Complaints Procedure in Accordance with ISO 17025

Complaints Procedure ISO 17025
Laboratory Accreditation

Complaints Procedure in Accordance with ISO 17025

Complaints Procedure ISO 17025

Organizations can’t avoid dealing with complaints. Therefore, your laboratory must have an effective complaints procedure according to ISO/IEC 17025 2017.

When there’s an established complaint procedure, your laboratory will be able to determine areas for improvement, especially in products, services, and processes. The complaints procedure according to ISO/IEC 17025 also removes the cause of the complaints and prevents problems from recurring.

The procedure’s purpose is to layout the process to receive, evaluate, and make decisions on complaints. As a result, your laboratory will be able to guarantee customer satisfaction.

This is why QSE Academy has made this post to explain the basic details you must know about the procedure of handling complaints as per ISO 17025. Do not worry, we also have available toolkits that you can utilize.

What Your Laboratory Should Know About Document Control:

  • The appropriate revision of a controlled copy is available at points of use.
  • The prevention of obsolete versions is achieved through their removal based on the document master list.
  • Controlled copy distribution is performed under the authority of the quality manager.
  • This document contains confidential information. It must not be distributed without prior approval from Company XYZ.

QSE Academy has created this article to assist your laboratory in following the complaints procedure following ISO 17025. Our packages and toolkits are also available for faster implementation.

Implement ISO 17025
Implement ISO 17025
  1.  Scope

The scope of this scheme extends to a special corrective action request when a customer discovers a problem instead of identifying and rectifying the problem within your laboratory.

  1. Standard Reference

For more information, you may refer to the ISO 17025: 2017 Section 7.9 or avail of our packages.

  1. Responsibility & Authority

Supervisors and managers constantly ask for customer feedback. They must analyze the nature of the complaint by:

  • Soliciting more details from the customer if necessary.
  • Launching an action to solve the complaint and keeping records of these actions.
  • Communicating with the customer to verify whether the solution is sufficient.
  • Implementing long-term solutions to avoid the recurrence of this type of complaint and keeping records of these solutions.
  • Checking the effectiveness of the long-term solution and keeping records of follow-up verifications.

Supervisors and managers should also circulate information about the nature of the complaint to all interested personnel within your laboratory.

On the other hand, it is the responsibility of employees who receive complaints to:

  • Document the information of the customer complaint.
  • Do what they can to deal with the immediate problem.
  • Guarantee the customer that immediate attention will be taken.
  • Notify the customer that your laboratory will contact them by a certain time or date.
  • Inform their supervisor about the details of the complaint and advise them if the nature of the complaint might cause legal action.

Finally, the quality manager follows up with all appropriate personnel to make sure that corrective action has been implemented and demonstrated.

  1. Procedure
  • Record-Keeping

This involves recording a complaint on a corrective action request form. It will then be identified as a customer complaint by checking off the customer complaint check-box on the corrective action request form.

The complaint must be confirmed that it relates to laboratory activities that it is responsible for. In this way, your laboratory can implement immediate corrections and record that information.

It must then be forwarded to the supervisor who will determine whether corrective action needs to be taken to avoid recurrence. Such actions should be recorded as well.

Perform a root cause analysis to determine what the true cause of the complaint was and keep records. If possible, your laboratory must provide the complainant with progress reports.

Lastly, conduct a follow-up verification to make sure the appropriate corrective action was taken and effective. Record the verification as well. Remember, all records are kept on the corrective action request form.

  • Resolving Difficult Situations

QSE Academy suggests laboratories to listen actively while the customer is explaining their issue and don’t interrupt. Employees involved should control their tone of voice and body language.

Start by empathizing first with a phrase that honestly shows concern. For instance, “I understand how frustrating that is”. Do not forget to apologize when your laboratory did make a mistake. This means a lot to the complainant.

Of course, show you are willing to help. Your laboratory must take responsibility for the situation and give your name to establish a personal bridge.

Ask the customer for basic details, especially the who, what, where, when, and how.

Summarise what you’ve heard by writing it down. If the complaint is over the phone, the employee needs to let the customer know that they are making a record of the complaint so that there is some assurance that the situation is being taken seriously.

Furthermore, the employee must say what your laboratory can do. Give the customer a choice to make the customer feel respected and empowered.

Finally, follow the action through to completion. Check that the customer is satisfied by following up.

  • Written Response

The supervisor or manager authorizes any required written responses, like formal notice of the complaint closure or progress reports, to customers.

Copies of the written response are attached to the corrective action request.

The technical manager or quality manager will perform the final review and approval of the outcomes.

  1. Documents & Records

QSE Academy reminds us that all records are kept on the Corrective Action & Improvement Request (CAIR) form.

Creating a complaints procedure that follows ISO 17025 standards is a good way to improve your laboratory’s handling of complaints. Your laboratory must always use and implement the complaints procedure.

We understand how this could become another hurdle to overcome. As a solution, QSE Academy has created toolkits to help your laboratory design a complaints procedure that adheres to ISO 17025. Not only that, but we also have expert ISO consultants who will ensure your complaints procedure’s continual improvement

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Comment (1)

  1. Seiichi

    Wondering if you have a guide for the Corrective Action & Improvement Request mentioned above?

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