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Proposed changes to ISO9001

Are you ready for the changes to the ISO9001 standard that are expected to roll out in 2015? While not available publicly, the proposed changes have been widely leaked. It is almost certain that there will be changes between the official released version due for 2015 and the current draft. How much change and where - who knows? This will depend on the reception and reaction to the current draft.

This is what the changes look like now:

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 of the process approach is lauded as an improvement.

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 confusing to many companies. While entrepreneurs and managers don’t think of what they do every day in the context of preventive action, they all understand RISK. Preventive action is considered to be replaced by planning, risk management, and the having of a management system in the first place.

3. The structure has changed

There are now 10 main clauses, 1-3 as before, with requirements now set out in clauses 4-10. One of the big changes to come in the new version of ISO 9001 (in development now, due for release in 2015) is its structure. There will now be 10 sections (instead of 8) in the Standard; the requirements themselves are set out in Clauses 4-10. See the new structure below:

The new structure for ISO 9001

When the new version is released, it will have these 10 sections:

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

4. New: Context of the Organization

Another big change: a whole new clause 4 requiring the organization 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, though it really just makes explicit what is more or less obvious common sense. One opinion about it is that the intent included stopping those awful 'cut and paste' just-add-water types of instant canned 'systems'. In which case, YEAH!

5.'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 certification bodies 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 hardcopy manuals and recognizing that there are many ways of delivering and recording information. It may not stay exactly as is.

6. 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. 'Continual' has been dropped from the phrase 'continual improvement' in favor of just 'improvement'.

Finally: now only 7 Quality Management Principles

The existing version of 9001 is based on 8 principles. They were revisited and updated by international experts of ISO/TC 176 (responsible for developing and maintaining the ISO 9000 series of documents). The main changes:

I will be attending several conferences in the next few months where there will be much discussion on these changes. So I will be able to relay to you, my clients and others who may be watching, the latest information on the changes. If we know what's coming, then we can prepare and get through the audits smoothly.


The best way to prepare for the changes coming in 2015, of course is to work with a competent consultant. Choosing one may be easier than you think. I advise potential clients to look at things like total time spent putting together quality systems (how many have they seen and worked with?). How does a consultant get updated information about the industry? Most really good ones have a relationship with a certification body that allows for ongoing training. Ask for references. A consultant should be able to provide you with a list of client references. Very important - see that the consultant understands your needs and offers solutions that seem practical and well thought out for you and your company.

If you are seeking a ISO 9001 Consultant in Florida, contact Donna Cialone: 888-588-4993