Quality management comprises improvement measures on a product or process with a focus on fulfilling customer requirements. A quality management system is therefore geared towards customer satisfaction. Quality management is therefore one of the benchmarks by which customers make their purchasing decisions. It is also a factor that interacts intensively with the competitive situation and performance of a provider.

Quality is derived from the Latin word "qualis", meaning "like". The term, which usually has a positive connotation, is therefore in principle value-neutral. According to the quality management standard ISO 9001, quality is the degree of fulfillment of given requirements. In QM reality, these requirements are usually set by the customer. Quality management is not an "either/or" concept. It is therefore not possible to attribute the presence or absence of quality to a unit. Rather, all characteristics between "very good" and "very poor" are possible. Therefore, there is no absolute quality, but it represents the degree and extent to which the result of an activity is adapted to the given requirements. This page provides you with an introduction and overview of the topic and tells you more about the core of the standard and the benefits of quality management. You will also find out which roles, for example that of the quality officer, are important for implementation.

The ISO 13485 standard "Medical devices: Quality management systems - Requirements for regulatory purposes" addresses the requirements that manufacturers and suppliers of medical devices must fulfill when developing, implementing and maintaining management systems for the medical device industry. Originally developed in the 1990s, the standard contains requirements for quality management systems that meet customer requirements as well as the regulatory requirements of the European Union (EU), Canada and other important markets worldwide.ISO 13485 is similar to ISO 9001 in its scope and purpose, but contains additional requirements specific to medical devices and reformulates some of the requirements of ISO 9001. In most markets, certification to ISO 9001 is therefore not an adequate substitute for certification to the requirements of ISO 13485.