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CAN/CSA-ISO 13488-98 (R2001)

Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9002 (Adopted ISO 13488:1996)

SKU: 2410880 Published by CSA Group Publication Year 1998 Reaffirmed in 2001 9 pages Withdrawn

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Preface/Scope

Scope

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 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.

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 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.

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CAN/CSA-ISO 13488-98 (R2001)

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