ISO 9001:2000 – What’s New

As most of our readers are aware, the new ISO 9001:2000 standard is now out, and will replace the 1994 version. By December 2003, all ISO 9000-registered firms will need to be 9001:2000 compliant. In this article, we review what’s new in the 2000 standard.

No more 9002 or 9003

The first difference you will notice is that the ISO 9002 and ISO 9003 standards are no longer. ISO 9003 is gone already and 9002 (same as 9001, but without the design component) will disappear with the 1994 standard in December 2003. Under the new rules, companies will no longer be able to opt out of the design element, unless they actually don’t do design or can demonstrate that excluding the element has no effect on the product. Under the 1994 rules, the choice of 9001 (with design) or 9002 (without design) was somewhat discretionary. For example, many laboratories which design and develop in-house methods for use on customer samples, have chosen to be registered to the 9002 standard.

More customer satisfaction data will be required

Under new section 8.2.1, companies will now need to collect information to determine whether customers feel the product or service met their needs. This is a new requirement, not in the 1994 standard. Some firms are using questionnaires, others are using business indicators such as the frequency or repeat clients, some are using face-to-face meetings to collect this information. Be prepared to expend considerable energy getting a true sense of whether your customers are happy with you.

Must now document sequence and interaction of processes

The need to define and document the processes needed for the Quality Management System is included in section 4.1 of the new standard. This was not formally required under the 1994 version, although some consideration had to be given to the issue in order to develop the QMS. The processes that the new standard refers to include management activities and processes for provision of resources, product realization and measurement. The sequence and interaction must be determined according to the new standard. Flow charts are a convenient way to demonstrate this. A table format may also work in some cases.

More monitoring of how your quality system is performing

The 9001:2000 standard requires much more monitoring of the output of key systems such as non-conformance, internal audits, management reviews, in order to determine whether they achieve the expected results. For example, the number and type of non-conformances raised in-house can be monitored in order to identify where the problem areas are, or whether earlier corrective action was successful. Auditors have suggested to us that target levels, or “comfort” levels should be set for each type of non-conformance. As well, it has been recommended that “percent achieved” values be assigned to policy objectives during management review, so that we can determine where to focus our efforts. No, we are not making this up!

What about the paperwork?

Our auditors have cheerfully informed us that there are fewer documentation requirements in the 9001:2000 standard compared to the 9001:1994. As most of the key elements (non-conformance, corrective action, management review, training, internal audit) are still present, but more monitoring of customer satisfaction and the quality system itself is required, we have yet to discover how the promised reduction in paperwork comes about. We are sure that with three or four years of experience with the new standard, it will become clear, but for now, don’t believe it!

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