Differentiate the major characteristics of the standards ISO 9001 and ISO 13485.
ISO 9001:2015
> Stand-alone standard
> General requirements for a QM system
> Generically applicable
> Risk based thinking for planning and realization of processes of the QM system
ISO 13485:2016
> Stand-alone standard, but based on ISO 9001 regarding general QM criteria
> Specific requirements of the QM systems for medical devices sector
> Only applicable in the sector of medical devices
> Application of risk management for the safety and performance of medical devices and with regard to the fulfillment of regulatory requirements
Summarize major content of documentation as needed for EN ISO 13485
- Document controls
- Quality policy & manuals
- Standard operating procedures
- Work instructions
- Forms
What are GLP PRINCIPLES?
What are GLP PRINCIPLES?
What are GLP PRINCIPLES?
Name three Good Practice QMS and order them in occurrence in a project.
1. Good laboratory practice (GLP) for early stages of drug development
2. Pre-clinical studies
3. Good manufacturing practice (GMP) for the manufacturing of clinicla product throughout the drug production
4. Good clinical practice (GCP) for/during the clinical studies/trials