From QA to IMS: the Changing Concept of Quality

Over the years, the understanding of quality has constantly evolved, being redefined and expanded time and again. Against this backdrop, we now come across many terms such as quality assurance (QA), quality management (QM), quality management system (QMS), integrated management system (IMS) and management system (MS) – making it difficult for many people to keep track. We can help: In this article, we would like to take a closer look at the terms, their relationship to each other, their meaning and the differences.

The meaning of the terms used in the context of quality has been constantly redefined. For a long time now, the term ‘quality control’ (QC) has no longer been used, as quality cannot ultimately be ‘tested’ into a finished product – the quality of the product must already be ensured and monitored during its manufacture. The term ‘quality assurance’ (QA) was born. And this term had been around for many years before the term ‘quality management’ (QM) was even coined. So how did this change come about? It became clear that product quality is always linked to process quality – not only with smooth production processes, but also with the quality of all other business processes. Therefore, in addition to quality assurance, other methods were developed that led to a comprehensive view of quality in companies and were established as quality management.

Countless publications with sometimes contradictory explanations and now several generations of active quality experts sometimes ensure that not everyone speaks the same language. This means that in everyday use and even in specialized literature, QA and QM are not clearly distinguishable and are sometimes even used interchangeably.

Important terms are of course defined in ISO 9000 – the definition of the term ‘quality’, which most of you have probably come across before, serves as an example here:

‘3.6.2 Quality: the degree to which a set of inherent characteristics (3.10.1) of an object (3.6.1) fulfils requirements (3.6.4).’

In order to understand what is meant by ‘object’ here, a further explanation follows directly:

‘3.6.1 Object: entity, object – something perceptible or imaginable | EXAMPLE product (3.7.6), service (3.7.7), process (3.4.1), person, organization (3.2.1), system (3.5.1), resource.’

You can understand this if you take a very close look at the topic of quality. However, these definitions are certainly not accessible and easy to understand for all employees in the company. For this reason, we would like to try to categorize the terms as clearly as possible here – from QA and QM to QMS and IMS.

By definition, QA includes all organizational and technical measures that are necessary to prepare, accompany and test the consistently high quality manufacture of a product. Through inspection and improvement, QA ensures that products and services are of a high quality – i.e. that they fulfil the requirements placed on them.

QM describes ‘coordinated activities for managing and controlling an organization with regard to quality’ (ISO 9000). This definition reveals a decisive difference to QA: QM is a specialized field that encompasses all activities and methods throughout the company that aim to plan, control and improve both the quality of products and the quality of all processes. QM includes several sub-disciplines and QA is now one of them.

According to ISO 9000, a management system is:

‘[A] set of interrelated or interdependent elements of an organization (3.2.1) to establish policies (3.5.8), objectives (3.7.1) and processes (3.4.1) to achieve those objectives.’

What exactly does that mean? ‘Elements of an organization’ refers to people or their roles and the company's business processes. This is because a company's management system essentially consists of an organizational structure and a process organization. The organizational structure (often depicted as an organizational chart) regulates the responsibilities, rights and powers (function, role) of all employees. The process organization comprises all processes and their logical temporal linkage with each other.

Important: Every company has a management system – regardless of whether it is aware of it or not. This is because every company has both an organizational structure and a process organization – whereby either the organizational structure or the process organization can lead the way. To be more precise: because every company has exactly one organizational structure and exactly one process organization, there can only be ONE management system in the company.

The QMS is therefore not a separate management system, but the part of a company's management system that deals with the topic of ‘quality’. The (minimum) requirements for a QMS are defined in internationally applicable norms and standards for quality management systems: ISO 9001, ISO 13489 (medical technology) or IATF 16949 (automotive). With the certification of the QMS, the company provides formal proof that these (minimum) requirements have been met.

Here is a small example of the different expectations that can be placed on the term quality management system: There are various abbreviations in circulation, e.g. QMS, which we also favor. However, ‘QM system’ is also frequently used – but from our point of view it refers to a ‘management system for quality’, not a ‘system for quality management’. In addition, ‘QM system’ is often used to refer to QM software, but the QMS is not a software solution. Nor is ‘QM system’ a suitable synonym for QM software.

‘If two or more discipline-specific management systems are integrated into a single management system, this is referred to as an integrated management system.’ (DIN EN ISO 19011:2018, 3.2 ‘Combined audit’) A management system referred to as an IMS therefore takes into account requirements from various management system standards, such as those for the discipline of quality management, occupational health and safety, the environment or information security. All of these specific disciplines are interlinked across systems in an IMS and linked in a process-orientated manner.

The ‘High Level Structure’ (HLS), now known as the Harmonized Structure, is an attempt by international standardization to support the integrated consideration and implementation of management system requirements. This is because it makes it easy to identify identical or similar requirements (often with step-by-step integration), recognize synergies and reduce costs. On the one hand, standardization with the HLS simplifies the integration of the requirements of all management system standards into one (integrated) management system. On the other hand, the existence of several management systems has often grown historically, so that in many companies several management systems exist in parallel.

This means that an IMS is nothing other than THE management system of a company (with its structural and process organization), which takes into account and ideally fulfils the relevant normative and regulatory requirements as well as all other requirements of the interested parties in its business processes.

All these terms and their definitions show us one thing very clearly: the concept of quality – i.e. what we include when we address the topic of quality – has expanded extensively over the years. Starting with quality as the pure quality of products and extending to an understanding of quality that encompasses the requirements for products, processes and the entire management system.

At the same time, the development and expansion of quality reflects the increasing complexity and the growing demands on companies not only to guarantee reliable quality assurance and comprehensive quality management, but also to take into account all requirements from the multitude of management system standards. At Babtec, we support these developments with our comprehensive software solutions that help companies to fulfil their operational QA tasks as well as to recognize the opportunities of a modern QMS and IMS.