@ AGF Consulting Group For training purposes only

AGF Consulting Group

Internal Quality Audit

Draft Version

Instructions

I. INTERNAL AUDIT INSTRUCTIONS

1. The Internal Lead Auditor shall prepare the Annual Internal Audit Plan (FM-RAI-04)
before the start of the fiscal year. The frequency of the audit for each area shall be
based on its performance on previous audits as well as on the criGcality of the
operaGons being performed.

2. Regular Internal Audit is to be conducted at least once a year covering the whole
quality management system with the objecGve to assess the organizaGon’s
conformance to the requirements of ISO 9001 Standard, to assess the effecGveness
of the implementaGon of planned management system, and to idenGfy areas for
improvement. Special audit may be conducted at any Gme upon the request of Top
Management, due to exisGng problem or nonconformance. While regular internal
audit is scheduled in the annual internal audit plan (FM-RAI-04), special audit may
be conducted as needed.

3. The lead auditor shall organize an audit team to be assigned for each schedule and
shall ensure that auditors will undergo necessary training needed before
conducGng the audit.
Selected auditors shall have the following minimum qualificaGons and
competence:
• At least graduate of secondary level
• Familiar with the organizaGon’s operaGons
• Undergone the ISO 19011: 2018 Internal Audit Training Course and ISO 9001
Standard Requirements (w/ CerGficate)

4. The lead auditor shall then generate Audit IGnerary (FM-RAI-05) for the specific
schedules of audit based on the Annual Internal Audit Plan (FM-RAI-04). IGnerary
should be published or communicated throughout the organizaGon at least one
week prior to the actual audit schedule.

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5. Audit Checklist (FM-RAI-06) shall be prepared by the auditors to serve as a guide

during the actual audit. The checklist generally contains requirements of the ISO
9001 standard, requirements of the documented Quality Management System
procedure and the findings from previous audits.

6. Internal auditors should conduct a desk audit on the current documented

procedures as well as the results of the previous audits before proceeding with the
actual audit.

7. Conduct an opening meeGng to introduce the audit team members and briefly
reviews audit criteria, scope, methods, objecGves and audit acGviGes to the
auditees, and to discuss any last-minute changes in the audit iGnerary. Reflect the
discussions using the Minutes of the MeeGng (FM-RAI-01).

8. Based on the audit iGnerary (FM-RAI-05) and the audit checklist (FM-RAI-06) the
auditor shall conduct the audit on the specific areas.

9. Conduct a wrap-up meeGng to discuss or explain the possible audit findings and
clarify unclear items for each audit area to the auditee at the end of the audit.
These audit findings shall later be classified as either a minor/major
nonconformance or observaGon aaer the deliberaGon of the enGre audit team.

10. Classify audit findings as:

• Nonconformance:
- non-fulfillment of a specified requirement

• Major Nonconformance:
- The absence or the total breakdown of a system to meet the
requirements of a clause of ISO 9001 or other reference documents.
- A number of minor nonconformiGes listed against one clause can
represent total breakdown of a system and thus be considered a major
nonconformity.
- a breach of the regulatory requirements.

• Minor Nonconformance:
- An isolated failure either to meet one requirement of a clause of ISO
9001 or other reference documents.
- A single observed lapse in following one item of an OrganizaGon
Procedure.
- General ObservaGon
- Minor lapses/discrepancies against established supporGng documents
such as guidelines, work instrucGons, etc.

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- Findings that could lead into a nonconformance if not addressed

(potenGal nonconformance)
- Non-fulfillment of other management systems standards or
requirements that are not in the audit criteria
- Other areas of concern

• Opportuni?es for Improvement

- these are recommendaGons or suggesGons for acGons to improve the
management system.

11. Auditors shall prepare CorrecGve AcGon Report (FM-RAI-09) for all the
nonconformances found during the audit. General ObservaGons and OFI List (FM-
RAI-10) shall also be presented and given to the auditees/concerned groups during
the closing meeGng.

12. Auditees shall formulate or generate correcGon(s) to eliminate the detected

nonconformity and correcGve acGon(s) to eliminate the cause of the detected
nonconformity or other desirable situaGon or prevenGve acGons for the issued
findings. Refer to Handling Non-Conformances and CorrecGve AcGon (PM-RAI-01)
procedure. Time frames and acGviGes shall be agreed both by the auditee and the
auditor(s).

13. Lead auditor shall summarize all nonconformance in the Audit Report form (FM-
RAI-07) and consolidate all general observaGons and OFI in the General
ObservaGon and OpportuniGes for Improvement Monitoring (FM-RAI-11) and
report the results of the conducted internal audit during the Management Review
(PM-RAI-03).

14. Lead Auditor shall schedule audit verificaGon to follow-up the implementaGon and
effecGveness of the correcGve acGons. VerificaGon of implementaGon shall be
conducted at an appropriate Gme as deemed necessary or as requested.
VerificaGon of effecGveness of the correcGve acGon(s) shall be conducted 2-3 days
aaer the implementaGon date.

15. Auditor(s) shall update the CorrecGve AcGon Report (FM-RAI-09) and General
ObservaGon and OpportuniGes for Improvement Monitoring (FM-RAI-11) of the
verificaGon results.

16. Lead auditor shall summarize all status of the audit findings during the
management review meeGng. Refer to Management Review (PM-RAI-03)
procedure.

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17. Lead Auditor shall then conduct evaluaGon of the audit process at the end of all
the audit schedule for the year and evaluate the performance of auditors using the
Internal Auditor EvaluaGon form (FM-RAI-10) for improvement plans the following
year.

II. RELATED PROCEDURES

Handling Non-Conformances and CorrecGve AcGon PM-RAI-01
Management Review PM-RAI-03

III. FORMS
Annual Internal Audit Plan FM-RAI-04
Audit IGnerary FM-RAI-05
Audit Checklist FM-RAI-06
Audit Report FM-RAI-07
CAR Monitoring FM-RAI-08
CorrecGve AcGon Report FM-RAI-09
General ObservaGon and OpportuniGes for Improvement List FM-RAI-10
General ObservaGon and OpportuniGes for Improvement Monitoring FM-RAI-11
Internal Auditor EvaluaGon FM-RAI-12

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