ISO 9001: Evolution of QMS Standards

What is ISO 9001?

ISO 9001 is global standard for quality management systems (QMS) that guides manufacturers in ensuring their products meet customer expectations and regulatory requirements. The International Organization for Standardization (ISO) says “implementing ISO 9001 means your organization has put in place effective processes and trained staff to deliver flawless products or services time after time.

ISO 9001:1987

The first version of ISO 9001, published in 1987, was based on the British Standard BS 5750. ISO 9001:1987’s key principles included document control and process auditing in quality assurance (QA).

ISO 9001:1994

ISO 9001 was modified in 1994 to increase emphasis on customer satisfaction, continuous improvement, and management responsibilities. ISO 9001:1994 introduced the “process approach” concept.

ISO 9001:2000

ISO 9001 underwent a major revamp in 2000, with a more holistic approach to quality management that aligns with other systems. ISO 9001:2000 introduced the Plan-Do-Check-Act (PDCA) approach to risk-based thinking.

ISO 9001: 2008

In 2008, minor updates addressed inconsistencies and clarified requirements. ISO 9001:2008’s structure remained largely identical to ISO 9001:2000.

ISO 9001: 2015

In 2015, the most significant revision of ISO 9001 was released. ISO 9001:2015 adopted a high-level structure (HLS) to make integrations with peripheral systems easier. This update introduced the concept of organizational context.

The Next ISO 9001 Standard

The ISO caught the industry off guard in July 2023 when it announced it was beginning the revision process of the latest version, ISO 9001:2015. After ISO declined to change ISO 9001 in 2021, another revision was not expected until at least 2030.

ISO 9001:2026

Since the revision process takes about three years, the next edition will likely be ISO 9001: 2026, according to 9001Simplified.com. “Every revision of ISO 9001 incurs cost to certified companies – even if changes are minimal.” As of the December 2022, more than 1 million organizations are ISO 9001 certified.