ISO 9001:2015 8.3 Design and development of products and services

glenn0004

Involved In Discussions
#1
We have always looked at requirements for Design and development (9001:2008) as an exempt clause, stating that as a business we don't covert a customers (external end users) specification(s) into a product, we supply a fixed product. However, I'm always cautious of the view that we may design and develop our own internal processes and that "internally" we design and develop our systems and reporting that may or may not be required to operate the processes (and thus the QMS) of the business. On the premise that the customer is internal, should the latter be inclusive of the QMS and therefor mandate compliance with requirements for design and development or as we don't covert a customers (external end users) specification(s) into a product can we state 8.3 as not applicable.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Good day glen0004,

I can appreciate your intentions, indeed it is important to address the needs of internal customers as well as external customers.

I would, however caution against your proposed approach since 2.2.1 of ISO 9000:2015 and numerous places in ISO 9001:2015 refer to both customers and interested parties. While we would agree an external customer is a relevant interested party, the standard attempts to differentiate them so we don't make a long list of requirements for an organization-wide set of processes and sub processes.

Therefore, sections 8.2, 8.3 and 8.4 apply to products and services you provide to external customers/constituencies (for those of us who are nonprofits) and section 8.5 addresses processes to help make sure internal customers' needs are met through controlled, available, suitable etc. resources and documentation in order to ensure external customer needs are met.

I hope this helps!
 

yodon

Staff member
Super Moderator
#3
I'm sorry, I got confused. It sounds to me like you DO actually perform design and development. You have design inputs (just not from a customer) and design outputs. You make that product and then sell to customers. The only reason you're exempting design & development is because the requirements (design inputs) are developed internally? Can you clarify?
 

glenn0004

Involved In Discussions
#4
Thanks for taking a look at my post - In the basic interpretation we dont take specifications from external customers to convert in to products - we supply a fixed product(s) to the end user. I am cautious that there are some instances under external audit of the 2008 standard where the development of internal business processes and syetems are classified as Design and Development so I need to clarify how this would translate to the 2015 standard as "internally" we have the ability to develop of ERP sytems, however this is not our product to the end customer.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Your interpretation seems to be 100% faulty because, as I understood, your organization is the product design responsible.

That being the case, you can not disregard the requirements for product design and claim compliance to the standard. An ethical and professional certification body would never issue certificates of conformity to ISO 9001 to an organization that does not satisfy it's obligation to design products as per the applicable requirements.

The basic question to be answered here for a definitive and authoritative answer is: who designs the products?
 

somashekar

Staff member
Super Moderator
#6
The design inputs are not necessarily and not always customer provided.
If you are making a 10mm washer that 100 customers buy, then you are design responsible. The design inputs for this can be from any standard. You are not researching ....
 

glenn0004

Involved In Discussions
#8
Many thanks again for those who has replied however they may fuel my fustrations. As we dont design a product to the end user, we distribute products manufactured by other organisations; I'm going to run on the premise that we can mark 8.3 as not applicable to our QMS
 

somashekar

Staff member
Super Moderator
#9
Many thanks again for those who has replied however they may fuel my fustrations. As we dont design a product to the end user, we distribute products manufactured by other organisations; I'm going to run on the premise that we can mark 8.3 as not applicable to our QMS
Your scope will dictate your activities. Being in service sector of product distribution, the 8.3 throws up tricky situation. Have you designed your distribution process before putting it to work for you ....... You must have, and based on customer expectations, you might have modified too so as to meet newer requirements. Its your distribution methodology for your requirement. You have designed it and you can make changes based on new inputs. Do you now see the 8.3 process .... ?
 

glenn0004

Involved In Discussions
#10
Your scope will dictate your activities. Being in service sector of product distribution, the 8.3 throws up tricky situation. Have you designed your distribution process before putting it to work for you ....... You must have, and based on customer expectations, you might have modified too so as to meet newer requirements. Its your distribution methodology for your requirement. You have designed it and you can make changes based on new inputs. Do you now see the 8.3 process .... ?
Thanks Somashekar, you have correctly identified my concerns in that under 9001:2015 8.3 does not only refer to the phyisical product or service to the end user but also to the planning of how the phyisical delivery of product or service is attained "distribution methodology" . Under 9001:2008 we interpretd Design and Development as being the phyisical product or service and became cautious of Design and Development being the whole QMS.
 

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