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. QMR shall nominate an Internal Auditor;
2. 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 the Quality Manual

PRE-AUDIT ACTIVITY

1. Lead auditor will prepare the Audit Plan.
2. The Audit Plan should define the audit criteria, scope and process need to be audited.
3. 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.
4. Lead Auditor has to ensure the selection of auditors is meeting the objectivity and impartiality of the audit process.
5. Lead auditor will organize the auditors which not audit their own work.
6. Audit Plan will be distribute to the auditor prior assessment conducted

DURING AUDIT ACTIVITY

1. Auditor will conduct audit as per Audit Plan
2. Audit tools need to be used;
• a. Audit Checklist
• b. ISO 9001 Standard, where necessary
3. 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.
4. All findings should be recorded down to the Audit Checklist.
5. 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)
6. 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

POST-AUDIT ACTIVITIES

1. Lead Auditor compile the OFI and keep as an input for management review to meet with clause 9.3 Management Review of Quality Manual.
2. CAR  form will issue to the respective parties and should follow with Corrective Action Procedure.