ISO 9001 audits to receive and maintain ISO certification.

Your ISO registrar will send a technician to conduct several on-site audits. Preparation for these visits is key.


Conformance Audits

At the outset of your ISO 9001 program, you'll choose a certification body (registrar), one that the American National Accreditation Board has certified for conformity assessment. This registrar will inform you of four external audits your company will be subject to:

  • ISO 9001 initial assessment audit.

    1.   Initial Assessment Audit

    The ISO auditor checks your quality manual and documented procedures to determine whether the QMS targets are attainable and measurable. All significant conformance gaps are noted for corrective action.
  • ISO 9001 registration audit.

    2.   Registration Audit

    Full onsite audit to verify that working practices follow documented procedures and that records are generated. This is a comprehensive audit and all requirements of ISO 9001 must be fulfilled to receive a certificate of conformance.
  • ISO 9001 surveillance audit.

    3.   Surveillance Audit

    A smaller scale audit once or twice yearly to assess for continued conformance. It will commonly emphasize management reviews, internal audits, records, corrective actions and changes to the QMS that may affect conformance.
  • ISO 9001 reassessment audit.

    4.   Reassessment Audit

    Another registration audit every three years. Procedures, records and onsite working practices will be reviewed to make sure you're committed to continuously improving the QMS (or, in the case of ISO 13485, maintaining its effectiveness).

ISO 9001 Tools

The following tools are designed for beginners to implement ISO 9001 on their own.

  • This guide offers high level instructions for becoming ISO 9001 certified. Request a free copy.
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