Internal Audit Guidance Example

ISO 9001:2008

Internal Audit

Solution Guidance

GD002

www.iso-9001-checklist.co.uk ISO 9001:2008 Internal Audit Solution Guidance

Document: GD002 Page 3 of 19

Table of Contents

INTRODUCTION ............................................................................................................................................................ 4

ABOUT THE INTERNAL AUDIT SOLUTION .................................................................................................................................... 4 NAVIGATING THE TEMPLATES .................................................................................................................................................. 4 AMENDING THE TEMPLATES .................................................................................................................................................... 5

8. MEASUREMENT, ANALYSIS & IMPROVEMENT ......................................................................................................... 6

8.1 GENERAL ....................................................................................................................................................................... 6 8.2 MONITORING & MEASUREMENT ....................................................................................................................................... 6

8.2.1 Customer Satisfaction ......................................................................................................................................... 6 8.2.2 Internal Audit ...................................................................................................................................................... 6

The Human Aspect of Auditing ................................................................................................................................................... 7 Preparing for the Audit ............................................................................................................................................................... 7 Elementary Audit Questions ....................................................................................................................................................... 8 How to Audit a Process ............................................................................................................................................................... 8 How to Measure a Process ......................................................................................................................................................... 9 How to Audit without Procedures .............................................................................................................................................. 9 Getting the Most from the Audit Schedule .............................................................................................................................. 10

8.2.3 Process Monitoring & Measurement ................................................................................................................ 10 8.2.4 Product Monitoring & Measurement ................................................................................................................ 10

8.3 CONTROL OF NON-CONFORMING PRODUCTS ...................................................................................................................... 10 8.4 ANALYSIS OF DATA ........................................................................................................................................................ 11 8.5 IMPROVEMENT ............................................................................................................................................................. 12

8.5.1 Continual Improvement .................................................................................................................................... 12 8.5.2 Corrective Action ............................................................................................................................................... 12

Practical Problem Solving (8D Emphasis) .................................................................................................................................. 13 Prepare the Problem Solving Process ....................................................................................................................................... 13 Describe the Problem ............................................................................................................................................................... 14 Initiate Interim Containment Action ......................................................................................................................................... 14

STEP 1 – Select an Interim Containment Action ................................................................................................................... 14 STEP 2 – Verify an ICA .......................................................................................................................................................... 14 STEP 3 – Implement an ICA .................................................................................................................................................. 14

Identify the Root-Cause ............................................................................................................................................................ 15 STEP 1 – Review the Problem Description ........................................................................................................................... 15 STEP 2 – Complete a Comparative Analysis ......................................................................................................................... 15 STEP 3 – Develop Root-cause Theories ................................................................................................................................ 15 STEP 4 – Test the Theories ................................................................................................................................................... 16 STEP 5 – Verify the Root-Cause ............................................................................................................................................ 16 STEP 6 – Determine and Verify the Escape Point ................................................................................................................. 16

Implement & Validate Permanent Corrective Actions .............................................................................................................. 17 Prevent Recurrence .................................................................................................................................................................. 17

8.5.3 Preventative Action ........................................................................................................................................... 18 Auditing Preventive Action ....................................................................................................................................................... 18 How to Audit Preventive Action ............................................................................................................................................... 19 Follow-up & Verification ........................................................................................................................................................... 19



8. Measurement, Analysis & Improvement

8.1 General

Plan your measurement processes:

How measurement processes will be used to assure conformity

How measurement processes will be used to improve the system

Implement and perform measurement processes:

Use measurement processes to demonstrate conformance

Use measurement processes to improve quality management system

8.2 Monitoring & Measurement

Monitor and measure customer satisfaction. Both internal and external auditors will look for proof that a consistent and systematic approach has been implemented to deal with customer complaints. This will typically include defined responsibilities for logging and tracking complaints, clearing technical issues, determination of problem causes and actions that address those causes. Specific examples of complaints must be sampled. The link between the customer complaint process and corrective action also requires special scrutiny (See 8.5.2).

8.2.1 Customer Satisfaction

Monitor and measure quality:

Identify ways to monitor and measure customer satisfaction

Monitor and measure customer satisfaction

Use customer satisfaction information

8.2.2 Internal Audit

The purpose of internal auditing is to assess the effectiveness of the quality management system and the organization's overall performance. ISO 9001:2008 Para 8.2.2 requires that your internal audits demonstrate compliance with your ‘planned arrangements’ (e.g. quality manual, procedures or process-maps) and that the planned arrangements are implemented and maintained.

Plan and perform regular internal audits:

Develop the internal audit procedure (QSP8.2.2)

Set up the internal audit program (QF8.2.2-1)

Plan your internal audits (QF8.2.2-2)

Assign audit duties (QF8.2.2-3)

Review and amend audit checklist (QF8.2.2-4)

Under take internal audit

Prepare audit report (QF8.2.2-5)

Obtain feedback from auditees (QF8.2.2-6)

Update audit schedule



The auditor’s role is to gauge how well this system is functioning by gathering of objective evidence of conformance. The auditee will often be a processes owner; they are the experts of that process and as such will provide an invaluable insight into the mechanics of that process.

The auditor will verify that processes are documented, implemented and understood. He will also seek confirmation that each process complies with the necessary requirements, that the process is effective and demonstrates continual improvement.

Solve problems discovered during audits

Verify that problems identified have been solved

Related documents:

Ref Definition

QSP8.2.2 Internal Audit Procedure

QF8.2.2-1 Internal Audit Schedule

QF8.2.2-2 Internal Audit Plan

QF8.2.2-3 Internal Audit Assignment

QF8.2.2-4 Internal Audit & Gap Analysis Checklist

QF8.2.2-5 Internal Audit Report

QF8.2.2-6 Internal Audit Feedback

The Human Aspect of Auditing

Good auditors realise very early on that they are dealing with personalities as much as processes and systems. Whilst the intent of the audit a serious one, often light humour, politeness and diplomacy are the best ways to build rapport. It is vital every effort is made to reassure those being audited that the audit’s primary function is to drive improvement, not to name and shame.

If you are new to auditing, acknowledge this fact, be open and honest. It is also important to explain to the auditees that they are free to express their views during the audit. Remember that you, the auditor, are also there to learn.

Always discuss the issues you have identified with the auditees and always provide guidance on what is expected in terms rectifying any non-conformances or closing out observations you raised. Let the auditees know they are welcome to read your notes and findings; the audit is not a secret.

Try not to be drawn into arguments concerning your observations. It is never appropriate to directly name people in the audit report as this may lead to defensiveness which is ultimately counter productive.

Preparing for the Audit

Preparation is the key to a meaningful audit and, as such, you should have an up-to-date audit schedule and a well defined audit plan for each process. Be sure to communicate the audit schedule to all parties involved as well as to top management as this will help reinforce your mandate.

The audit schedule is a living document and should not be cast in stone, but instead, it should be allowed to evolve organically with the needs of the business. Always review historical audit reports and check during the audit that any previous corrective or preventive actions are still operating.

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Internal Audit Guidance Example