ISO 9001 is an internationally recognised standard for Quality Management and one of the most widely used management tools in the world today. The International Organization for Standardization (ISO) is currently revising the ISO 9001:2008 standard and significant changes are on the way!
Some of the concepts that are driving the revision to the standard are strategic direction, risk based thinking, opportunities, leadership, planning, process-oriented approach, documented information, goods and services, performance evaluation, and knowledge.
Following the recent meeting from 3rd to 7th March 2014, the ISO 9001:2015 working group still hope to be able to publish the revised standard in November 2015. It should be noted that it is currently unknown which of the above concepts will find its way into the newly revised standard. Although it’s likely some of the ideas will be incorporated, many others will continue to be perceived as outside of the scope of ISO 9001 standard.
What is known is that the new ISO 9001 standard will adopt the high level structure, identical core text and common terms and core definitions of the new “Annex SL” ModelWhat is known is that the new ISO 9001 standard will adopt the high level structure, identical core text and common terms and core definitions of the new “Annex SL” Model. The new structure (so called “Annex SL”, “Higher Level Structure”, and “HLS” etc.) is common to all new or recently revised management system standards and this will change the way management system standards look. This HLS and text is not allowed to be changed without serious justification so forms the basis of the new ISO 9001.
Changes to ISO 9001 are partly due to the HLS and partly due to the quality specific text that flows around the HLS. Documentation and records have been refreshed by using the term “Documented Information”, nothing ground-breaking but it makes a less rigid requirement (no specific need for a quality manual, for instance). However, there may still be a requirement for the same amount of documentation but it will just be documented information.
The context and interaction with customers and interested parties is highlighted in the first section of HLS; this is important to understand in the context of the purpose and direction of the management system and the “risk based thinking”. “Risk based thinking” is to distinguish the requirement from ISO 31000 (the risk management standard). It has been called ISO 31000-lite. “Risk based thinking” is understanding what can get in the way of the organisation reaching its objectives with an eye to leveraging on any opportunities that may present themselves.
In the “quality text”, there has been the addition of requirements for knowledge management (organisational knowledge) and effective change management has been highlighted. There is consideration of the need to include contingency planning and process validation but, otherwise, most of the requirements are similar to the 2008 version. Some requirements have been updated to reflect modern business practices. An example would be “contract review” which is now consistent with internet sourcing where an organisation advertises its wares and the customer decides whether or not to buy, capability and accuracy become more important.
Much work has been done to make the standard services friendlyMuch work has been done to make the standard services friendly which includes the change from “product” to “products and services”. The section on monitoring and measurement has been changed to relate to services where measurement may not involve calibrated equipment.
The jury is out on “innovation” which, although important for any organisation’s sustainability is difficult to introduce to ISO 9001. At present it is being included with improvement.
In response to the most significant revision in the standard’s history, CG Business Consulting will be running a seminar on 4th June in City West which will provide attendees with an opportunity to find out what the proposed changes are, the rationale behind them, and what your business will need to do differently in the future in order to maintain your certification.
If you would be interested in attending the CG Business Consulting Seminar, please fine more details of the event and how to register here.
About the guest author:
Caroline Geoghegan – MD of CG Business Consulting
Caroline Geoghegan is the Managing Director of CG Business Consulting Ltd –one of Ireland’s leading ISO Consultancy practices. Caroline has successfully implemented ISO quality management systems in hundreds of diverse organisations both in Ireland and overseas since 2007. Connect with Caroline on Linkedin.
Phone: 01 902 3961
For further discussion on the ISO 9001:2015 proposed revision Join Our ISO 9001:2015 Group