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ISO 14001 Audit Services

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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:

  • General Requirements
  • Environmental Policy
  • Environmental Aspects
  • Legal and Other Requirements
  • Objectives, Targets and Programme(s), and
  • Emergency Preparedness and Response.

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.