Lernkarten
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
Differences between S1 and S2?
See picture
What are GLP PRINCIPLES?
Resources, facilities & equipment
Resources, fatalities & equipment
Rules, guidelines, procedures, protocols
Rules, guidelines, procecution, protocols
Archive
What are GLP PRINCIPLES?
Performance of study, study plan, conduct of study, final report
Performance of study, seat plan, conduct of study, final report
Computerized Systems
Computer-based System
Quality assurance, advice, audit, inspection, training
What are GLP PRINCIPLES?
Characterization test article, identification, quality test system, reference item
Characterization test article, identification, quantity test system, referral item
Documentation, SOP, raw data, final report, software, archives, retention of materials
Documentation, SOP, processed data, final report, software, archives, referral of materials
Personnel, qualified, special training, good scientific practice
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
