🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
CAN/CSA-ISO 13488-98 (R2001):1998 Edition

CAN/CSA-ISO 13488-98 (R2001):1998 Edition

$17.55

Quality Systems – Medical Devices – Particular Requirements for the Application of ISO 9002

Published By Publication Date Number of Pages
CSA 1998 21
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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 suppliers 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.

Related products

CAN/CSA-ISO 13488-98 (R2001)
$17.55