PRA International Achieves ISO 9001:2000 Registration for Global Management System

Strategic Insights -

PRA International, a leading global clinical research organization, has received ISO 9001:2000 registration for its integrated management system, following a comprehensive audit by Bureau Veritas Quality International (BVQi). This achievement confirms the company's commitment to quality and acknowledges its customer-first focus. The registration includes all business and support activities within PRA, such as clinical trials, information technology, quality assurance, business development, human resources, and finance. The ISO 9001:2000 standard is recognized globally as the guideline for establishing and maintaining an effective quality program.

Key Takeaways:

  • PRA International has achieved ISO 9001:2000 registration for its global, integrated management system, signifying a commitment to quality and customer satisfaction.
  • The scope of the registration includes all business and support segments within PRA, such as clinical trials, information technology, quality assurance, business development, human resources, and finance.
  • The registration demonstrates PRA's ability to consistently provide products or services that meet customer and regulatory requirements.
  • PRA's achievement is a result of a comprehensive audit by BVQi, which thoroughly examined the company's business processes, data, and records.
  • Dr. Pat Donnelly, PRA President and Chief Executive Officer, stated, "I am very proud of PRA International and our achievement of this important milestone."
  • Don E. Hall, Lead Auditor at BVQi, commended PRA for its professionalism and consistency across all offices worldwide.
  • PRA International is one of the world's leading clinical development organizations, with over 2,500 employees working from offices globally.
  • PRA delivers services to clients through a unique approach called Project Assurance(SM), which represents the company's commitment to reliable service delivery, program-level therapeutic expertise, and global access to knowledge.

Statistics:

  • 52,000 companies worldwide have been certified by BVQi (NA).
  • ISO 9001:2000 is the latest international standard for Quality Management Systems set forth by the International Organization for Standardization (ISO).
  • The BVQi audit team examined the company's business processes, data, and records, and interviewed employees at over 200 locations worldwide.
  • PRA International has over 2,500 employees working from offices in North America, Europe, South America, Africa, Australia, and Asia.

Sources:

  • Bureau Veritas Quality International (BVQi)
  • International Organization for Standardization (ISO)
  • PRA International website: http://www.prainternational.com