Re: ISO 13485 - Procedure for a Feedback System
Yes it is a SOP but it would be better if a template is available so that we can provide it directly to the customers.. The doctors prefer not to waste their time in filling out long forms.. Is there a possibility to get Post market survey form in a single page template?
It is not a requirement to get the feedback from customer only.
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 (see 8.5.1).
This part above in the standard ISO13485 covers requirements of post market surveillance, for timely feedback to CAPA process
8.2.1 Feedback
As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to whether the organization has met customer requirements.
The methods for obtaining and using this information shall be determined.
The organization shall establish a documented procedure for a feedback system [see 7.2.3 c)] to provide early warning of quality problems and for input into the corrective and preventive action processes (see 8.5.2 and 8.5.3).
This part above in the standard ISO13485 is about monitoring all the information to assess if the customer requirements are met. Method how it can be done has to be determined. The key is to gather as much info and from as many areas., internal and from the field and service and hospital user's, doctor's, para medics, hospital equipment maintenance personnel, etc etc .... for early warnings (means be sensitive to assess and fine tune the medical device to avoid potential failures or other safety related effects.)
So the documented procedure for feedback when it covers only the feedback from customers is partial. This procedures must identify what and how and when and by whom the feedback information is to be monitored for timely feedback to CAPA process.
This procedure structures and supplements the CAPA documented procedure.