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Internal Audit - SOP
Internal Audit - SOP
Internal Audit - SOP
EEP/QMS/CORP/SOP/O4
Location: QMS Manager Issue No. 1
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Internal Quality Audit Title Page
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1.0 Purpose
The purpose of this procedure is to provide information on whether the QMS
a) Conforms to:
1) the company’s own requirements for the QMS;
2) the requirements of ISO:2015 standard;
b) is effectively implemented and maintained
2.0 Scope
This procedure covers planning, implementation and maintenance of the audit programme
including the frequency, methods, responsibilities, planning requirements and reporting.
4.0 References
3.1 ISO 9000:2015 QMS Fundamentals and vocabulary
3.2 ISO 9001:2015 QMS requirements
3.2 ISO 19011:2018 Guidelines for auditing management systems
ISO 9001:2015 QMS Doc. No. EEP/QMS/CORP/SOP/O4
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5.5 Responsibilities
The QMSM, Auditors and Managers are responsible for the implementation of the
procedure
5.6 Risks and opportunities
The risks and opportunities associated with the processes are documented in the
enterprise risk and opportunities’ register, EEP/QMS/CORP/QMSR/21/1
5.7 Improvement
a. Internal quality audits
b. Corrective actions
c. Audit closure
d. Management reviews
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6. METHOD/PROCEDURE
6.1 Audit planning
6.1.1 At the beginning of the year the QMSM will prepare an audit plan
6.1.2 The QMSM shall develop and distribute to the management and staff of all the audit areas an
IQA plan 14 days before the audits start based on the results of previous reports, as well as the
status and importance of the processes and areas.
6.1.3 The QMSM shall appoint auditors from a list of qualified auditors for the various audit areas 14
days before the expected audit date. In appointing the auditors, the QMSM shall ensure
objectivity and impartiality.
6.1.4 The lead auditor/auditor shall prepare an audit timetable and submit it to the auditee and / or
the auditees’ management at least three (3) working days before the start of the audits.
6.1.4 The auditors shall prepare for the desk and site audit by reviewing quality manual, corporate
and operating procedures, work instructions, records, quality objectives and other submitted
QMS documentation and prepare relevant audit questions using the audit checklists as in
appendix 8.2.
6.2 Conduction of audit
6.2.1 On the scheduled date/s the auditors shall carry out the audit as per the audit timetable. The
audit team shall hold an opening meeting with the auditees and the auditees’ management. The
agenda of the opening meeting shall be as per appendix 8.3. Attendance to the opening
meeting shall be recorded.
6.2.2 The auditors shall conduct a documentation/desk audit and determine conformity of the
documents with the requirements of ISO 9001:2015 standard as well as determine
effectiveness of the documentation.
6.2.3 The auditors shall then proceed to execute site audits by asking the audit questions as per the
checklist questions and subsequent follow up questions, interviews, inspections and make
observations. All audit findings shall be recorded in the audit findings form appendix 8.4. The
auditee shall sign against all audit observations as a confirmation of the finding.
6.2.4 After collecting all the audit observations, the auditors shall hold an auditors’ review meeting to
evaluate the audit evidence and come up with audit findings, which shall include observations,
opportunities for improvement and nonconformities (NC).
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6.2.5 Where NCs are identified with respect to the documentation and site audits, the auditors will
raise a CAR for each NC as per appendix 3 and submit to the auditee for signing as an
acceptance of the NC’s and undertaking of corrective action(s). The lead auditor shall agree
with the auditee on the follow-up date, which shall not be more than 30 days from the audit
date.
6.2.6 The auditors shall then hold a closing meeting with the auditee and the auditees’
management where the lead auditor shall explain the results of the IQA. The agenda for the
closing meeting shall as per appendix 8.5. Attendance to the closing meeting shall also be
recorded.
6.3 Reporting of audits
6.3.1 The lead auditor/auditor shall prepare a final audit report in the format given in appendix
8.6 and submit it to the QMSM within five working (5) days of the audit and submit copies to
the auditee and / or auditee’s management.
6.4. Follow up audits
6.4.1 The audit team shall undertake the follow-up audit on the agreed date, complete the CAR
form and leave the auditee and / or auditee’s management with a copy of the CAR form as
the lead auditor carries the original for the QMSM to file.
6.4.2 The lead auditor/Auditor shall prepare a final audit report, which will be given to the QMSM
and a copy to the auditee and or auditee’s management.
6.4.3 The auditee and / or the auditee's management shall then undertake timely and effective
corrections and corrective actions to ensure that the NC does not recur.
6.4.3 Evaluation for the effectiveness of the corrective actions will be carried out in the following
audit and results filled by the auditor in the audit findings form
6.5 Maintenance of records
6.5.1 The QMSM shall analyze all the reports, summarize them and prepare a management
report.
6.5.2 The QMSM shall maintain all the original reports of all the internal quality audit reports while
the auditee and /or the auditee’s management shall maintain copies of the reports within
the audit areas.
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Appoint Auditors
QMSM
Perform
documentation/desk
audit
Auditors review
3
meeting
NC No
identified?
1
YES
Raise CAR
Closing meeting
Complete CAR
form
2
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Are all
actions
taken?
Submit report to
MR
Maintain original
audit / CAR reports
1
End
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The summary should include positive statements about satisfactory performance, highlight any areas of
weakness, and reveal any non-compliance.
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Date Time Auditor Organisational and Functional Units/ Processes and Key Contact
Activities
0830 Auditor arrives
0845 ALL Opening meeting with Management
0900
1030
1130
1300 ALL LUNCH
1400
1500
1600 Review of outstanding issues
1630 ALL Closing meeting with organizations management
1700 End of audit
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