A review of Laboratory Quality Management Systems

A review of Laboratory Quality Management Systems

A review of Laboratory Quality Management Systems

by Kari du Plessis

There is no way around 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 cannot 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 optimized 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 customer needs.

The fundamental concepts of a QMS can be described as follows:

  • Speak up!
  • Do what we say
  • Could you 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 organization. It integrates the processes and departments holistically through coordinated, standardized activities.

A QMS is a standardized activity covering 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 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:

  • 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 address the issue and reduce customer complaints quickly.

Respecting QMS standards will help customers trust the laboratory results.

These are just a few factors that will increase customer satisfaction. A satisfied customer is a returning customer.

  • 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.

These factors significantly impact lowering staff turnover, which is costly due to staff training and slower productivity.

  • Optimizing and improving efficiency and productivity

If a company’s bottom line starts to drop, it can often be a sign of 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 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 regarding 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 constantly be improved. A fully optimized QMS can quickly identify the need for improvement. From there, the laboratory can reach any level of productivity or quality.

  • You are 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 sound record-keeping system can track each test result back to the day it was taken, and any Quality Control checks necessary to verify its validity.

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

  • Bottom line: Save money and make money

If none of these factors have piqued interest in you implementing a QMS in your laboratory, then look at 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 training and recruitment costs. 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 essential to understand the requirements for laboratory standards. The International Organisation of Standardization (ISO) is the basis of most standardized laboratory QMS. ISO is the international federation of 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 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 implement 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 sampling, testing, and calibration can use ISO/IEC 17025. This standard guarantees reliable results in any laboratory 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?

Any medical laboratory can follow the ISO/IEC 15189 guidelines to establish and maintain their QMS and assess their competence.

  • 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 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.

  • 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 the 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.

  • Good Laboratory Practice (GLP).

“GLP” is a quality system that describes the organization and conditions in which non-clinical laboratory research is 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.

QMS implementation can improve lab productivity, staff appreciation, and the bottom line. It will also help keep your customers happy and reduce waste.

 LabSPACE Africa can help you if you believe your laboratory could benefit from an optimized QMS but are unsure where to begin.

 Consultation is one of the services we offer regarding QMS regulation.

  • We are discussing, advising, and customizing methods according to client needs.
  • Contribution to regulation and accreditation
  • Assistance with permits, registration, and accreditation

We are looking forward to working together!

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