Internal Auditor By: Neal Stiemert Internal Auditing One of the requirements of the ISO 9001:2000 standard is that you have an internal auditing process in place. As an auditor, I write a large number of audit findings against the internal auditing process and the related process of corrective action. Typical audit findings are: Audits not done in accordance with an audit schedule Audits not done when scheduled Audit findings did not receive corrective action Auitors not qualified Auditing process not effective (an automatic major nonconformance) ISO Requirement: (Key requirements are italicized) 8.2.2 Internal Audit The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and b) is effectively implemented and maintained. An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results. Section from a typical quality manual 8.2 Monitoring and Measurement Internal Audit Acme conducts internal audits at planned intervals to determine whether the quality management system: conforms to the requirements of ISO 9001:2000 and the Acme organization is effectively implemented and maintained. Acme plans the audit program, taking into consideration the status and importance of the activities and areas to be audited as well as the results of previous audits. The audit scope, frequency and methodologies are defined. Auditors shall not audit their own work. A documented procedure includes the responsibilities and requirements for conducting audits, ensuring auditor independence, objectivity and impartiality. Results of internal audits are recorded and reported to management. Management takes timely corrective action, without undue delay on deficiencies found during the audit. Follow-up actions shall include the verification of the actions taken and the reporting of the verification results. Sample Procedure Acme Operating Procedure Title: Internal Quality Audits No. 5.11         Rev. 0 Approved By:       Larry Acme                           Date:     6-02-03       SCOPE: This procedure applies to internal quality audits of the Acme documented quality system. 1.0 SELECT AREA TO AUDIT Area selection shall be based on: areas not previously audited areas scheduled for audit areas selected for audit by Acme management 2.0 NOTIFY AREA MANAGER AND AUDITORS The Q.A. Coordinator selects and notifies the auditors and also notifies the manager responsible for the area being audited. Auditors and the area manager are notified by the Q.A. Coordinator who assigns an audit control an audit control number from the internal audit log and assigns auditors. Auditor selection is based on auditor availability and knowledge of the process being audited, one audit will be assigned as lead auditor. No person shall audit work where they have direct responsibility. 3.0 CONFIRM AUDIT DATE The area manager responsible for the area being audited schedules a specific audit date and confirms the date with the Q.A. Coordinator. The confirmed audit date is entered into the internal audit log by the Q.A. Coordinator. The auditors are notified of the confirmed audit date by the Q.A. Coordinator. 4.0 PREPARE WORKING DOCUMENTS The lead auditor and members of the audit team make up an internal audit checklist and/or note audit questions on a copy of the procedure which is being audited. The lead auditor shall review any previous audit reports, findings and corrective actions issued during the last audit of the procedure being audited. Internal quality audits shall verify compliance to and the effectiveness of the Acme documented quality system. 5.0 CONDUCT AUDIT The audit team conducts the audit against Acme procedures and/or audit checklists. 6.0 POST AUDIT MEETING The audit team discusses the audit results and determines if there are any audit findings or concerns. An audit report is prepared by the lead auditor that summarizes the audit. Any findings issued are recorded on an internal audit finding form, concerns are noted in the audit report. Audit findings shall be based on objective evidence (facts) observed during the audit. Objective evidence is defined as follows: Information, records, or statements of fact pertaining to the quality of an item or service which is based on observation, measurement, or testing which can be verified. Findings are defined as follows: The non-fulfillment of specified requirements (findings require written corrective action). Concerns are defined as follows: A minor nonconformance that may result in a finding at a later date if not corrected (concerns do not require written corrective action). 7.0 CLOSING MEETING The lead auditor presents the audit results to the area manager and any other appropriate personnel at a closing meeting after completion of the audit. Any findings or concerns issued are discussed during the closing meeting and any unclear issues are resolved. The responsible are manager acknowledges the audit report by signing it after it is reviewed with the audit team. 8.0 FILE AUDIT REPORT The original of the audit report is retained by the Q.A. Coordinator and copy of the report and findings are given to the appropriate area manager by the Q.A. Coordinator. Appropriate entries are made in the internal audit log by the Q.A. Coordinator. 9.0 CORRECTIVE ACTION If any audit findings are issued, corrective action is performed by the area manager of a designee to deficiencies receiving audit findings. Corrective action shall be performed in accordance with the Acme corrective and preventive action procedure. 10.0 AUDIT COMPLETION After completion of corrective action, the responsible area manager notifies the Q.A. Coordinator who reviews the corrective action taken. After the Q.A. Coordinator determines that the corrective action is adequate, complete, and contains sufficient effectiveness verification, the corrective action is completed. Notes: Audits report and audit findings are filed as quality records. Internal audit results are submitted for management review. Preventive actions may be initiated as a result of internal audits. Internal auditors shall be Acme personnel or contractors qualified with a minimum of two days of documented auditor training. End of Document Summary As always, the existence of your company is dependent on your ability to deliver quality products and services that get to your customer on time. How well you plan and control your processes are vital if you are to provide quality. The purpose of internal audits is to verify that our processes assure quality and that our documentation and training are current and being followed. Here are copies of the Purchasing sample documents in PDF format:   Sample Internal Audit Section in a Quality Manual   Sample Internal Quality Audit Operating Procedure I hope this information helps you with your transition. Feel free to contact me with any questions at 800-959-0632. Neal Stiemert President Independent Quality Consultants, Inc. About the Author Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science degree from Indiana University school of business. Neal is an ASQ Certified Quality Engineer, a certified lead auditor and has over 24 years of management, auditing, consulting and training experience in the quality profession. Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at Purdue University and an officer and committee member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance Services. Comment on this article