A review of Laboratory Quality Management Systems
A review of Laboratory Quality Management Systems
There is no way around the term quality management when working in a commercial laboratory. It's a good thing!
A quality management system (QMS), which is well implemented, can help a laboratory achieve its maximum productivity and financial success. Although QMS implementation can provide comfort and success for both employees and managers, many people are unable to see the point.
This article will cover the basics of a laboratory QMS. It will also discuss why your lab should have one. We'll also show you where to begin when creating your own optimised QMS.
What is a QMS and how does it work?
A QMS is simply a set of business processes, policies, and procedures that are implemented consistently to satisfy a specific set of customer needs.
The fundamental concepts of a QMS can be described as follows:
- Speak up!
- Do what we say
- Do it!
- It can be improved
Quality data is not the only goal. Traceability and integrity are also important.
QMS covers every department and system within an organisation. It integrates the processes and departments in a holistic way through coordinated, standardised activities.
A QMS is a standardised activity that covers administration, the laboratory environment, methods and techniques, staff training, record keeping, and other related activities.
What is the point?
We won't leave anything to chance.
It is not exciting to think about adding unnecessary paperwork to your company's daily activities at work. Why not?
A QMS can be implemented in your Laboratory for many benefits that go beyond "because we have".
These are just a few of the many benefits that a well-implemented quality management system (QMS) can bring to a laboratory environment:
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A reputation for excellence
Standardizing every procedure and protocol in your laboratory will make it easier to identify problems when they occur. This will enable you to quickly address the issue and reduce customer complaints.
Respecting QMS standards will help customers trust the laboratory results.
These are just a few of the many factors that will increase customer satisfaction. A satisfied customer is a returning customer.
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Be confident
Extensive research has shown that QMSs can have a significant impact on productivity.
Research has shown that QMSs can increase job satisfaction by allowing staff to be accountable and work within a defined set of tasks. These factors have been shown to increase employee confidence, which leads to higher morale in the company.
All of these factors have an important impact on lowering staff turnover, which is costly due to staff training and slower productivity.
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Optimizing and improving efficiency and productivity
If a company's bottom line starts to drop, it can often be a sign that there is a problem with the productivity chain. A QMS can quickly identify and fix a productivity gap before it affects the bottom line.
Pre-determined protocols can save valuable time by eliminating any guesswork from each experiment, assay or procedure. This predictability allows for flexibility and the ability to respond to any challenges or obstacles that may (and most likely will) arise. appear at some point.
A predictable laboratory also has predictable needs.
It is possible to negotiate lower rates with suppliers when it comes to waste removal and consumables. Predictability is also helpful in identifying waste and consumables that are not needed.
A laboratory that functions as a well-oiled machine can always be improved. A fully optimized QMS can easily identify the need for improvement. From there, the laboratory can reach any level of productivity or quality.
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Protecting your business.
Sometimes, we underestimate the importance of laboratory results and their impact on downstream decision-making, diagnosis, and subsequent treatment. A well-designed laboratory QMS can be an unofficial policy of insurance.
A good record-keeping system can track each test result back to the day it was taken and any Quality Control checks that were necessary to verify its validity.
You may not feel the urgency until it's too late, just like with any other policy.
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Bottom line: Save money and make money
If none of these factors have piqued interest in you implementing a QMS in your laboratory, then take a look to the bottom line.
- Managing customer complaints will earn you more by returning clients.
- Promoting excellence will attract new customers and make you more money.
- By reducing staff turnover and boosting morale, you can lower your costs of training and recruitment. This will save you money.
- You can predict your consumable requirements and buy in bulk. This will help you save money.
- You can save money by protecting your business from lawsuits and litigation through quality control and record-keeping.
How to begin: South Africa's Laboratory QMS
You are now convinced that your laboratory requires an accredited QMS. Great!
What now?
It is important to understand the requirements for laboratory standards. The International Organisation of Standardization (ISO) is the basis of most standardised laboratory QMS. ISO is the international federation for more than 160 national standard bodies from all over the world.
The South African National Accreditation System is South Africa's designated Accreditation Body for ISO standardization.
Although the terms SANAS or ISO are often interchangeable, SANAS is South Africa's Accreditation Body. However, ISO certification will recognize the lab as ISO certified, not SANAS accredited.
You can purchase the South African Bureau of Standards (SABS) Standard online to get started in implementing a QMS within your laboratory organization.
What QMS does my laboratory require? Below are some details to help.
Laboratory QMS Standards:
ISO/IEC 17025 Testing and Calibration Laboratories
The ISO website:
"ISO/IEC 17025 allows laboratories to prove that they operate competently, and produce valid results. This promotes confidence in their work around the globe."
Who is this for?
Any laboratory that does sampling, testing, and calibration can use ISO/IEC 17025. This standard guarantees reliable results in any laboratory that is owned or operated by the industry, government, universities, inspection bodies, or any other laboratory organization.
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ISO/IEC 15189 Medical Laboratories -- Quality and Competence
The ISO website:
"ISO 15189.2012" specifies the requirements for competence and quality in medical laboratories.
Who is this for?
Any medical laboratory can follow the ISO/IEC 15189 guidelines in order to establish and maintain their QMS, and assess their own competence.
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ISO/IEC 1345 - Medical Devices
The ISO website:
"Safety is a top priority in the medical device industry. That's why ISO 13485 was created."
What medical device is ISO considered to be medical?
A medical device is an instrument, intracellular reagent, or implant that's used to diagnose, treat, and prevent medical conditions.
Who is this for?
ISO/IEC 13485 is available for use by any organization or certification body that deals with the design, production and installation of medical devices and related services.
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GCLP – Good Clinical Laboratory Practice
The World Health Organisation published Good Laboratory Clinical Practice.
"Good Clinical Laboratory Practice" (GCLP), applies the principles of GLP data generation to regulatory submissions that relate to analysis of clinical trial samples. It also ensures that GCP principles are met. This guarantees the integrity and reliability of data generated in analytical laboratories.
Who is this for?
GCLP is most suitable for labs that test human samples in clinical trials.
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Good Laboratory Practice (GLP).
"GLP" is a quality system that describes the organization and conditions in which non-clinical laboratory research are planned, performed and monitored. It also records, archives, and reports the results (OECD 1998)
Who is this for?
GLP is most often used for non-clinical or pharmaceutical testing facilities that do not involve human testing or tissue.
Conclusion
A QMS is not just a big brother to tie up your lab in unnecessary red tape.
QMS implementation can improve lab productivity, staff appreciation, and bottom line. It will also help keep your customers happy and reduce waste.
LabSPACE Africa is able to help you if you believe your laboratory could benefit from an optimised QMS but are unsure where to begin.
Consultation is one of the services we offer regarding QMS regulation.
- Discussing, advising, and customizing methods according to client needs.
- Contribution to regulation and accreditation
- Assistance with permits, registration, and/or accreditation
We are looking forward to working together!