SO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations 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 organizations can certify.

ISO 9001 was first published in 1987 by the International Organization for Standardization (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.

The standard has been written using a new high-level structure found in all new management systems standards allowing for easy integration with other standards within an organisation’s management system.

The most significant change to ISO 9001:2015 is the Annex SL high-level structure. In addition, several terms have changed, including the use of “products and services” in place of “product”, a shift to “improvement” as opposed to “continual improvement” and “purchasing” and “outsourcing” will be replaced with “external provision of products and services”. The new standard also speaks about the identification and of needs and expectations concerning ‘interested parties’. There is a greater emphasis on the production of desired outputs and process management in general. Risk is another frequently discussed change within the new standard. What was once referred to as ‘preventative action’ has evolved to require organizations to employ risk-based thinking. Further to these changes, there is no longer a requirement for a quality manual, however, while documentation procedures will be less prescriptive, requirements for documentation of information will be more explicit.