Published: 29 Apr 2021

Members of the International Organization for Standardization (ISO) Technical Committee 176, Sub-Committee 2 (TC176/SC2) have taken the surprising decision not to proceed with the much-anticipated update of ISO 9001:2015.

TC176/SC2 conducted a systematic review of ISO 9001:2015 “Quality management systems — Requirements”. By the narrowest of margins, they agreed that ISO 9001:2015 should be unchanged.

The committee proposes that:

  • It will examine if a revision of ISO 9001 should be started earlier than would usually be determined through the systematic review process
  • The Strategic Planning and Operations Task Group (SPOTG) should review the full portfolio of SC2 standards

A bit about ISO 9001

ISO 9001 is one of the most recognised standards in the world. According to the latest data, there are 878,664 valid certificates related to 1,180,654 sites across the globe.

ISO 9001 specifies requirements for a QMS when an organisation:

  • Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements
  • Aims to enhance customer satisfaction through the effective application of a QMS, including processes for improvement of the system, assurance of conformity to customer and applicable statutory and regulatory requirements

The standard is also the basis for numerous industry standards that define the requirements for management systems in sectors including automotive, aircraft, and medical device manufacturing. Tens of millions of people around the world are involved in the development and use of quality management systems based on the ISO 9001 standard.

ISO 9001 was first published in 1987. Like all ISO standards, it is subject to periodic review to ensure its continuing relevance and usefulness. ISO 9001 and has been revised four times since then, to address the challenges of changing economies, advances in technology and trends in society. The current version of ISO 9001 was published in 2015.

Reviewing the standard

In 2020, TC176/SC2 undertook a systematic review of ISO 9001:2015. It also conducted survey of ISO 9001 Users. The purpose of the survey was to gather the thoughts of ISO 9001 end users on the current version of the Standard and to secure their ideas as to what new material the next edition of the Standard should contain.

In addition to the systematic review, and results of the user survey, TC176/SC2 took into consideration:

  • A report on the Future Concepts and brand integrity
  • A report on the potential impacts of the revision of the Annex SL “High Level Structure” on ISO 9001

Outcomes

The review resulted in a majority vote to leave ISO 9001:2015 unchanged. This may mean that, following a further systematic review starting in 5 years, plus time for the review, and then allowing for 3 years of development time, a new edition of ISO 9001 may not be published until 2030.

Many users wish to see the standard revised to improve clarity and to give greater value to users. The business environment is changing so quickly, with factors being accelerated both by the Covid-19 pandemic and by the continued pace of digital transformation.

Consequently, it is proposed that a project should be started at the preliminary stage of the standard lifecycle, to examine if a revision of ISO 9001 should be started earlier than would usually be determined through the review process.

CQI’s response

CQI strongly believes that ISO 9001 must provide a framework on which organisations can base their system for managing quality, that is fit for a digitally transformed world, and delivers value to all stakeholders. If the revision of ISO 9001 is delayed, the standard risks becoming out-of-date with industry best practice and of diminishing value to all stakeholders. The CQI does not agree with the decision to confirm the standard and would support initiatives that attempt to bring the date of the next revision forward.

In preparing for revisions to ISO 9001, CQI will bring to the attention of TC176/SC2 four factors it considers critical to the future integrity of ISO 9001:

  • The CQI’s Quality Futures report on the Future of Work, discussing the effect of digital transformation on workforce, workflow, and workplace
  • The increasing prominence of Environmental, Social and Governance (ESG) factors
  • TC176/SC2’s work on Future Quality Concepts
  • The CQI’s research programme on Quality 4.0

The CQI will be consulting extensively to coordinate the expert knowledge and experience of its members and partners and will use this to feed into the development of the new edition of ISO 9001.