December 15, 2000 is a date that will be remembered by quality practitioners globally. It was on this date that the new ISO 9000:2000 series of Quality Management System (QMS) standards were officially launched as an International Standard by the International Organisation of Standardisation. This standard went through several draft stages viz. committee draft (CD) 1, CD 2, draft international standard (DIS), final draft international standard (FDIS) before it was finally accepted by the global fraternity as an international standard (IS).
This first version of the internationally accepted ISO 9000 series of standards, released in 1987, were actually based on several standards, namely BS 5750 (UK standard), CSA Z299 (Canadian) and the NATO AQAP series. Before the 2000 revision it has undergone one minor revision in 1994. As a standard focussed on customer satisfaction it is therefore necessary for it to be continually reviewed for suitability and effectiveness in meeting this objective. Five years since, Technical Committee 176 (TC 176) had led the major review of the standard with the relevant working committees and produced this third revision. This 2000 edition of the standard is intended to cancel and replace the 1994 versions of the ISO 9000 family in its entirety. However, the 1994 versions will continue to co-exist with this newer version until December 15, 2003.
The 2000 edition of the standard is a radical change when compared to 1994 edition. Changes can be seen in the language, structure, emphasis and even the name of the standard. What used to be a standard based on the requirements for a quality assurance system it is now a quality management system. The title in itself indicates how the standard has grown in its focus from being a system focussed on preventive measures as an approach to customer satisfaction to one that is concerned with the entire management practice and how quality integrates into the mainstream of activities.
The need for change and the areas requiring attention during the revision process were identified by sending out surveys to customers and organisations alike, globally. These responses were then analysed and then debated upon before the emphasis for the change were agreed upon. Among the major reasons for the change were:
- emphasizing the need to monitor customer satisfaction,
- meeting the need for more user-friendly documents,
- assuring consistency between quality management system requirements and guidelines,
- promoting the use of generic quality management principles by organizations, and
- enhancement of their compatibility with ISO 14001 (Environment Management System).
The 2000 version was also realigned in order to allow for this revision to align itself better with other internationally accepted quality programmes and initiatives including Total Quality Management (TQM) principles. This version is based on 8 quality management principles:
- Customer focus,
- Leadership,
- Involvement of people,
- Process approach,
- System approach to management,
- Continual improvement,
- Factual approach to decision making, and
- Mutually beneficial supplier relationships.
It must be pointed out that the newer version of the standard has a significant reduction in the number of documents that come with the family of standards. The 1994 version of the standard comprised ISO 9000, 9001, 9002, 9003, 9004, 8402 and a whole host of other support documentation. The new ISO 9000:2000 family only comprise 3 mainstream documents:
- ISO 9000:2000 - Quality management systems - Fundamentals and vocabulary (replaces ISO 8402 & ISO 9000-1)
- ISO 9001:2000 - Quality management systems - Requirements (replaces ISO 9001, 9002 & 9003)
- ISO 9004:2000 - Quality management systems - Guidelines for performance improvements
The new standard has also adopted a different approach in dealing with the QMS implementation as compared to the older versions. The old versions focussed more on the 20 elements/clauses in the manner in which the standards were written. Organisations had a tendency to follow the similar structure in their organisations and developed documentation along those lines, often causing confusion to the users. The newer edition emphasises a process approach in adopting the standard. The organisation is expected to review its existing process in producing outputs and manage them effectively using the principles and requirements as identified in the new standard. This has made the new standard more business friendly and suited to operating needs as opposed to the fragmented view the older standard offered.
The process approach means that we take a holistic view of the organisation from the point of inputs into the process and trace all activity to the point of delivering the output. As you know this typically involves layered processes and sub-processes that are inter-linked. When all the interactions between the various processes and sub-processes are identified and managed effectively, it can be inferred that a process approach has been adopted. In addition to this, the new standard requires that management system adopted also conform to the requirements of ISO 9001:2000.
It is for the same reason that the structure of the new standard is markedly different from that of the old. The new standard is divided into 8 clauses unlike the 20 clauses of the past. Effectively the requirements of the standards begin with clause 4 and ends with clause 8. The main clauses are:
- 4. Quality management system
- 5. Management responsibility
- 6. Resource management
- 7. Product realization
- 8. Measurement, analysis and improvement.
Another significant deviation from the older standards is the reliance on documented procedures. When reference was made to the older standard, it was often, although simplistically, referred to as the "write what you do and do what you write" standard. It did not matter if you had a very small and specialised workforce, if there were no procedures then you do not get certified. This has changed in the new standard. The new standard officially requires 6 documented procedures (although I prefer to say procedures to cover six main activities.) These six activities are:
- Control of documents (clause 4.2.3)
- Control of records (clause 4.2.4)
- Internal audit (clause 8.2.2)
- Control of nonconforming product (clause 8.3)
- Corrective action (clause 8.5.2)
- Preventive action (clause 8.5.3)
Please take note that it should not be interpreted that other procedures are not needed. The need for procedures now shall be decided upon by the organisation and not dictated by the standard, as done previously. The organisation might want to take into consideration the size of the organisation, the processes that need to be managed and controlled and the complexity of these activities before deciding.
It must also be noted that one of the major requirements for the new standard is the demonstration of continual improvement as part of the management system. While the requirement for continual improvement was an implied requirement in the older standards in this version it is now a stated requirement. It is quite right to say that organisations cannot purely concentrate on maintaining their systems as status quo, year in and year and hope to maintain certification.
Organisations are expected to incorporate the element of continual improvement as part of the organisation's business plan. Continual improvement is along the lines of better, faster and cheaper. While the standard demands the need for continual improvement it however does not specify the area where it should be implemented or the amount. It must be said also that among the areas where one might want to consider improvement would be in enhancing customer satisfaction.