This International Standard specifies, in conjunction with ISO 9001, the quality system requirements for the design /development, production and, when relevant, installation and servicing of medical devices.
This International Standard, in conjunction with ISO 9001, is applicable when there is a need to assess a medical device supplier's quality system.
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 International Standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.
In this International Standard the term if appropriate is used several times. When a requirement is qualified by this phrase, it is deemed to be appropriate unless the supplier can document a justification otherwise. A requirement is considered appropriate if its non-implementation could result in
- the product not meeting its specified requirements, and/or
- the supplier being unable to carry out corrective action.