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European quality systems
- Staff and management training on the
requirements of ISO 13485:2003
- Conducting internal audit and design
effective corrective action plans
- Assisting in the implementation of corrective
audit plans
- Implementation of Risk Management Procedure
in accordance with ISO 14971
- Development of an effective corrective and
preventive action systems (CAPA system)
US quality systems
- Staff and management training to the
requirements of quality system regulations (QSR)
- Development of an effective Corrective
Actions and Preventive Action systems (CAPA system)
- Implementation of an effective Hazard
Analysis and Critical Control Points (HACCP) program
- Process validation, including facility master
plans and assistance in the development of procedures, protocols and
reports, In process-controls and sampling, Failure investigation
Supplier Assessments
- Established a documented supplier evaluation
and surveillance system
- Conducting audits of suppliers of products
and services as part of the FDA and European quality systems requirements
- Assist suppliers in meeting quality
requirements
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