at

Invest in Excellence

Optimize your Quality Management System with our expertly crafted Design and Development Procedure template. Tailored to meet ISO 9001:2015 requirements, this tool ensures your organization effectively manages design and development processes. Purchase our Design and Development 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

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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