ABSTRACT
This chapter provides a detailed description of the 20 elements that make up ISO 9001:1994 together with the additional quality management requirements which are needed to comply fully with MDD.
The MDD specific quality management requirements are supplemental to ISO 9000:1994 and are fully detailed in ISO Standards EN ISO 46001:1996 and EN ISO 46002:1996 (for the application of ISO 9001 and ISO 9002 respectively).
