The International Standards ISO 9001 and ISO 13485 both define requirements for quality management systems, but one has a much broader user group than the other. ISO 9001 provides a quality management framework that can apply to organizations of any size or sector.

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ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

The objective of ISO 9001 is to provide a set of require - ments that, if effectively implemented, will give you confidence that your supplier can consistently provide products and services that : • Meet your needs and expectations • Comply with applicable regulations What is ISO 9001? ISO 9001 in the supply chain – 3

ISO 9001 est une norme de management de la qualité reconnue dans le monde entier. Elle aide les organismes de toutes tailles, quelle que soit le secteur, à améliorer leurs performances, à répondre aux attentes de leurs clients et à démontrer leur engagement en faveur de la qualité.

context in which they are used in ISO 9000:2015 and ISO 9001:2015. The aim of this document is to assist standards’ users, standards’ developers, and translators of the ISO 9000 family of standards by

ISO 9001 is one of the world’s most widely recognized quality management systems. It helps companies and organizations of all sizes and sectors streamline their core quality management processes, improve performance and demonstrate their commitment to quality.

What is a nonconformity? According to the definition in ISO 9000 a nonconformity is "non-fulfillment of a requirement". There are three parts to a well-documented nonconformity: • the audit evidence to support auditor findings; • a record of the requirement against which the nonconformity is detected; • the statement of nonconformity.

These three concepts together form an integral part of the ISO 9001:2015 standard. Risks that may impact on objectives and results must be addressed by the management system.

We are the ISO Technical Committee (TC) 176 Subcommittee (SC1) for Quality Systems. We are responsible for the development of ISO 9000 Concepts and Terminology, one of the most widely used International Standards in the world, in support of ISO 9001.