ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organisations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organisations can certify.

ISO 9001 was first published in 1987 by the International Organisation for Standardisation (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.

Who Should Use the ISO 9001:2015 Revision?

ISO 9001:2015 applies to any organisation, regardless of size or industry. More than one million organisations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.

Organisations of all types and sizes find that using the ISO 9001 standard helps them:

  • Organise processes
  • Improve the efficiency of processes
  • Continually improve

All organisations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organisations that are certified to ISO 9001:2008, but also any organisations involved in training or certifying others.

As of September 14, 2018 organisations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard.

What topics does ISO 9001:2015 cover?

ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organisation. Specific sections of the standard contain information on many topics, such as:

  • Requirements for a QMS, including documented information, planning and determining process interactions
  • Responsibilities of management
  • Management of resources, including human resources and an organisation’s work environment
  • Product realisation, including the steps from design to delivery
  • Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action

Changes introduced in the 2015 ISO 9001 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organisations operate. Some key updates in ISO 9001:2015 include:

  • The introduction of new terminology
  • Restructuring some information
  • An emphasis on risk-based thinking to enhance the application of the process approach
  • Improved applicability for services
  • Increased leadership requirements