ISO 9001:2015 Clause 8.3.3, titled "Design and Development Inputs," outlines the requirements for handling inputs related to the design and development of products and services. This clause emphasizes the importance of determining, documenting, and maintaining the inputs necessary for the design and development process. Key aspects include:
- Relevance and Completeness: Inputs must be relevant to the product or service and should be complete. They should include requirements specified by the customer, applicable statutory and regulatory requirements, standards or codes of practice the organization has committed to, and any internal requirements.
- Functional and Performance Requirements: Inputs should clearly state the functional and performance requirements of the products or services.
- Previous Similar Experiences: Information derived from previous designs, user feedback, and lessons learned should be considered to enhance the design process.
- Other Essential Criteria: This could involve requirements related to product identification, traceability, environmental considerations, and any necessary documentation for the product or service.
The purpose of Clause 8.3.3 is to ensure that the design and development process is based on clear, well-defined inputs that are necessary to create products and services that meet customer requirements and regulatory obligations. This foundation is critical for successful design and development outcomes.