Question
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?
Answers
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.
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