Quality systems - Medical devices - Particular requirements for the application of ISO 9002

Document Number: ISO 13488:1996
File Size: 694 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $54.00
Product Details

This International Standard specifies, in conjunction with IS0 9002, the quality system requirements for the production and, when relevant, installation and servicing of medical devices.

  • This lnternational Standard, in conjunction with IS0 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.

It also includes information on:

  • Definitions
  • Quality system requirements
  • Management responsibility
  • Quality system
  • Design control
  • Document and data control

Who will benefit:

  • Organization
  • Quality system
  • Customers
  • Suppliers


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