ISO 9001:2015 Clause 8.3.5, titled "Design and Development Outputs," details the requirements for the outputs of the design and development process. This clause ensures that the outputs are adequate for the subsequent processes for the provision of products and services, including their potential to meet the requirements. Key elements include:
- Conformity to Design and Development Inputs: Outputs must meet the requirements set out in the design and development inputs. This includes ensuring that the product or service specifications are defined to meet customer requirements and applicable statutory and regulatory requirements.
- Appropriate for Subsequent Processes: Design and development outputs should be in a form that enables verification against the design and development inputs and is suitable for use in subsequent processes, such as production, service delivery, and maintenance.
- Include or Refer to Monitoring and Measuring Requirements: Outputs must include or reference monitoring and measuring requirements and acceptance criteria. This is crucial for ensuring that the product or service can be effectively monitored and measured to meet quality standards.
- Specify Characteristics Essential for Safe and Proper Use: Outputs must identify those characteristics of the products and services that are crucial for their safe and proper use, including handling, installation, maintenance, and final disposal where applicable.
The focus of Clause 8.3.5 is on ensuring that the results of the design and development process are comprehensive, clearly documented, and communicated. This ensures that what has been developed can be correctly produced, implemented, or delivered and will meet the intended purpose and requirements.