Standard ISO 13485 is an industry-specific alternative to ISO 9001 and is also based on the overall picture of business processes. ISO 13485 also in conjuction with Directive 93/42/EEC European Rat specify die requirements for a Qualitymanagement-System (QMS) for a medical devices manufacturer. The focus of the standard is on the product’s safety.

For the manufacturer, who have already gained a certification according to ISO 9001, lends itself to the certification according to ISO 13485, since the both standards extensive consistent basid requirements.

Standard is divided in five main parts:

• Qualitymanagement – System
• Management requirements
• Resource requirements
• Product realization
• Measurement, analyse and improvement