PART 2 - OVERVIEW OF THE STANDARD
The year 2000 revision contains five requirements sections, each dealing with one of the fundamental building blocks required by any process. These are:
Quality management system: This section details the general and documentation requirements that are the foundation of the management system. The general requirements ask you to look at the processes of the management system, how they interact with each other, what resources you need to run the processes; and how you will measure and monitor the processes. The second part of the section then sets out the requirements for the documentation needed to operate the system effectively and how the documentation should be controlled.
Management responsibility: The management of the systems is the responsibility of the "top management" at a strategic level in the organisation. The "top management" must know customers' requirements at a strategic level and make a commitment to meeting these as well as statutory and regulatory requirements. "Top management" must also set policies; and to achieve these policies set objectives through planning how the objectives will be met. "Top management" should also ensure that there are clear internal communications and that the management system is regularly reviewed.
Resource management: This covers the people and physical resources needed to carry out the process. People should be competent to carry out their tasks and the physical resources and work environment need to be capable of ensuring that the customers' requirements are met.
Product/Service realisation: These are the processes necessary to produce the product or to provide the service. This is the act of converting the input of the process to the output. For a manufacturing organisation, this may be the process of converting iron ore to steel via a blast furnace for example. For a service organisation, this may be the process of moving a product or person from one place to another, for example, a taxi journey.
Measurement, analysis and improvement: These are the measurements to enable the systems to be monitored to provide information on how the systems are performing with respect to the customer, the management systems themselves through internal audits, the processes and the product. Analysing these, including any defect or shortfall in performance, will provide valuable information for use in improving the systems and products where this is required.
Each of these five fundamental building blocks is required for any process because, if one is missing, a controlled process does not occur. This is recognised in the new standard and represents a shift to viewing the quality system as a series of processes.
This shift will require an internal or external auditor to look at the organisation's processes and audit them and their output as they occur, rather than audit compliance with the requirements of the ISO 9000:1994 series of standards. The new standard will require significant changes in auditing methods for both internal and external auditors. Auditing will become more subjective and less objective, relying more upon questioning than hard evidence.
In order to carry out a "process audit" the auditor will start with the inputs, follow the process through its various stages to examine how it is controlled and verify that the output meet what is required.
Such a process may be, for example, the actions required by the organisation on receipt of a customer order, and the steps taken to convert that order into something that will allow a product ordered to be manufactured. The input here would be the customer order, and the output, the organisation's internal documents, resources and materials that allow the manufacture of the product. Another example of a process could be those steps that a dry cleaner would take to procure the chemicals required by the cleaning process itself. The input would be the need to buy chemicals, the output would be the receipt of the chemicals from the supplier.
Thus the auditor will need to look at the process, determine the inputs, examine how it is controlled, and look at the outputs. The way the process is controlled may require an examination of mechanisms other than documented procedures.
Such control mechanisms could be by, for example, control charts, process flow diagrams or by training of operatives to ensure they are competent. Whatever the means by which the organisation decides to control the process, the auditor will seek evidence that the control mechanism is indeed effective. The ultimate test of effectiveness is an examination of whether the end result of the process is in accordance with the inputs.
An example of a buying process end result could be receipt of chemicals. If the purchase order did not contain sufficient information to allow the correct product to be supplied or was deficient in some way, then the output would not be acceptable. The customer may not get the chemicals that were required. Thus the process would not be giving the output required. Some change to the process would need to occur in order that the chemicals required were received, thereby making the process output acceptable. Thus, during an audit of the process, the auditor would need to determine if the process output, i.e. the chemicals received, met the requirements of the organisation and the process for obtaining them was operating under the controlled conditions that the organisation had defined.
Auditing of processes should result in a logical audit of the activities of organisations in carrying out the various functions required to supply customers with a product or service which meets their needs. This change should therefore be viewed very positively.
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