JIS Q 13485:1998Quality systems - Medical devices - Particular requirements for the application of JIS Z 9901
Abstract
This Standard specifies, in conjunction with JIS Z 9901, the quality system requirements for the design/development, production and, when relevant, installation and servicing of medical devices. This Standard, in conjunction with JIS Z 9901, is applicable when there is a need to a 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 Standard. The supplier may be required to exhibit these data but is not obliged to provide copies for retention.
Details
Status |
Superseded |
Pages |
11 |
Language |
English |
Supersedes |
|
Superseded By |
JIS Q 13485:2005 |
DocumentFormat |
PDF(Copy/Paste/Networkable) |
Published |
01-09-2002 |
History |
|
Note
We will send the latest version to you, please contact us if you want the exact document as the title. Some old Standards are in scancopy and no reaffirmed stamp
This product was added to our catalog on Saturday 10 March, 2018.