IN T E R N A L
Q U AL I T Y A U D I T
APMC 2018
AUDIT?
• SYSTEMATIC, INDEPENDENT AND DOCUMENTED PROCESS TO CHECK IF
PROCESSES ARE BEING FOLLOWED
THREE TYPES OF AUDIT
• FIRST PARTY
• SECOND PARTY EXTERNAL AUDIT – AUDITING A SUPPLIER
• THIRD PARY – LEADS TO CERTIFICATION
COMPILE AUDIT SCHEDULE
WHO WILL CARRY
OUT AUDIT WHEN NOTE:
DATE OF LAST AUDIT
IQA TEAM COMPLETE AUDIT
RESULTS OF LAST AUDIT
PROGRAM BY DEPARTMENT
GET THE PROGRAM OF
INTERNAL AUDIT FROM
TOP MANAGEMENT
STAGES OF AN AUDIT
• 1. PREPARATION AND PLANNING
• 2. AUDIT EXECUTION
• 3. REPORTING
• 4. FOLLOW UP AND CLOSE OUT
PREPARATION
1. GET REFERENCES – QMS, STANDARD
ISO 9001:2015; PREVIOUS AUDIT
FINDINGS
2. STUDY THE PROCESSES OF SECTION
TO BE AUDITED
3. PREPARE AND CONSIDER QUESTIONS
4. CONTACT SPOC/DEPARTMENT
REPRESETATIVE WHO WILL BE
REQUIRED TO RESPOND TO AUDIT
QUESTIONS
5. ARRANGE TIME AND DATE FOR AUDIT
MONTH
Department/Unit
Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec
1) X-Ray
1) Laboratory
1) ECG
1) Audiometry
1) Psychology
1) Medical Section
(Physical
examination/Visual Acuity)
1) Dental
1) Top Management
1) Administrative
EXECUTION OF • REPORTING OF AUDIT RESULTS
AUDIT • AUDITOR PREPARES THE REPORT
• WHEN NECESSARY A REQUEST OF
CORRECTIVE ACTION WILL BE MADE (SET
[Link] OPENING MEETING TO TIME LIMIT AS AGREED BY DEPT. REP AND
EXPLAIN PURPOSE TO AUDITEE AUDITOR)
[Link] THE CHECKLIST • COPIES OF THE REPORT FORM WILL BE
CIRCULATED TO ALL PERSONNEL INVOLVED
AND SUBMITTED TO QUALITY ASSURANCE
REPRESENTATIVE
FOLLOW UP
• AUDITOR MUST CHECK IF CORRECTIVE ACTION HAS BEEN TAKEN AND
COMPLETED
• REPORTS CONTAINING NONCONFORMANCES WILL NOT BE CLOSED OUT
UNTIL ALL NON CONFORMANCES ARE CORRECTED
REMINDERS TO AUDITORS…
• BE DIPLOMATIC
• PATIENT
• HONEST
• OPEN MINDED
• UNBIASED
• KNOWLEDGEABLE
PLEASE DO NOT
BE……
ARGUMENTATIVE
CYNICAL
NIT PICKER
OPINIONATED
