Design and Development Outputs – Clause 8.3.5 of ISO 9001/AS9100D Standard

Design and Development Control - Clause 8.3.5 of ISO 9001/AS9100 Standard

In our most recent blog posts, we have been covering the subclauses within clause 8.3 of the ISO 9001/AS9100 standards, Design and Development of Products and Services. This article pertains specifically to section 8.3.5, Design and Development Outputs. This section requires the organization to provide and document the output of the design process in some form. 

What is 8.3.5 Design and Development Outputs about?

Section 8.3.5 of the ISO 9001/AS9100 standards pertains to the presentable end result of the design process. A question that might come up is “What actually qualifies as an output?”. The design output dictates what the organization will produce in order to meet the design input requirements. Additionally, the output utilizes the input and turns it into something the organization can present. The output will typically be in some form of documentation, such as:

  • Blueprints
  • Manufacturing instructions
  • Product specifications
  • Flowcharts
  • Operating criteria
  • Packaging specifications
  • Physical product or prototype product

The organization can choose to document their design output in a variety of ways. Regardless of the form of the output, the organization must meet these requirements in accordance with the ISO 9001/AS9100 standards:

  • Meet the input requirements. The goal of design output is to assist the organization in developing a new or improved product. To do this, the outputs must clearly fulfill the input requirements. This is beneficial since it ensures that the organization is cognizant of its customers’ and market’s expectations throughout the design process.


  • Outputs are adequate for the subsequent processes for the provision of products and services. Design outputs serve as means of communication. Their main function is to guide members of the organization on how to develop a new product successfully. As a result, they must share data with departments such as purchasing, logistics, production, quality assurance, and sales. For this reason, there could be multiple design outputs.


  • Outputs must include reference monitoring, measuring requirements (as appropriate), and acceptance criteria. The outputs must specify what comprises acceptable product quality. In other words, what specific standards does the product have to meet? Dimensional tolerances, performance parameters, material requirements, aesthetic requirements, etc. are some examples of acceptance criteria. The nature of the product dictates the type of acceptance criteria that will be utilized. Acceptance criteria applies not only to the design of products but also to the design of services that the organization may provide.


  • Outputs specify characteristics of products and services that are essential for their intended purpose and their safe and proper provision. Customers are very inventive in their application of items, particularly new ones. They will occasionally use things in ways that could cause injury or death. The product’s safe and acceptable use must be clearly indicated in the design outputs. This safeguards both the organization and its customers. Organizations who fail to do their due diligence during this process frequently face costly lawsuits, bankruptcy, and criminal prosecution.

Overall, the design output takes the design input and transforms it into something that the organization can present. While the design output might take many different forms, according to ISO 9001/AS9100, they must all meet the same requirements. As a result, the organization will produce a product or service that matches consumer and market demands.