ISO 9001: 2015 Clause 8.3.4 and Product Design

PLCs, programmable logic controllers


My company is implementing ISO 9001:2015 and my question is regarding Clause 8.3.4 d. Our company designs product for only 20% of our customer base. We do not have a validation process. We do send a prototype to the customer to test the part for a period of time to approve the design. In determining the scope of our organization, can we exclude the validation process and still become ISO 9001:2015 certified?


From John Surak:

This organization is involved in product design.  Therefore, the product design cannot be excluded.  However, the organization needs to review the validation clause.  8.3.4d states the following:   “validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use.”  It should be noted that neither 8.4.3d not the validation refences in ISO 9001 do not prescribe a method on how to conduct validation.  It would appear that the company has some sort of process they use to develop the prototypes.  This process should be codified or documented so that it is done in a consistent manner and in a way to ensure that the customer needs are met.

John G. Surak, PhD

From George Hummel:

Basically, you are outsourcing validation.  Therefore, you need to control that process per 8.4. I would not accept the exclusion. In the future, you may have a customer that requires you to do the validation. However, the final answer would be provided by your certification body.

Click here for more resources about ISO 9001: 2015.

Design for Six Sigma

Control chart, data, analysis

Q: I am preparing a short training session for my company on the topic of Design for Six Sigma.  I am interested in looking at some examples of how other companies or organizations have used DFSS.  Is it possible to get case studies from ASQ on this topic?

A: Thank you for contacting ASQ and the Quality Information Center.  Design for Six Sigma (DFSS) can be defined as “robust design that is consistent with the applicable manufacturing processes to assure a fully capable process that will deliver quality products” (from The Quality Improvement Glossary by Donald L. Siebels).

For DFSS case studies, please visit ASQ’s website.