Quality refresh - highlighting the proposed changes to ISO 9001:2015
With over 1m users worldwide, ISO 9001 – the international quality management system standard – is arguably one of the most influential pieces of business literature ever written. With a global community watching these developments with interest, David Lawson, LRQA Technical Director gave his views on what this latest development in the ISO standard revision could potentially deliver in terms of functionality and structure.
With ISO elevating the status of ISO 9001:2015 to Committee Draft stage (CD) on 4 June, this means that it has now gone to the members of the International Organisation for Standardisation (ISO) for voting.
One month after ISO 9001:2015 reaching the first significant version of its current development phase, this is a good point for us to review some of the proposed changes and structure to the world’s most popular standard. Naturally, there has been much speculation on these changes and their implications, with a great deal of readily available information being generated across traditional and digital channels.
So let’s start with what we all know; well as we anticipated, CD ISO 9001:2015 incorporates the high level structure and common text from ISO Directive Annex SL.
On first reading there’s a lot to look at and much to consider but this is facilitated by the standards writers themselves having written a specific introduction to this version to highlight the areas of specific change in the document.
These changes are readily available in the public domain and include the introduction of Annex SL Appendix 2, redrafting to make the standard more generic and more easily applicable by service industries as well as looking at the context of the organisation to name but three of the widely reported changes.
But as well as these changes, this CD version of ISO 9001:2015 has also modified the text in other requirements that also must be considered for management systems and their use such as the extended use of ‘ensure’ as a responsibility of Top Management, planning of changes and knowledge.
In addition to these three, other areas that fall under this amendment to the text include;
• External provision of goods and services (formally Purchasing)
• Development of goods and services (formally Design and development)
• Post-delivery activities
• Analysis and evaluation of data
• Management review inputs
In the areas above we see a subtle shift from implicit requirements in previous versions of ISO 9001 to more explicit requirements in this CD version. To try and delve into the detailed implications for each of these headings would be nothing but pure conjecture at this moment.
However, there is still much to consider and debate for the industry to ensure that the changes incorporated into ISO 9001:2015 realise the intended benefits to organisations and stakeholders of ISO 9001 certified organisations.
Conjecture aside, LRQA believes that what is fundamental to the continued growth and worldwide adoption of management systems is their applicability and relevance, underpinned with new management thinking. By relevance, I mean their proven ability to play a key role in relating directly to a company’s performance and ability to successfully manage risk.
At LRQA, we see it as our role to help our clients understand what the changes mean to their management systems and their organisation. This will become a key area of focus as we move throughout the standard revisions process; we need to help organisations of all sizes to understand what the implications of the changes will be. From an LRQA perspective, this latest draft of ISO 9001:2015 leads to some interesting questions;
• How might the knowledge and skills of a system manager need to change or adapt?
• What does this mean for auditor competence?
• Are traditional auditor methods still appropriate or do they need to be changed or be supplemented?
• Will the audit duration be affected?
Obviously there is still a long way to go in the revision process and the CD ISO 9001:2015 requirements will be reviewed and revised through the commenting process, but the intent has been created.
With this revision being cast by the standards writers as a ‘significant revision’, it’s now time for the industry to begin understanding the potential impact by thinking about the possible extent of change, debate its’ meaning for users worldwide and to think about what across the 3rd party certification industry should remain the same and what needs to be different.
We need to be mindful that since the last significant revision in 2000 much has changed. Growth in technology, the emergence of BRIC countries and world events – both natural and man-made - all of these factors have influenced our thinking for what’s important for business and organisations. The difficult task the standards writers have is how to construct a set of requirements that is ‘fit for purpose today’ and for the next 5-7 years at least.
The commenting period for this version of ISO 9001:2015 is open until the 10th September and will be through committee members and their respective national mirror committee structures.
Further information about the ISO Standard Revisions - to include blogs and round table discussions - will appear on www.lrqa.com. Alternatively, please email firstname.lastname@example.org.