ISO 9001 – 2015 Update

9001imageYou may be aware that the most commonly used management system standard, ISO 9001, is currently being updated. If not, you need to know that big changes are ahead. The new version of the standard is due to be published September 2015. Although that seems a long way off, now is the time to start planning for the changes and the work involved in maintaining your certification.

Why is ISO 9001 changing?

  • ‘Quality’ has evolved since the 2008 version. Quality isn’t about ‘widgets’ and ‘quality control’ anymore. It’s about aligning controls, processes, people and other resource to meeting the needs of our customers. It’s now strategic. And it’s in the boardroom.
  • Management system standards have evolved. The use of standards to manage how organisations meet specific objectives is growing. And now the format of such standards has changed – they are now aligned to something called Annex SL, which comprises 10 sections which all management system standards will follow. ISO 9001 is playing catch up.
  • ISO itself requires management system standards to be periodically reviewed and updated. ISO 9001 is actually overdue for its revision.

So what can we expect in 2015?

Last week I attended a CQI meeting that focused on ISO 9001 and the proposed changes. On viewing a copy of the latest proposed revision, it’s clear that the standard is hugely different. Probably about 50% of the 2008 version has changed. Not only does it read differently, it looks different as well. It follows the 10 section format as per Annex SL, consisting of:

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement.

Over time, Annex SL (a standard for writing management system standards) will make it easier to navigate, understand and integrate management system standards.

Other significant changes include:

1. The Process Approach is now embedded in requirements

Clause 4.4 specifies requirements ‘considered essential to the adoption of the process approach’. Mostly, these consist of requirements that were already in 9001, but which have now been brought together. But the explicit requirement for an organisation to understand and control its processes is progression in my eyes.

2. Risk management is in, preventive action out

Risk management is a requirement. Preventive action has been removed – which I think a good thing as it was so confusing to many.  It’s considered to be replaced by planning, risk management and the having of a management system in the first place.

3. Context of the Organisation

Another BIG change: a whole new clause 4 requiring the organisation to consider itself and its context, and to determine the scope of its quality management system.

This clause is probably going to cause a lot of head-scratching and confusion, but it’s going to reduce the number of organisations trying to get a ‘quick-win’ or a ‘tick in the box’. So again, it’s a good thing in my opinion.

4. Documented information’ replaces both procedures and records – nil mandatory procedures

One of the most controversial changes, and one where further changes are likely before publication.

I can imagine a collective drawing of horrified breaths by the certifiers across the world as they try to imagine auditing to this Standard, where not a single mandatory procedure is specified. I think it’s attempting to get away from the culture of big thick hard-copy manuals etc and recognising that – especially in this electronic age – there are many ways of delivering and recording information. It may not stay exactly as is.

Also, there is NO requirement for a Quality Manual!

5. Terminology changes

The term ‘product’ has been replaced with ‘goods and services’.This is to make it more generic and applicable to service fields, and remove the inherent manufacturing bias. A very good idea methinks (although many manufacturers disagree already). Continual’ has been dropped from the phrase ‘continual improvement’ in favour of just ‘improvement’.

I will blog more about the changes to ISO 9001 as the update progresses, but I think you will now see that this is a significant change and one that will have a huge impact on many organisations. So much so, that ISO are considering a 3 year period to update existing ISO 9001 systems to the 2015 standard.

Now is the time to plan though, not in 12 months’ time. consider:

  • learning about the new standard yourself, now
  • communicating the changes internally and involving others
  • whether you need to re-design your entire system, or keep the same format

Lastly, there is no requirement for a ‘management representative’ in the 2015 version. It implies that the management system is owned by top management. Gulp! Take note – MD’s, CEO’s, Owners – you will be responsible for the management system, and therefore you will need to show evidence that you manage it, drive it, and improve it.

Any questions? Drop me an email or call me.

Finally, what will you do to begin the transition to ISO 9001: 2015?

 

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