scope:

Specifies, in conjunction with EN ISO 9001, the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices. The field of application of EN ISO 9001 applies. In adition, this European Standard, in conjunction with EN ISO 9001, is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements. As part of an assessment by a third party for the purpose of regulatory requirements, the supplier may be required to provide access to confidential data in order to demonstrate compliance with this standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.