ISO 9001 has been revised to ISO 9001:2015, act now to Implement the New Requirements.

The standard for ISO 9001 has now been revised and if you have been certified to the old ISO Quality Management System, then you will have up to September 2018 to get your revision in place. Call Quality Systems Consultancy today on 01889 881 887

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The revised ISO 9001:2015 standard has been out since September 2015 and is now the recognised standard for companies to attain, with a cut off date of September 2018 for pre registered companies who are holding the old ISO 9001:2008 standard.

So what are the key differences to the 2015 standard ?

ISO 9001:2015 is more compatible with other management systems, such as ISO 14001, making it more effective and efficient to integrate management systems.

There are changes to the ISO 9001 Quality Management System:

structure – which follows the ten section structure defined in Annex SL.
key concepts
terminology

Key Concepts of ISO 9001:2015

High level changes to all management system standards – The most significant changes expected in the 2015 standard are in Clauses 4, 5 and 6, i.e. Context of the organisation, Leadership and Planning, but there are many others throughout the standard.

Context of the Organisation

This is a new concept and relates to the external factors and conditions that could affect an organisation and it’s ability to provide products and services to customer requirements. Examples could include governance, regulation, sector, stakeholders and shareholders to name but a few.

Leadership

There are enhanced requirements for top management to demonstrate leadership and commitment directly with the Quality Management System (QMS). This means that auditors will be expected to spend more time with the senior / top management to ensure the business QMS is driven from top to bottom.

Planning

Is a new term introduced to the high level structure, with a requirement to address risks and opportunities and to carefully plan changes within the management system.

Tip: Risks and opportunities, for example, could relate to the use of electronic systems within the management system. Introducing such systems would require change and transition arrangements, which should be planned within the management system. Similarly what are the risks if the UK decided to leave the EU ?

Support

This new section builds upon the 2008 requirements for competence and awareness (now extended to include persons under the organisation’s control, not just employees) and communication.

Performance Evaluation

This section has similar requirements to the existing standard, but with a new emphasis on evaluation in addition to the monitoring, measuring and analysing requirements.

Conclusion

ISO 9001:2015 is expected to be much less rigid than previous versions, and to incorporate more business management terminology and concepts. Documentation requirements are much less prescriptive and left more to the organisation to judge its own needs.The standard is written for the benefit of organisations, not auditors. There are likely to be more challenges to auditors to understand and recognise the extent and type of evidence that would be acceptable to confirm compliance to the 2015 requirements.ISO 9001:2015 auditors will be engaging in dialogue with business leaders, seeking understanding and explanations from them about policy, strategy and quality objectives, and ensuring these are compatible.The audit experience from the client perspective is could be very different. Systems should be updated to benefit the user, not the author!

Further Reading on ISO 9001:2015

Reaping the benefits of ISO 9001 – <reaping_the_benefits_of_iso_9001.pdf>
The new ISO 9001 Quality Management System – <Why it’s better for your organization?>

Quality Systems Consultancy Ltd are ready to be your first contact to the road of implementing and successfully achieving ISO 9001:2015 accreditation.