CEN/CLC/WG QS - CEN/CENELEC Coordinating working group on quality supplements

This European Standard specifies, in conjunction with EN ISO 9003 : 1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements.  NOTE: For sterile medical devices the relevant particular clauses inEN 46002 : 1996 apply as this standard alone is not sufficient for manufacturers of sterile medical devices seeking to comply 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.

This European Standard 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 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.

This European Standard 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 addition, 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.