''Clause 0: Introduction''

* Can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development,and provision of related services.
* Question: does your organisation has related services?
* It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements
* Based on a process approach to quality management. Any activity that receives inputs and converts them to outputs can be considered as a proces

Clause 0: ISO13485 difference with ISO9001:2008
ISO13485 focus on
# Meeting customer requirements
# Maintenance of continuing (continuous) effectiveness of the Q system
# Regulatory, safety & effectiveness
ISO9001 focus on
# Customer satisfaction
# Continual improvement
## Format chapters ISO13485 follow ISO9001:2008
## Effectiveness is focus, not efficient!
## Differences with respect to ISO9001 in blue italic
bag
quality_public
created
Thu, 19 Mar 2015 19:20:28 GMT
creator
dirkjan
modified
Thu, 19 Mar 2015 19:31:45 GMT
modifier
dirkjan
tags
ISO13485:2003