BS EN ISO 9001:2015 The quality Management Standard with some 1 million plus certificates to the existing 2008 Standard worldwide. Publication was due in September 2015.
The most recent drafts were submitted to the 45 member countries of ISO for approval; It is a mandatory requirement that all countries endorse the changes to allow the review process to move forward to the drafts for public comment and then Final drafts before publication.
We have been notified by one of the UKAS Accredited Certification Bodies that two member countries including USA have challenged the drafts. This has, as you can imagine put the proverbial ‘cat amongst the pigeons’. This may delay the publication of the next stages of these two Standards and may result in considerable changes.
There are other Standards that use ISO9001 as the basis of their own Standards:
- IAQG, AS 9100 series which cover the aerospace and defence industries;
- SMMT, TS16949 series which cover the automotive industries;
- HACCP, ISO 22000 series which cover the food safety industry;
- ISO 13485 series which cover the medical devices sector.
There are many others which use 9001 as the base model.
All these must consider whether they will follow the 9001:2015 model; there is some doubt at this stage as some of the above are also unhappy with the proposed Standards. If they decided to go their own way as standalone standards it may well cause the systems to become fragmented.
Time will tell…. Watch this space.