Creating Effective ISO 15189 Service Agreements in Labs

ISO 15189 Service Agreements

The purpose behind ISO 15189 has already been established in previous blogs, but here is a short reminder…

ISO 15189 is specific to medical laboratories and sets out the requirements for quality and competence in medical laboratory testing. It covers all aspects of the laboratory, including management, personnel, infrastructure, and the laboratory’s processes and procedures .

What is the process behind ISO 15189 Service Agreements?

ISO 15189 orients external agreements towards the medical field. It divides this heading into two main group, the establishment of the service agreement and the review of such service agreement. As all standards, a documented procedure should be available to guide employees on how such agreements are kept and recorded. Before delving into the main requirements of the standard, it is important to understand that the each and every request accepted by the laboratory for examination shall be considered an agreement. A simple example of this would be an agreement with a specific department such as ICU department, which may require urgent blood tests or urine analysis for quick diagnosis.

Once such agreements are in place the laboratory shall ensure that specific conditions are in place. These are outlined in clause 4.4.1 of the mentioned document, which shall include the requirements of the customers and users, resources required, laboratory personnel, procedures to be used, information of any deviations and any needed referral.

It is important to note and identify, that such standards do not specify the form of such agreements i.e. digital or not. So, it is ultimately in the hands of the laboratory to use whatever format it needs, provided that the service user and the laboratory are in agreement. Two most common methods for such requests are electronic system or paper-bases systems. Both of these will be termed as request forms. These request forms shall have the requirements stipulated in the agreement, where an auditee might be able to refer back and get the necessary information when required.

Furthermore, traceability to the sample, or samples is crucial, and as such the request form should be able to follow through the life cycle of the sample, with the request being eventually attached to the report.

These ISO 15189 service agreements normally take form on a periodic review, where the laboratory will formulate an agreement with the end user. The most important aspects covered shall include type of analysis, timeframes for data reporting, sample frequency and also spec limits. Such an agreement, will allow the laboratory to issue data up to the clients’ requirements, with stipulated requirements and agreed analysis.

Laboratories must then be able to periodically review such agreements. This requirement is comparable to other ISO documents specifically ISO 9001:2015. Such reviews are a requirement to ensure that the laboratory and all relevant parties are keeping with the established agreements. Data should be recorded in a way, that during review a form of order acceptance can be carried out. This will allow that all contracts and/or orders would be able to be accepted only if the requirements are clear and understood.


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.
ISO Consultant in Malta


Luke has a plan for you whether you want ISO certification, internal audits, or results-oriented consulting. Contact him immediately to begin your adventure.

Breaking down ISO 15189 Service Agreements into smaller chunks

1.) What is a service agreement?

Understanding what defines a service agreement is key. As per the standard, ISO 15189 service agreements are contracts between the laboratory and its clients, which represent the scope and quality of the services to be provided. These clients can be anything from healthcare providers, like clinics and hospitals, or even other laboratories. Whoever the client is, a service agreement is a core part of setting the scene and understanding the scope and any other considerations that must be evaluated.

2.) Identification of Client Needs

The ISO 15189 service agreement is not only there to identify the objectives, but also to understand what the client actually needs. The customer’s needs and the scope of the ISO 15189 service agreement go hand in hand with one another. Understanding what the client is after means that the laboratory will have an idea of what tests must be used, what equipment is needed and what methods are to be used to perform tests and procedures as necessary.

3.) Agreement on Quality Requirements

Quality requirements are based mainly on the needs of the client. That is when specifications can be set and get a clearer image of what shall be done and when. What are the resources that are needed to ensure a high quality service? That is the question that must be answered!

4.) Risk Management 

Details on the risks involved and how they will be handled should be included in service agreements. The laboratory should determine any dangers involved with the services offered and take precautions to reduce those risks. The service agreements should specify how the facility will handle any potential problems or complaints that might arise.

5.) Monitoring and Reviewing

ISO 15189 service agreements should be monitored and reviewed regularly to make sure that the services being offered are satisfying both the needs of the clients and the requirements of ISO 15189. The laboratory should have procedures in place for assessing the caliber of its offerings and also for spotting and resolving any problems or issues that may come up. To ensure that all service agreements are current and applicable, they should also be evaluated continuously.

Do you want TO LEARN MORE ABOISO 15189 Service Agreements 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.

Don’t forget to follow us on our Facebook and LinkedIn profiles, and subscribe to our Youtube Channel for more great content.


Book a Free 15 minute discovery call

Select a date and time to schedule a free 15 minute discovery call with Luke Desira.

Message Luke through an email


Give Luke a call

+356 7920 6686

Related Articles

Clause 10 of ISO 9001
ISO 9001

Close Examination | Clause 10 of ISO 9001

Clause 10 of ISO 9001 is the final clause of the standard. Clause 10 of ISO 9001 talks about improvement and the purpose of this blog is to give more information about this particular clause by going through what the standard says in this clause. Here, you can either listen to the video where Luke

Read More »
High Level Structure

Breakdown of the High Level Structure of ISO Standards

If you take a look at all the ISO standards that have been published after 2015, you may notice a pattern in their structure. You see, ISO 9001, ISO 45001, ISO 14001 and the latest ISO 27001, amongst others, have adopted a high level structure. What this effectively means is that every one of these

Read More »
ISO 9001 Clause 9 - Management Review
ISO 9001

ISO 9001 Clause 9 – Performance Evaluation

Hey there, are you interested in ISO 9001? Well, you’re in the right place. This blog covers ISO 9001 Clause 9, to be exact. This blog is in fact part of a mini-series where the ISO 9001 standard is put under the spotlight and examined really closely. If you haven’t looked at the other blogs

Read More »
Scroll to Top