ISO 9001 is currently used by 1.1 million people and organisations in 180 countries worldwide (ISO survey 2012). Now that the upcoming 2015 draft revision has been announced, this will mean a significant impact for all the businesses that currently work with the standard.
Similar to the 2000 edition, this change will affect all accreditation and certification bodies, training and implementing organisations, consultants and of course the clients or customers.
Although the revision is subsequently named ISO 9001: 2015, there will in all likelihood be a long transition period with talks planned up to 2018.
• Service businesses recognised:
One of the major changes undertaken is that the new 2015 version will now recognise the fact that organisations are often providing a service rather than a physical product and to show this the term “product” will be rewritten as “goods or services”.
• Increased requirement for senior management involvement and commitment:
The new version indicates an increased requirement for senior management to take a greater involvement in the quality management system, as well as a greater overall business focus.
• Greater emphasis on productivity and quality of product:
The ongoing focus of the 2008 version on efficient process management will be preserved, however there will be more emphasis on generating desired productivity and providing confidence in the organisation’s products.
• Auditor proficiency more of a focus:
Another interesting factor is that (while ISO management system obligations are not created purely for the purpose of being audited) there will be tighter controls on auditor proficiency to ensure that a high standard of auditing can be met and maintained.
• A new consistent structure and language for all standards – Annex SL- what it is and what it means:
The new structure, format and language used in ISO 9001:2015 are to be standardised via the introduction of common core text, terms and definitions for all future standards called “Annex SL”. This has been introduced in order to create standards that are more user-friendly and to allow easy integration between different ISO systems.
Annex SL, for example, replaces, the term “document control” with “documented information” and has removed “preventive action” and added “risks and opportunities”.
• New sections:
There will be a couple of new sections indicating a change of emphasis in the new standard.
4.0 Context of the organisation
This section will be similar to what currently exists in 4.0 in the 2008 standard, but the aim will more closely focus on making sure the quality management system is really integrated into the organisation. Experience shows that organisations which make ISO 9001 an integral part of “the way we do business” get a lot more benefit from ISO 9001 compliance and incur fewer ongoing upkeep costs and hassles. 4.0 aims to address the tendency of organisations to adopt a “bolt-on” and/ or “silo” approach to ISO implementation.
4.2 Understanding the needs and expectations of interested parties
A new emphasis of the ISO 9001:2015 will be the need to identify all external and internal concerns as well as stakeholders and ensure effective communication and alignment between them, the organisation’s systems and the organisation’s strategies and purpose.
Traditionally ISO 9001 focussed on the need to identify and satisfy mainly customer needs but the new standard seems set to expand on the range of stakeholders whose needs should be considered. One example of this is the need to address the requirements of shareholders/owners, management, employees and possibly even the public in some organisations will have to be explicitly considered.
While it could be that the organisation still maintains the customer is the primary or only focus, the broader range of interested parties must at least be considered for inclusion in the system in order to avoid a negative audit finding.
6.1 Actions to address risks and opportunities
A much more deliberate focus on risk in terms of terminology is reflected in this change of title above.
In order to comply with the requirements of 6.1, organisations will need to be:
• assuring the management system can achieve its intended outcome(s)
• preventing, or reducing, undesired effects
• achieving continual improvement
• actions to address these risks and opportunities
• how to integrate and implement the actions into its management system processes
• how to evaluate the effectiveness of these actions
Once implemented, it is hoped the new 2015 version will ensure a solid foundation for quality management over the next 25 years and beyond.