Product requirement Review record
We are a small company, but many hospitals - companies and private persons are sending a request for a quote or price information on our product.
I am now looking at chapter 3.3 Receiving and recording customers request.
My question is if we by 1st. contact should fill in the appendix 1 Product requirement Review record?
The reason for my asking is that we might have a rate of app. 50% of the complete numbers of quotes we are making that we do not get any reply when contacting them. Sometimes it is only a request to see if pricing is competitive. So my thought was not to make this record until we know that this is a more solid contact to proceed with.
How does this comply with the ISO13485?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
It is absolutely OK not to make this record until you know that this is a more solid contact with potential customers. With this approach, you will fulfill the necessary requirement and be in compliance with ISO 13485:2016.
For more details on complying with the latest changes in ISO 13485 clause 7.2.3 Communication, see the following link
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Apr 22, 2020