Laboratory Quality Management Systems:
An overview

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Your brainchild is coming to fruition and you’re finally setting up a new lab. Exciting!

When working in a commercial laboratory setting, there is no way to avoid the term “quality management”. And with good reason! 

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. 

In this article, we will discuss the basic concepts regarding a laboratory QMS, why your lab needs one to thrive and where to start when implementing your own optimised QMS.

What is a QMS?

Simply put, a QMS can be defined as a collection of business processes, policies and procedures that is implemented to meet a specified set of customer requirements, consistently. 

The basic concepts of a QMS are quite simple:

  • Say what we do
  • Do what we say
  • Prove it and
  • Improve it

The objective is not only quality data but also traceability and integrity of the data.

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. 

In a laboratory setting, a QMS will include standardised activities surrounding administration, the laboratory work environment, methods, laboratory techniques, reagents and instrumentation, staff training and record keeping to name a few.

Why does it matter?

Let’s not beat around the bush. 

The thought of adding costly paperwork and red tape to your company’s day-to-day activities in the workplace does not inspire excitement. Then why do it?

Implementing a QMS for your Laboratory has benefits far exceeding “because we have to”. 

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

  • Building a reputation of excellence

By standardising every protocol and procedure in your laboratory, it is possible to easily identify issues when they surface. This will allow you to address and improve upon an issue swiftly, hereby limiting customer complaints.

Conforming to specific QMS standards will instill a customer’s trust in the results generated in your laboratory.

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. 

Results have shown that a QMS can improve job satisfaction in staff through accountability management and working within a predefined set of duties. 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. 

  • Optimising and improving efficiency & productivity

When a company’s bottom line is dwindling, it is often the first clue to a weak link in 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.

Furthermore, a predictable laboratory has predictable needs. 

When it comes to consumables and waste removal, negotiating lower rates with suppliers based on the laboratory’s needs becomes possible. Predictability also aids in identifying unnecessary waste or consumable use.

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 impact that laboratory work and results may have on down-stream decision-making, diagnoses, or subsequent treatments. 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. 

Unfortunately, much like any other insurance policy, you may not sense the urgency until it’s too late!

  • 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.
  • Protecting your business from litigation and lawsuits through meticulous quality control and record keeping will save you money. 

Where to start: Laboratory QMS in South Africa

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

Now what?

Understanding requirements for laboratory standards are important. Most standardised laboratory QMS is based on the standards stipulated by the International Organisation of Standardisation (ISO). ISO is the federation of national standards bodies of more than 160 countries worldwide.

In South Africa, the designated Accreditation body for ISO standardisation is the South African National Accreditation System (SANAS). 

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.

To start implementing an appropriate QMS in your laboratory organisation, you can start by purchasing the appropriate Standard online from the South African Bureau of Standards (SABS).

But what QMS will my laboratory need? Listed below are some details that may help.

The standards that govern Laboratory QMS:

  1. ISO/IEC 17025 – Testing and Calibration Laboratories

From the ISO website:

“ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.”

Who is this for? 

ISO/IEC 17025 is applicable to any laboratory that performs sampling, testing and calibration. This standard ensures reliable results in a laboratory owned and operated by industry, governments, universities, inspection bodies and any other laboratory organisation.

  • ISO/IEC 15189 – Medical laboratories — Quality and Competence

From the ISO website:

“ISO 15189:2012 specifies requirements for quality and competence 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 and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485.”

What is considered to be a medical device according to ISO? 

A medical device can be an instrument, in vitro reagent or implant used in the prevention, diagnosis and treatment of 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 those principles established under GLP for data generation used in regulatory submissions relevant to the analysis of samples from a clinical trial. At the same time, it ensures that the objectives of the GCP principles are carried out. This ensures the reliability and integrity of data generated by analytical laboratories.”

Who is this for?

GCLP is best suited for laboratories that perform clinical trial testing on human samples.

  • Good Laboratory Practice (GLP)

“GLP is a quality system that covers the organisational process and the conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, archived and reported (OECD 1998).”

Who is this for?

GLP most commonly applies to pharmaceutical or academic, non-clinical testing facilities where experiments do not include human testing or tissues. 

Conclusion

A QMS is more than a “big brother” to tie your lab up 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 in permits, registration and or accreditation.

QUICK SEARCH!

We look forward to working with you!

Written by: Kari du Plessis

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