This procedure defines the various steps taken to plan, audit, and report internal audits of the Quality Management System at XXX. In addition, it also includes the provision for conducting follow up audits to verify effective closure of non-conformances raised during the internal audit(s)
The purpose of this procedure is to ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.
3. REFERENCE DOCUMENTS
3.1 XXX Quality Manual,
3.2 ISO 9001:2015 standard
3.3 ISO 19011:2018 standard
4. TERMS & DEFINITIONS
MR- Management Representative
NC- Non-conformity ie non-fulfilment of a requirement
SOP- Standard Operating System
5. RESPONSIBILITY AND AUTHORITY
5.1 Management Representative
5.2 Internal Quality Auditors
6. DETAILS OF PROCEDURE
6.1 Audit Planning
6.1.1 Internal Audits of the QMS are planned and controlled by the Management Representative. The MR maintains an Annual Audit Plan. The audits are planned in such a way that the entire scope of the QMS is covered at least once every 6 months. The audit plan and schedule developed takes into consideration the results of XXX activities, the importance of the company’s operation(s) concerned as well as the results of previous audits.
6.1.2 Internal audits are carried out by trained & certified auditors. A list of trained & certified auditors is available with the MR. Audits are planned as such that auditors do not audit their own work. Selection of auditors and conduct of audits shall ensure objectivity and the impartiality of the audit process. The audit schedule is communicated to all concerned in the format defined.
6.1.3 The MR ensures that the Internal audits are based on the documented QMS that includes Policy, Objectives, Manual, System Procedures, and Other applicable Documents and Records.
6.1.4 The auditors may prepare appropriate checklists to be used as aides- memoir while conducting the audit. ISO 9001:2015 standard shall also be referred by Auditor while preparing the Audit Checklist.
6.2 Auditing and Reporting
6.2.1 Internal audits are carried out through a process of review of documents, records, observing the activities, and interviews with people within the area being audited. The focus is on compliance, effectiveness as well as adequacy of the system.
6.2.2 On completion of the audit, the auditor will discuss his/her findings with the auditee and agree on the identified non-conformances and observations.
6.3.3 The MR will prepare the final Internal Audit Report and obtain the signature from
6.3.4 The Auditor will record the Non-conformance in the Corrective Action Request for necessary correction and corrective action. The MR will review the corrective action-filled by Auditee and discuss the corrective action with the department manager & auditor.
The report also has a provision for recording the root cause analysis as applicable considering the impact of the detected non-conformance and the corrective action plan including the target date of completion, which the Auditee will record.
6.2.5 The auditor then submits the correction, corrective action requests to the MR who records the same in the Corrective Action Tracker such that he/ she can track the open non-conformances for earliest closure.
6.2.6 The MR reviews the Corrective Action Tracker monthly and requests the respective auditor to verify effective closure of non-conformances through a follow-up audit.
6.3 Follow up Audits
6.3.1 The respective internal auditors shall conduct a follow-up audit to verify the effective closure of the non-conformance and based on the facts verified and record their comments on the Corrective Action Request. The report is submitted back to the MR.
6.3.2 MR updates the status of the non-conformance in the Corrective Action Tracker as open or closed. MR uses this tracker to generate a report on internal audits for the Management Review.
6.3.2 After every internal audit cycle, the MR reviews the reports and, if required, holds a debrief session for the auditors to provide feedback and tips on improving the audit process. This audit procedure is reviewed for its effectiveness, and revised if required.
7. RETAINED DOCUMENTED INFORMATION
7.1 List of Trained & Certified Auditors (QMS F002)
7.2 Audit Plan (QMS F003)
7.3 Audit Schedule (QMS F004)
7.4 Corrective action request (QMS F001)
7.5 Corrective Action Tracker (QMS F005)
7.6 List of Trained & Certified Auditors (QMS F006)
7.7 Internal Audit Report (QMS F007)
7.8 Internal Audit Schedule (QMS F008)
7.9 Internal Audit checklist (QMS F009)