Customer Feedback and ISO 13485 Management Review

R

relad

#1
Hello,
I need help with examples for customer feedback as part of the ISO 13485 management review issue.
Thank you.
 
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Stijloor

Staff member
Super Moderator
#2
Customer Feedback and Management Review

Welcome to The Cove Forums!! :bigwave: :bigwave:

A quick search on the Post Attachments List yielded this information.

Another search on "satisfaction."

Search through the documents and see which one(s) would be of use to you.

Hope this helps to get you started.
 

somashekar

Staff member
Super Moderator
#3
Re: Customer Feedback and Management Review

Hello,
I need help with examples for customer feedback as part of the ISO 13485 management review issue.
Thank you.
As a part of your monitoring and measurement, you are expected to get measurements of the performance of the quality management system, about whether the organization has met customer requirements.
One of the source for this is from the customer itself, and the formal customer complaint is a part of the customer feedback.
Here apart from the customer making a complaint, you are going to be proactive with the customer / user / medical device professional to get feedback about your medical device performance, usability, expectations, any other inputs that may have an idea for you to make an improvement.
These form the input in your management review.
An other aspect here is this :
If national or regional regulations require the organization to gain experience from the post-production phase, the review of this experience shall form part of the feedback system
So this also includes here.
I hope I have been helpful to you...


Note: For more and better response, this thread has now been moved to ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
 
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