Dirkjan: Created page with "'''Clause 1 Scope''' 1.1 General * Demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory require..."

2020-08-25T09:45:42Z

Created page with "'''Clause 1 Scope''' 1.1 General * Demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory require..."

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'''Clause 1 Scope'''

1.1 General
* 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.
1.2 Application
* Possible exclusion of clause 7.3 (design & development)
* Possible non applicable of parts of clause 7
* Both must be justified in quality manual
* Examples: 7.5.1.2.1 (cleanliness), 7.5.1.3 & 7.5.2.2 (sterile); 7.5.3.2.2 (implant)
* Question: what about section 8.2.4.2 (implant)?

“Appropriate” Term
[[Category:quality]]

[[Category:13485]]

[[Category:ISO]]

ISO13485 - Clause 1 Scope - Revision history

Dirkjan: Created page with "'''Clause 1 Scope''' 1.1 General * Demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory require..."