INTERNAL QUALITY AUDIT

1.              PURPOSE

1.1        To define the procedure for conducting internal audits in order  to ensure that:

1.1.1       All activities and results comply with planned arrangements and

1.1.2       That the QMS is effectively implemented and maintained.

2              SCOPE

2.1          This procedure is applicable to the whole QMS of ABC.

3.         REFERENCE

           

3.1          ISO 13485:2012             - Quality Management Systems Requirements

3.2          QM – 001                      - Quality Manual

4.             DEFINITIONS

4.1          QMS     : Quality Management System

4.2          CPAR   : Corrective and Preventive Action Request

4.3          NC        : Nonconformity

4.4          OFI       : Opportunity of improvement

5.             PROCEDURE

5.1. Selection of auditors

5.1.1.             QMR shall nominate Auditors to conduct internal audit.

5.1.2.             Auditor should be selected having either one of the following criteria;

a.             An internal auditor, who had attended ISO 13485:2012 audit training and having a basic knowledge of ISO 13485:2012 standard requirement. Lead auditor will be selected based from seniority.

            or,

b.            Third party appointed and recognized by the Top Management with proven of competency qualification. He/she will the act as a Lead Auditor.

                 

5.2. Pre-Audit

5.2.1.             Lead auditor prepare the Audit Plan as per describe in the QMS Planning.

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

5.2.3.             Lead Auditor has to ensure the selection of auditors meet the objectivity and impartiality of the audit process.

5.2.4.             Lead auditor will inform the auditors not to audit their own department.

5.2.5.             Audit Plan will be distributed to the auditors prior to the assessment.

5.3. During Audit

5.3.1.             Auditor will conduct the audit as per Audit Plan

5.3.2.             Audit tools need to be used;

a)             Audit Checklist.

b)                            ISO 13485:2023 Standard Requirement (where necessary)

5.3.3.             Audit method:

a)             Based from records

b)                            Cross reference with the procedure and work instruction

c)             Observation of process

d)                            Interview to the process owner

5.3.4.             All findings should be recorded down to the Audit Checklist.

5.3.5.             Classification of findings

a)                 Comply and fulfill with the ISO 13485:2012 Requirement and company procedures (OK)

b)                Observation or OFI

c)                 NC

5.3.6.             Next to do for the findings;

a)                 All OFI should be listed in the Audit Summary for Lead Auditor further action

b)                Any NC, Auditor should fill-in the particular information in the CPAR form and submit to Lead Auditor

5.4. Post Audit

5.4.1.             Lead Auditor compile the OFI and keep as an input for Management Review.

5.4.2.             CPAR form will be issued to the respective parties and should follow the Corrective and Preventive Action Procedure.

5.4.3.             Following records to be maintained as per Control of Records Procedure

5.3.1.             Audit Plan

5.3.2.             Audit Checklist / Report

5.3.3.             Audit Summary

5.3.4.             CPAR form

6.     RECORDS

The following records shall be maintained:

No.	Name of Record	Document No.	PIC
1	Audit  Plan	SM-F-011	Lead Auditor
2	Audit Checklist / Report	SM-F-012	Lead Auditor
3	CPAR form	SM-F-004	QMR
4	Summary of Audit	SM-F-013	Lead Auditor