ISO 9002 Internal Audit Program

Version 2.0 of our ISO 9002 Audit Program comes in three flavors:
a hardcopy edition, a Word 97 edition, and a PDF edition.

The hardcopy edition of our Audit Program comes in a three-ring binder. We've used a binder so that you can add your own working papers and documents to the audit file. As you carry out your audit, you will gather or create a variety of notes, queries, forms, and reports. If you add these items to your audit binder, you will automatically create a complete record of your audit.

The Word 97 edition of our Audit Program is available on a 3.5" diskette and is designed for Windows 95/98/NT. We provide a Word 97 edition of our Program so that you can create your own unique audit program by customizing ours!

The PDF edition of our Audit Program is also available on a 3.5" diskette (Windows format). PDF (portable document format) is a file format developed by Adobe Systems Incorporated. The PDF edition of our Audit Program has been optimized for printing. This means that it will print properly regardless of which Windows computer and laser or inkjet printer you happen to be using. This is because documents distributed in PDF format preserve the exact look and content of the original.

The PDF edition of our Internal Audit Program can be viewed and printed using the Adobe Acrobat Reader 4.0 which is available FREE from Adobe. To download a FREE copy of Adobe Acrobat Reader 4.0, please visit the Adobe website at: http://www.adobe.com/

The following material will introduce our new ISO 9002 Internal Audit Program. However, it will not present the complete program. Instead, it will show you how our Internal Audit Program is organized and it will provide you with several detailed samples of our approach. Once you've examined our approach, we hope you'll consider purchasing our complete ISO 9002 Internal Audit Program.

We begin with a table of contents. It shows how we've organized our ISO 9002 Internal Audit Program. Next, we present an overview of the program. This overview shows that it is made up of seven separate phases. Since you probably want more than generalities, we've also included a sample of our audit questionnaire. We've included one detailed questionnaire
(the complete ISO 9002 Internal Audit Program has 19).

Once these kinds of questionnaires and worksheets have been completed and the audit file has been done, it's time to review the file. In order to fulfill this requirement, we've developed an audit file review questionnaire. You'll find the complete questionnaire in the material that follows.

If you purchase our new ISO 9002 Audit Program, you'll find that it's integrated, detailed, exhaustive, and easy to understand. You'll find that we've worked hard to create a high quality program. In fact, we guarantee the quality!

ISO 9002 INTERNAL AUDIT PROGRAM
TABLE OF CONTENTS
PART	INTRODUCTION	PAGE
A	Table of Contents	1
B	Identification	2
C	Program Overview	4
D	Audit Procedure	9
E	Audit Plan	10
PART	AUDIT PROCESS	PAGE
4.1	Management Responsibilities	13
4.2	Quality System Requirements	18
4.3	Contract Review Requirements	23
4.4	Does not apply to ISO 9002	00
4.5	Document and Data Control	26
4.6	Purchasing Requirements	30
4.7	Products Supplied by Customers	34
4.8	Product Identification and Tracing	37
4.9	Process Control Requirements	40
4.10	Product Inspection and Testing	45
4.11	Control of Inspection and Test Equipment	50
4.12	Inspection and Test Status of Products	55
4.13	Control of Nonconforming Products	58
4.14	Corrective and Preventive Action	62
4.15	Handling, Storage, and Delivery	67
4.16	Control of Quality Records	70
4.17	Internal Audit Requirements	74
4.18	Training Requirements	77
4.19	Servicing Requirements	80
4.20	Statistical Techniques	83
PART	CONCLUSION	PAGE
T	Audit Summary	86
U	Audit Evaluation	91
V	Audit Report	93
W	Audit File Review	95
X	Implementation Record	98
JUN 1999	Ó PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED.	VER 2.0
PART A	TABLE OF CONTENTS	PAGE 1

Our ISO 9002 Internal Audit Program has seven phases.
The following material will introduce these phases.

Phase 1 asks you to prepare an internal audit plan. In order to do so, you would use our planning checklist and our outline (in Part E). Once you’ve answered all the planning questions and prepared your internal audit plan using our outline, you’re ready to perform the audit.

However, you need more than a plan. You also need to know how to carry out the audit. You also need a procedure. While the structure of this Internal Quality Audit Program is itself a detailed audit procedure, we have also provided a diagrammatic summary of this procedure. Part D introduces this general audit procedure using a flow chart.

This procedure distinguishes between two kinds of internal quality audits: a Standards Audit and a Procedures Audit. The Standards Audit evaluates how well the ISO standard is being applied, while the Procedures Audit evaluates how effective your quality procedures, policies, plans, and instructions are.

You would start your Standards Audit by studying the audit questions. Once you're familiar with these audit questions, you can begin collecting evidence. You need evidence in order to answer the questions. You would collect your evidence by interviewing auditee personnel, reading documents, reviewing manuals, checking records, examining data, observing activities, and studying working conditions.

As you collect your evidence, you would answer each audit question and record your observations using our 20 questionnaires. Three answers are possible: YES, NO, and N/A. A YES answer means you're in compliance with the standard, a NO answer means you're not in compliance, and an N/A answer means that this question is not applicable in your situation. Once you've completed an audit questionnaire, list all nonconformities (NO responses) and summarize your evidence. We have provided a Noncompliance Worksheet for this purpose.

You would start your Procedures Audit by listing your quality procedures, policies, plans, and work instructions using the Procedures Audit Form. You would do this for each of the 19 parts that make up the audit process. Then for each procedure, policy, plan, or work instruction you would answer three questions: Is it documented? Is it being followed? Is it effective?

On the basis of the evidence you collect, you would answer YES or NO to each question. A YES answer means you're in compliance, while a NO answer means you're not in compliance. Once you've completed a Procedures Audit Form, you would list your nonconformities (NO responses), summarize your evidence, and formulate your conclusions using our Noncompliance Worksheet.

Once you've collected all your evidence and answered all the audit questions, you've completed the audit of your quality management system.

Next you would summarize your audit results. Part T provides a checklist and some forms for this purpose. In order to summarize your audit, you would use our Audit Summary Checklist as a guide, and you would use our Noncompliance Summary Report to list your nonconformities.

Part T also shows how to summarize your audit results in quantitative terms. It provides two forms that you can use to prepare two reports: the Compliance Status Report and the Compliance Scores Report. The Compliance Status Report allows you to summarize your compliance status using YES and NO totals, while the Compliance Scores Report allows you to use these totals to calculate Compliance Scores.

Compliance Scores can be used in at least two ways. Firstly, they can give you a quick way of determining where remedial resources ought to be allocated and therefore which areas your audit report ought to emphasize. Secondly, these scores can be used to measure whether the performance of your quality system is improving over time.

Now you’re ready to audit the audit process. Please use the Audit Evaluation questionnaire in Part U for this purpose. This audit evaluation questionnaire is designed to help the Lead Auditor ensure that the quality system audit was carried out in a fair and reasonable manner. Its purpose is to help the internal audit team do a good job and to help improve the performance of future audits.

Just like the Standards Audit questionnaires, a YES answer means you're in compliance, a NO answer means you're not in compliance, and an N/A answer means that the question is not applicable.

Now that you’ve audited the audit process and summarized your audit results, you’re ready to prepare your audit report. To do so, you would use our Reporting Checklist and our Report Outline (Part V). Your audit report would list the nonconformities you have discovered and summarize the observations you have made. Your audit report would also summarize the evidence you have collected and discuss the conclusions you have drawn. Finally, your report would discuss the recommendations that should be implemented in order to remove nonconformities and improve quality system performance.

Once the audit has been completed and the audit report has been finalized, it’s time for the Audit Manager or Senior Audit Executive to review and evaluate the audit file. The file review is carried out by answering a set of audit file review questions (Part W). These questions are designed to ensure that the audit is complete and that all tasks have been carried out. In addition, it gives your management a chance to review and evaluate the quality of both the audit and the audit file.

The final phase in the program asks you to monitor, control, and record the implementation process using our Implementation Record (Part X). You would begin by recording a nonconformity. You would describe it, discuss root causes, and list effects. Next, you would record the remedial actions that should be carried out to correct or prevent the nonconformity. Then you would prepare an implementation plan and monitor its implementation. And once the plan has been implemented, you would record the results achieved and recommend follow-up actions.

Q	STANDARDS AUDIT QUESTION	YES	NO	N/A	OBSERVATION
1	Have you designed and implemented a quality record keeping system?
2	Have you developed procedures to control your quality record keeping system?
3	Have you identified and defined the quality information that needs to be collected?
4	Have you developed methods and procedures to collect quality system information?
5	Have you developed methods and procedures to record quality system information?
6	Have you developed methods and procedures to file quality records?
7	Have you developed methods and procedures to index quality records?
8	Have you developed methods and procedures to store quality records?
9	Have you developed methods and procedures to maintain quality records?
10	Have you developed methods and procedures to remove quality records?
11	Have you developed methods and procedures to archive quality records?
12	Have you developed methods and procedures to destroy quality records?
13	Do you have procedures to protect quality records from unauthorized access?
14	Do you have procedures to prevent quality records from being altered without approval?
15	Do you have procedures to safeguard quality records from damage or deterioration?
16	Can your quality record keeping system prove that your quality system is implemented?
17	Can your quality record keeping system prove that your quality system is effective?
18	Does your quality record keeping system define how long old records must be retained?
19	Does your quality record keeping system ensure that all quality information is dated?
20	Does your quality record keeping system allow information to be retrieved without difficulty?
21	Does your quality record keeping system produce documents that are easy to read?
22	Does your quality record keeping system also include records provided by suppliers?
23	When contractually required, do you allow customers to access your quality records?

	FILE REVIEW QUESTIONS	YES	NO	N/A	COMMENTS
1	Has Identification page been completed?
2	Has an Audit Plan been prepared?
3	Have all audit sections been completed?
4	Has the audit process been evaluated?
5	Have audit results been summarized?
6	Has an Audit Report been prepared?
7	Has an Implementation Record been started?
8	Have working papers been signed and dated?
9	Have working papers been approved & dated?
10	Has Audit Report been signed and dated?
11	Did auditors conduct audit interviews?
12	Did auditors study quality documents and data?
13	Did auditors study quality records and manuals?
14	Did auditors evaluate quality work activities?
15	Did auditors answer all audit questions?
16	Did auditors document their observations?
17	Did auditors document their evidence?
18	Did auditors document their conclusions?
19	Did auditors document nonconformities?
20	Did auditors do a good job?
21	Did auditors stay on track?
22	Did auditors make fair evaluations?
23	Did auditors make realistic judgments?
24	Did auditors make objective assessments?
25	Did auditors make reasonable observations?
26	Did auditors behave in a professional manner?
27	Did auditors treat all auditee management and staff with courtesy and respect?
28	Did auditors respect the confidentiality of all audit documents, data, records, and manuals?
29	Did auditors resist the temptation to water down audit conclusions and recommendations?
30	Did auditors have the necessary authority?
31	Did auditors have the necessary resources?
32	Did auditors have the necessary training?
33	Were auditors qualified to do the job?
34	Were auditors given enough time to do the job?
35	Has each auditor been evaluated at least once during the past three years?
36	Did lead auditor prepare a good Audit Plan?
37	Did lead auditor write a good Audit Summary?
38	Did lead auditor prepare a good Audit Report?
39	Did lead auditor organize an effective audit?
40	Did lead auditor manage his team effectively?
41	Did lead auditor help his team to do its best?
42	Did lead auditor exploit the talents of his team?
43	Did auditee staff cooperate fully with auditors?
44	Have auditee managers agreed to eliminate the nonconformities listed in the Audit Report?
45	Have auditee managers agreed to implement the recommendations presented in the Report?
46	Has auditee manager agreed to follow-up audit?
47	Does the Audit Report discuss observations?
48	Does Audit Report identify nonconformities?
49	Does the Audit Report summarize evidence?
50	Does the Audit Report present conclusions?
51	Does Audit Report make recommendations?
52	Does the Audit Report review and evaluate how well the quality policy is being applied?
53	Does the Audit Report evaluate how well quality system procedures are being followed?
54	Does the Audit Report review and evaluate how well quality plans are being followed?
55	Does the Audit Report review and evaluate how well quality objectives are being achieved?
56	Does the Audit Report review and evaluate the overall performance of the quality system?
57	Does the Audit Report make recommendations to improve quality system performance?
58	Are you confident that the evidence is valid?
59	Are you confident that the evidence supports the conclusions that were drawn?
60	Are you confident that the evidence supports the recommendations that were made?
61	Are you personally satisfied that all important nonconformities have been identified?
62	Do you believe that the audit was carried out in a fair and reasonable manner?
63	Do you believe that the Audit Report presents a fair assessment of the quality system?

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PHASE 1	PLAN QUALITY AUDIT	USE PART E
PHASE 2	PERFORM QUALITY AUDIT	USE PART D, E AND 4.1 TO 4.20
PHASE 3	SUMMARIZE AUDIT RESULTS	USE PART T
PHASE 4	EVALUATE QUALITY AUDIT	USE PART U
PHASE 5	PREPARE AUDIT REPORT	USE PART V
PHASE 6	REVIEW AUDIT FILE	USE PART W
PHASE 7	TRACK IMPLEMENTATION	USE PART X

ISO 9002 INTERNAL AUDIT PROGRAM
4. 16 CONTROL OF QUALITY RECORDS
AUDIT AREA:	ORGANIZATION:

PREPARED BY:	APPROVED BY:
DATE PREPARED:	DATE APPROVED:

ISO 9002 INTERNAL AUDIT PROGRAM
AUDIT FILE REVIEW
AUDIT AREA:	ORGANIZATION:

PREPARED BY:	APPROVED BY:
DATE PREPARED:	DATE APPROVED:

ISO 9000 Translated into Plain English
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