Quality Management System
Quality is our Backbone, and we are proud of our strength and achievements to provide high quality services to our clients.
- Everest is proud to be an ISO 9001:2015 certified company.
- Everest has a strong Quality Management System (QMS) consisting of the following 6 Major Components:
- Everest’s Quality Management System supports project teams to collaborate with pharmaceutical, biotechnology, and medical device companies in developing and commercializing their products with high quality and cost-effectiveness.
- We have become and continue to develop as a center of excellence in clinical research by maintaining our sound operating principles, quality and customer-focused approach, strong culture and values, benchmarking and continuous improvement, factual method to decision making, and a process- and system-approach to management.
- Clinical research services performed at Everest are governed by policies, controlled processes, and standard operating procedures that are compliant with laws, regulatory requirements, and industry standards.
- These governing documents form the foundation for Everest's success:
- Code of Conduct
- Quality Management System Manual
- Process Maps
- Standard Operating Procedures (SOPs)
- Working Instructions, including QC/QA Checklists
- Training Materials
- Everest believes that good practices and a process-driven approach are beneficial to achieving high quality, shorter timelines, lower costs, and consistent and predictable results.
Our Quality Assurance & Compliance Focus
- Our Quality Assurance and Compliance independent oversight is based on the requirements as specified in the Everest Quality Management System Manual and includes the following responsibilities:
- Control and maintain Everest's corporate governing documents.
- Monitor and audit adherence to policies, controlled processes, and standard operating procedures; follow up on all adherence issues through to resolution.
- Monitor and assess compliance to defined mandatory training requirements.
- Plan and perform internal audits, follow up on audit findings until resolved.
- Prepare for and coordinate client and regulatory agency audits, and follow up on audit findings through to resolution.
- Perform vendor audits, follow up on audit findings until resolved.
- Plan and lead teams to perform Corrective and Preventive Action (CAPA).
- Everest has successfully passed 60+ on-site and remote sponsors and regulatory agencies audits/inspections from the company’s inception in January 2004 to present.