The ISO9001 standard has just about completed its latest update and will be issued this autumn, although the original plan of September seems to be unlikely. The good news is that the changes appear to be fairly minor; however, it is still important that we comply with the updates.
While mostly there is a change in wording and slight change in emphasis, e.g. changes from "identify" to "determine".
Some of these small changes may be significant within your system, for example, within section 4 there has been the addition of processes required for "analysis and improvement" to be documented. This may be for example the preventive action process that you already have documented; however, it may require some process regarding the analysis of your data to be formalised, depending on your current systems and documents.
There appears to be recognition (in section 6) of the new facts of life within industry today in that further clarification with regards to direct and indirect staff.
Section 7 has clarification with regards to the design review, validation, and verification in that although they are separate activities it is recognised that they may all be done at the one time.
There is an addition to intellectual property to include "personal data" , perhaps a none too surprising addition in the current climate where such data appears to be handled in a variety of ways, some of which can be catastrophic to clients and staff.
Within section 8 there has been a welcome addition in the notes to give some ideas on how customer satisfaction can be measured, something that has given a few of our clients some sleepless nights.
To get a full overview of the changes and how they might affect your own organisation, look out for our short seminars running this winter.
Also see our News section for further news items.
