Juhani Anttila
Venture Knowledgist Quality Integration
Helsinki, Finland


What should the implementing organizations understand and do?


After three working years the international standardization committee ISO/TC176 has finished the fifth revised version of the standard ISO 9001 (Quality management systems – Requirements) that will be published in the autumn of 2015. In this article we will consider the baselines of the drafting work, key aspects of the drafting process, the results obtained including positive aspects and pitfalls, and important issues from the viewpoints of quality and business practitioners of the implementing organizations.
Although initially the ISO 9001:2015 revision project had the good purpose and the challenging objectives, the drafting work fell into crisis at the final stage. This was not, however, acknowledged by the responsible task leaders. There was a disaster in the working process when the standard working policy was not respected. As the result, the new version of the standard text does not respond to the challenges of the modern business environments. In fact, there is nothing contentually new in the text, but all the requirements were featured already in the previous versions of the standard. The draft mainly consists of editorial changes. The draft does not fulfill the essential requirements of the accepted design specification, and the verification test was denied. Validation test was made, but its results, which indicated critical comments on auditability, were presented too late, when it was not any more possible to make necessary improvements. There are many terminological difficulties in the standard that in particular confuse implementing organizations.

These issues are not very well-known among the quality people and very little recognized among the business people. This can also be detected as you follow the discussions on the national and international level. Only certifiers and consultants have not expressed their concern, because ambiquities in the standard  mean increasing business for them.

This article considers how to effectively take the advantage of the good features of the standard. This also emphasizes the responsibility of the implementing organizations to continue the standardization through completing the gaps and ambiguities of the standard, and hence avoiding the pitfalls with their own creative and overpowering solutions for ensuring their competitiveness.

[This full text was prepared together with Kari Jussila, and will be presented at the World Quality Forum in Budapest, Hungary in 2015.]