ISO 9001:2015 has officially been released as of the 23rd of September 2015.
In this article we will focus on ISO 9001:2015 and the changes that are being introduced. We will provide some practical advice on what you need to consider as you start to prepare for your transition.
The new version of ISO 9001, although still focusing on ‘Quality’ and requirement to ensure customer satisfaction, is now far more aligned with the overall business strategy and the risk and opportunities that exist for an organisation. A large part of this risk-based approach is the requirement to understand both the context of the organisation, and the needs and expectations of interested parties.
There is now a far greater focus on leadership, and Top Management will now have to be demonstrably involved with the strategic alignment of both the management system and the organisational objectives and continual improvement. Although a management representative is no longer a specific requirement, you may find certification bodies will still require a nominated contact.
The focus is now on performance rather than procedures of the organisation. There are also some fundamental documentation related changes that reflect the ways in which businesses now record and document how they operate. For instance, they may utilise a CRM/ERP software system that provides the structure and controls required to perform actions. This can be demonstrated without the requirement of an additional documented procedure. There is also no requirement for a quality manual and the need for six mandatory procedures has been withdrawn.Instead, there is now a requirement for ‘Documented Information’.
What should I do to prepare for transition?
The transition process should be considered an opportunity for you to review and refresh your management system.
Often, elements are reviewed in isolation following either an internal audit or a non-conformance, but when was the last time you reviewed your management system holistically?
We would suggest that you undertake a ‘Gap Analysis’ of your current QMS against the requirements of the new Standard. At the same time, review your existing processes and procedures and see where they may have changed in reality over time. Any changes identified can be considered opportunities for improvement.
You will need to engage with the leaders of the business (as many of the proposed changes will impact on them) and help them understand those issues which they must manage and those they can delegate within the business.
Most likely, you will need to change your documented information to reflect the new structure of the Standard.
If you’ve had your system in place for a while, this might be the opportunity to re-launch it internally, garner some additional champions within the business or simply remind everyone of the business objectives and targets that you’re all working towards.
ISO 9001:2015 – Specific Changes
The following concepts have either been introduced (indicated as New) or have been revised in line with the language/ structure used in Annex SL:
Blackmores can help you with your ISO 9001:2015 transition, feel free to enquire either on our contacts page or by calling us on +44 01462 450591