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Quality Systems

A new perspective 

An article written by David Hoyle for Quality World in October 1996

Around the world, there are many types of quality management systems but one dominates the field. the ISO 9000 element based quality management system. Where it originated is uncertain, but it is advocated with monotonous regularity. This approach facilitates the comparisons of various systems but it defeats the objective of providing systems that enable organizations to design, develop, produce and deliver products and services that meet customer needs and expectations. Quality management systems should be developed to serve the needs of the business not the auditors. Off-the-shelf solutions should be outlawed even though they can save money in the short term.. Whilst any reduction in cost is welcomed these solutions are akin to the student who studies past exam papers and learns how to answer certain types of questions then gets stuck when faced with a question that appears for the first time. Such solutions remove the opportunity for people to learn. They may be able to pass the assessment but they are unlikely to be educated. Using software tools will help maintain control of the documents and speed development, they will also provide many useful aids to data collection, analysis, retrieval and storage. However, many of the packages have built in prescriptions and templates for documentation which may not suit your organization and will force you into the ISO Element approach.

Every organization wants a painless and swift solution to meeting ISO 9000, but in doing so they are missing the point. ISO 9000 is not about a system of documentation, it is about quality management systems. ISO 8402 defines a quality management system as the organization structure, processes, procedures and resources needed to implement quality management.

Organisational structure

To many this means an organisation chart or several charts that depict the various positions and their relationships. But this is where it stops. Is this all there is to an organization structure - a piece of paper with boxes containing names? No. The organization structure is far more than this. As David Packard remarks in The HP Way, "The way the organization is structured affects individual motivation and performance" Well, if the structure is merely a chart, I don't see how this can affect individual motivation and performance. It is more than likely to demotivate than motivate by showing how low some people are in the hierarchy. So what else reflects the organization structure? 

Consider two organization charts, one for a private company that maintains road vehicles and another for a unit of the military that maintains road vehicles. They may well look alike on paper - but in practice they are quite different. The private company may operate in a way that provides employees the freedom to innovate, to participate in decisions, to discuss matters directly with the MD, to work flexible hours. The military unit has none of these freedoms, every employee has to obey the instructions handed down from above without question. Each is appropriate to their environment but neither is shown on the chart.

If the quality management system is to comprise the organization structure then it must consist of more than a chart. There should be a description of the organizational policies which are employed to foster individual motivation and performance. These could cover.

  • Division of work within the organization and its component parts
  • Selection of personnel for appointments and the promotion policies
  • Defining and communicating responsibility and authority
  • Staff involvement in policy decisions
  • The way policies and instructions are issued and feedback obtained
  • The use that is made of staff suggestions
  • Resourcing of projects and redeployment of surplus resources
  • Employee benefits, share options, sick pay, insurance schemes etc.
  • How managers obtain the confidence of the workforce
  • How managers show their trust in the workforce
  • Policies on working hours, holidays, absence etc.

The vision and values to which the organization subscribes will also be important and the ways in which these are embedded in the culture and periodically reinforced. What all this stuff relates to is of course the style of management and therefore, the organization structure is a reflection of management style. To accurately reflect this, the description of the organization structure in the quality manual should cover all significant facets of the management style such as those above. many claim that ISO 9000 says nothing about the people aspects of quality since the achievement of quality is primarily dependent on people, this is a serious omission. However, if one takes a new perspective towards the meaning of an organization structure, then all manner of human factors can be introduced into the system.

The typical response to clause of ISO 9001 is to insert an organization chart and a few job descriptions in the quality manual. This hardly reflects an organization structure of the type described above. the manual should reflect the policies of the organization towards the other elements of the standard so why when it come to clause are no policies ever stated. only a picture of the organization as is current formed is portrayed no policies for shaping the organization to cope with the varying demands of its customers and responding to change.


Processes are the means to transform inputs into outputs of added value. They include all the materials, machines, environment, personnel, documentation and techniques to convert given inputs into required outputs. And yet the majority of the quality manuals do not describe the processes of the organization. All they describe are the organization's response to the elements of ISO 9001 or ISO 9002 which themselves are not in general processes but topics. If the manual is supposed to describe the quality management system then one would expect it to describe the processes of the business. A manual laid out in ISO element fashion is not describing a system, it is merely responding to the requirements.

Taking an engineering example to illustrate what I mean. A requirement specification for a product will specify the features and characteristics which a product needs to exhibit for it to fulfil a given need. such as performance, reliability, safety, physical and functional requirements. These requirements do not describe any particular product. since there could be many solutions all differing significantly in form, construction and technology. Thus a supplier's description will be unique. It will illustrate the product with diagrams and , pictures and the. actual performance characteristics are stated which often will exceed those in the original requirement specification. The product does not have a size function, a reliability function, a safety function etc. It consists of a carefully chosen set of components which are interconnected in such a way as to provide the stated functions reliably and safely etc. Even when considering the operational functions, it is not often possible to point to any component and claim that it alone fulfils a requirement of the specification. Collectively they work together to deliver the required performance. So why when describing our quality management systems are the requirements simply repeated?

To meet the intent of ISO 9001 and ISO 8402, processes such as system management, marketing, design, development, purchasing, manufacture, shipping, distribution, installation and servicing need to be described and shown to meet the relevant requirements of the standard. In other words lay out the manual as a series of processes not as elements.

Turning again to the people factor which many say is absent in ISO 9000. Processes involve people. People contribute both tangible and intangible inputs such as leadership to the process. Without leadership, the processes will not function effectively.


Here is another term that has been abused by the consultants and auditors. Procedures seem have become the documents which relate to an element of ISO 9001 or ISO 9002. such as Contract Review Procedures, Inspection and Test Status Procedures, Corrective and Preventive Action Procedures even Responsibility and Authority procedures. Procedures are limited to these elements while all lower level procedures are called work instructions. Where did this concept come from?. The ISO 8402 definition has its drawbacks but. does not imply any levels. A procedure is simply a way of proceeding to accomplish a task. It can be a few lines or a book full of instructions. How do we proceed to do anything? Step by step rather than in huge jumps. One might eat an elephant a bite at a time so they say - this then is the procedure, but you may need to preface the eating with a few preparatory steps to avoid indigestion! Any document that lays out a way of doing something step by step is a procedure There is no reason why the word in ISO 9000 quality management systems should be limited to documentation levels below the quality manual

ISO 9001 requires procedures to be established, documented and maintained for 18 topics. although this does not mean 18 documents are required. . The word procedure in the standard is always plural, thereby implying many procedures may implement a particular requirement. To illustrate this point take Corrective and Preventive Action Procedures as an example. In several systems , these two quite different topics are covered in one procedure usually with the result that the company is noncompliant with the preventive action requirements but still gets registered. many people are confused by the meaning of corrective action and treat it as the action to fix the nonconformity. Indeed clause 4.14.2 of the standard addressed customer complaints under corrective action and the complaint must be fixed to prevent it from recurring. However three actions need to be taken and all, require quite different procedures. Remedial action, corrective action and preventive action. The first two are related and may follow in sequence. But we cannot take preventive action on a problem that already exists. From the definitions in ISO 8402 corrective action is action taken to prevent the recurrence of a nonconformity and preventive action, action taken to prevent the occurrence of a nonconformity.

corrective and preventive action procedures cannot be mixed together. In fact many actions such as planning, training, FMEA, auditing, management review are preventive actions but do not come under the preventive action heading. They are often the subject of other procedures.


The system includes the resources to implement quality management. this is sometimes interpreted as being limited to the numbers of inspectors and auditors employed and the organization concerned is duly registered. Resources include personnel, materials, equipment, facilities, plant, space, finance and time. To describe resources the system would have to describe how each requirements is identified and acquired. Few if any manuals go this far. But again, resources is a topic and so there cannot be a single procedure to govern its identification and acquisition. A system without adequate resources will not function. If the managers do not allow sufficient time for the procedures they have issued to be carried out then the system is ineffective. If there are insufficient or inadequate tools, equipment, staff and space for the activities described by the procedures then the system is ineffective. If the staff is not equipped with the education, training and motivation needed then the system is not effective. Resources from this perspective, takes on a whole new meaning but how many auditors really assess the organization's resources? Very few primarily because there is no documentation required by the standard on which to judge conformity However while clause, may not require documentation clause 4.2.1 requires the system to provide a means of ensuring product conforms to specified requirements - and this has to be documented. If product is not meeting such requirements it could be that there are inadequate resources. In clause 4.2.3 suppliers are required to consider the resources needed to achieve the required quality and in clause 4.3.1, suppliers are required to review contracts before acceptance to ensure that they have the capability of meeting the requirements. Again under clause 4.4.2, design staff have to be equipped with adequate resources and in clause 4.9 the supplier is required to use suitable production, installation and servicing equipment - all related to resources. Clause 4.17 also requires internal audits to determine the effectiveness of the system but no audit programme (to my knowledge) does this. Even the third party auditors do not check for effectiveness. It is probably due to the fact that none of the standards in the ISO 9000 series give a clue as to how this might be carried out.

A quality manual that describes the resources required to implement quality management should therefore identify the plant, personnel and equipment at its disposal to execute its business. In the manual this need be no more than an outline supplemented by the policies that govern the identification, acquisition and disposal of resources with reference to the procedures in which these polices are implemented. It would also need to indicate how such data was made available to the decision makers especially those accepting contracts.

Finally returning to the people factor, motivation might be an element of resources and that the organization structure will affect individual motivation.. Everyone has the ability to be motivated. the secret is to create the right environment to extract that drive.


Is all this required in ISO 9001?. Yes. ISO 8402 is part of ISO 9001. It defines both what a quality management system and a quality manual is so the quality manual has to describe the quality management system not the requirements of the standard that are satisfied by the system. the words used in the ISO 9000 must be respected for the standards to be of value. The peddlers of the Element approach have done ISO 9000 a great disservice.  There are other more beneficial approaches to ISO 9000 than the element-based approach. A new perspective must be adopted now to show TQM advocates that ISO 9000 is not all about documentation without an ounce of the human element.


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