ISO 9001 DESIGN AND DEVELOPMENT
ISO 9001 Design and Development requirements (Clause 8.3 of ISO standards) are applicable to your organization when design and development are within the scope of the Quality Management System.
The scope includes all design and development work undertaken by your organization that directly impacts the quality of your products or services. Your organization is required to define and implement processes with these requirements only when you provide design and development services or develop proprietary products or services.
According to ISO 9001:2015 certification standards, the organization shall control the entire design and development cycle. This process includes review, verification, and validation at various stages to make sure that your organization is developing a product or service identified in the input. The phases of design and development process include:
ISO 9001 8.3.2 Design and Development Planning
ISO 9001 8.3.3 Design and Development Inputs
ISO 9001 8.3.4 Design and Development Controls
ISO 9001 8.3.5 Design and Development Outputs
ISO 9001 8.3.6 Design and Development Changes