ISO13485 Customer Satisfaction Survey?

Danielkim

Starting to get Involved
Hello,
We are selling class I medical devices all over the world and mostly it's B2B sales.

I'm trying to create a customer satisfaction survey format according to article 8.2.1 feedback of ISO 13485 standard.

The question is that is the customer satisfaction survey mandatory to get ISO13485 certified?
I'm wondering if most of customers actually eager to fill out the survey form and even answer...

It would be very helpful if you share some experiences or how you manage documentation regarding customer feedback part for ISO 13485 QMS and relevant audits.

Thank you in advance!
 

Tidge

Trusted Information Resource
We use the Complaints Handling system as the primary mechanism for on-market feedback; I am unaware of any specific regulatory requirements for "specific experience" (per 8.2.1) for our devices. Pre-market: we use customer representatives during validation to answer the question of "whether the organization has met customer requirements."

I should note: We also incorporate the Design Change, Non-Conformance and CA/PA systems into the (on-going) risk management and product improvement activities per clause 8.2.1, but neither of these would necessarily directly represent customer feedback as the complaints handling efforts. "Customer (dis)satisfaction" would be manifested as a Design Change. Sometimes we've had CA/PA driving Design Changes but ever instance I can think of was first motivated by customer complaints.(*1)

(*1) It has also been my experience that some fraction of customers will not be shy to leverage the complaints handling process to register a personal dislike of a device feature. Without sharing any specific details: one of our devices had something akin to a number of different, uniquely colored, quasi-ornamental cover pieces that played a no practical functional role in the device design... the purpose was basically to let someone say "look at the red/blue/green/yellow ____". One customer HATED the way these attached to the device, and after every service visit (when we'd replace the missing ones, if necessary) the customer would immediately (usually within 24 hours) file a complaint that these pieces were "missing". The customer would (rather forwardly) mock our service techs saying he was just throwing them out after the visit, and wanted us to change the design. One year that customer filed multiple complaints the same day, one for each "missing" piece from the set.
 

Danielkim

Starting to get Involved
We use the Complaints Handling system as the primary mechanism for on-market feedback; I am unaware of any specific regulatory requirements for "specific experience" (per 8.2.1) for our devices. Pre-market: we use customer representatives during validation to answer the question of "whether the organization has met customer requirements."

I should note: We also incorporate the Design Change, Non-Conformance and CA/PA systems into the (on-going) risk management and product improvement activities per clause 8.2.1, but neither of these would necessarily directly represent customer feedback as the complaints handling efforts. "Customer (dis)satisfaction" would be manifested as a Design Change. Sometimes we've had CA/PA driving Design Changes but ever instance I can think of was first motivated by customer complaints.(*1)

(*1) It has also been my experience that some fraction of customers will not be shy to leverage the complaints handling process to register a personal dislike of a device feature. Without sharing any specific details: one of our devices had something akin to a number of different, uniquely colored, quasi-ornamental cover pieces that played a no practical functional role in the device design... the purpose was basically to let someone say "look at the red/blue/green/yellow ____". One customer HATED the way these attached to the device, and after every service visit (when we'd replace the missing ones, if necessary) the customer would immediately (usually within 24 hours) file a complaint that these pieces were "missing". The customer would (rather forwardly) mock our service techs saying he was just throwing them out after the visit, and wanted us to change the design. One year that customer filed multiple complaints the same day, one for each "missing" piece from the set.
Thank you for your opinion and sharing experiences.

What's the "Complaints handling system" here? Does it mean that non-conformity devices you receive from customers for warranty service?
I thought we need somehting more than complaint handling system to check if customers are happy with quality, correspondent, delivery, price or our device or whether the customer has specific requirement, as customers inform us only defectives of our devices via complain handling process.
 

Tidge

Trusted Information Resource
Any alleged deficiency of the device is handled by our Complaints Handling center; some fraction of these are reportable (to regulatory authorities) events, some are not. The input process at our end is the same. Calls to the CH center may not be non-conformances, some may be non-conformances that are not recognized as such. We occasionally get complaints for competitors' products!

I would be skeptical about any medical device manufacturer that tried to use "customer surveys" of on-market medical devices to satisfy 8.2.1 of 13485. My opinion is that such surveys would be fine for marketing and sales reasons, but 13485 doesn't exist as a consensus standard to make customers happier with a product (or willing to pay a certain price for it). Compliance to 13485 for an on-market device presumes a safe and effective medical device that has been validated, i.e. the device meets user needs.
 

DannyK

Trusted Information Resource
While not obligatory, customer surveys is one way to meet the requirements for ISO 13485:2016 clause 8.2.1 Feedback.
 

Danielkim

Starting to get Involved
Thank you for the opnions, guys.
I would probably find a more efficient way than customer satisfaction survey to gather customer feedback to comply with 8.2.1.
It helped me a lot to get some ideas.
 

LUFAN

Quite Involved in Discussions
Thank you for the opnions, guys.
I would probably find a more efficient way than customer satisfaction survey to gather customer feedback to comply with 8.2.1.
It helped me a lot to get some ideas.

I realize I am a bit late on the response here, but I'll offer my 2 cents. Proactively reaching out to customers to obtain feedback is undoubtedly not required under ISO 13485. What is required is that you have a Feedback Process capable of appropriately handling, sorting and dealing with feedback, of any source/type, within your QMS, and per 8.2.2b) an evaluation that feedback is not a complaint. This feedback could be from customer requests, production feedback from operators, service reports, etc.

You can define your feedback threshold to something like all, requests, actionable tasks, etc. For example, your customer may indicate to you that they wish you offered a part in red, or a different size, etc. You may get that same request once per year and that may not be of great use, but if you're constantly getting the same request, that type of feedback should be presented to management. Further if your sales rep is visiting a customer and is told that the parts your company sent may not be within tolerances. Can your QMS appropriately route that comment to your complaint process? There's flexibility in how you handling 8.2.2, but the point is that the system exists to capture it.
 

Danielkim

Starting to get Involved
I realize I am a bit late on the response here, but I'll offer my 2 cents. Proactively reaching out to customers to obtain feedback is undoubtedly not required under ISO 13485. What is required is that you have a Feedback Process capable of appropriately handling, sorting and dealing with feedback, of any source/type, within your QMS, and per 8.2.2b) an evaluation that feedback is not a complaint. This feedback could be from customer requests, production feedback from operators, service reports, etc.

You can define your feedback threshold to something like all, requests, actionable tasks, etc. For example, your customer may indicate to you that they wish you offered a part in red, or a different size, etc. You may get that same request once per year and that may not be of great use, but if you're constantly getting the same request, that type of feedback should be presented to management. Further if your sales rep is visiting a customer and is told that the parts your company sent may not be within tolerances. Can your QMS appropriately route that comment to your complaint process? There's flexibility in how you handling 8.2.2, but the point is that the system exists to capture it.
Hello Lufan, Thank you very much your feedback.
I agree with your idea of customer's feedback, and I already have made "Customer feedback Report" which our sales representatives shall write at least once a year before Management review.

Your response made me understand even better for this process.
Thanks!
 
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