How Changes to ISO 9001 Will Affect Your Business


The ISO 9001 standard is due its next update, but how will these changes affect businesses?

What changes are being made to ISO 9001’s high-level structure?

While all ISO management systems have some related elements, standards are currently produced in a range of different structures, which can make it more difficult for businesses to become certified for multiple standards. As a result, ISO are working towards migrating all management system standards to an identical high-level structure, known as Annex SL. These standards will now be developed using this structure as a foundation, ensuring terminology and structure is consistent across all standards.

The new high-level structure will abide by the following outline:

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. Context of the Organisation
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance Evaluation
  10. Improvement

With all ISO management system standards following the Annex SL structure, the hope is that they’ll be much easier to read and interpret, making it easier for businesses to implement them. This is expected to be a good change for businesses, especially those looking to become certified for multiple standards.

What changes are being made to the individual clauses?

Of the ten clauses, seven of them will be seeing changes with regard to ISO 9001. Clause four is the first of these, since it’s a new clause that requires senior management to understand how internal and external challenges could affect their ability to meet the expectations of relevant parties. To achieve this, the clause has a focus on process management, requiring businesses to investigate risks with their processes, implementing measures to ensure effective operations and giving team members specific responsibilities over certain processes.

The main objective of this part of the document is to unite the quality management system with the business’ strategy, helping to align the two by bringing a better understanding of the way processes work to the boardroom. Clause five has been amended to reflect this, helping the company leadership ensure processes are in place to meet the strategic direction of the business.

Meanwhile, clause six has seen a big change, focusing on risk and opportunities for customer satisfaction and product conformity, replacing the need for preventive action. It also sets out changed requirements for businesses to manage change in a systematic way.

Next, clause seven focuses on improving customer satisfaction, with a new focus on developing knowledge within the business to meet customer needs.

Clause eight brings in two new operations requirements. Firstly, there is a new focus on outsourcing, ensuring all outsourced activity is given a consideration for risk management. The second change is designed to improve customer communication with greater contingency planning.

Finally, clause nine has seen amendments designed to monitor requirements in greater detail, while clause ten offers a more structured approach for internal audits.

How should your business respond to the newly published draft standard?

The best way to react to the release of this draft of the ISO 9001:2015 standard is to be aware of it, but not to make any non-trivial changes for the time being. The truth is, even though the draft standard is available, the actual details of the new standard can still change significantly prior to the final version. While it might seem logical to begin implementing certain aspects of the draft standard now to make it easier to become certified later, it’s best to remain cautious at this stage in case changes are made during the consultation period. Just remember that the draft standard is open for review and so can be changed based on feedback.

To find out more about the upgrade or to discuss your ISO 9001 requirements, please contact one of our experienced Certification Development Consultants at [email protected] or 0333 344 3646.

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About the author

  • Name:

    Michelle Whitehouse

  • Company:

    Brand and Content Marketing Manager

  • Bio:

    Michelle joined Citation ISO Certification in 2012. Having held several different roles across the business, she uses the insight and experience gained to shape and drive the brand and content marketing strategy. Managing a small team; she ensures that the customer is at the forefront of everything we do. Delivering event programmes and communication strategies that pack value into the overarching experience for both new and existing customers, Michelle is an innovative thinker that believes in offering services that add real value to people’s lives. With a background in sales, digital marketing, content strategy and marketing communications, Michelle takes an in-depth, hands-on approach to her role within the business and is passionate about developing the relationship that exists between the brand and customers through a combination of technology and communication.


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