Sometime after the release of ISO 9001:2000, a shortcoming of ISO 9001 auditing became clear: certifying body (CB) auditors were often using a standard-based approach to auditing. Auditors would arrive at an audit client’s worksite armed with a copy of ISO 9001 as a stage 2 audit checklist.  This appeared to allow inconsistent application of the requirements.

Since the 2000 standard only reputedly required six procedures, stage 1 document review consisted of reviewing an organization’s 6 procedures against requirements contained in the 6 ISO 9001 clauses calling for documented procedures. This same mind-set is a carry-over from the 1987/1994 idea of auditing.  Then, document review consisted of reviewing an organization’s 20 procedures against the 20 elements calling for documented procedures; stage 2 auditing consisted of assessing working practice against procedures responding to ISO 9001 requirements. Continue reading →