Implementing ISO 9001:2000
Early feedback indicates six areas of challenge
by John E. "Jack" West
ISO 9001:2000 (ANSI/ISO/ASQ Q9001-2000) has now been available for several months. This new edition of ISO 9001, which is based on the eight quality management principles, represents a significant departure from the 1987 and 1994 versions. The principles were reviewed in detail in an earlier standards column.1
During roundtable discussions at seminars I conducted this year using the new standard (and in 2000 using the last two drafts), I received feedback from several hundred organizations.
In general the participants in these discussions were very satisfied with the new standard. In fact, most have been enthusiastic about its additional focus on the role of top management and on customers, its simplified documentation requirements and the specific inclusion of the concept of continual improvement.
I asked each of these roundtable groups to identify challenges and solutions related to implementing the new ISO 9001. It is not surprising that some of the things people really like about the new standard also turn out to be challenging. The issues that appear important from an implementation point of view can be summarized in six categories.
1. New structure of the standard
The new standard is structured differently from the 20-element model of earlier versions. In fact, the new model is better connected with the way organizations are normally managed, so new users find it much easier to work with. But organizations transitioning from the 1994 version often initially mention the new structure as a major challenge.
After some discussion, however, most users are able to see how to demonstrate compliance with the new standard by using a matrix or by revising only their top level quality manuals. Even then, the new structure remains challenging for organizations that did not use the process approach in initial system development.
2. Process approach
ISO 9001:2000 requires identification of the processes of the quality management system, along with their sequence and interactions. In effect, this means the quality management system must reflect the actual way in which the organization operates. This is normally accomplished by using techniques such as process mapping.
A majority of the organizations reported they used this approach in establishing their current quality management system. On the other hand, a minority said they had developed their documented system using the earlier standard--but without real consideration of the processes in the business.
For this latter group, adoption of the process approach represents a significant challenge. In some cases, these organizations reported they had created "shadow" quality systems in which the actual quality management processes are quite different from those described in the documented manual and procedures.
Organizations finding themselves in this situation must think hard about their approach to the new standard. Most of this minority agreed, however, the use of the new approach will help them align their written processes with actual practice to create a more effective system.
An implementation module that provides insight into the use of the process approach is available.2
3. Simplified documentation requirements
One of the key objectives of the revision process was to make the new ISO 9001 user friendly for small organizations. While the quality management system must still be described fully in the documentation needed to ensure its effectiveness, the number of system level documented procedures specifically called out has been reduced--from 18 in the 1994 version to six in 2000.
The notes in clause 4.2 provide good guidance on the extent to which an organization should go to document its system. Unfortunately, some organizations think auditors will continue to demand documented procedures where they have no value. And some auditors say they are unable or unwilling to audit without documentation.
Where documentation of a process has no value and the criteria of the notes in clause 4.2 have been met, organizations should stand their ground and resist creating useless paperwork.
In such cases, auditors need to learn to assure process effectiveness by talking to multiple individuals--from top managers or supervisors to workers who carry out the process. In that way, auditors can determine whether the process is actually carried out as intended by the leadership. On the other hand, auditors should seriously question processes where there is a lack of such alignment.
4. Focus on the role of top management
The new ISO 9001 has a greater emphasis on the role of top management than earlier versions. In fact, top managers are assigned specific new responsibilities.
In the quality policy, leadership must include a commitment to meeting requirements and to continual improvement of quality management system effectiveness. Top managers must also ensure requirements are determined and met.
There are major robust requirements for management review, including its use to identify improvement opportunities. Most roundtable participants see this emphasis as a positive shift in focus and an opportunity to improve the involvement of senior leaders in the quality management system. But others are concerned they will not be able to gain the required level of commitment.
Certainly, the transition to the new standard is a good time for quality professionals to demonstrate the benefits of senior management involvement.
5. Measurement of customer satisfaction
The new ISO 9001:2000 requires organizations to monitor information relating to customer perception on whether the organization has met customer requirements. This information is to be used as a measurement of the performance of the quality management system.
About half the organizations at the roundtable discussions indicated they now comply with the requirement. The other half is divided into two groups. Some have no system to measure satisfaction at all. Others report they have a corporate system (in some cases very sophisticated) for measuring customer satisfaction, but the data are not provided in a form that can be used within the quality management system.
In either case, these organizations will need to address this gap during the transition period.
6. Inclusion of design and development
There is a challenge for the 5% or so of roundtable participants whose organizations were previously certified to ISO 9002. While their organizations perform design and development activities, compliance with ISO 9001:2000 cannot be claimed if an organization performs these activities but excludes them from the scope of the quality management system.
The groups described a wide variety of circumstances, which are discussed in the implementation module on application.3 Organizations in this situation should get the module, study it and review their situation with their certification body. It is also clear that the certification bodies will need to exercise care in crafting the scope of certificates.
Auditing the quality management system
Some of these six topics are very important to auditors as well as system implementers. Issues important from an audit perspective will be discussed in future "Standards Outlook" columns.
1. Jack West, Charles A. Cianfrani and Joseph J. Tsiakals, "Quality Management Principles: Foundation of ISO 9000:2000 Family," Quality Progress, February 2000, pp. 113-116.
2. Implementation modules can be downloaded from www.bsi.org.uk/iso-tc176-sc2.
The U.S. Technical Advisory Group to Technical Committee (TC) 176 has also established a product support program under the leadership of Sandford Liebesman of Lucent Technologies, who is a member of TC 176 and is another "Standards Outlook" columnist. For information on participation contact Liebesman by e-mail at firstname.lastname@example.org.
JOHN E. (JACK) WEST is a professional management consultant in the areas of productivity and quality after being with Tenneco Inc. for 30 years in a wide variety of industries. He served on the Board of Examiners for the Malcolm Baldrige National Quality Award and is now the chair of the U.S. Technical Advisory Group to ISO Technical Committee 176 and lead delegate for the United States to the International Organization for Standardization (known as ISO) committee responsible for the ISO 9000 family of quality management standards. He is co-author of ISO 9001:2000 Explained, published by ASQ's Quality Press.