I.S. EN ISO 13485:2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
10-09-2018
English
01-01-2003
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
This International Standard 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.
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