ISO13485 - Clause 0: Introduction

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

1. Meeting customer requirements
2. Maintenance of continuing (continuous) effectiveness of the Q system
3. Regulatory, safety & effectiveness

ISO9001 focus on

1. Customer satisfaction
2. Continual improvement
   1. Format chapters ISO13485 follow ISO9001:2008
   2. Effectiveness is focus, not efficient!
   3. Differences with respect to ISO9001 in blue italic