Professional Documents
Culture Documents
During an ISO audit, the auditor will be asking for records or evidence the quality
system being audited has effectively maintained the records required. For example,
when an auditor is reviewing the corrective and preventive action system, he or she
will be looking for a CAPA Report to provide evidence that the CAPA system has
met the requirements for section 8.52 Corrective Action and 8.5.3 Preventive Action.
The ISO 9001:2008 Quality Management System Standard has many references to
4.2.4 Control of Records. Everywhere ISO 9001 references 4.2.4, there must be a
record. Although the ISO 9001:2008 only requires six procedures the standard has
twenty one (21) references to Control of Records (4.2.4). Note: Section 7.6 of the
standard contains two references.