ISO 13485 - Procedure for a Feedback System (Post Market Surveillance)

J

Jojo63

#1
Hello,

I am new on the forum, I am French and my english is a google translation. :rolleyes:

I can not define a documented procedure for a feedback system. (§8.2.1).

If someone have a example (even in English), I will be happy. :)

Thank you.

Jojo
 
Last edited by a moderator:
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: ISO 13485 - Procedure for a Feedback System

Hopefully one of the medical device folks here will help out, but this is the requirement:

ISO 13485 said:
8.2 Monitoring and measurement
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).
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).
I don't think there is an example procedure here. My Thanks in advance to anyone who will share one.
 
M

mcervantes

#4
Re: ISO 13485 - Procedure for a Feedback System

Jojo, do you still need a sample procedure?
 
J

Jojo63

#5
Re: ISO 13485 - Procedure for a Feedback System

Hi all,

Steve : Thanks you for your procedure.

Mcervantes : I will. That will give me more ideas.

:thanx: for your help.

Jojo.
 
I

ishwaryanarayan

#6
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?
 

somashekar

Staff member
Super Moderator
#7
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.
 
Last edited:
R

Ram1nta

#8
Re: ISO 13485 - Procedure for a Feedback System

Hello,

I am new in this ISO standard thing and do not have any experience. However, my authorities requested to write a Feedback system process. I have the ISO 14969 standard where there are some explanations of ISO 13485, but it is still hard for me to start the process and to make all necessary templates. I have searched in Google for some templates and found that you have a template. I would like to ask you a big favor, to send me the template.

I would be very grateful for any help, because now I am in a critical situation.

if you could provide any help, it would a great help for me.

Sincerely
Raminta
 
N

Nagesh U.R

#9
Hello
Any body having the standard procedure for the feed back systems in ISO 13485 for contract manufacturor of medical devices.
We can not do post market servilence since we are supplying to the OEM
Thanks
Nagesh U.R
 
Z

zeklein

#10
Bonjour,

Avez-vous trouvé un example de procédure de feedback? Si oui, je serai volontiers preneur.
Merci,
Alain
 
Thread starter Similar threads Forum Replies Date
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
S Procedure on Privacy Policy in the ISO 13485 quality management system ISO 13485:2016 - Medical Device Quality Management Systems 3
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
J ISO 13485 8.4 Analysis of Data - Procedure example ISO 13485:2016 - Medical Device Quality Management Systems 1
C Is a First Article Inspection (FAI) Procedure required by ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Risk Based Approach for ISO 13485:2016 Form/Procedure ISO 13485:2016 - Medical Device Quality Management Systems 23
Y Analysis of Data Procedure: Requirements for OBL (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 2
T ISO 13485 Procedure Content Requirements Other ISO and International Standards and European Regulations 2
T ISO 13485 Documented Data Protection Procedure Requirement ISO 13485:2016 - Medical Device Quality Management Systems 3
R Definition Reference Measurement Procedure - Definition as specified in ISO 13485 7.5.1.1 b) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
C GMP Standard Operation Procedure - Differences between ISO 13485 and 21 CFR 810 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Q ISO 13485 Design Control Procedure for Virtual Manufacturer wanted ISO 13485:2016 - Medical Device Quality Management Systems 8
C Process Validation procedure for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
K Root Cause for lacking Analysis of Data procedure? ISO 13485 Problem Solving, Root Cause Fault and Failure Analysis 7
T Risk Management Procedure Mandatory in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
C Established procedure for Advisory Notices - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
somashekar Documented Rework Procedure - ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
M Engineering Drawing Number Procedure Requirement - ISO 13485:2003 4.2.1 d)? Document Control Systems, Procedures, Forms and Templates 3
C Monitoring and measurement - 7.6 of ISO 13485 - Documented procedure required? ISO 13485:2016 - Medical Device Quality Management Systems 5
O Is a Contract Review Procedure necessary to comply with ISO 13485:2003? Contract Review Process 5
L ISO 13485: 2003 - Clause 8.4 Analysis of Data - Seeking an example procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
D Implementing ISO 13485:2003 - 8.5.1 - Advisory Notices - Recall Procedure ISO 13485:2016 - Medical Device Quality Management Systems 12
B ISO 13485 Calibration Requirements - Requiring a Documented Procedure for control? ISO 13485:2016 - Medical Device Quality Management Systems 8
Q ISO 9001 / ISO 13485 - What is considered a 'documented' procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom