Why Should Have ISO 15189 Complaint Handling Procedures Implemented?

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?

1. 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.
2. 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.
3. 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!
4. 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.          

Have You Heard About the Revision of the ISO 15189:2022 Standard?

On December 6, 2022, the International Organization for Standardization (ISO) released the fourth revision of ISO 15189:2022. ISO 15189 is implemented by medical laboratories to build management systems and evaluate their competence. It is also relevant for laboratory users, regulatory agencies, and accreditation bodies to certify or recognize the competence of medical laboratories. The standard was revised to include a greater emphasis on the patient, including enhanced standards for point-of-care testing (POCT). POCT requirements were originally described in ISO 22870:2016, which has now been integrated as an appendix in ISO 15189’s 4th edition. The revised standard is less restrictive, with a greater emphasis on risk management, putting patient care rightly at the forefront of the criteria.

The management requirements are now included towards the conclusion of the publication as a result of additional revisions made to the standard to bring it into compliance with ISO/IEC 17025:2017. The ILAC Resolution GA 26.08, which was released by the International Laboratory Accreditation Cooperation, stipulates a transition time of three years starting from the date of publication. To keep their current certification and provide testing laboratories enough time to adjust to the new regulations. Individuals find the changes in quality management changes, equipment updates, new terms & definitions in ISO 15189:2022, and management system documentation changes.

ISO 15189:2022 Requirements for Quality and Competence aim to improve patient welfare and laboratory users’ satisfaction by fostering trust in the caliber and expertise of medical laboratories. After 10 years, technical updates to ISO 15189 have been made. The ISO 15189 Standard for Quality and Competence in Medical Laboratories ISO 15189:2022 specifies requirements for quality and competence in medical laboratories. This standard contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. Besides applying to medical laboratories developing their management systems and assessing their competence, ISO 15189 is also applicable to users, regulatory authorities, and accreditation bodies confirming or recognizing the competence of medical laboratories by the laboratory.

The benefits of the standard’s approach include: Increasing the effectiveness of the management system Decreasing the probability of invalid results Reducing potential harm to patients, laboratory personnel, the public, and the environment. The main changes of the ISO 15189:2022 standard are alignment with ISO/IEC 17025:2017- General Requirements for The Competence of Testing and Calibration Laboratories resulted in the management requirements now appearing at the end of the document Requirements in ISO 22870:2016 for point-of-care testing (POCT) have been incorporated and is a new inclusion in the standard’s scope Increased emphasis on risk management.

General requirements for management system documentation are categorized in the new ISO 15189 specification under the following categories like ISO 15189:2022 documents, personnel access, proof of commitment, competence, and quality. It also goes into considerably more detail about document control, with subsections on record generation, record amendment, and record retention. The earlier ISO 15189 specification is more comprehensive and uses a list/bullet point structure in its management parts rather than segmenting sections with sub-sections. The management system documentation may, but is not needed to, be included in a quality manual, according to a substantial revision to ISO 15189:2022; nevertheless, ISO 15189:2012 specified that the laboratory should produce and maintain a quality manual.

Meanwhile, documentationconsultancy.com began developing editable ISO 15189:2022 Documents that adhere to all of the most recent standards criteria. The easy and quick implementation/revision of the ISO 15189:2022 standard can be supported by the ready-to-use ISO 15189:2022 documents. So, stay tuned for more details, about the ISO 15189:2022 documents.

Recognize the Benefits and Key Processes of ISO 15189 Accreditation of Medical and Clinical Laboratories

ISO 15189 is a universal standard is designed for the accreditation of medical laboratories. The quality management system and technical procedures of laboratories are evaluated by the ISO 15189 standard. Officials and end users can both use ISO 15189 since it assures them that labs are qualified to perform medical tests and examinations, that their staff is dedicated to the lab’s quality, and that their service uses the most recent technologies and practices that comply with best practices.

What are the benefits of ISO 15189 accreditation?

The implementation of the ISO 15189 standard has numerous advantages. Here are a few benefits that medical laboratories can make use of.

• Risk reduction: Systems will be more rigorous if the organization develops its operations on best practices. Particularly in laboratories that deal with sensitive information, complex technology, and issues involving people’s health, planning for, and detecting any potential hazards will significantly lessen them.
• Cost-saving: The laboratory will save costs by ensuring results are technically valid and avoiding the need for retesting. As the efficiency rises, other cost-cutting methods will be applied across the standard.
• Improved team morale: The standard helps in reducing staff errors and other unnecessary mistakes.  It shows higher performance, also the staff’s motivation will increase if their technical proficiency is acknowledged and promoted.
• Legally compliant: By applying regulation and industry standards to the medical laboratory, ISO 15189 guarantees that the clinical services are secure, dependable, and cost-effective. This inspires confidence in decision-makers and stakeholders who understand and value the commitment. Laws and regulations will be less likely to occur, and if they do, the framework will be able to support the organization.
• Continual improvement: By integrating the framework into the basis of what the business does, the organization will gradually establish additional programs. Best practices will not end with the ISO 15189 certification. The framework serves as an important tool for evaluating developments in quality and constantly improving consistency.
• Globally recognized: Being a universally accepted standard offers advantages beyond just reputation. Global recognition is especially important for ISO 15189. The International Laboratory Accreditation Cooperation (ILAC) has a series of Multilateral Mutual Recognition Arrangements that guarantee that laboratories accredited to ISO 15189 will have their certificates and test results recognized in more than 80 nations worldwide. In this approach, the work can improve global as well as domestic medical health.

After understanding the benefits, here are the several processes that must be implemented to get all the benefits. So, a list of actions that should be properly considered is as follows:

Key processes

• Handling, storage, and disposal of samples
• Reception, storage, acceptance testing
• Collection and handling of primary samples
• Evaluation of customer requirements and handling customer agreements
• Safe handling, transport, storage, and use tools to prevent their contamination or deterioration
• transportation of samples
• Sample receipt

Supporting activities

• Control of ISO 15189 documents and ISO 15189 records
• Selecting and assessing external providers and Purchasing
• Management of complaints and other feedback from clinicians, patients, laboratory staff, and other parties
• Personnel auditor training
• Corrective and preventive actions
• Internal Audits Criteria and the management reviews
• Facility and work environment maintenance and improvement