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ISO 9001 - Implementing 7.3.2 - 7.3.7

M

microstrip

#1
Our company manufactures and sells wire stripping tools and we are in the beginning stages of implementing ISO9001. I have some confusion on the clauses relating to design and development (7.3.2 through 7.3.7). We very rarely have requests for design changes, maybe one or two in total. What exactly is required to show compliance in this area? Information regarding input, review, verification and validation are simply stated on a form describing our progress:

7.3.2 Design/Development inputs: We have a conference with the customer where we determine their requirements, write it down on our form and attach any specs they send us.
7.3.4 Results of review: Again, we have a meeting where we discuss exactly what is going to be produced with time frame and acceptance from the customer and note this on the form.
7.3.5 Verification: We then generate AutoCAD drawings to confirm fit and function and attach them to the report.
7.3.6 Validation: A prototype is made using SLA printing and sent to the customer for approval before being sent to production.

Is this enough to show compliance or are there additional forms or requirements needed? I'm not exactly sure how else we would go about doing this. Any help is much appreciated!

:thanx:
 
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Mikishots

Trusted Information Resource
#2
Our company manufactures and sells wire stripping tools and we are in the beginning stages of implementing ISO9001. I have some confusion on the clauses relating to design and development (7.3.2 through 7.3.7). We very rarely have requests for design changes, maybe one or two in total. What exactly is required to show compliance in this area? Information regarding input, review, verification and validation are simply stated on a form describing our progress:

7.3.2 Design/Development inputs: We have a conference with the customer where we determine their requirements, write it down on our form and attach any specs they send us.
7.3.4 Results of review: Again, we have a meeting where we discuss exactly what is going to be produced with time frame and acceptance from the customer and note this on the form.
7.3.5 Verification: We then generate AutoCAD drawings to confirm fit and function and attach them to the report.
7.3.6 Validation: A prototype is made using SLA printing and sent to the customer for approval before being sent to production.

Is this enough to show compliance or are there additional forms or requirements needed? I'm not exactly sure how else we would go about doing this. Any help is much appreciated!

:thanx:
It needs to be stressed that the "review" takes place many times throughout the design and development process; it's not a one-time deal. Typically, we see this done after each design stage (defined in Subclause 7.3.1). The reviews need to be triggered as part of your design plan so that they don't become random events. As far as records of each review (which are required), consider using simple meeting minutes; agenda/topics that were covered, who was there, critical action items, along with any reference docs attached.
 
M

Mike_H

#3
It needs to be stressed that the "review" takes place many times throughout the design and development process....
.. or just once if the design plan calls for it, yes? It would not be typical, but it is possible if the D&D outputs meets product requirement inputs and only one single review was conducted before customer validation. Would this just be seen as 'poor planning' however, or a function of the product's complexity?
 
J

JaneB

#4
.. or just once if the design plan calls for it, yes? It would not be typical, but it is possible if the D&D outputs meets product requirement inputs and only one single review was conducted before customer validation. Would this just be seen as 'poor planning' however, or a function of the product's complexity?
You do the number of reviews that you decide are required in order to get the required output. If that's one (and it might be), then it's one. If more are required, you do more.
 

somashekar

Staff member
Super Moderator
#5
7.3.2 Design/Development inputs: We have a conference with the customer where we determine their requirements, write it down on our form and attach any specs they send us.
Add all the learning from your previous design and development experiences
7.3.4 Results of review: Again, we have a meeting where we discuss exactly what is going to be produced with time frame and acceptance from the customer and note this on the form.
A very important design review record is the evidence that the design outputs are meeting the design input requirements
 
M

microstrip

#6
Thanks everyone for your informative posts! Much obliged! :)

Still a bit hazy on this part though...

A very important design review record is the evidence that the design outputs are meeting the design input requirements
Is specifications versus prototype not enough evidence of meeting these requirements? Could this be proven by a few additional reviews and approvals by the customer?
 
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