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Internal Audit Procedure

GENERAL REQUIREMENT

This procedure provides guideline to extent information


explained in clause Internal Audit of the Quality Manual.
The requirement is also enable to provide conformity to
clause 9.2.2 (Internal Audit) of ISO 9001:2015 Standard
Requirement.
COMMON DEFINITION USED

The definitions addressed are mainly refer to IS0


9000:2015
RESPONSIBILITY AND AUTHORITY

SELECTION OF AUDITORS
1.
2.

QMR shall nominate an Internal Auditor;


Selected auditor should be complied with one of the
following criteria

a) Experienced and/or trained in ISO 9001.

b) Third party appointed and recognized by the


Top Management with proven of competency
qualification.

c) Where necessary, training will be arranged for


internal auditor to assure their competency. The

process shall follow as per 7.2 Competence of


theQuality Manual
PRE-AUDIT ACTIVITY
1.
2.

3.

4.

5.

6.

Lead auditor will prepare the Audit Plan.


The Audit Plan should define the audit criteria, scope
and process need to be audited.
Determination of audit intensity

a. All active projects shall be audited.

b. If there is no active project is running, scope of


audit may focus on adequacy of QMS process
(such as Organizational Context of company,
Leadership and commitment, Management of
Risks and Quality Objectives, section 7 Support,
section 9. Performance Evaluation and section 10.
Improvement, or,

c. If QMR identified that there is no project is


running and no change in QMS implementation,
he has authority to decide the necessity of internal
audit to be conducted due with circumstances
reason should be determined.
Lead Auditor has to ensure the selection of auditors is
meeting the objectivity and impartiality of the audit
process.
Lead auditor will organize the auditors which not audit
their own work.
Audit Plan will be distribute to the auditor prior
assessment conducted

DURING AUDIT ACTIVITY


1.
2.

Auditor will conduct audit as per Audit Plan


Audit tools need to be used;

a. Audit Checklist

b. ISO 9001 Standard, where necessary


Audit Method

a. Based from records (It shall consistently meet


with Documented Information Control Procedure

b. Cross reference with the procedure and work


instruction (It shall consistently maintained as per
clause 8. Operation of Quality Manual)

c. Observation of process to meet with clause 8.


Operation of Quality Manual.

d. Interview to the process owner to obtain input


for justifying the effectiveness of process defined
in Quality Manual in clause 7 Support, 7.1
Resource, 7.2 Competence, 7.3 Awareness and
7.4 Communication.
All findings should be recorded down to the Audit
Checklist.
Classification of findings;

a. Comply and fulfil with the ISO 9001


Requirement Standard and company QMS
established (Quality Manual and procedures).

b. Observation or OFI

c. NC: Non-compliance with the with the ISO


9001 Requirement and company QMS
established (Quality Manual and procedures)
Next to do for the findings;

a. All OFI should be listed in the Audit Summary


for Lead Auditor take further action

b. Any NC, Auditor should follow action


determined in the Corrective Action
Procedure and submit to Lead Auditor

3.

4.

5.

6.

POST-AUDIT ACTIVITIES
1.

2.

Lead Auditor compile the OFI and keep as an input for


management review to meet with clause 9.3
Management Review of Quality Manual.
CAR form will issue to the respective parties and
should follow with Corrective Action Procedure.

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