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A review of Laboratory Quality Management Systems

May 6

A review of Laboratory Quality Management Systems

There is no way around the term quality management when working in a commercial laboratory. And with good reason!

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A well-implemented Quality Management System (QMS) has the ability to make a laboratory reach its peak productivity and, in turn, to thrive financially. Despite the comfort and success that a well-implemented laboratory QMS can bring to employees and management alike, most people tend to glaze over when the topic of QMS is brought up.


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
  • Prove it and
  • Improve it


Quality data is not the only goal. Traceability and integrity are also important.


A QMS encompasses every department and internal system of an organisation, integrating the various departments and processes in a holistic manner through standardised, coordinated activities, every step of the way.




A QMS is a standardised activity that covers administration, the laboratory environment, methods and techniques, staff training, record keeping, and other related activities.

Why does it matter?

We won't leave anything to chance.


It is not exciting to think about adding unnecessary paperwork and red tape in 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".


Here are some of the benefits associated with a well-implemented QMS in a laboratory setting:

  • A reputation for excellence

Standardizing every procedure and protocol in your laboratory will make it easier to identify problems when they occur. This will allow you to address and improve upon an issue swiftly, hereby limiting customer complaints.

Respecting QMS standards will help customers trust the laboratory results.


These, among many other factors, will improve customer satisfaction. And a satisfied customer is a return customer.

  • Proceeding with confidence

The impact of a QMS on the productivity of an organisation has been extensively studied.


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 are known to instill confidence in personnel that leads to higher company morale overall.



These factors all have a significant impact on lowering staff turnover that is known to be costly through both staff training and slowing productivity.

  • 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. With an efficient QMS in place, a gap in productivity can be quickly identified and rectified, sometimes even before it impacts the bottom line.


Predetermined protocols shave valuable time off each experiment, assay, or procedure by taking any guesswork out of the equation. There is also comfort in this kind of predictability because it allows room for flexibility to react to challenges and obstacles that could (and probably will!) 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.


Once a laboratory operates as a well-oiled machine, there is always room for improvement. The need for improvement is easily identified through a fully optimised QMS and from there onwards, the sky's the limit to the level of productivity and quality a laboratory can achieve.

  • Protecting your business.

Sometimes, we underestimate the importance of laboratory results and their impact on downstream decision-making, diagnosis, or treatment. A well-implemented laboratory QMS could serve as an unofficial insurance policy.


Good record keeping can trace each result to its day of testing and its necessary Quality Control check points to confirm its validity.


You may not feel the urgency until it's too late, just like with any other policy.

  • The bottom line: Saving & making money

If none of the factors discussed above has piqued your interest in implementing a QMS for your laboratory, take a look at the bottom line.



  • Limiting customer complaints will make you more money through return clients.
  • Promoting a reputation of excellence will gain new customers and make more money.
  • Limiting staff-turnover by boosting morale will lower the cost of recruitment and training and in turn, save you money.
  • Predictability of requirements in terms of consumables will allow you to buy in bulk and limit waste that will save you 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

Hopefully, you are convinced that your laboratory needs an accredited QMS. Great!


Now what?


Understanding requirements for laboratory standards are important. 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 standardisation.




Some people use the terms SANAS and ISO interchangeably, but although SANAS is the Accreditation Body in South Africa, the lab will be recognized as ISO certified and 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.


But what QMS will my laboratory need? Below are some details to help.

Laboratory QMS Standards:

ISO/IEC 17025 Testing and Calibration Laboratories

From 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?


ISO/IEC 17025 is applicable to any laboratory that performs sampling, testing and calibration. 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.

  • 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?


The guidelines stipulated by ISO/IEC 15189 can be implemented by any medical laboratory in establishing and maintaining their QMS and assessing their own competence.


  • ISO/IEC 13485 - Medical Devices

From 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 has been compiled for implementation by any organisation and/or certification body involved in the design, production, installation and servicing of medical devices and related services.


  • GCLP – Good Clinical Laboratory Practice



According to Good Laboratory Clinical Practice published by the World Health Organisation:


"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 ensures the reliability and integrity of data generated by analytical laboratories."


Who is this for?

GCLP is most suitable for labs that test human samples in clinical trials.



  • 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.




A QMS is not just a big brother to tie up your lab in unnecessary red tape.


A thoroughly implemented QMS has the potential to optimise lab's productivity, elevate staff appreciation and improve the bottom line dramatically by keeping your customers satisfied and limiting waste.


If you are convinced that your laboratory can benefit from an optimised QMS, but you are still unsure of where to start, LabSPACE Africa can help.


Some of our services regarding QMS regulation include consultation involving the following:

  • Discussing, advising and customising methods to the needs of the client.
  • Input in regulation and accreditation.
  • Assistance with permits, registration, and/or accreditation


We look forward to working with you!


Written by: Kari du Plessis