PART 1 - THE INTRODUCTION OF ISO 9001:2000

Why the ISO 9000:1994 series of standards is changing

It is normal practice to revise a standard every few years. The world moves on, and standards have to keep up. The revision of the ISO 9000:1994 series of standards in year 2000 has been planned since before the 1994 versions were issued.

Few standards have had more impact around the world than the ISO 9000:1994 series and the interest it has generated has inevitably led to many suggestions for its improvement. Before embarking upon the revision process, the responsible committee carried out extensive surveys, to determine what issues should be addressed by the revised standard. Some of the concerns with the ISO 9000:1994 series of standards are:

too much emphasis on documentation rather than results
customer satisfaction and improvement are not specifically addressed
the standard is now used globally and universally [not just in manufacturing]
the '20 elements' is not the best structure
too many standards in the series
duplication and/or incompatibility with other standards [e.g. ISO 14001].

The revised standard seeks to address these shortcomings, having evolved to meet the changing needs and expectations of users.

The Year 2000 revision

The revision comprises a family of standards:

ISO 9000:2000 - Quality Management Systems: Concepts and Vocabulary
ISO 9001:2000 - Quality Management Systems: Requirements
ISO 9004:2000 - Quality Management Systems: Guidance for Performance Improvement

Organisations will be assessed and awarded certification against ISO 9001:2000, whether or not they are involved in design. Further explanation of how this will work in practice is in Part 4.

ISO 9004:2000 offers guidance on implementing a quality management system and although it is consistent with ISO 9001:2000 it is not intended for use for certification or contractual purposes.

Differences from the ISO 9000:1994 series of standards

It is important to recognise that the revised standard does not represent a radical change and that large sections of the revised standard have not significantly altered from the 1994 series.

However, the new standard does introduce the following conceptual changes:

The most significant is the movement away from a procedurally based approach to management, i.e. stating 'how' you control your activities, to a 'process' based approach which is more about 'what' you do
The standard is now much simpler in its structure and approach, which makes it easier to use and understand
There is now considerable flexibility within the standard which requires a balance between documenting an activity and the competence of the staff involved

Its presentation is also different and it introduces certain aspects that were not directly addressed previously. We discuss these aspects in more detail later but some of the more notable ones are:

the replacement of the somewhat artificial '20 elements' by 5 broad headings:
- quality management system
- management responsibility
- resource management
- product/service realisation
- measurement, analysis and improvement
'Continual improvement' [see "Improvement"]
the move to 'customer satisfaction' [rather than 'customer complaints']

Benefits of the revised standard

There seems little doubt that the revision is beneficial in terms of making the standard relevant both to the organisations that adopt it and to their clients.

The move towards process management and the removal of the 20 elements will help organisations implement a quality management system that moulds itself to their business, and should avoid the pitfalls of re-designing the business to suit the standard. The emphasis on product/service realisation and customer satisfaction, rather than documentation, is a response to criticisms that the old standard concentrated on the wrong things. The need to address continual improvement is something that most responsible organisations had already recognised and this is now brought into the revised standard.

In addition to the major changes, there are a whole host of minor improvements which combine to make the revised standard more user-friendly.

Timescale for introduction

The revised standard was published towards the end of 2000. From that date onwards, certification bodies are able to certificate organisations to ISO 9001:2000, provided that the organisation's quality management system is in compliance.

However, if your organisation is already registered to the 1994 series of standards and you wish to adopt the year 2000 revision, there is no immediate need to change. There will be a 3-year transition period from the date of publication of the revised standard, i.e. until late 2003. During this time, you can continue to be assessed and certificated against the 1994 standard. You can decide when you are ready to be assessed against ISO 9001:2000. You should notify your certification body when you are ready for this. It is unlikely that the certification body will need appreciably more or less time to audit to the revised standard.

What happens to the old standard?

When the 3-year transition period expires towards the end of 2003, the 1994 series of standards will be withdrawn, certification to these standards will no longer be possible and 1994 certificates will become invalid. This means that any organisation holding an ISO 9000:1994 series certificate, issued with a Government recognised accreditation and who has not updated to ISO 9001:2000, will have its certificate withdrawn.

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