Remember there are a few more years and more drafts to come before the official published version of ISO 9001:2015 is released and based on the current committee draft the reception and reaction to the current draft from CB’s (certifiers; those who audit and issue the certificates) will I am sure have a great effect on the final outcome.
But for now here is a continued high level view of changes
1. The structure has changed
There are now 10 main clauses, 1-3 as before, with requirements now set out in clauses 4-10.
This brings it into line with ISO’s new harmonized and consistent structure, to be used for all management system standards in future.
One impact is that many requirements from the existing version are now located differently. For example, requirements for both management review and internal audit are now under Performance Evaluation (clause 9); and most of what used to be called ‘Management Responsibilities’ is now under clause 5 Leadership.
2. 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.
3. Risk management is in preventive action is out.
Risk management is a requirement. Preventive action has been removed – because it is being replaced by planning, risk management and by having of a management system in the first place.
4. Context of the Organization.
A new section 4; is requiring the organization to consider itself and its context and to determine the scope of its quality management system.
Hopefully this will stop ‘cut and paste’ practices.
5. ‘Documented information’ replaces both procedures and records – NO mandatory procedures
This is one of the most controversial changes and one where further changes are likely to take place.
This may be an attempt to get away from the culture of lengthy Manuals and procedures and recognizing that there are many ways of delivering and recording information especially in our electronic age.
6. Terminology changes.
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.
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
The main changes are:
The principle of ‘A systems approach to management’ has been dropped. (May be because it was considered covered by the act of having a management system)
The last principle is now called ‘Relationship Management’