ISO 9001:2015 - Clause 8.3 - Design in the Custom Manufacturing industry

[John P (2016 Owner)]

The company that I work for is a custom manufacturing house. We do not have "shelf" items, nor do we market any specific products we build. Our engineering team is responsible for designing some product, however those designs are based on customer specs/requirements and at the end of the design phase the designs are customer approved. In our quest to reach ISO compliance, we have excluded clause 8.3 from the audit plan. Unfortunately, the president of the company is starting to worry about our ability to "sell" that we aren't actually designing product and that excluding clause 8.3 may not be applicable. All of the CBs I have talked to during the quoting process seemed to be on the side of excluding 8.3 because we dont actually design product and market that product to have specific characteristics and capabilities. We just design and build what our customers want and essentially those customers own that design. However, since our engineering team is doing some design work (again, all customer based) do we need to think about including 8.3 in our audit plan?

Our current "Design" process is not at all documented because our engineers are typically working one on one with the customer to achieve their desired outcome. Each RFQ has the potential to be handled differently, it just all depends on the customer and the product they want built.

Discussion is here: ISO 9001:2015 - Clause 8.3 - Design in the Custom Manufacturing industry

 

[harry]

Certification is usually a result of an organization's strategic decision. If design capability is important to the business, it should be part of their scope of certification. In which case, the relevant design clause will not be excluded.

Many forward looking organizations are including it as they are doing designs anyway. As to the problems with documenting the design process, there should be ways to overcome it if one were to make a detail study.

 

[Big Jim]

There has been and will continue to be some confusion on this topic.

What it rests on is simply if the definition is based on responsibility or if it is based on involvement.

The most common and longer held criteria is that as long as the organization is not responsible for design, they can exclude it. No matter just how much involvement they have, as long as the customer approves final design they sidestep the whole thing.

There is no other clause for which that criteria is used to determine exclusion. Only design.

There is a growing school of thought that if you have any involvement with design, you need to own up to it. Some CBs even have a category of "partial design".

Whichever way you go, you will have plenty of company.

 

[DannyK]

Based on your description of design activities at your company, you cannot exclude. I would recommend create a design plan for each project that shows the responsibilities and activities to be done within engineering. It does not have to be more than 1-2 pages and will formalize the requirements with your customers.

It is an advantage for your company to have design capabilities and including it within your quality system is the right way to go.

 

[Ettore]

Unfortunately, the president of the company is starting to worry about our ability to "sell" that we aren't actually designing product and that excluding clause 8.3 may not be applicable.

Great President !!!
i would like suggest you to follow APQP also if you aren't Automotive suppliers, it's a very good guide for product and process project plan like suggested by Danny, and help you to identify for every step all inputs and ouputs necessary to sell products without defects.

 

[Sidney Vianna]

Unfortunately, the president of the company is starting to worry about our ability to "sell" that we aren't actually designing product and that excluding clause 8.3 may not be applicable.

S/he should be worried that your organization's part of the design process is not adequately established, instead of being concerned with marketability issues.

All of the CBs I have talked to during the quoting process seemed to be on the side of excluding 8.3 because we dont actually design product and market that product to have specific characteristics and capabilities.

You are probably communicating with sales people who are driven to make the sale and don't want to "create roadblocks" between you and the contract signature.

We just designand build what our customers want and essentially those customers own that design.

I think that answers your own question.

The fact that you have co-responsibility for product design with your customers does not justify your organization disregarding the appropriate steps of the product design process.

8.3.2 i) of ISO 9001:2015 is critical in your case, but several other sub-paragraphs of 8.3.2 play a critical role in determining what aspects of product design you need to be in control of.

 

[dsanabria]

The company that I work for is a custom manufacturing house. We do not have "shelf" items, nor do we market any specific products we build. Our engineering team is responsible for designing some product, however those designs are based on customer specs/requirements and at the end of the design phase the designs are customer approved. In our quest to reach ISO compliance, we have excluded clause 8.3 from the audit plan. Unfortunately, the president of the company is starting to worry about our ability to "sell" that we aren't actually designing product and that excluding clause 8.3 may not be applicable. All of the CBs I have talked to during the quoting process seemed to be on the side of excluding 8.3 because we dont actually design product and market that product to have specific characteristics and capabilities. We just design and build what our customers want and essentially those customers own that design. However, since our engineering team is doing some design work (again, all customer based) do we need to think about including 8.3 in our audit plan?

Our current "Design" process is not at all documented because our engineers are typically working one on one with the customer to achieve their desired outcome. Each RFQ has the potential to be handled differently, it just all depends on the customer and the product they want built.

Discussion is here: ISO 9001:2015 - Clause 8.3 - Design in the Custom Manufacturing industry

"... In order for to determine if the organization is in fact involved in design and development, auditors need to establish who is responsible for defining the characteristics of the product or service, together with how and when this is carried out. This may apply to original design or ongoing design changes..."

For additional information read the following article.

https://isotc.iso.org/livelink/live...opment2015.pdf?func=doc.Fetch&nodeid=17526260