NewswireToday - /newswire/ -
Emmaus, PA, United States, 2010/06/08 - Copernicus Group IRB (CGIRB) announced that it has received ISO 9001:2008 Certification, affirming that the company’s quality management system meets the strict qualifications for the globally accepted ISO standard.
The ISO 9001:2008 standard outlines requirements and provides guidance on good quality management systems for businesses and other organizations. Achieving ISO 9001:2008 certification demonstrates that CGIRB’s quality management system consistently provides products and services that meet customer needs.
As an independent institutional review board (IRB), CGIRB is dedicated to ensuring the rights and welfare of research study participants. ISO 9001 Certification is just one example of the quality assurance process that goes into maintaining this top-tier independent institutional review board. A state-of-the-art web portal and a paperless operational workflow that meets all 21 CFR Part 11 compliance requirements are part of CGIRB’s tireless efforts on behalf of human research study participants.
“To our knowledge, CGIRB is the only central IRB that has achieved this certification. It is further evidence to our clients and the subjects of research studies that the quality of our services and our strong business practices are unsurpassed, and will always remain at a high level,” said Bruce Tomason, CEO of CGIRB. “CGIRB maintains very high standards and this certification along with our AAHRPP accreditation demonstrates our continued and unwavering, commitment to quality in everything we do.”
Copernicus Group IRB (copernicusgroup.com), established in July 1996, is a leading independent institutional review board ("IRB") dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004.
About ISO 9001
The ISO 9001:2008 standard contains the quality management system framework, specifying requirements for quality management systems that apply regardless of what an organization does. The standard evaluates various activities for a company’s quality management system, including product development, testing and performance reviews, process audits, documentation of problems and corrective actions taken to prevent future occurrences, how a company or organization continues to improve its management practices over time, executive review, and, most importantly, customer feedback and satisfaction. The ISO 9001:2008 standard is governed by the International Organization for Standardization, the internationally-recognized developer and publisher of international standards, and is administered by various accreditation and certification bodies.
AAHRPP (aahrpp.org) is a non-profit organization that works with organizations that conduct human research to raise the level of protection for research participants. Available to organizations worldwide that conduct biomedical, behavioral or social sciences research involving human participants, the accreditation program utilizes a voluntary, peer-driven educational model.
Organizations must demonstrate that they have built extensive safeguards into every level of their research operation and that they adhere to the high ethical standards.