How widely used is the standard and who employs it?
It is employed by 1.1 million users in 184 countries and the ISO Survey 2012 suggests or indicates that Machinery and Equipment is one of the five largest sectors for ISO 9001 globally.
Why is the standard being revised?
The current version is ISO 9001:2008. That edition contained only minor changes from the 2000 version, which means that it is well over a decade since the standard was altered significantly, and much has changed – technology, a more international approach to business, growing customer awareness and demands for quality. Additionally, ISO has introduced a common structure with core text for all management systems, intended to help organisations align and integrate different management systems.
Is this a major change, then?
Yes, this is a large revision, mainly because of the transition to the common structure, but key changes include: a risk-based approach throughout; a greater onus on top management to make sure ISO 9001 is part of the organisation's overall business management and works in synch with other systems; less prescriptive requirements to allow greater flexibility; a change in key terms; greater focus on customer satisfaction and risks to that.
Should I be concerned about such a large change?
There has been concern that the new revision is so different to ISO 9001:2008 that organisations will find it very difficult to make the transition. This is more a matter of perception than fact, however. Many of the requirements are the same; they have simply been re-ordered and made more applicable to contemporary business practice, smaller organisations, those that deal with non-traditional products and the service industry. But organisations that already have ISO 9001 certification will find that their existing quality management system already meets most, if not all, of the requirements of ISO 9001:2015, though a gap analysis is advised.
Who's involved in prompting, directing and accepting changes to ISO 9001?
Around 100 countries and many international liaison bodies decided that a revision was needed. Experts nominated by the countries or organisations that make up the ISO committee member bodies drive the process. Most have hands-on experience of implementing or auditing ISO 9001. They hail from huge multinational corporations, as well as smaller organisations. Certification and accreditation bodies are also represented, as are labour organisations, employer bodies, government bodies and academia – but the vast majority of experts come from industry.
Once a draft is written, it is first distributed to the participating member bodies for comment and ballot, then the process is repeated to incorporate those comments and resolve any outstanding issues. The public is also able to comment, once a stable draft is agreed (available now at http://is.gd/TAk6f4
till 31 August) – it is usual to receive 10,000+ comments on ISO 9001 from all over the world. Each of these comments is given consideration and discussed by experts before the final draft is put out for ballot to the ISO committee member bodies. The ballot must be approved before a standard can be published.
If I have the current ISO 9001 standard, when do I have to adopt the new one?
When the new standard is published in September 2015, organisations will have three years during which they may be certified to 2008 or 2015. By September 2018, however, all companies will need to be certified to the new standard.
And what do I need to do to upgrade?
To update your system, it is simply necessary to work through the new standard against your existing quality management system to identify gaps. As there is a three-year transition period, there is no need to rush to change anything: the review can be done systematically and over a period of time, with upgrading built into day-to-day reviews, processes and procedures. It need not, therefore, be complex, time-consuming or expensive.
When will the standard be reviewed again?
Five years after publication, but it is anticipated that no substantial changes will be made for at least 10 years. Changes will only be needed when it is found that the standard no longer accurately reflects industry needs.