YOUR LABORATORY CAN IMPLEMENT ISO 15189 QMS TOO!
As laboratories become more complex and the demand for quality practices and services increases, so does the need for an effective quality management system (QMS). A QMS is a set of processes and procedures that ensure the quality of services a laboratory provides meets universally acceptable requirements. Implementing a QMS can be overwhelming, but it is important to do so to maintain and improve the quality of your laboratory’s services.
Implementing a QMS can be overwhelming, but it is important to do so to maintain and improve the quality of your laboratory’s services
I work for a public health laboratory facility in West Africa, and I have experienced firsthand, what it means to start implementing QMS from zero experience. Star zero!
In this article, we will discuss the basics of implementing a QMS in medical, public health, or diagnostic laboratory,
Essentials of quality management systems (QMS)
Quality policy
This is a statement that defines the organization’s commitment to quality. The quality policy should be specific, measurable, achievable, relevant, and time-bound. To put it straight, it is a summarized statement that defines what will be achieved, how it will be achieved, when it will be achieved, and how effective will the expected outcome improve laboratory operations.
Documentation and Records
It is an aspect of QMS that describes procedures or processes and reports actions. Simply put, an aspect concerned with writing an agreed manner of doing things according to the identified standards and recording what has just been done.
Occurrence management
When things go wrong, what should be done? We usually record, address and ensure the errors are corrected. The bigger area of concern in occurrence management is determining what can be categorized as non-conformance or mere occurrence. Non-conformity technically means a failure in the process as specified or implied in a standardized document e.g ISO 15189. There are software programs that can be used to manage this operation. I usually help laboratory facilities to set up a Microsoft SharePoint environment for real-time occurrence and file-sharing management experience.
Facilities and safety
The facility and safety section describes how compliant the laboratory is in terms of the structural design requirements which specify the size, space, and light adequacy. The ISO 15189 also specifies basic laboratory safety requirement and reference the implementation of ISO 15190 safety practices in the laboratory.
Personnel
All employees working in the laboratory must be documented and their training, competency assessment, qualification, and continuous professional education must be well recorded in each employee’s electronic or physical folders/file. Personnel is a key driving component in any organization and when laboratories don’t address personnel management effectively the outcome and key performing indices of the laboratory will be affected.
Purchasing and inventory management
Materials and equipment purchases are critical to the operations of medical and public health laboratories. Labs buy reagents, kits, and other essential materials for conducting tests. How these materials will be purchased, and the evaluation of the supplier’s performance will be clearly described by the laboratory
Other essential aspects of the QMS include; Equipment Process, Nonconforming event management, Assessments, Information management, Continual improvement management
My observations implementing laboratory QMS
I work for a public health laboratory facility in West Africa and I have experienced firsthand, what it means to start implementing QMS from zero experience. Star zero! We call it. While the goal was to reach the maximum score possible using the Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist published by the World Health Organization (WHO), scoring each point isn’t as easy.
For the QMS implementing team — we call ourselves, the quality team! The commitment is unparallel.
To start with, there is the need to understand the work before you and the provision of all the requirements, in this case, the ISO 15189 standards.
Also, it is important to consider the following elements :
The management
Implementation of QMS without the keen interest of the laboratory management is a failure from the onset. This is not even an exaggeration. The needs span from ensuring funds are available to make sure specified materials and reagents are purchased and ensuring implementing personnel’s interests are well stimulated. Enrollment in the right QMS implementation program is also a critical role of the management. This is just to mention but a few.
The Mentors
They are consultants QMS experts with core laboratory backgrounds who provide both physical and virtual support to participating facilities. They train, give tasks, monitor progress, and ensure the delivery of action plans. Despite this structured implementation methodology, dealing with adult mentees can be very daunting, and it requires consistent perseverance and patience to push most laboratory quality teams forward.
The Team
Add alt text
We were made up of the laboratory head, quality manager (a senior laboratory lead), Quality officer, facility manager, safety officer (myself), and all laboratory unit team leads.
The strategy
During most of the QMS training, a common question mentors ask is; how do you eat a dinosaur? Students’ answers are always — in bits! You don’t want to think more and do less, you want to do things consistently well but gradually. Like the popular cliché, ‘slow and steady wins the race’.
Get Abdulakeem’s stories in your inbox
Join Medium for free to get updates from this writer.
Another interesting part of this strategy was documentation. We Identified the key documentation that was needed in the laboratory, we got our ISO standards, and started writing our standard operating procedures (SOPs), and quality and safety manuals according to the provision of the respective standards. We followed this with our forms and ensured people use these tools as we forge ahead.
Challenges with QMS implementation in low-resource laboratories
Based on personal observation which was very similar to what was observed by a manufacturing organization study conducted in Brazil. The following identified challenges are almost always present :
1. Top management support
Let’s create a scenario to drive home this point. Imagine a facility implementing QMS has not gotten its management to buy the needs for the implementation of QMS. The Management won’t buy additional materials e.g papers and printers, they won’t train staff, and internal communication will be strongly affected while the organization’s output will be strongly miniaturized or starved. One deficient input will always lead to one deficient outcome. That is the management role.
This management must provide both funding and oversight functions towards implementing a complete QMS in all levels of laboratories.
2. Employee resistance and negative attitude
A popular quote from Julie Bevackua — a renowned human resource industry leader reads
‘In order to build a rewarding employee experience, you need to understand what matters most to your people’. — Julie Bevackua
Laboratories within low-resource settings or Low and Middle-Income Countries (LMIC) mostly have challenges rewarding their staff appropriately. An unhappy staff will likely be unproductive which will likely have a huge blow on the goal of QMS implementation.
It is the role of the management to identify, reward well and select staff who are genuinely interested in the implementation of QMS from the start. The reward might not necessarily be in terms of money. It could be exposure to opportunities, conference sponsorships, publicized appreciation et cetera. Just make them know their jobs are key to the laboratory outcome.
The staff must have the ability to influence change in other staff and should be trained, guided, and mentored by qualified consultants. Also important to note is that, the staff involved must be encouraged to work as a team always. I have seen this strategy work well in facilities I have visited.
3. Inadequate understanding of how QMS can improve laboratory operations and output
At some point in our implementation phase, external auditors have on two different occasions called upon a janitor to ask about some basic but standardized laboratory cleaning procedures. At first, they all goofed. We were forced to have an interaction with those staff in the local dialect to put every single person in the laboratory on the same page. After all, It’s a seriously serious teamwork affair!
QMS training and an effective internal knowledge-sharing atmosphere must be well promoted. This will enable everyone — including the cleaners understand what QMS is in its basic terms and contribute immensely to its full implementation.
At the beginning of the implementation of QMS, I had zero implementation knowledge. Until I learned more from training, bench discussions, staff interaction, and mentorship sessions and started implementation with colleagues. It became so interesting, and I’ve never wanted to stop sharing what I know with every staff and even you now.
4. Resistance to change
Quality improvement is a hallmark of QMS. But, it is hard for you to see any system that isn’t sluggish in admitting new practices, technologies and procedures. One way out of this is the continuous strengthening of internal communications. Training, meetings, continuous professional education, and lots of engagement with staff.
Opportunities for improvement in QMS
Since 2020, My participatory and collaborative journey to implementing a quality management system in a public health laboratory from ‘zero-star’ to ‘five-star rating’ wasn’t only phenomenal but was also a learning curve dimension that I might not have been opportune to be part of if not for the COVID-19 pandemic.
I have seen my laboratory moved from the one covering errors to the one willing to identify and correct errors after adequate investigation and root cause analysis have been conducted.
I have observed how huge and insurmountable our yearnings for a five-star rating appears before my team when it all started and how we moved in steps to becoming a set of internal auditors and external QMS facilitators.
The journey was not only like yesterday, it was one per excellence.
If ours can, your laboratory can implement QMS too!
