Friday, December 18, 2015

WHAT IS ISO 9001 2015 INTRODUCTION (PART 3 MAJOR CHANGES)


Structural and Philosophical
Those of us who have been around these standards for a while might have the most difficulty with the changes. The reason could be two fold. One is that the standard has had practically no change since 2000, or for the last 15 years, and we are used to the same standard for a long time. Even though it is all for the better harmony with all other management standards, it is a change nevertheless, and major one.
Perhaps the biggest change is that the standard has matured. With the publication of the new version, the standard is now 28 years old. Perhaps consequently, those of us accustomed to the standard prior to 2000 will have the most difficulty, since the familiar requirements/ restrictions/ admonitions seem to have disappeared. This has left many with the impression that the standard has been watered down.
The fact is that not a single requirement has been eliminated. It just (may) seem that they have been. We will see why it seems that way when we get into the details of the new requirements, and the language/ style of presentation in the ISO 2015 version.
In fact, there are net additions. Here again, some may argue that these were previously implied, and not really new. Regardless, now they are explicitly required. Following are synopses of some of the major additions:

Context of the Organization
  • Organizations are now required to determine external and internal issues that impact its purpose and strategic direction and ability to achieve goals of the Quality Management Standard.
  • Understanding who are interested parties, and the requirements of these interested parties on the organization

Risk Based Thinking
  • Clause A.4 gives detail on this topic, but Clause 6 is likely one of the most clear in the requirement to make risk based thinking the foundation of a Quality Management System QMS complying with ISO 9001:2015

Management of Change
  • Clause 6.3 requires the organization to carry out change in a planned manner, and address purpose of change, and risk associated so as to minimize it.

Organizational Knowledge
  • Organizations are now required to determine the knowledge necessary for the operation of its processes, and to achieve conformity of its product.
  • This knowledge must be maintained, and made available as necessary.
The above gives us a first look at the new ISO 9001:2015, and a peek at the more significant additions to requirements. The standard has matured; the language is much more subtle. You will find that the authors have done a tremendous job of presenting the original requirements in a much gentler fashion, with much fewer words. And yet, the size of the document has increased over the 2008 version.  That itself is a clue. Another clue is that we will have three years for the transition. Organizations are being expected to make decisions on their own regarding just how to effectively implement these requirements. We hope that you will stay with us over the next weeks/ months as we dig deep and mine some jewels.