ISO 9001 Clause 8.3.5 focuses on the outputs of the design and development process. Its purpose is to ensure that the outputs of the design and development process satisfy the required standards for quality and functionality, are compatible with what was intended, and are appropriate for use in subsequent manufacturing and quality processes.
In other words, the output of design and development should ensure the product is made to the required specifications. It should include all drawings, work instructions, control plans, personnel requirements, measuring devices, test criteria, metrics, materials, and tooling needed to make the product.
If production encounters nonconformances in making the product, design and development should update the documentation appropriately to resolve the problems. Manufacturing engineering sometimes performs this to ensure the product is manufactured according to the design.
Details of ISO 9001 Clause 8.3.5 Design and Development Outputs
a) Meet the Input Requirements: This means that the design and development process results must align with the initial input requirements. For example, the output should have these features if the input requirement is to create a software application with specific 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. For example, 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 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.
e) Documented Information: The organization must retain documented information on these design and development outputs. This documentation proves that the outputs have been reviewed and meet the requirements.
Example Manufacturing Company Developing a New High-Efficiency Water Heater
a) Meet the Input Requirements: The input requirement provides specifications and tolerances for a high-efficiency water heater with specific features for energy consumption targets, water heating capacity, and safety standards. The design and development process should produce a product that meets these requirements.
b) Adequate for Subsequent Processes: The design outputs, which may include detailed engineering drawings, specifications, work instructions, tooling, measuring devices, and samples 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 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.
e) Documented Information: The organization retains documented information, including design specifications, test protocols, and performance criteria. This documentation indicates that the design and development outputs have been reviewed and meet the requirements for the water heater.
This example illustrates how Clause 8.3.5 ensures that the design and development outputs align with the initial requirements and are suitable for subsequent processes, meeting the necessary criteria for the product’s intended purpose.
ISO 9001:2015 Clause 8.3.5 Design and Development Outputs
ISO 9001 Clause 8.3.5 ensures that the design and development process outputs are in line with the plan, suitable for subsequent manufacturing and quality processes, and meet the necessary criteria for quality and functionality.
