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Quality Audits
DOC ID: 454


To ensure quality audits are planned and performed to verify whether quality activities and related results comply with the Quality System and to determine the effectiveness of the Quality System.


This procedure applies to internal audits of the Quality System and related procedures as well as audits of suppliers.


  • 3.0 Responsibility

    3.1 Management Representative

                The Management Representative is responsible for:

    developing the Internal Quality Audit Schedule;

    ensuring audits are carried out by personnel qualified and independent of the activities being audited;

    submitting results of Internal Audits during Management Review Meetings;

    3.2 Quality Engineer

    The Quality Engineer is responsible for:

    Initiating Internal Audit processes utilizing applicable checklists, ATP, QIP, MFG Plans, Specific Work Instructions and Process Forms,

    ensuring the Internal Audit Summary Report is completed;

    reporting findings, if applicable, by issuing an Internal Audit Finding Report to the responsible department;

    implementing follow up audits to verify the implementation and effectiveness of corrective actions taken,

    maintaining the Internal Audit Summary Reports and Internal Audit Finding Reports as quality records per PTD-4.2.4, Control of Records.

    3.3 All Employees

    All employees are responsible for taking timely corrective actions for deficiencies reported during the audits.

    3.3 Management Team

    The Management Team is responsible for reviewing the results of Internal Audits during Management Reviews and verification of any corrective action generated by those audits.

    4.0 References

    Section 4.17 of ISO-9001, 1994; Internal Quality Audits

    Section 4.17 of AS9100-2000 (Internal Quality Audits)

    Section 8 of ISO 9001:2001; Measurement, Analysis and Improvement


Audit Process
Internal Audit Summary Report
Internal Audit Finding Report
Internal Quality Audit Schedule


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