Which ISO 13485 clause(es) are applicable for Value Proposition Creation

P

pheuvelmans

#1
Hi all,

I am wondering to what degree a value proposition process should be compliant with ISO 13485 and if yes, which clauses apply.

This is the description of the VP process:
"The Define offering and customer value proposition process includes all processes necessary to develop and flesh out the details of a customer or market offering. These offerings should address and align with customer needs as determined in the product development processes.
This process also includes the development and positioning of any new, related branding for the target customer segments.
Customer case studies and qualifications are used to support the proposition."

To my opinion, following clauses apply:
Clause 7.2 Customer-related processes, all 3 sub clauses (7.2.1, 7.2.2, 7.2.3), as in the VP building, customer requirements are gathered, in various cases even while having contact with customers and endusers.
Clause 7.3 Design and Development is on the edge: sub clauses

Alternatively, you could also ensure that the VP outcome does not end up in the DHF.

Any thoughts by anyone?
 
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#2
This seems like a business process to me (and not the low-level work processes).

ISO 13485 only deals with business processes in general terms, such as the general requirements in class 4. The other clauses, including the product realization process in 7.3, are related to more specific activities (I would not even call those processes, such as design and development process as the standard to, because the manufacturer should define the process, not the standard. I?ve said it sometimes during the meeting of TC 210 WG 1 but not one was willing to correct this "mistake" :p).

Anyway, from you description, I would say that different requirements do apply to your process, including the ones you mentioned.

However, if you are concerned with controlling it to much, you might view it in the same vein as the research part of D&D, it?s excluded from design controls (until you have the product requirements defined), so you donut need to follow design control requirements - so it?s a little more open how you control them.
 
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