Design and development is one of the most important components of ISO 9001:2015. Clause 8.3 outlines how organizations should plan, control, implement, verify, and validate their design and development activities. Whether you are creating a new product, improving an existing service, or developing a technical process, Clause 8.3 ensures that everything is done systematically, efficiently, and with customer satisfaction as the main priority.
This blog provides a complete, easy-to-understand explanation of Clause 8.3, its requirements, practical examples, and how organizations can implement it effectively. It also includes related ISO tools such as Internal Audit Pack ISO 9001:2015, Internal Audit Pack ISO 14001:2015, Internal Audit Pack ISO 50001, and others that support quality and compliance programs.
Introduction: Why Clause 8.3 Matters
Organizations that develop new products or services must ensure consistency, reliability, compliance, and customer satisfaction. ISO 9001:2015 Clause 8.3 ensures that design and development is carried out using a structured approach—from planning to validation.
This clause applies to:
- Product manufacturers
- Service providers
- Engineering firms
- Software development companies
- Research and development teams
Any organization involved in creating something new must apply Clause 8.3, unless design activities are outsourced or not applicable.
1. What Is ISO 9001:2015 Clause 8.3?
Clause 8.3 focuses on controlling design and development activities. It ensures that organizations identify requirements, follow structured processes, implement reviews, and validate the outputs before they are released to customers.
The clause is divided into six subclauses:
- 8.3.1 General Requirements
- 8.3.2 Design and Development Planning
- 8.3.3 Design and Development Inputs
- 8.3.4 Design and Development Controls
- 8.3.5 Design and Development Outputs
- 8.3.6 Design and Development Changes
Understanding each section ensures compliance and improved product quality.
2. Clause 8.3.1 – General Requirements
This section emphasizes the importance of establishing a design and development process that ensures the product/service meets:
- Customer requirements
- Legal and regulatory requirements
- Industry standards
- Operational needs
Key expectations include:
✔ Having a documented design process
✔ Defining responsibilities
✔ Evaluating the impact of design stages
✔ Maintaining evidence and records
Organizations must demonstrate that design activities are planned, controlled, and aligned with the organization’s Quality Management System (QMS).
3. Clause 8.3.2 – Design and Development Planning
Design success depends on strategic planning. ISO 9001:2015 requires organizations to consider:
- Design stages
- Review methods
- Verification and validation
- Resources needed
- Responsibilities and authorities
- Internal and external input
- Control of interfaces between departments
- Required documentation
Example:
A software company planning to build a new mobile app must outline:
- Design phases
- Customer requirement gathering
- Prototype development
- Testing methods
- Team responsibilities
- Timeline and approval points
This structured planning prevents delays, miscommunication, and unexpected issues.
4. Clause 8.3.3 – Design and Development Inputs
Inputs include all information required to carry out the design process.
ISO requires inputs to be:
✔ Complete
✔ Clear
✔ Measurable
✔ Relevant
✔ Feasible
Design inputs may include:
- Customer specifications
- Functional requirements
- Performance expectations
- Legal and regulatory requirements
- Environmental considerations
- Past design experience
- Industry standards
Example:
When designing a medical device, regulatory requirements (FDA, CE, ISO 13485) must be included in the design input list.
5. Clause 8.3.4 – Design and Development Controls
Controls ensure that every step of the design process is managed and evaluated. ISO requires organizations to:
- Perform design reviews
- Verify outputs meet inputs
- Validate that the final product works as intended
- Address changes or risks
Typical design controls:
- Review meetings
- Cross-functional assessments
- Prototype testing
- Risk assessments
- Documentation approvals
These controls help detect problems early in the process rather than after production.
6. Clause 8.3.5 – Design and Development Outputs
Design outputs must meet the input requirements and be suitable for production or service delivery.
Outputs include:
- Engineering drawings
- Technical specifications
- Manufacturing instructions
- Test procedures
- Software code
- Material lists
Outputs must also indicate acceptance criteria and essential performance characteristics.
Example:
Before launching a new automobile component, design outputs such as 3D models, assembly drawings, and safety specifications must be clearly documented.
7. Clause 8.3.6 – Design and Development Changes
Changes often occur during or after design completion. ISO requires organizations to:
- Review and approve changes
- Evaluate impacts on existing design
- Maintain records of changes
- Communicate changes to key stakeholders
Example:
If a material shortage forces a design change, the team must assess its impact on product durability, safety, and compliance.
8. Benefits of Implementing Clause 8.3
✔ Improved customer satisfaction
✔ Reduced design errors
✔ Better communication across teams
✔ Stronger risk management
✔ Compliance with legal and regulatory requirements
✔ Faster time-to-market
✔ Higher product reliability and performance
Organizations gain a competitive edge by adopting a systematic design and development approach.
9. I Guru Store – Your Trusted Partner for ISO Internal Audit Tools
To implement ISO 9001:2015 Clause 8.3 successfully, organizations need strong internal auditing processes, templates, checklists, and guides. IGuruStore provides high-quality ISO internal audit resources, including:
- ISO 45001 internal auditor training
- ISO 45001 risk assessment internal audit materials
- Internal Audit Pack ISO 50001
- Internal Audit Pack ISO 14001:2015
- Internal Audit Pack ISO 9001:2015
- Internal Audit Pack ISO (General)
- Internal Audit Pack (All-purpose auditing toolkit)
These tools help companies maintain compliance, identify gaps, and strengthen their Quality Management System. Whether you are preparing for certification or improving your existing processes, IGuruStore enables quick, professional, and accurate audits.
10. Simple Example of Clause 8.3 in Real Life
Imagine a company designing a new air conditioner:
Step-by-step application:
1. Planning (8.3.2)
Plan design stages, responsibilities, resources.
2. Inputs (8.3.3)
Collect customer needs, energy efficiency requirements, environmental laws.
3. Controls (8.3.4)
Review design, test prototypes, validate cooling performance.
4. Outputs (8.3.5)
Generate wiring diagrams, performance reports, assembly instructions.
5. Changes (8.3.6)
If a compressor supplier changes, evaluate impact on product efficiency.
11. Tips for Passing a Design & Development Audit
To ensure compliance with Clause 8.3:
✔ Keep detailed records
✔ Maintain version control
✔ Document design reviews
✔ Conduct regular internal audits
✔ Use standardized templates
✔ Maintain traceability
✔ Document all changes
Most nonconformities happen because of poor documentation—using Internal Audit Packs can help avoid major issues.
Conclusion
ISO 9001:2015 Clause 8.3 is essential for organizations that design products or develop services. It ensures a controlled, structured, and measurable approach to design, leading to improved quality, customer satisfaction, and operational efficiency. By understanding the requirements of planning, inputs, controls, outputs, and changes, organizations can implement a strong and effective design and development system.
Tools such as Internal Audit Pack ISO 9001:2015, Internal Audit Pack ISO 14001:2015, Internal Audit Pack ISO 50001, and risk-based auditing materials can significantly strengthen compliance and streamline audits.
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