Dirkjan: Created page with "'''Clause 0: Introduction''' * Can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, devel..."

2020-08-25T09:45:41Z

Created page with "'''Clause 0: Introduction''' * Can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, devel..."

New page

'''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
[[Category:quality]]

[[Category:ISO13485:2003]]

ISO13485 - Clause 0: Introduction - Revision history

Dirkjan: Created page with "'''Clause 0: Introduction''' * Can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, devel..."