Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services

Joe Smith

Starting to get Involved
#1
8.3.1 says "The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services." Apart from the addition of 'services', that's basically the same as in 2008.

No problem so far - we've got a mature and robust D & D process for production of our manufactured products. The only service we provide is the occasional assembly of a product at a customer's site, and all we do there is follow the assembly instructions that the customer would otherwise use.

However - a recent visiting CB auditor has left us some notes after taking a look at our 'Readiness Review' for the transition to 2015, and he's saying that D & D must now cover not only our products, but also the planning of our order fulfilment processes e.g. picking and packing.

How is that going to work, or am I just being obtuse? Our picking and packing processes have been in place for years, and are totally driven by the software we use (off-the-shelf, with a few tweaks just for us). What kind of evidence could we hope to provide to show how these were designed or planned? Even if we changed our software in the future (highly unlikely, at least in my lifetime), I don't see where D & D comes into it, as we would just have to follow the stages built into that software. Any advice would be welcome.
 

howste

Thaumaturge
Moderator
#2
Picking and packing is not a service you are providing to your customer. I see no reason to show the auditor evidence of D&D for this. This is part of Operations and it should be verified that the product picked and packed is correct.
 

Joe Smith

Starting to get Involved
#3
Thank you, howste, that's exactly what I thought. I can see we'll have to have some words with that auditor. His exact comment was "Clause 8.3 is not just design and development of the products you supply, it is also design and development of your internal processes for order fulfilment etc, e.g. designing your picking and packing processes." How he gets that from that clause I don't know!
 

howste

Thaumaturge
Moderator
#4
ISO 9001:2015 does say
clause 8.3.2h said:
In determining the stages and controls for design and development, the organization shall consider... the requirements for subsequent provision of products and services
and
clause 8.3.5b said:
The organization shall ensure that design and development outputs... are adequate for the subsequent processes for the provision of products and services
I believe that this requires that the Product Design Process considers manufacturability and what manufacturing processes will be used to create the product.

In the automotive industry, ISO/TS 16949 clause 7.3 and the newly released IATF 16949 clause 8.3 do require "Manufacturing Process Design" and expects the design of the manufacturing processes to meet the requirements of this section of the standard. Even with that though, picking and packing are not manufacturing processes. :confused:
 

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