Design and Development control, clause 8.3.4, requires the organization to review, verify and validate that the design is acceptable for the product/service goals that were established during the design and development planning phase. 

As stated in the ISO 9001/AS9100 D standards, the organization where design and development function is applicable, the following is required:

Results to be achieved are defined

As mentioned in the previous clause, the objectives of the design are established in the design inputs activity. The organization should verify that controls are in place to ensure that the outcomes of the design process are clearly specified. In other words, the organization needs to ask themselves “What are we trying to achieve?”.

Conduct reviews to evaluate the ability of the results of design and development to meet requirements

This clause refers to meeting the design and development requirements that were identified in the planning stage. Additionally, the number of design reviews required for a design will vary based on its complexity and risk. Overall, the fundamental goal of design reviews is for the organization to evaluate the results of design and development to ensure that they fulfill requirements, identify any deficiency, and propose any necessary adjustments.

Conduct verification activities to ensure that the design and development outputs meet the input requirements

The verification process ensures that the design outputs correspond to the design inputs. It is comparable to an inspection activity. Verification can be done once at the conclusion of the design process or several times when incremental design outputs are developed, depending on the nature of the product being designed. Generally, complex products will need more than one design verification. Verification activities can include inspection and testing, accompanied by review of inspection reports, test results, traceability, and approvals.

Conduct validation activities to ensure that the resulting products and services meet the requirements for the specified application or intended use

Validation is comparable to verification, except the organization no longer analyzes abstract product representations like drawings or specifications. Instead, the organization analyzes a real-world version of the product. The product might be a prototype, sample, beta version, etc. It will be a more accurate representation of the product that will be presented to the end user. Validation is intended to put the product to the test in a real-world context to confirm that it accomplishes what it is supposed to do in the eyes of the customer. Typically, design validation follows successful design verification. Design verification can be seen as “did you design the product/service right?”. Whereas design validation would be “did you design the right product?”.

Address problem areas that are determined during reviews or verification and validation activities

The goal of this requirement is to evaluate the findings from the reviews, verification, or validation sections and correct any issues that have emerged in order to assure that the product or service fits the initial design and development criteria. Once the problem areas have been corrected, only then should the organization proceed.

Retain documented information of these activities

Several documents, specifications, findings, and reports will have been prepared during the validation, verification, and review phases of this process. The clause refers to this as the organization’s documented information, and it must be retained as part of the objective evidence from the design and development process.

Overall, this section of the ISO 9001/AS9100D is crucial in ensuring adequate controls are applied so that the output of the design and development process align with the customer’s requirements. It is important to review the objectives and follow the design and development plan to successfully produce a product or service that does what it is supposed to.