''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
bag
quality_public
created
Thu, 19 Mar 2015 19:31:15 GMT
creator
dirkjan
modified
Thu, 19 Mar 2015 19:31:36 GMT
modifier
dirkjan
tags
13485
ISO