Article on Vocabulary and Definitions Added To the Ombu Web Site

The article explains how to clarify definitions and terms. It starts with an understanding of the specific vocabulary in a standard such as ISO 13485:2003. This standard applies to medical devices and includes some specific terms from that file. In addition, it also incorporates, by reference, technical terms in ISO 9000:2005.

The article explains the role of ISO 9000:2005 and explains how it organizes terms and provides diagrams that help improve understanding.

In addition, the article explains the role of an ISO guidance document that provides definitions of common terms used in the family of standards.

The article uses an example, from the requirements for customer supplied property, that illustrates using the various terms to help satisfy the requirement in a QMS