What is Design&Development and what is product in a Research company

Gerhard

Registered
We are a research company where every customer request is organized as a project. Now we are looking into ISO 9001 certification.
There is a discussion emerging whether the sold product (a report and a demonstrator) needs a Design and Development (Clause 8.3) procedure or a Production (Clause 8.5) procedure? It is only occasionally that a customer requires a second demonstrator.

I would consider any sold item " Production" but our scientist emphasize that they decide on the specifications, making it a Design and development project.

Whos has had any experience with such discussion?
 

Jim Wynne

Leader
Admin
The question should be about what needs a documented procedure and not so much which ISO 9001 bucket it goes in. Write your process documentation such that the requirements of the standard are satisfied, and the standard will take care of itself.
 

Randy

Super Moderator
Your "projects" (output) are your product, everything else is/are inputs to their creation. Works the same was as a government service contract (delivery of the contract is the product). And yes many of the parts of 8.3 could be applicable.
 

Big Jim

Admin
And technically, you don't need to have a written procedure for any of it unless you want to. There is no require written procedures in ISO 9001:2015. It may still be in your best interest to have written procedures though, at least some.
 

John Broomfield

Leader
Super Moderator
We are a research company where every customer request is organized as a project. Now we are looking into ISO 9001 certification.
There is a discussion emerging whether the sold product (a report and a demonstrator) needs a Design and Development (Clause 8.3) procedure or a Production (Clause 8.5) procedure? It is only occasionally that a customer requires a second demonstrator.

I would consider any sold item " Production" but our scientist emphasize that they decide on the specifications, making it a Design and development project.

Whos has had any experience with such discussion?
From what you say you and your colleagues are designing your services to satisfy the needs of each client. This usually is part of the sales process and results in a service specification that is approved by the client and costed to form the contract.

On winning the contract your organization fulfills the contract and delivers the report and a demonstrator (prototype?).

Do not write your system around the standard but focus on what you do to convert the needs of your clients into cash in the bank (so you have the resources to invest in continual improvement). Do this and you’ll find that your system (both documented and undocumented) already mostly conforms to the requirements of ISO 9001.

You’ll need to invest in auditor training to establish auditing as a new process so you and a colleague may as well do that now; unless you’ve already done this.

You cannot document the entirety of your system so don’t even try. Document only to the extent needed by a competent workforce. And competence comes from processes such as recruiting, training and informing.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I did 21 CFR 820.30 design controls for pure medical device research at the Dept Of Veterans Affairs. I was asked to have our design files audited. This was interesting. "Whats the scope of your QMS?" "Design Controls" Who is the customer? The Sponsors or granting authorities.

What is the product? We had to define that as the research itself. Did the research demonstrate a new technology, was it translatable? Was there IP as a result?

After years of arguing we determined the scope of the organization was to provide a complete design file ready to be commercialized if a private customer wanted to pay for the licensing of it. the purpose of research is to discover new information and either use that to educate others or use it directly in the real world to improve the state of the art in whatever field the research was in.
 
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