Quality

Standards : often applied to a process to ensure it meets a specific level of requirement.

• ISO9001 - set of quality requirements for an organisation that delivers a product to a defined quality (customer satisfaction)

• ISO13485 - a specialised version of ISO9001 for the medical sector

• ISO14971 - risk management standard for medical sector

• GMP - US FDA Good Manufacturing Practice

• GCP - US FDA Good Clinical Practice

• 21CFR11 - US

• FDA 820 -

• CE Marking and EU Directives

Tools and Techniques:

• PDCA - Plan, Do , Check, Act