Why Should Have ISO 15189 Complaint Handling Procedures Implemented?

Why Should Have ISO 15189 Complaint Handling Procedures Implemented?
5 min read

ISO 15189 is the ISO standard that sheds light on medical laboratories. This standard covers a wide range of subjects, including staff management and competency, equipment testing, and management systems. This standard also addresses complaint-handling methods. This article goes over the ISO 15189 complaint-handling procedure in depth.

ISO 15189 Complaint Handling Procedures Implementation Reasons

The purpose of a complaint handling procedure is to have a standardised approach for receiving, considering, and acting on any complaints that the laboratory receives. Depending on the lab's demands, such procedures could be written policies or simple flowcharts.

The following, however, must be included in the procedure:

  • How to file a complaint
  • The process of validating and investigating a complaint.
  • The procedure for determining which steps to take
  • How does the lab track, ISO 15189 documents, and handle complaints?
  • The procedure by which the lab ensures that the right course of action is followed.

If someone inquiries about your complaint-handling procedure, you must make it available. You must decide whether you must take action after receiving a consumer complaint. You can determine the legitimacy of the complaint by gathering and verifying relevant facts. Remember that you can only respond to a complaint if it is about your laboratory's operations.

Any component of a laboratory may be the topic of a multitude of complaints, ranging from erroneous test findings to delays in reporting such results to poor customer service. By having a mechanism in place to handle complaints from stakeholders, the laboratory can demonstrate its commitment to customer satisfaction and continuous development.

Keeping the customer aware is good business practice and common courtesy, assuming the complaint is something you need to address. Inform them that you have received their complaint and are investigating it. Give them an estimate of how long it will take to investigate their complaint. Keep this in mind. If you know you won't be able to react within 24 hours, don't guarantee it. If the procedure is likely to take some time, make sure to keep the complainant updated on the progress and outcome.

It's also critical to reassure the complainant that, by your usual laboratory process and confidentiality policy, all information about their complaint and the outcome will be kept strictly confidential.

ISO 15189 Standards require labs to include non-involved parties in the inquiry process, which is frequently done as part of open disclosure practices. To reassure complainants, the problem must be addressed as soon as possible. Use social media to communicate and demonstrate empathy. Provide the complainant with information on the complaint procedure and a link to the form. Be alert and avoid making excuses. To comprehend the problem, ask inquiries and make notes in the complaint. If the issue has been fixed, mark it as a non-conformance and initiate the corrective action procedure. Keep track of the root cause analysis, efficiency, and any other verifications.

What are the Advantages of ISO 15189 for Complaint Handling Procedures?

  • Improved the Satisfaction of Consumers: This is one best advantage gained via ISO 15189 complaint handling procedures Improved customer satisfaction is one clear advantage of using an ISO 15189 complaint management system. Most customers value prompt resolution of problems. Customers like it when a brand goes out of its way to handle any complaints and make the customer's life a little simpler.
  • Improved Brand Reputation: Others frequently value error correction. Thus, when you handle complaints successfully, stakeholders will recognise your efforts in proving your dedication to quality and continuous development. Maintain your brand's reputation! This benefit of the ISO 15189 complaint management approach complements the preceding one.
  • Errors and non-conformity are Reduced: Complaints are the result of something going wrong, correct? As a result, use such complaints to learn more about the company and its wrongdoings. Complaints are one of the key sources that indicate any deviations from the norm. Take advantage of this knowledge!
  • Compliance with Regulatory Requirements: This is an added benefit of using an ISO 15189 complaint-handling method. Although it may not appear to be a benefit, an ISO 15189 Complaint Handling Procedure is required by the ISO 15189 Standard. This is one of the measures a laboratory must take to get one step closer to ISO 15189 accreditation.

Source Link: https://documentationconsultancy.wordpress.com/2024/01/04/iso-15189-complaint-handling-procedures-implemented/        

 

In case you have found a mistake in the text, please send a message to the author by selecting the mistake and pressing Ctrl-Enter.
Miana Charles 0
Joined: 9 months ago
Comments (0)

    No comments yet

You must be logged in to comment.

Sign In / Sign Up