scope:

Specifies, in conjunction with EN ISO 9002 the quality system requirements for the production and where relevant installation of medical devices. The field of application of EN ISO 9002 applies. In addition, this European standard, in conjunction with EN ISO 9002, 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 national regulations, the supplier may be required by the auditor to provide access to confidential data. However the supplier is not obliged to provide copies of these data for retention.