Streamline Your Path to ISO 9001:2015 Compliance with Our Engineering Design & Development Document Series

Streamline Your Path to ISO 9001:2015 Compliance with Our Engineering Design & Development Document Series

For manufacturers aiming to comply with ISO 9001:2015 standards and to set themselves up for the 2026 ISO update, building a comprehensive Quality Management System (QMS) is non-negotiable. In particular, the 8.3 Engineering Design and Development clause requires manufacturers to develop structured, documented procedures for managing design and development activities. But for many companies, creating compliant documentation from scratch can be a daunting, time-consuming and a costly task. That’s why we’ve designed an easy, plug and play solution: our 9-document ISO 9001:2015 Design and Development series.

At True North Quality our ISO 9001:2015 Design & Development Document Series provides your company with fully customizable templates, tailored for the 8.3 clause requirements. For just $489, you’ll receive 8 essential documents and 1 supporting form, all expertly formatted and structured to save your team countless hours and ensure that you’re on the fast track to ISO compliance.

Why Documented Procedures Are Essential for ISO 9001:2015 Compliance

ISO 9001:2015 sets the global standard for quality management, and at the core of this standard is effective documentation. Documented procedures ensure that every aspect of a product’s lifecycle, from initial design to final development, follows a clear and repeatable process. This level of structure brings numerous benefits:

1. Enhanced Quality and Consistency: Proper documentation helps eliminate variation and errors, ensuring that each product meets the same high standards.
2. Increased Efficiency: Clear procedures reduce the likelihood of rework and delays, allowing your team to work faster and more effectively.
3. Risk Mitigation: Documented procedures allow you to identify and manage potential risks early in the design process.
4. Compliance and Traceability: Having thorough documentation is a requirement for ISO 9001:2015 audits, as it demonstrates that your company adheres to industry best practices and standards.

For manufacturing companies, compliance with ISO 9001:2015 is not only a mark of quality but also a competitive advantage, giving customers confidence in your products and processes. The challenge for many organizations, however, is developing all necessary documents to meet the 8.3 requirements without consuming valuable time and resources.

The ISO 9001:2015 Design & Development Document Series: Your Turnkey Solution

Our document series was created specifically to address the needs of manufacturers aiming to comply with ISO 9001:2015 clause 8.3. With our templates, you don’t have to start from scratch. You’ll get a suite of expertly crafted documents that can be customized to your brand’s unique requirements, including:

ISO 8.3.0 - Design and Development Operating Procedure
ISO 8.3.3 - Design Input 
ISO 8.3.4 - Design Review
ISO 8.3.4 - Design Verification
ISO 8.3.5 - Design Output
ISO 8.3.5 - Design Validation
ISO 8.3.6 - Engineering Change Notice Process
ISO 8.3.6 - Engineering Redline Process
ISO 8.3.6 - Engineering Notice Change (Form)

Each document in the series has been developed with ISO compliance in mind and has been proven to comply through countless registrar audits. This ensures that your QMS is aligned with clause 8.3’s requirements. By implementing these templates, you’ll eliminate months of drafting, revising, and formatting, allowing your team to focus on actual engineering and production tasks.

How This Document Series Supports Compliance

Each template in our many series is designed to address a specific aspect of the ISO 9001:2015 requirements for design and development:

• Consistency in Design Processes: Our templates ensure that your team follows consistent practices for each project, minimizing variability and maintaining high standards.
• Clear Criteria for Design Inputs and Outputs: Define and document design inputs and outputs, as required by ISO, ensuring all relevant requirements are considered.
• Structured Reviews, Verification, and Validation: With dedicated templates for design reviews, verification, and validation, our series ensures that each project phase is monitored, assessed, and documented for future reference.
• Effective Change Management: The templates provide a structure for managing and documenting changes in design, so any adjustments are controlled and traceable.

Together, these templates create a comprehensive, step-by-step approach to managing design and development that’s fully aligned with ISO 9001:2015.

Get Started Today!

If you’re ready to make ISO 9001:2015 compliance easier and more accessible, our ISO 8.3 Design & Development Document Series is the perfect solution. With everything you need to streamline the documentation process, meet ISO standards, and improve your design and development practices, this series will give you the confidence and support to excel.

For additional assistance schedule a 45 min free Game Plan call to discuss any of your quality issues.