ISO 9001:2015 – What Changed and Why It Matters

16 March 2017  |  Note: This article has been updated to reflect that ISO 9001:2015 remains the current version as of 2026, with the next revision now expected in 2026–2027.

The International Organization for Standardization (ISO) reviews and revises the ISO 9001 standard periodically – typically every 6–8 years, though that pattern isn't fixed. It was first revised in 1994 and underwent a major revision in 2000. In 2008 another revision was published, though it included only minor changes. The latest revision, ISO 9001:2015, was published in September 2015 and remains the current version more than a decade later – a testament to how well it was designed.

The 2015 revision improved on the former standard in several ways. Vocabulary and structure changed as part of ISO's new "Annex SL" initiative, aligning its management systems standards to improve consistency and simplify the implementation of more than one standard. In practical terms, this means ISO 9001-certified companies now find it much easier to also implement the environmental management standard, ISO 14001. In terms of content, ISO 9001:2015 introduced several new and modified requirements, placing more focus on results and making it easier for companies to integrate the QMS with their existing business processes.

The following video is presented by Kevin McKinley, ISO's Acting Secretary‑General at the time, and answers numerous frequently asked questions about ISO 9001:2015 and how it improved on its predecessor. The new revision was a major undertaking – it involved input from 153 experts from 81 participating countries.

ISO 9001:2015

The most important changes introduced in ISO 9001:2015 were:

More emphasis on leadership
ISO 9001's coverage now further extends to senior management's understanding of its business environment (including social, cultural and regulatory) and its internal strengths and weaknesses. This results in the Quality Management System becoming more integrated into operational processes, quality policy and objectives fully aligned with corporate strategy, and top management more involved in ISO 9001.

New focus on risk management
The 2015 version of the standard introduced a new clause on risk management (clause 6.1 "Actions to address risks and opportunities") which built upon the ISO 9001:2008 section on preventive action. The combination of risk-based thinking and process approach refocused the standard on performance and results, and the Plan Do Check Act cycle is employed at all strata in the organization.

Clarifications on objectives, measurement and change
The requirements regarding quality objectives, measurement and change became more detailed. However, this mainly involved clarifications of requirements in the 2008 version rather than entirely new requirements.

More emphasis on communication and awareness
Two new clauses (7.3 "Awareness" and 7.4 "Communication") placed further emphasis on these areas.

Fewer prescriptive requirements
The new standard is less prescriptive than its predecessor and focuses more on performance and results. There are fewer explicit documentation requirements than in all previous versions – even "quality procedures" and a "quality manual" aren't mentioned. However, the standard contains numerous implicit documentation requirements which, for all practical purposes, mean that procedures covering most or all ISO 9001:2015 requirements should be established. Additionally, a so‑called "Management Representative" is no longer required (though in practice most companies continue to assign a member of staff to fulfill this role).

New high level structure
ISO 9001:2015 is based on Annex SL, the high-level framework for all management systems standards, which brought a common structure and common language to all standards. The advantage: it's now easier to integrate ISO 9001 with ISO 14001 and other ISO standards.

The structure introduced in 2015:

Clause 0: Introduction

Clause 1: Scope

Clause 2: Normative references

Clause 3: Terms and definitions

Clause 4: Context of the organization

Clause 5: Leadership

Clause 6: Planning

Clause 7: Support

Clause 8: Operation

Clause 9: Performance evaluation

Clause 10: Improvement

Why ISO 9001:2015 is better

There are several key reasons why ISO 9001:2015 was an improvement over its predecessor, some of which are highlighted in the infographic below. Possibly the most important changes are the standard's new Annex SL structure and its focus on risk-based thinking.

The most obvious change to the standard was its new structure – ISO 9001:2015 now uses the same overall structure as other ISO management system standards, making it easier for enterprises using multiple ISO management systems. Another significant improvement was the focus on risk‑based thinking. While the preventive action requirements of ISO 9001:2008 partially addressed this, the 2015 revision lent increased emphasis to the concept.

ISO 9001:2015

The world has changed, and the 9001:2015 revision is needed to reflect some of these changes

Kevin McKinley, Acting ISO Secretary‑General

When is the next revision due?

When this article was originally published, we anticipated the next revision around 2022–2023. That didn't happen – and in retrospect, it's become clear that ISO 9001:2015 has proven far more durable than anyone expected.

As of 2026, the next revision – expected to be designated ISO 9001:2026 – is in development. The technical committee responsible for the standard (ISO/TC 176) has released working drafts that indicate a stronger emphasis on leadership accountability, quality culture, ethics and integrity, and climate action considerations. Organizations that built a lean, well‑integrated QMS under the 2015 framework should find the transition relatively straightforward.

Our ISO 9001 recommendations page covers the implementation approaches and training options that will help you stay ahead of any upcoming changes.

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