ISO 15189 Complaint Handling Procedure: Tips for Success

ISO 15189 complaint handling procedure

As already mentioned in previous blog articles, ISO 15189 is the ISO standard that shines a light on medical laboratories. This standard covers a wide array of topics dealing from employee management and competency, equipment testing and even management systems. One additional topic that this standard covers is complaint handling procedures. This article goes over the ISO 15190 complaint handling procedure in detail.

Why have an ISO 15189 complaint handling procedure?

The whole point of having a complaint handling procedure is to have a standardized manner outlining the methods for receiving, considering, and acting on any complaints that the laboratory receives. Such procedures could be written policies or straightforward flowcharts, depending on the needs of the lab.

However, the subsequent must be incorporated into the procedure:

  1. Information regarding how to file a complaint
  2. The method used to validate and investigate a complaint
  3. The process for choosing what steps to take
  4. How does the lab keep track of complaints, document them, and take any necessary steps to resolve them?
  5. The method by which the lab makes sure that the proper course of action is taken.

If someone inquires about your procedure for processing complaints, you must make this accessible. You must determine whether you need to act after receiving a consumer complaint. You can ascertain the validity of the complaint by compiling and checking relevant information. Remember that you can only respond to a complaint if it pertains to your laboratory’s operations.

Any element of a laboratory can be subject to a number of complaints, ranging from inaccurate test results, delays in reporting of said results or even subpar customer service. The laboratory can demonstrate its dedication to customer satisfaction and ongoing improvement by having such a process in place for handling complaints coming in from stakeholders.

Keeping the customer aware is a smart business practice, and basic politeness, presuming the complaint is something you need to address. Inform them that you have received their complaint and are looking into it. Give them an estimate of how long it will take to investigate their complaint. Keep this in perspective. If you know you won’t be able to respond in 24 hours, don’t guarantee it. If the procedure may take some time, be careful to give the complainant updates as well as the result.

It’s also crucial to reassure the complainant that, in accordance with your standard laboratory procedure and confidentiality policy, all information regarding their complaint and the outcome will remain confidential.

The ISO 15189 Standards further stipulates that people who were not involved in the lab activities in question shall make, review, and approve the investigation’s findings. This frequently forms an element of open disclosure policy for medical labs.

This ought to reassure the complainant that their problem has been thoroughly investigated. Consider it a plus that your consumer has given you permission to fix the issue. Therefore, it is in everyone’s best interests to address the problem right away.

Social media nowadays, increases customer critique, try to use the same platform to communicate. This doesn’t entail carrying out the complete procedure under Facebook’s spotlight! Instead, express your understanding of their situation and promise to message them personally.

Inform them up front whether your procedure calls for writing down the complaint.

Describe this procedure. If there is a complaint form, inform them that you will email it to them and ask them to fill it. If your process calls for a website link or email address, point them there.

But it doesn’t mean you shouldn’t pay attention if they want to talk to you about the problem. Pay close attention and refrain from making any justifications or excuses. Instead, use things like “I realize how frustrating this must be for you” to demonstrate your sincere concern.

Asking questions can also help you fully comprehend the issue at hand and will reassure the client that you are paying attention and genuinely interested in finding a solution. Additionally, let them know that you’ll be including notes from your talk with their written complaint.

If the consumer is satisfied with the outcome because the problem has been resolved, it does not necessarily imply that you can mark this as “solved” and move on. Treat this like any other non-conformance and start the corrective action procedure using the documentation you’ve gathered. Naturally, this also entails a root cause analysis, recording both the process and any long-term fixes. Check this solution’s efficiency. Keep a record of any additional verification you conduct.


Whether you’re after ISO Certification, internal audits, or results-oriented consultancy, Luke has the plan for you. Reach out to him and start your journey today.
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Luke has a plan for you whether you want ISO certification, internal audits, or results-oriented consulting. Contact him immediately to begin your adventure.

What are the benefits of an ISO 15189 Complaint Handling Procedure?

Let’s have a look at some of the benefits your organization can reap from an ISO 15189 complaint handling procedure:

Benefit #1 | Improved Customer Satisfaction

One obvious benefit which can be gained via an ISO 15189 complaint handling procedure is improved customer satisfaction. Addressing complaints swiftly is something that most customers take seriously. Customers love it when a brand goes out of its way to handle any complaints and make the customer’s life a tad easier. 

Benefit #2 | Enhanced Brand Reputation

Fixing errors is often greatly perceived by others. Thus, when effectively handling complaints, stakeholders will recognize your efforts in demonstrating your commitment to quality and continual improvement. Keep on building your brand reputation! This benefit of ISO 15189 complaint handling procedure goes hand in hand with the previous one.

Benefit #3 | Reducing the Risks of Errors and Non-Conformities

Complaints are the product of something that went wrong, right? Therefore, use such complaints to learn about the business and its wrongdoings. Complaints are one of the primary sources that highlight any non-conformities. Use this knowledge to your advantage!

Benefit #4 | Achieving Compliance with Regulatory Requirements

This is an additional benefit reaped through a ISO 15189 complaint handling procedure. Although this may not be perceived as a benefit, having an ISO 15189 Complaint Handling Procedure is a requirement for the ISO 15189 Standard. This is one of the steps that a laboratory must take in order to be one step closer to achieving ISO 15189 certification.

Concluding Remarks for ISO 15189 complaint handling procedure

All in all, the ISO 15189 complaint handling procedure is a core part of the laboratory’s management system. With it, a laboratory can reach a high enough quality to satisfy consumers.

Laboratories can improve customer satisfaction and processes by having a structured method for receiving, investigating, and resolving complaints. Laboratories can reap the benefits of an effective complaint handling process through the ideology of continual improvement.

Do you want TO LEARN MORE ABOUT ISO 15189 complaint handling procedure and how to get ISO accredited for ISO 15189?

Luke Desira is an ISO management system consultant whose main goal is to put your company in a class of its own! Learn more about the laboratory medical management system that can be achieved through ISO 15189 accreditation!

All management systems based on ISO Standards that are implemented should pertain directly to the organization’s objectives. Regarding ISO 15189 – Medical Laboratories Management System, the same mindset must be applied. Look at the ISO Certification specialised by Industry to understand which ISO certifications and accreditations your laboratory can benefit from.

Luke offers a variety of ISO certification services that puts him as the top ISO Certification consultant in Malta. He can help you achieve ISO accreditation efficiently. When ready, just call Luke Desira – he’ll gladly lend a helping hand.

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