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The purpose of this session is to:

Make audit trainees aware of the need for internal audits
Describe the method for internal audits Train employees to become internal auditors

During this session we will look at:
Why we need to perform internal audits
What an internal audit is Who needs to be audited When audits are to be performed How to perform an internal audit

Defining the Internal Audit

Periodic, independent , documented verification of:
Records Processes Performance

To ensure the management system conforms to the requirements of ISO 9001.

Benefits of Auditing
Can facilitate continuous improvement

Can Identify System Failures

Provide feedback to Management regarding efficiency of the Quality System

Audit Objectives
To verify that the quality system:
Conforms to ISO 9001 Processes conform to requirements Helps the organization to satisfy its customers

To identify weakness in processes To acquire data and information

To help make balanced decisions
To help make decisions based on fact

Audit System Structure

The internal audit process covers:
Scheduling Planning

Reporting Follow-up

Audit System Structure

The system combines 3 functions required by ISO 9001:
Management Representative schedules audits and maintains the audit system Internal Auditors perform audits and reports findings Management Review Team reviews the audit findings

Audit Requirements
Internal audits are required by ISO 9001
Must be conducted by personnel independent of responsibility for process being audited Results must be recorded Must follow organizational objectives Frequency is determined by organizational need

Scheduling Audits
All QMS processes are subject to auditing
Each process is audited at minimum once in a 12 month period Audit scheduling is performed by the Quality Management Representative The schedule is issued to Auditors & Auditees

Audit Scope
Full audit of the entire Quality System
How many auditors will be needed How will responsibilities be divided Appoint a lead auditor to keep the audit focused

Which departments or processes
Which clause of the standard

Audit Overview
The typical audit cycle will include:
Arranging a time and date for the audit A preparation stage Performing the audit on the scheduled date Compilation of the audit report Summary of non-conformance reports

Review of any corrective actions proposed

Verification of any corrective actions implemented

How Audits are Conducted

starting with the final process and working backward to the beginning

starting with the first process and flowing forward

across similar processes, e.g. auditing document control across all departments

Performing an Audit
Audit arrangement Audit preparation Performance of the audit

Compilation of the audit report

Non-conformances and observations
Minor/Major non-conformances Observations (opportunities for improvement)

Steps to a Successful Audit

Review results of previous audits Determine priorities Develop the checklist Perform the audit Record findings Follow-up Review of corrective actions Verification of non-conformances

Develop the Audit Checklist

Become familiar with:
The processes being audited Documentation to be audited

Make notes of possible questions

List items to look for and observe

Note the clause being checked

Leave space to record observations

Audit Questions
Use open questions to ensure you get full answers:
What are outputs does this process create? How do you know which document to use? Who is responsible for this process? When something goes wrong, what do you do? Where do you find work instructions and procedures?

Open questions keep the auditee talking Avoid questions that illicit a yes or no response.

Recording Observations
Record location of observation List the names of interviewees and their position

Notes on non-conformances should be

short to the point thorough

Issue a Corrective Action Request
Make sure it is thorough Note process ownership

Note the paragraph of the standard that has been violated

State requirements of resolutions

Reporting to Management
Reports must be
thorough and specific objective

evidence based
reviewed by management

Audits are important because they:
Provide transparency Give a means for continual improvement

Prove that standards are being followed

Promote effective control Increase efficiency

End of Presentation
Thank you for your time.