INTERNAL AUDIT

SCHOOL OF MEDICAL SCIENCES

UNIVERSITI SAINS MALAYSIA

MS ISO 9001:2015

INTERNAL AUDIT
(PPSP/QMS/IA)

Revision no : 02
Effective date: 10 May 2022

CONTENT

Aim
Scope
Reference documents
Definition
Abbreviation
Procedure
Flowchart
Records
Appendices
Amendment Records

1. AIM

This procedure shall be used by the Internal Audit Team appointed by the Dean of PPSP to ensure that the QMS for teaching, learning, research management and support service processes in PPSP are effectively conducted and maintained and conforms to all the MS ISO 9001:2015 and other requirements set by the PPSP as well as to identify aspects for improvement

2. SCOPE

This procedure shall be used to conduct the internal audit on the QMS of Teaching & Learning and research management in PPSP according to the audit plan.

3. REFERENCE DOCUMENTS

Malaysian Standard ISO 9001:2015 Quality Management Systems-requirements (PPSP/QMS/QM/ER 1).
PPSP Quality Manual (PPSP/QMS/QM).

4. DEFINITION

Audit:

A systematic, independent and documented process for obtaining audit evidences from various sources, cross referencing and evaluating it objectively to determine the extent to which audit criteria are fulfilled as documented.

Internal Audit:

An audit conducted by staff appointed by the top management against the QMS of PPSP.

Opening Meeting:

A meeting among the internal audit team and the auditee of PPSP at the beginning of internal audit process.

Closing Meeting:

A meeting among the internal audit team and the auditee of PPSP at the end of internal audit process to report on the audit results.

Follow-up audit:

An audit conducted by the internal audit team to ensure that the corrective actions against the nonconformities found during the internal audit have been implemented effectively.

Nonconformity:

The non-fulfillment of a requirement of the MS ISO 9001:2015 standard, the QMS set by PPSP as well as other relevant mandatory and legal requirements. Corrective action is mandatory.

Observation / suggestion for improvement:

Findings raised for situations where there is insufficient evidence to justify a nonconformity but which may lead to one in the future. Also includes measures that can be takan to improve the overall effectiveness of the quality system or the quality of the services/product being offered. Corrective action is not mandatory.

5. ABBREVIATION

QM = Quality Manager
CIA = Chief Internal Auditor
DCIA = Deputy Chief Internal Auditor
IA = Internal Auditor
IAT = Internal Audit Team
NCR = Non-Conformance Report
SFI = Suggestion for Improvement
MRM = Management Review Meeting

6. PROCEDURE

RESPONSIBILITY

6.1 Internal audit programme planning

The internal audit is conducted at least once a year.

6.1.1 Prepare an internal audit planning schedule.

6.1.2 Approve the annual internal audit planning schedule.

CIA/DCIA

Dean

6.2 Appoint auditor and form an internal audit team

6.2.1 Identify and select the qualified auditors.

6.2.2 Appoint auditor to conduct the internal audit.

6.2.3 Prepare an IAT.

CIA/DCIA

Dean

CIA/DCIA

6.3 Prepare, inform and approve the audit schedule

6.3.1 Prepare and inform the audit schedule to Dean and QM. The audit schedule is about the following:

a. Audit time table.

b. Scope and audit objectives.

c. Procedures to be audited.

d. Audit techniques.

e. Facility/support required from the auditee.

f. Others (if any).

6.3.2 Approve the audit schedule.

CIA/DCIA

Dean

6.4 Conduct of audit

6.4.1 Conduct an opening meeting as below:

a. Introduce IA to the auditee.

b. Explain the scope and aim of the audit.

c. Explain the audit process and the time table.

d. Request any facility/support needed during audit.

e. Determine the date/time for closing meeting.

6.4.2 Conduct the audit to ensure that the QMS for teaching, learning and research processes in PPSP are effectively conducted and maintained and conforms to all the MS ISO 9001:2015 standards and other requirements set by the PPSP as well as to identify aspects for improvement and record the findings.

Note: IA shall not audit his/her own procedure / work / department.

6.4.3 Provide a summary of the audit findings report to be presented at the closing meeting.

6.4.4 Conduct closing meeting to discuss the audit findings.Each team presents their audit findings.

6.4.5 Inform the date of the follow-up audit that has been specified

CIA/DCIA

CIA/DCIA/IA

6.5 Perform follow-up audit

6.5.1 Conduct a follow-up audit to ensure that corrections and corrective actions have been effectively taken.

6.5.2 Evaluate its effectiveness

6.5.3 If the action taken is effective, close the NCR

Note: Close the NCR only if the action taken by the auditee

meets the relevant requirements.

CIA/DCIA & IA

6.6 Prepare audit report

6.6.1 Collect all checklist, NCR and SFI forms.

6.6.2 Provide a summary of internal audit reports.

6.6.3 Submit a copy of the summary of the internal audit report to the Dean and QM.

CIA/DCIA

6.5. Present at Management Review Meeting

Present the overall internal audit results at the MRM meeting.

QM/CIA/DCIA

7. FLOWCHART :

Summary of internal audit

8. RECORDS

NAME	REFERENCE NO.	PERIOD (YEAR)	LOCATION	RESPONSIBILITY
Internal Audit Plan & Time Table	PPSP/QMS/IA/R1	5	Secretariat Quality Office	CIA/DCIA
Internal Audit Team	PPSP/QMS/IA/R2	5	Secretariat Quality Office	CIA/DCIA
Objective Quality	PPSP/QMS/IA/R3	5	Secretariat Quality Office	CIA/DCIA
Internal Audit Checklist	PPSP/QMS/IA/R4	5	Secretariat Quality Office	CIA/DCIA
NCR	PPSP/QMS/IA/R5	5	Secretariat Quality Office	CIA/DCIA
SFI	PPSP/QMS/IA/R6	5	Secretariat Quality Office	CIA/DCIA
Internal Audit Report	PPSP/QMS/IA/R7	5	Secretariat Quality Office	CIA/DCIA
Competence & Communications	PPSP/QMS/IA/R8	5	Secretariat Quality Office	CIA/DCIA
Performance & Evaluation	PPSP/QMS/IA/R9	5	Secretariat Quality Office	CIA/DCIA

9. APPENDICES

REFERENCE NO.	TITLE
PPSP/QMS/IA/L1	Internal Audit Planning Schedule
PPSP/QMS/IA/L2	Internal Audit Team Form
PPSP/QMS/IA/L3	Internal Audit Time Table
PPSP/QMS/IA/L4	Internal Audit Checklist Form
PPSP/QMS/IA/L5	NCR Form
PPSP/QMS/IA/L6	SFI Form

10.AMENDMENT RECORDS