ISO 9001, revised approximately every five years, last saw revisions in 2008. ISO have announced that the next revision of the standard will be in September 2015. ISO 9001 is one of ISO’s most important standards, with many major purchasers requiring suppliers to hold a certificate. As such an important standard, revisions are being made using a three year revision cycle to provide quality management systems that are of as much benefit as possible to certified organisations.
What are the timescales for the changes?
The committee draft (CD) is the 1st general consultation for the next revision to the ISO 9001 standard. ISO members (usually individual countries) that have decided to help out in the development of this update have between June and the start of September to comment on the changes and how it will affect them. Although you can buy a copy of this draft document on the iso.org website, the general public cannot officially comment on it at this stage.
This document is known as ISO CD 9001.
Each ISO members comments will be discussed by experts from the ISO/TC 176 technical committee. Once agreement has been reached a Draft International Standard (DIS) is then released for public comment.
This document is known as ISO/DIS 9001.
As with the previous DIS stage, all comments are discussed by the technical committee to ensure that all parties comments and interests have been addressed. Minor changes may be made at this stage, but based on previous revisions to the ISO 9001 standard, the FDIS document remains largely unchanged.
Once all of the drafting stages have been accepted, it then becomes a published document with a new date at the end (hopefully ISO 9001:2015)
If all goes according to plan and the revised standard is published in 2015, a transition period is given before ISO 9001 : 2008 becomes out-of-date.
This usually happens approx. 3 years after the standard is revised.
What are the main changes?
- ISO 9001 will now follow a new high level structure, identical core text and common terms and definitions
- This new common structure is taken from Annex SL and means that every new or revised ISO standard released from now on will have approx. 30% identical text. For an explanation please see what is Annex SL?
- Using a simplified language and style of writing will help people (of all levels) to understand the requirements
- Top management (now called Leadership) must now have more involvement – e.g. customer satisfaction has now been added to the management review process
- New entire clause 4 called “Context of the organization” that defines how you must explain your organisation to all interested parties (not just traditional stakeholders)
- No more mandatory procedures required
- Less documentation requirements
- Instead of referring to ‘products’, the revised standard uses the term ‘goods and services’ – reflecting changes in the environments in which ISO-certified companies operate
- Other significant changes in terms are ‘purchasing’ and ‘outsourcing’ are being replaced with ‘external provision of goods and services’
- Perhaps one of the biggest changes is that the term ‘preventive action’ is due to be removed. This revision now talks far more about risk instead – this identifies that virtually every decision we make in business has an element of risk attached to it, therefore the standard asks you to identify the risk (and opportunities) and plan your actions
- When writing the scope of the QMS, the organisation must consider that both the quality policies and objectives must be aligned “with the strategic direction of the organization”
What do these changes mean to me?
Whether you are the quality manager or an auditor (or both), there will obviously be many changes that need to be made to your systems in order to meet the requirements of the revised standard. As you can see from the short list above, the changes are fairly major and will impact on a large proportion of your management systems. For example – how are you going to tell your leadership (top management) that they now have to play an active role in the running of the QMS, rather than simply delegating this to the management rep as many companies did before?
In other words a lot of planning will be needed in order to implement the changes.
ISO 9001 transition training
Don’t despair, Batalas will be running transition training courses which will teach you everything you need to know about the new standard.
We cannot give a date for this yet as we are not quite at the FDIS stage, but as Batalas were the 1st company worldwide to deliver an IRCA approved transition course when the ISO 9001 : 2000 was released, you can rest assured that we will do our utmost to be 1st again.
What is Annex SL?
***Page originally posted on the 10th April 2013, 7 updates since.