ISO 9001 Clause 8.3.5 focuses on the outputs of the design and development process. The purpose is that the product of the design and development process satisfy the required standards for quality and functionality, is compatible with what was intended, and is appropriate for use in subsequent manufacturing and quality processes.
Details of ISO 9001 Clause 8.3.5
a) Meet the Input Requirements: This means that the results of the design and development process must align with the initial input requirements. For example, if the input requirement is to create a software application with specific features, the output should indeed have these features.
b) Adequate for Subsequent Processes: The design and development outputs should be suitable for the subsequent processes in providing the final products or services. For a software development company, if the design outputs are the code and system architecture, these should be adequate for the coding, testing, and deployment phases.
c) Include or Reference Monitoring and Measuring Requirements: The outputs should specify or reference any requirements for monitoring and measuring. In the software development context, this could include performance metrics or specific criteria for testing. If the software needs to load within a certain time frame, that would be a monitoring requirement included in the output.
d) Specify Characteristics Essential for Intended Purpose: The outputs should clearly specify the characteristics necessary for the product or service's intended purpose. For our software example, if security is a critical characteristic, the design and development outputs should explicitly outline how security is achieved.
Documented Information: The organization is required to retain documented information on these design and development outputs. This documentation serves as evidence that the outputs have been reviewed and meet the necessary requirements.
Example Manufacturing Company Developing a New High-Efficiency Water Heater
a) Meet the Input Requirements: The input requirement provide specifications and tolerances for a high-efficiency water heater with specific features spelled out for energy consumption targets, water heating capacity, and safety standards. The design and development process should result in a product that meets these specific requirements.
b) Adequate for Subsequent Processes: The design outputs, which may include detailed engineering drawings, specifications, work instructions, tooling, measuring devices, and sample or prototypes, that are suitable for subsequent processes like manufacturing, quality testing, and shipping. The manufacturing team should be able to use the design outputs to produce the water heaters effectively.
c) Include or Reference Monitoring and Measuring Requirements: The design outputs specify the performance criteria for monitoring and measuring. For the water heater, this might include temperature sensors, efficiency testing protocols, and safety checks during the manufacturing and testing phases.
d) Specify Characteristics Essential for Intended Purpose: The design outputs clearly specify critical characteristics to be monitored such as the materials to be used, the technology for energy efficiency, and safety features to meet the intended purpose of providing a high-efficiency and safe water heating solution.
Documented Information: The organization retains documented information, including design specifications, test protocols, and performance criteria. This documentation serves as evidence that the design and development outputs have been reviewed and meet the necessary requirements for the water heater.
This example illustrates how Clause 8.3.5 ensures that the design and development outputs are aligned with the initial requirements and are suitable for subsequent processes, meeting the necessary criteria for the intended purpose of the product.
ISO 9001:2015 Clause 8.3.5 Design and Development Outputs
In summary, ISO 9001 Clause 8.3.5 ensures that what comes out of the design and development process is in line with what was planned, suitable for subsequent manufacturing and quality processes, and meets the necessary criteria for quality and functionality.