Customer Survey Example - ISO 13485:2016


Hi All,

I was wondering if anyone had an example of a customer survey they have used. I am new to the med device world, but we want to use this as a means for 1 of the avenues to receive customer feedback.

Thank you.

John C. Abnet

Teacher, sensei, kennari
Super Moderator
Hi All,

I was wondering if anyone had an example of a customer survey they have used. I am new to the med device world, but we want to use this as a means for 1 of the avenues to receive customer feedback.

Thank you.
Good day @danabigler83 ;
Surveys are certainly one option. Services such as "Survey Monkey", others...can even assist in the administration.

I would counsel, however, that your organization may want to consider further before determining to use a survey as a method of simply "...arrang(ing) ...customer feedback..."

From my experience, ...
1- customers are not too thrilled about needing to reply to a survey.
2- those that take the time to provide feedback are usually only those with negative perception of your organization (valuable to be sure, but not
but often very anecdotal usually a complete picture)
3- someone has to manage the survey process including prompting annoyed customers for feedback.
4- results are often "pencil whipped" and not comprehensive/accurate.
5- It is often a task that is completely controlled by an individual and not systemic (for example, if "you" are not there...i.e. vacation, retirement,
moved on, etc...), who/how will this be managed?

In other may be creating a monster that someone has to feed.

Instead, i would counsel that your organization simply reverse engineer by determining how your organization may ALREADY receive customer feedback.
- Does your organization ever receive customer complaints for quality? (that's customer feedback)
- Does your organization ever receive customer complaints for delivery? (that's customer feedback)
- Do any of your customers provide a periodic performance scorecard? (that's customer feedback).
- Does your sales group have periodic performance, future business, competitor pressure, etc...conversations with customers? (that's customer
- Does your order/scheduling/production control group interact regularly with customers? (that's customer feedback).

Identify, articulate, and take credit for these applicable methods and maybe you can avoid the dreaded survey?

Food for thought.

Hope this helps.
Be well.
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Involved In Discussions
Oh boy, what a topic. I would write a small novel on my thoughts regarding the role of customer surveys within the medical device industry, but I will try to keep it short. I am, at this very moment, working on completely removing my company's requirement to send out customer surveys. But I must note that I work for a small medical device design consulting company (<20 employees), so a "customer" for us is quite different than a "customer" of the legal manufacturer of the device. So our survey process likely looks very different from an OEMs.

The topic of customer requirements/customer satisfaction/feedback is, in my opinion, one of the areas where ISO 9001 and 13485 differ most significantly, and where one of the areas where a legal manufacturer would do things most differently from a 13485-certified component or service supplier. (I mention 9001 because that is the standard upon which 13485 was originally based, and @danabigler83 mentions they are "new to medical device world"). ISO 9001 cares much more about general "customer satisfaction", and all the squishy things that come along with that. And ISO 9001 can be applied by almost literally any industry. In comparison, 13485 is much more narrowly focused on medical device safety/effectiveness, and compliance to regulatory requirements.

I say all that because I think that anyone operating, or considering changes to, a survey process for a medical device company really needs to think about what regulatory requirement they are trying to fulfill by conducting surveys, and whether or not there are more effective ways at meeting those requirements.

The closest thing I see in 13485 is 8.2.1 feedback, which states simply:
As one of the measurements of the effectiveness of the quality management system, the organization shall gather and monitor information relating to whether the organization has met customer requirements.
(emphasis mine)

I think @John C. Abnet hit the nail on the head with the idea that surveys can very quickly become an administrative burden, while ultimately providing very little value back to the organization. In my experience, survey responses tend to be very anecdotal - dependent entirely on the person completing it, the the time they received it, and what side of the bed they woke up on. The "requirements" of one survey recipient may be entirely different from the "requirements" of another person within the same organization. AND, they may not even represent product-related requirements, or requirements that are within the purview of 13845 to begin with.

Anyways, all this goes to say that, as John rightly suggests, if your company really cares about whether they are meeting customer requirements, then they likely already have other processes in place for monitoring it that are far more integrated, effective, and objective in nature than a periodic customer survey would be.


Involved In Discussions
Also, to answer your question more directly... our current survey (the one I am getting rid of), is sent to customers at the end of defined project milestones, and consists of two "questions":
1. Was this milestone achieved on time, per the contract?
2. Any additional milestone-related feedback?

Obviously not much to be gained here.

We considered a more comprehensive survey of our overall performance as a services company. Something like:
For each of the following topics, rate our company's performance with respect to your needs/expectations (Exceeding, Meeting, or Failing to meet needs/expectations, or Unable to rate): 1. Technical design execution, 2. Project timeliness, 3. Project communications, 4. Responsiveness to requests/project's needs changes, 5. Overall quality of service.

After a lot of discussion, we (the management team) agreed that this still feels like a check the box activity. So now we are shelving the idea of surveys completely, in exchange for those (in my opinion) much more valuable processes we already have in place, such as regular, frequent meetings with our clients, technical design reviews, planned project milestone reviews, contract review/modification processes, etc.

Jen Kirley

Quality and Auditing Expert
Surveys are notorious for their
  • Vague questions that are difficult for the customer to answer in an actionable way
  • Tendency to be responded to only by angry customers (not including those who simply shop elsewhere without responding to surveys)
  • Potential to get thrown away without answering
  • Potential to be answered by someone who has no idea of what to say or why
The result is a dismal response rate that, statistically speaking can't possibly represent your customer base and in any case doesn't provide clues of what to do to improve based on the returns.

This is the case for all industries, including medical instruments.


Super Moderator
A good majority of survey's never get to where they need to go anyway, I see a similar thing with the delivery contracts I work under where a large majority of the people I deal with have never seen the "Conditions of Contract" governing conduct and performance on their end of the bargain.
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