A review of Laboratory Quality Management Systems

A review of Laboratory Quality Management Systems

When working in a commercial laboratory setting, there is no way to avoid the term "quality management". It's a good thing!

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?

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

 

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.

Why does it matter?

Let's not beat around the bush.

 

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:

• 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. A satisfied customer is a returning customer.

• Be confident

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 have been shown to increase employee confidence, which leads to higher morale in the company.

 

 

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

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 allows you to respond to any challenges or obstacles that may (and most likely will) arise. appear at some point.

 

 

 

Furthermore, a predictable laboratory has predictable needs.

 

It is possible to negotiate lower rates with suppliers when it comes to waste removal and consumables. 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. A fully optimized QMS can easily identify the need for improvement. From there, the laboratory can reach any level of productivity or quality.

• 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.

 

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.

• Bottom line: Save money and make 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.

 

 

• Managing customer complaints will earn you more by returning clients.
• Promoting excellence will attract new customers and make you 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!

 

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 federation of national standards bodies of more than 160 countries worldwide.

 

The South African National Accreditation System is South Africa's designated Accreditation Body for ISO standardisation.

 

 

 

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.

 

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

The ISO website:

 

"ISO 15189:2012 specifies requirements for quality and competence 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.

 

• 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 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

 

 

The World Health Organisation published Good Laboratory Clinical Practice.

 

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

 

 

• 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.

 

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.

 

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

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

 

We are looking forward to working together!

 

Written by: Kari du Plessis