International Organization for Standardization

Quality Systems - Medical Devices - Particular Requirements for the Application of  9002 - First Edition
 N 13488

Annotation

This International Standard specifies, in conjunction with ISO 9002, the quality System requirements for the production and, when relevant, installation and servicing of medical devices.

This International Standard, in conjunction with ISO 9002, is applicable when there is a need to assess a medical device supplier’s quality system.

As patt 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.

NOTE – 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 tan 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.

Автоматический перевод:

Систем качества - медицинские приборы - особые требования по применению ИСО 9002 - первое издание

Этот Международный Стандарт определяет, совместно с ISO 9002, требования к системе качества производства и, если применимо, монтаже и обслуживании медицинских изделий.