7.1.5 and design and development of product

armani

Quite Involved in Discussions
#1
For organizations whose activities are only design and development of product, how do you apply cap. 7.1.5 ISO 9001:2015?
 
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John Broomfield

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Super Moderator
#2
For organizations whose activities are only design and development of product, how do you apply cap. 7.1.5 ISO 9001:2015?
As a design services company you will find that most clauses of ISO 9001 still apply including monitoring and measurement.

Study how your organization works to determine and satisfy the needs of your clients and their customers to see for yourself.

You will find that briefing the client to determine their needs is monitored, the design process is managed and measured for its progress in translating client and their customer’s needs into specified requirements per the design plan. You may also find that you are reporting progress on a regular basis to ensure early attention to any needed corrections.

Your design team will also involve the client in reviews, verification and validation of their designs per their client-approved design plan. Finally, you’ll be ascertaining the degree of client satisfaction; likewise for their customers that are affected by your design services.

All of these actions amount to the monitoring and measurement the cost and quality of your design services.
 

armani

Quite Involved in Discussions
#3
Sure, but I cannot identify what specific Measuring and Monitoring resources is ISO 9001:2015 cap. 7.1.5 referring to, e.g.
" resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements"
and
"appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources."

.
 
Last edited:

John Broomfield

Leader
Super Moderator
#4
What are the criteria used by your colleagues to select competent people for design monitoring?

What are the criteria used by your colleagues to select people for design review?

What are the criteria used by your colleagues to select competent people for approval of designs?

What are the criteria used by your colleagues to select competent people for approval of design changes?

These are your firm's measuring and monitoring resources you may see them specified in your design plan.
 
#5
This sure went sideways in a hurry. Monitoring and measuring resources refers to calibrated tools. You really can't separate 7.1.5.1 and 7.1.5.2. Collectively 7.1.5.1 and 7.1.5.2 take the place of 7.6 in the old ISO 9001:2008 where it was titled "Control of Monitoring and Measuring Equipment".

How does that apply to 8.3 Design & Development? Answer the question in 7.1.5.1. What measuring tools do you need to ensure valid and reliable results when monitoring and measuring is used to verify the conformity of products and services? Do you need calibrated tools during design activities? If you do, what tools do you need? Micrometers, calipers, pressure gages, or whatever? Do they need to be calibrated to ensure accuracy? Do they need to be precise to ensure accuracy when the product moves to production?
 

armani

Quite Involved in Discussions
#6
I would need some examples of monitoring and measuring resources used for 8.3.
I see everybody is avoiding a direct answer.
And, BTW, 71.6 is not only about calibrated tools (micrometer etc.), but also about , e.g., check-lists, soft used for monitoring etc., isn't it?
 

John Broomfield

Leader
Super Moderator
#7
armani,

Please ask your direct questions in full.

We don’t all have access to a current version of the standard.

Then more of us can help with direct answers.

Thanks.
 
#8
I would need some examples of monitoring and measuring resources used for 8.3.
I see everybody is avoiding a direct answer.
And, BTW, 71.6 is not only about calibrated tools (micrometer etc.), but also about , e.g., check-lists, soft used for monitoring etc., isn't it?
I don't read that into 7.1.5 that way. Maybe some do but it seems to be a severe stretch.
 
#10
So, for companies providing design is not applicable?
Or maybe a prototype (if any) could be 7.1.6?
7.1.6 is Organizational Knowledge, which doesn't seem to be the topic of this thread. Did you mean 7.1.5?

7.5.1.1 leads off with "The organization shall determine and provide resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements."

Answer the question as to if design (8.3) involves monitoring and measuring at your organization affects conformity of products or services and you will have your answer. I believe in most cases it does not.
 
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