Whether your business has a 50-year history or just opened last year, you need to make sure you have a system of sustained success. ISO Q9004: Quality Management Systems–Managing for the Sustained Success of an Organization “provides guidance to management for achieving sustained success of any organization in a complex, demanding, and ever-changing environment.” 

With organizations completing ISO 9001:2015 updating by the fall deadline, ISO 9004 readies to be reintroduced in an updated version. With these two updates in full swing, it appears an opportune moment to compare these quality management system (QMS) standards and offer insight into the ISO 9004 update.

ISO 9001:2015 vs. ISO 9004:2018

A common misconception is that ISO 9004 is a guideline for the implementation of ISO 9001. This is not the case. The standards have been designed to complement one another but serve different purposes. That said, it is important to note that an organization can use ISO 9001 and 9004 simultaneously or independently of one another. The International Organization for Standardization (ISO) website includes an excellent summary of the differences between the ISO 9001 and 9004 standards. Here is a list of some of the key components of each standard (found on https://www.iso.org/news/Ref2187.htm).

Purpose

ISO 9001 provides a framework for a systematic approach to managing an organization’s processes so that their products or services are consistent and meet client expectations. 

ISO 9004 is intended to help organizations extend the benefits of their quality management system (QMS) to all interested parties, helping to give sustained success.

Certification

ISO 9001 is a requirements document that an organization can be certified against to demonstrate conformance to its requirements.

ISO 9004 is not intended for certification. It is a guidance document on how to achieve continuous improvement. 

Focus

ISO 9001 is primarily a customer requirements standard, ensuring conformance to defined customer requirements and ensuring effective response to customer feedback.

ISO 9004 focuses on meeting the requirements of customers and all other interested parties to achieve sustained success.

Continual Improvement

In ISO 9001 continual improvement of the QMS is achieved mainly by performing management reviews, internal/external audits and corrective/preventive actions.

ISO 9004 promotes self-assessment in order for organizations to identify areas of strength or weakness and opportunities for either improvements or innovations, or both. 

How is ISO 9004:2018 different from ISO 9004:2009?

While ISO 9001:2015 was a major revision, incorporating risk management throughout the standard, it appears ISO 9004:2018 is closer to a maintenance revision. 

On the ISO website, Nigel Croft, chair of ISO/TC 176/SC 2, the technical subcommittee in charge of revising the standard, whose secretariat is held by BSI, ISO’s member for the U.K., is quoted as saying, “The new edition of ISO 9004 will build on, and improve the guidance of, the previous 2009 version and will help organizations improve their overall performance by releasing the full potential of their quality management system.”

Of significance to organizations is the inclusion of an enhanced self-assessment tool. The tool was designed to assist organizations in assessing the level of maturity of the various components of the QMS. After assessing their organizations, the quality improvement team can identify and prioritize potential areas for improvement. 

To learn more about ISO 9004:2018, visit iso.org.