ISO9001:2015 clause 8

Kimjay

Registered
Hi everyone, I am trying to understand how clause 8.3 the design and development process corresponds to my company.
We are a small biotech company who genetically modify bacteria, and sell them as an innoculum to dye houses. They use them in fermentation to produce coloured fabrics. So we don’t design and develop, for example a machine, we don’t have drawings or BOMs etc. But do our laboratory experiments and tests correspond to the design and development? Also part stating ‘where the products and services are not defined by your customer.’ They might specify the end colour of their fabric, but not define the product we sell to them.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
Hi everyone, I am trying to understand how clause 8.3 the design and development process corresponds to my company.
We are a small biotech company who genetically modify bacteria, and sell them as an innoculum to dye houses. They use them in fermentation to produce coloured fabrics. So we don’t design and develop, for example a machine, we don’t have drawings or BOMs etc. But do our laboratory experiments and tests correspond to the design and development? Also part stating ‘where the products and services are not defined by your customer.’ They might specify the end colour of their fabric, but not define the product we sell to them.

Good day @Kimjay ;
From the information in your post, I believe you may have answered your own question by your statement...
"but not define the product we sell to them". So if I understand correctly your organization designs the content/makeup of genetically modified bacteria. Therefore, "Design and development of products...." per clause 8.3.

Remember, however , that ISO 9001 is NOT overly prescriptive. For example, within clause 8.3 the following terms are used...
* The organization shall establish
* process that is appropriate
* shall consider:


This is not meant to diminish, however, the requirements that are specifically dictated by clause 8.3. Regardless of what the organization determines/establishes, your organization must (shall) ...
"... establish, implement and maintain a design and development process that is
appropriate to ensure the subsequent provision of products and services."


Hope this helps.
Be well.
 
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