Quality Management System definition

Introduction

ISO/IEC 15189 is the Quality Management System(QMS) standard specific to Medical Laboratories. It is one of several Quality Management System standards produced by ISO (International Organisation for Standardisation). Although there are many approaches to achieving quality, the principles of QMS remain the same. It is important therefore that we start with the Quality Management System definition before we delve any further into the subject.

Quality Management System Definition

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction.  The American Society for Quality (ASQ) defines a QMS  as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.

A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

Every Quality Management System must have a defined quality policy and objectives as these give direction to the QMS. Implementing a QMS without a clear policy and objectives would be like setting on a journey without a destination in mind.

How do you know if you are going in the right direction and when do you know if you are completely lost? Now, once you have set out your destination it’s time to define exactly how you will get there, will you take a train, a bus perhaps, will you drive?

Careful thought and planning have to be put into these decisions for the objectives of the QMS to be achieved in the most effective and efficient manner.

What are the benefits of a Quality Management System-Why should we bother?

You will see from the definition that keys results of implementing a Quality Management System  are:

1. Meeting customer requirements
2. Meeting regulatory requirements
3. Improving the effectiveness and efficiency of the business

If these three are important for you and your organisation (they should be!), then you definitely need to think about a QMS.

Meeting Customer Requirements-It follows that an organisation that meets customer requirements achieves customer satisfaction. A satisfied customer is a retained customer and more importantly, a satisfied customer will spread the word and bring in more customers. A QMS is a good marketing tool.

Meeting regulatory Requirements-There is an increasing expectation for organisations to meet regulatory requirements and ISO certification and/or accreditation can be one such requirement. The ability of an organisation to meet regulatory requirements gives confidence that it is producing quality work.  Many large organisations including government require evidence of certifications and /or accreditation to particular standards in order to offer tenders or contracts.  This is especially significant in the Pathology industry where in some countries laboratories have to be accredited to ISO 15189 to be eligible to claim from medical insurance companies including government. A pathology service provider who is not accredited would not have access to a significant segment of the market who are on medical insurance.

Improving effectiveness and efficiency of the business- This is another major benefit to any business implementing a Quality Management System.

Because the system is formalized and all processes and procedures are documented, a well-implemented Quality Management System is able to detect and correct any deficiencies and deviations from the expected process before the product/service gets to the customer. Overall there are fewer errors, less repetition/rework and fewer costs associated with the results of defective or substandard products/ services getting to the customer. These costs can be substantial and even destroy the business. Picture a wrong result released by a pathology service provider. The doctor manages the patient using this wrong result with debilitating or fatal results. The company may have to pay heavy litigation costs risking its very existence.

A QMS is definitely a substantial financial investment for any organisation, however, in the long run, it may save the organisation a lot of time and money.

What are the different Quality Management Systems

An organisation can take different approaches to achieve Quality and some of these are outlined below:

Total Quality Management (TQM)

Continuous Quality Improvement (CQI)

CQI is a quality system that is  focused on continual and constant improvement. It focuses less on the processes and places more emphasis on the role that teams and individuals play in the road to quality. The “Plan, Do, Check, Act” approach has been adapted to fit many industries and companies.

Six Sigma

This is a disciplined, statistical-based, data-driven approach and continuous improvement methodology for eliminating defects in a product, process or service. Six Sigma is a disciplined, data-driven approach and methodology that aims for perfection in quality. It has been used by multimillion-dollar companies such as Motorola and General Electric.

Standardized Systems

Standardized systems are any quality management systems that follow a set of federal codes and regulations. These include ISO certifications which give world-class specifications for products, services and systems, to ensure quality, safety and efficiency, and are instrumental in facilitating international trade.

ISO is an independent, non-governmental international organization which through its members, brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges. ISO has published more than 20 000  International Standards and related documents, covering almost every industry, from technology to food safety, to agriculture and healthcare.

Conclusion

No matter how small your business is, it is important to find the QMS that is relevant to your operations and start implementing it. While it may be difficult at first the benefits are real and can make the difference between the failure and success of your business. Get the background knowledge on QMS by reading further to ensure quality management success and success for your organisation.