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From High Level Structure to Harmonised Approach

Published: September 02, 2021
Woman using whiteboard in a small team meeting

Have you ever noticed that most standards (whether newly-released or updated) are very similar in the way they are structured? This is not a coincidence – it’s due to ISO’s alignment with the High Level Structure, or HLS. The HLS ensures management systems standards are structured in the same way so that users who are familiar with one particular standard will feel comfortable with another, unfamiliar standard. 

Issued in 2012, the HLS, also known as Annex SL, provides a 10-clause structure for all management systems standards to follow. Clauses 1 to 3 are introductory and clauses 4 through 10 provide requirements for the management system, as follows:

  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

Prior to the release of the HLS, co-endorsed by the International Electrotechnical Commission, it was largely up to individual technical committees within ISO to determine the structure of their standards. We often saw that different standards would ask organisations to do the same thing in a different way (for example, ISO 9001:2008 required the procedure for document control to be documented, ISO 14001:2004 did not). The intent of the HLS is perhaps best described by ISO themselves:

The aim of this document is to enhance the consistency and alignment of ISO management system standards by providing a unifying and agreed upon high level structure, identical core text and common terms and core definitions. 

The consistency in approach to different disciplines enables greater ease of integration for organisations who wish to implement more than one ISO standard. A single, integrated system reduces duplication and significantly increases efficiency; it provides a clear, uniform image of the entire organisation, how each area impacts one another, and the associated risks.

Revision to the HLS

A review of Annex SL was undertaken in 2018 by different ISO committees and their constituents. They found that while there was no need for a major revision, there were a few points that could be improved upon. In response, a new taskforce of ISO’s Joint Technical Coordination Group (JTCG) conducted an update of the HLS. 

The taskforce applied a benefit/impact rationale to each update as to not to make changes for the sake of making change. In May 2021, ISO published the updated version of Annex SL as part of the ISO Supplement to Part 1 of the ISO/IEC Directives. It applies to all new and revised ISO management systems standards and focuses on a “harmonised approach”, resulting in fully-aligned management systems standards. The changes to HLS, now called the “Harmonised Structure” (HS), will not have an immediate impact on users as they are reasonably small and standards are not required to be updated due to the revision of Annex SL, nor within a specific timeframe. 

What are some of the main changes?


The scope of a management systems standard should outline the intended results of the management system specified in the standard. This provides the foundation upon which organisations can review the applicable threats and opportunities they need to manage or leverage in order to meet or exceed the goals of the management system. For auditors, these intended results are a vital reference in establishing the effectiveness of the management system. 

Terms and definitions 

The terms and definitions from Appendix 2 must now always be contained within each management system standard, and supplemented, if required, with the specific terms and definitions applicable to that standard. A clear understanding of the terminology within the standard is vital for a clear understanding of the standard as a whole. 

Removal of outsourcing 

“Outsourced” and “control of outsourced processes” will now be consistently referred to as “externally provided”. Clause 8 (Operation) now sets requirements for the externally provided processes, products and services that are relevant to the management system. 

Understanding the needs and expectations of interested parties

In the previous version of Annex SL, it was not clear how an organisation should deal with requirements of stakeholders beyond what is required by law. The new version now allows the organisation to decide which identified requirements of stakeholders and other interested parties will be addressed in the management system. 

Planning of change

ISO 9001’s clause 6.3 Planning of change has now been included to ensure consistency across all disciplines. It states that any changes to the management systems will be carried out in a pre-planned manner. 

Documented information

In the previous version of Annex SL, clauses that required documented information referred to it as either being “maintained” or “retained”. All references now state it needs to “be available”, rather than prescribing exactly how that should happen.


Clause 10 has been modified to clarify intent of improvement. The taskforce identified that the previous version placed too much emphasis on learning from mistakes by correcting nonconformities. Clause 10 now starts with a section on continual improvement.

In developing the HLS, ISO themselves did what they have been trying to get organisations to do for a long time – achieve consistency. Thanks to the HLS, each management system standard looks like it was developed and written by the same team. The new Annex SL has expanded upon this and provides organisations with the basic elements for a single, consistent, and robust management systems model. This consistent approach allows organisations to more easily understand and implement management systems standards for the benefit of the organisation to achieve their goals and improve their processes, products, and services.


Did you know that everyone who attends a Management Systems training course with RTP completes the ISO 9001 Quality module? If you’ve enrolled in Environmental Management Systems and/or OH&S Management Systems, you’ll also complete the Quality Management Systems module as part of your training. 

There are a couple of reasons for this. Firstly, quality should be at the heart of any business. ISO 9001 is relevant to most businesses, their products or their services. Secondly, when we cover the Quality content, we talk about the ISO Harmonised Approach that applies to the Environment ISO 14001 and OH&S ISO 45001 modules. 

For more information on the Harmonised Approach please visit:


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