ISO 9001 is the international standard that specifies requirements for a quality management system (QMS) and is used to ensure that products and services meet quality and customer requirements. It is the most practiced standard in the ISO 9000 series. The first version of ISO 9001 was published in 1987 by the International Organization for Standardization with the most current version being released in September 2015.
ISO 9001:2015 applies to all organizations to help with the standardization of their quality management system. More than one million organizations in over 160 countries have been certified to the ISO 9001 standard requirements. Using the standard helps organize processes, improve efficiencies, and continually improve processes in ways that maintain the quality of the product.
ISO 9001 gives an approach based on the plan-do-check-act methodology which helps achieve an effective quality management system within an organization. Specific sections covered in the standard include information on requirements for a QMS, responsibilities of management, management of resources, product realization, and measurement, analysis, and improvement of the QMS.
The most recent update to the standard was the second major revision and included an introduction of new terminology, a major update to the structuring of information so that it now follows the same overall structure as other ISO management standards, a greater emphasis on risk-based thinking, improved applicability for services, and increased leadership requirements.
An organization can become certified to ISO 9001 by implementing the requirements of ISO 9001:2015 and then completing a successful registrar’s audit. Many customers are beginning to require this certification from their suppliers. Having this certification shows that an organization follows the guidelines of the ISO 9001 standard, fulfills its own requirements, meets customer and quality requirements, and maintains accurate documentation of all products.
If you need support in developing an effective Quality Management System that aligns with the requirements of ISO 9001:2015 the experts at EMMA can help! Call us at 248-987-4497 or email us at info@emmainternational.com to learn more.
Resources:
[1] ASQ. (n.d.). What is ISO 9001:2015 – Quality Management Systems?. WHAT IS ISO 9001:2015 – QUALITY MANAGEMENT SYSTEMS? https://asq.org/quality-resources/iso-9001
[2] International Organization for Standardization. (n.d.). Moving from ISO 9001 2008 to ISO 9001:2015. https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100370.pdf
