ISO 9001:2015 - published

The latest edition of ISO 9001 - Quality Management Systems standard, is published. For many years now, the internationally recognised standard ISO 9001 has provided the basis for efficient quality management in a large number of organisations. The current version was issued in 2008. However, for around two years now Technical Committee ISO/TC 176 was working on an amended version. We have summarised the expected modifications to the revised version of ISO 9001 as follows.

Changes at a glance

• ISO 9001 will remain the only cross-sector QM certification standard, and will provide a consistent basis for the coming ten years in its revised version.
• The aim of the revision is to take account of the growing complexity of the operating environment. Consideration of opportunities and risks is a new element. However, the most important objectives of ISO 9001, such as customer satisfaction and creation of compliant products and services, remain the same.
• The new High Level Structure creates greater harmony between the ISO management system standards, making it easier to extend existing systems into an integrated whole.
• The themes of user friendliness and market orientation are accorded more emphasis. This means that the standard focuses more strongly on the characteristics and needs of service companies and that documentation requirements are more flexible.
• The direct responsibility of organisations is emphasised much more strongly than before. The same applies to the process approach and theresponsibility of top management.

New structure, similar to other standards

ISO 9001:2015 has a new structure, the so-called High Level Structure. This is intended to provide the same binding structure for all the management system standards, and results in two very important benefits. Firstly, terms, definitions and structures can be used for all the standards and secondly, standards are easier to understand and synergies possible when different standards and certifications are combined.

In detail, this version indicates that the structure of the ten clauses are as follows:

1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organisation 5. Leadership 6. Planning for the quality management system 7. Support 8. Operation 9. Performance evaluation 10. Improvement

Greater focus on the process approach
The process approach is much stronger in the new version of ISO 9001 than in the previous version. Key Performance Indicators (KPIs) must be established and monitored for the defined processes. Required inputs and expected outputs must be specified for each process defined as necessary for the quality management system. 

More consideration of risks
The treatment of risks plays a more central role than is currently the case – among others in the clauses on “Leadership” and “Planning”. Although a specific risk management system as such is not demanded, organisations should be capable of identifying risks and taking them into consideration in an appropriate way. However,there is no specific requirement for preventive measures. Companies profit from this new way of seeing things, as they have the chance to recognise risks early on and take corresponding action.

Spotlight on service providers
The service sector continues to grow – and the new ISO 9001:2015 has taken account of this.

More stakeholders included
The new version of the standard also requires companies to consider the outside world in a wider sense. They will not only have to fulfil legal requirements and the expectations of customers, but will also need to engage with other interested parties. This means that the complexity of today’s working and social environment is taken into account, and also offers opportunities to achieve desired improvements and minimise risks.

Impact of changes on certification
Certification according to the amended standard ISO 9001 is now possible. There is a three-year transitional period. The changeover can take place after the certifiability of the organisation has been established and will generally be implemented during recertification.

Timeline for the new ISO 9001:2015

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