Quality Management System
Quality is our Backbone
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.
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:
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 governing documents.
- Monitor and audit compliance to Everest governing documents and follow-up on all compliance 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/inspections, follow- up on audit/inspection findings until resolved.
- Perform vendor audits, follow-up on audit findings until resolved.
- Facilitate the identification and investigation of quality incidence(s) resulting in a Corrective and Preventive Action (CAPA). Plan and lead teams to perform CAPA process.
- Perform periodic review and assessment of the Everest Quality Management System.
Everest has successfully passed 130+ on-site and remote sponsors and regulatory agencies audits/inspections from the company’s inception in January 2004 to present.