Dispositifs médicaux - Systèmes de management de la qualité - Lignes directrices pour l'application de l'ISO 13485: 2003

1.1 General

This Technical Report provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. This Technical Report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

NOTE The terms "should", "can" and "might" within this Technical Report are used as follows. "Should" is used to indicate that, amongst several possibilities to meet a requirement in ISO 13485, one is recommended as being particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required. "Can" and "might" are used to indicate possibilities or options. These terms do not indicate requirements. This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.