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AS ISO 13485-2003 PDF

AS ISO 13485-2003 PDF

Name:
AS ISO 13485-2003 PDF

Published Date:
01/01/2003

Status:
[ Superseded ]

Description:

Medical devices - Quality management systems - Requirements for regulatory purposes

Publisher:
Standards Australia

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$38.214
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Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. It is identical with and reproduced from ISO 13485:2003.
Edition : 2nd
File Size : 1 file , 1.1 MB
ISBN(s) : 0733757154
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 57
Product Code(s) : 10139590, 10139554, 10139568
Published : 01/01/2003

History

AS ISO 13485:2017
AS ISO 13485:2017
Published Date: 12/14/2017
Medical devices - Quality management systems - Requirements for regulatory processes
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AS ISO 13485-2003
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Medical devices - Quality management systems - Requirements for regulatory purposes
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AS ISO 13485-2002
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Quality systems - Medical devices - Particular requirements for the application of ISO 9001
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AS ISO 13488-2002
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