A medical device manufacturer with multiple facilities in Memphis, Tennessee and their environmental staff requested assistance in performing an annual elemental internal audit in accordance with the ISO14001:2004 standard.
Based upon the organizations audit procedure it was determined that a number of ISO elements would be reviewed for conformance during one day on-site. This audit consisted of a review of documents, records and interviews as they related to a number of the organization’s primary specification documents. The elemental audit consisted of an evaluation of conformance with Clause 4 of the ISO14001:2004 standard to include:
The audit protocol consisted of pre-planning prior to the site visit including discussions to focus the audit scope; an on-site review of records and documents; interviews with staff; a closeout meeting and the preparation of an audit report.