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


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design and development, exemptions, iso 9001:2015
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  Post Number #1  
Old 7th June 2016, 03:36 AM
glenn0004

 
 
Total Posts: 61
Please Help! ISO 9001:2015 8.3 Design and development of products and services

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.

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  Post Number #2  
Old 7th June 2016, 09:03 AM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,021
Re: ISO 9001:2015 8.3 Design and development of products and services

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!
Thank You to Jen Kirley for your informative Post and/or Attachment!
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  Post Number #3  
Old 7th June 2016, 10:08 AM
yodon

 
 
Total Posts: 974
Re: ISO 9001:2015 8.3 Design and development of products and services

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?
Thanks to yodon for your informative Post and/or Attachment!
  Post Number #4  
Old 7th June 2016, 11:50 AM
glenn0004

 
 
Total Posts: 61
Re: ISO 9001:2015 8.3 Design and development of products and services

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.
  Post Number #5  
Old 7th June 2016, 12:05 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,889
Re: ISO 9001:2015 8.3 Design and development of products and services

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?
Thanks to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #6  
Old 7th June 2016, 12:49 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,254
Re: ISO 9001:2015 8.3 Design and development of products and services

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 ....
Thanks to somashekar for your informative Post and/or Attachment!
  Post Number #7  
Old 8th June 2016, 03:22 AM
Ajay Akole

 
 
Total Posts: 19
Re: ISO 9001:2015 8.3 Design and development of products and services

Design responsible Organization means they have authority to change product specification
Thank You to Ajay Akole for your informative Post and/or Attachment!
  Post Number #8  
Old 8th June 2016, 04:45 AM
glenn0004

 
 
Total Posts: 61
Re: ISO 9001:2015 8.3 Design and development of products and services

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
Thanks to glenn0004 for your informative Post and/or Attachment!
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