For Steps of Internal quality audit

1. Internal Quality Auditor

2. Content :
1. Purpose
2. Knowledge of QMS
3. Preparation for the Audit
4. Observations during Audit
5. Points to be considered during audit
6. Non Conformance reporting

3. PURPOSE
To check the
Health
of the
Quality Management System (QMS)
in the organisation

4. Knowledge of QMS
One should have thorough
understanding of the various
clauses of the Management system
to be audited like,
• Various clauses
• Mandatory procedures etc.

5. Preparation for the Audit
• CIRCULATE ADVANCE INTIMATION ONE WEEK BEFORE (IA
schedule)
• GO TO DESIGNATED PROCESS OWNERS
• BECOME FAMILIAR WITH HIM/HER
• READ ALL SOP AND WI
• PREPARE NOTES
• THEN OPEN RELEVANT SOP AND WI to be audited
• COLLECT COMPLIANCE TO SYSTEM

6. Observation Sheet
• ENTER DETAILS/FINDINGS INTO
OBSERVATION SHEET.
• FIND OUT WHAT RECORDS ARE TO
BE KEPT AND WRITE DOWN
EVIDENCE.

7. POINTS TO BE CONSIDERED DURING AUDIT
RATE YOUR OBSERVATIONS AS
• MAJOR NC,
• MINOR NC,
• OBSERVATION,
• OPPORTUNITY FOR IMPROVEMENT.
• NOTEWORTHY EFFORTS

8. Non Conformance Reporting
FOR NC
• FILL UP CAPA FORM
• TAKE SIGNATURE ON OBSERVATION
SHEET
• HAND OVER TO MR