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Quality Management Systems

What a QMS could be

When we refer to something as a system we tend to be referring to a set of interconnected elements that does something which none of the elements can do by themselves.  

When we refer to a QMS we may be referring to: A set of interconnected:

  1. concepts such as a system of ideas, rules or methods expressed in documents such as policies, procedures, requirements which people use to produce the products, services and level of customer satisfaction. These are abstract systems which have no purpose other than what we ascribe to them .
  2. physical objects such as equipment, facilities, buildings or infrastructure which people use to produce the products, services and level of customer satisfaction. These are deterministic systems which cannot determine their own purpose but which always produce the same output from a given input or starting conditions as in the Toyota Production System. This perspective is commonly referred to as a functional perspective because it assumes all parts have a predetermined function and work together to fulfil the predetermined goal of the system.
  3. human relationships such as a team, department or whole organization engaged in producing the products, services and level of customer satisfaction. These are social systems in which the whole and the parts can determine their own purpose.

Type A was the dominant meaning of the term after WWII (see below) until the mid 1980s when Type B meaning became more dominant during the “quality revolution” promoted by Edwards Deming and others. With type A meaning, people are users of the QMS who have no choice of what they do, they always do as instructed and with Type B meaning people are both users and architects of the system but external to it.

If we consider the QMS to be a combination of an abstract system, a deterministic system and a social system because it includes elements of all three, we are ascribing to it the properties of being a goal-seeking, self-organizing, self maintaining and resilient system of which people are an inherent part. We are therefore viewing the organization as a whole and focusing on those elements that increase the quality of its outputs and therefore the QMS becomes a systemic view of an organization from the perspective of how it creates and retains its customers.

What ISO says a QMS is

ISO 9000 defines a quality management system (QMS) as part of a management system with regard to quality.  Substituting the words underlined with the corresponding definitions in ISO 9000 we can deduce that a QMS is part of a set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives with regard to the degree to which a set of inherent characteristics  of an object fulfils requirements.

If this doesn’t make sense, it’s not surprising. For one thing, it’s telling us that the QMS:

  1. is a set of interrelated or interacting elements (that’s ok because this is how ISO define a system);
  2. is part of the management system (that’s ok because there are things other than product and service quality that need to be managed);
  3. establishes quality policies and quality objectives (and a load of others things as well)

But is it also telling us that the QMS:

  1. establishes processes to achieve the quality objectives? (But what about managing the processes?);

or that in addition to establishing policies and objectives it:

  1. is a set of processes to achieve the quality objectives? (implying processes are not one of the interrelated or interacting elements but also, there are elements other than processes in a system e.g. trust, commitment, infrastructure, people or are these considered to be part of the processes?).

This definition is therefore ambiguous but that’s not all. When we examine Figure 2 in ISO 9001 which is redrawn in the ISO document, Selection and use of the ISO 9000 family of standards we see that the results of the QMS are stated as being products and services and customer satisfaction, therefore we can deduce that the QMS to which ISO refers is a set of interrelated or interacting elements of an organization that provides products, services and customer satisfaction. But we still have a problem because this implies a QMS that produces nonconforming product that dissatisfied customers is not a QMS - how absurd. The inconsistency is between the requirement in ISO 9001 clause 5.1.1 and the diagram. The diagram portrays a QMS whereas the requirement refers to intended results and therefore an outcome of a QMS may be customer satisfaction but we can’t assume it always will be.

In addition to the formal definitions in ISO 9000, there are also several statements in ISO documents that potentially could clear up the ambiguity but alas they just make it worse and are totally different to the formal definition. Here are a few:

ISO 9000 clause 2.2.2 ~ A QMS comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results.

This implies the QMS doesn’t produce the products and services but simply identifies and determines things suggesting that the QMS is a set of documents which describe the objectives, processes and resources required which is then implemented to produce the products and services.

ISO Small Enterprise Handbook ~A quality management system (QMS) is the way your organization directs and controls those activities which are related (either directly or indirectly) to achieving its intended results”.

This is fundamentally different because it's a way of directing and controlling activities a concept that is derived from the definition of management in ISO 9000.  It implies it's a method because a method is a way of doing something, but for some reason it was not also derived from the definition of system. This description implies the QMS is a management subsystem but it doesn't include the delivery subsystem.

ISO Guide Reaping the benefits of ISO 9001~ “A quality management system is a way of defining how an organization can meet the requirements of its customers and other stakeholders affected by its work”. This definition also appears in an ISO Powerpoint presentation

This is different to the others by being a way of defining how an organization can do something, rather than a way of doing something.  The word define as used in ISO documents means: "state or describe exactly" (ISO Glossary, 2016) and as above a way of doing something is a method therefore this definition implies a management system is a method for producing a description, prescription or perhaps a specification.

ISO Web site (Nov 2017) ~ “A management system is the way in which an organization manages the inter-related parts of its business in order to achieve its objectives”.

This is another definition that contains the descriptor “is the way” and again different to the formal one in ISO 9000. The way an organization manages to achieve its objectives could be through fear, command and control or by any other style of management. It seems to reinforce the view that a QMS is a method rather than a set of interrelated or interacting elements.

Why is there such inconsistency in the way ISO define a QMS?

The only explanation that can be supported with objective evidence is that until the 2000 revision of these standards the term system had not been defined in ISO 9000 or its predecessor ISO 8402. Prior to 2000 it was not referred to as a QMS but as a quality system and this was defined in ISO 8402:1986 as the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. ISO 9001:1994. The notion of quality systems emerged after WWII when the industrial practices were still largely based on scientific management as defined by Frederick Winslow Taylor. One of the earliest definitions of a quality system comes from Armand Feigenbaum who defined it as “the network of administrative and technical procedures required to produce and deliver a product of specified quality standards” (Feigenbaum, 1961). While the 1994 definition is worded differently, in concept it is very similar and probably stems from one of the two uses of the word “system”. From the Oxford English Dictionary we find that it is used to describe:

(a) a connected group of objects forming a complex whole and;

(b) an orderly way of doing something.

and it is this distinction that creates communication problems because when the term system is used, it may not be clear whether it is being used in sense (a) or sense (b).

When we examine ISO 9001 and ISO 9000 we can find evidence of its pedigree in the growth of manufacturing industry of the post WWII years. For many years organizations have been encouraged to document what they do, do what they document and prove they conform to what they document to third parties. The product of this effort has been referred to as a quality management system.

Establishing an orderly way of doing something is indeed a sensible approach for organizations to take but, when ISO redefined the system concept in 2000, the term system was used in the sense of a set of interacting or interrelated elements and therefore, we could deduce that the term “quality management system” was no longer intended to be used in the sense of a set of policies and procedures to be implemented. However, the requirement for a QMS to be established, implemented and maintained has been included in ISO 9001 in various forms since the first edition in 1987 and it remains in the 2015 version in clause 4.1. This portrays the QMS as a set of concepts thereby conflicting with such requirements as “ensuring that the quality management system achieves its intended results” which implies the QMS is a dynamic system that has people and all the artefacts they use to determine and provide products and services to customers as its elements.

Now 17 years since the term “system” was defined differently to its use in previous versions of ISO 9001, remnants of its former use remain in the current version thereby perpetuating inconsistency and creating uncertainty as to what ISO believes a QMS to be.

Why does it matter?

These contradictory statements at best, induce doubt into the user's mind and at worst, reinforce erroneous beliefs depending on which documents they read. This is not consistent with the intent stated in Annex SL that a management system standard be easily understood and unambiguous.

It is vital that there is no uncertainty as to what a management system and more specifically what a quality management system is because the standards requires that we determine its scope, its boundaries, the processes needed for it, the resources needed for it and top management are to demonstrate leadership and commitment to it, we have to report on the performance of it, determine its effectiveness, ensure its integrity and establish, implement, maintain and continually improve it, so it’s vital that we are in no doubt as to what it is.

So what should a QMS be?

Outside of ISO 9001, a QMS can be anything you want it to be but, as the ISO documents are not clear on the subject, you will need to construct a definition that: