Open AccessISO 9002 certification – expectations of the sponsor's auditor
Author(s) -
Widler Beat
Publication year - 2002
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.162
Subject(s) - certification , audit , business , accounting , reliability (semiconductor) , management , economics , power (physics) , physics , quantum mechanics
The value of ISO standards or rather the reliability of their application by clinical laboratories and CROs must be questioned. Results from audits performed by auditors overseeing ISO certification and maintenance do not necessarily provide full confidence in the ISO certification process to sponsors. Based on our sponsor‐audits, we concluded that an ISO certification cannot substitute a systems' audit conducted by our own auditors against GCP and, where appropriate, GLP standards. Copyright © 2002 John Wiley & Sons, Ltd.