ISO 9001 2000

INTERNAL AUDIT PROGRAM

 

ISO 9001 Audit

OTHER AUDIT TOOLS

Plain English Process Audit Program

ISO 13485 2003 Internal Audit Program

ISO 14001 2004 Internal Audit Program

ISO 22000 2005 Food Safety Audit Program

ISO 27002 2005 Information Security Audit Tool

NFPA 1600 2007 Business Continuity Audit Program

OHSAS 18001 2007 Occupational Health and Safety Audit Program

Praxiom Research Group Limited

Introduction to ISO 9001 Audit Program

Our Audit Program is made up of five programs:

  1. ISO 9001 Compliance Audit Program
  2. ISO 9001 Policy Audit Program
  3. ISO 9001 Procedures Audit Program
  4. ISO 9001 Process Audit Program
  5. ISO 9001 Records Audit Program

Each of these five programs will be discussed below.

We begin with a table of contents. It shows how we've organized our ISO 9001 Internal Audit Program. While the content of each program
is different, the following table shows that each one of our five audit
programs is organized in the same way.

This web page will introduce our ISO 9001 2000 Internal Audit Program.
However, it will not present the complete audit program. Instead, it will
show you how our audit program is organized and it will explain how
it works. Once you've examined our approach, we hope you'll consider
purchasing our complete ISO 9001 2000 Internal Audit Program.

Our ISO 9001 Internal Audit Program (Title 22) is 163 pages
long, and is available in both pdf and MS doc file formats.

 

ISO 9001 2000 INTERNAL AUDIT PROGRAM
TABLE OF CONTENTS
 
PART INTRODUCTION PAGE
1 Introduction to ISO 9001 4
2 Introduction to Audit Program 5
A ISO 9001 COMPLIANCE AUDIT PROGRAM 14
1 Compliance Audit Procedure 14
2 Compliance Audit Profile 15
3 Compliance Audit Questions SAMPLE
HTML
4 Compliance Audit Scores 65
5 Compliance Audit Summary 66
6 Compliance Audit Conclusions 67
7 Compliance Audit Recommendations 68
8 Compliance Audit Implementation Record 69
B ISO 9001 POLICY AUDIT PROGRAM 70
1 Policy Audit Procedure 70
2 Policy Audit Profile 71
3 Policy Audit Questions 72
4 Policy Audit Scores 75
5 Policy Audit Summary 77
6 Policy Audit Conclusions 78
7 Policy Audit Recommendations 79
8 Policy Audit Implementation Record 80
C ISO 9001 PROCEDURES AUDIT PROGRAM 81
1 Procedures Audit Procedure 81
2 Procedures Audit Profile 82
3 Procedures Audit Questions 83
4 Procedures Audit Scores 89
5 Procedures Audit Summary 91
6 Procedures Audit Conclusions 92
7 Procedures Audit Recommendations 93
8 Procedures Audit Implementation Record 94
D ISO 9001 PROCESS AUDIT PROGRAM 95
1 Process Audit Procedure 95
2 Process Audit Profile 96
3 Process Audit Questions SAMPLE PDF
4 Process Audit Scores 140
5 Process Audit Summary 142
6 Process Audit Conclusions 143
7 Process Audit Recommendations 144
8 Process Audit Implementation Record 145
E ISO 9001 RECORDS AUDIT PROGRAM 146
1 Records Audit Procedure 146
2 Records Audit Profile 147
3 Records Audit Questions 148
4 Records Audit Scores 156
5 Records Audit Summary 158
6 Records Audit Conclusions 159
7 Records Audit Recommendations 160
8 Records Audit Implementation Record 161
F ADMINISTRATIVE INFORMATION 162
MAY 2007 COPYRIGHT Ó 2007 BY PRAXIOM RESEARCH GROUP LIMITED  VER 3.0
If you purchase our ISO 9001 2000 Internal 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 9001 Compliance Audit Program

Overview of ISO 9001 Compliance Audit Program
Our Compliance Audit Program uses questions to list the ISO 9001 quality management system requirements. Like ISO’s five sets of requirements, our Audit Program consists of five separate questionnaires:
  1. Systemic Audit Questionnaire
  2. Management Audit Questionnaire
  3. Resource Audit Questionnaire
  4. Realization Audit Questionnaire
  5. Remedial Audit Questionnaire

Our audit starts with section 4 because ISO's requirements start there.

In general, our Compliance Audit Program asks two types of questions: questions that specify ISO 9001 mandatory quality management system requirements and questions that specify requirements that may be excluded or ignored under some circumstances. Questions that point to mandatory requirements allow two response options: YES or NO, while questions that specify requirements that may be excluded offer three response options: YES, NO, or N/A. An N/A response option is provided because you may exclude or ignore some requirements if you can justify doing so.

YES answers mean you’re in compliance with the standard, NO answers mean you’re not in compliance, and N/A answers mean that a question is not applicable in your case. NO answers to Compliance Audit questions point to compliance problems (also known as nonconformities or noncompliances).

Once you’ve answered all the Compliance Audit Questions, you’re ready to summarize your audit, calculate compliance scores, draw general audit conclusions, and make and implement recommendations to address your compliance problems.

ISO 9001 Policy Audit Program

Overview of ISO 9001 Policy Audit Program
Our ISO 9001 Policy Audit covers the following topics:
  1. Management
  2. Documentation
  3. Usability
  4. Training
  5. Implementation
  6. Changes

Start by selecting a policy that you want to audit. Then prepare your Policy Audit Profile. Before you begin answering policy audit questions, please record the name of this policy at the top of the Policy Audit questionnaire. This will help to maintain the focus of your audit.

Three response options are provided: YES, NO, and N/A. NO answers point to policy performance problems, YES answers identify positive areas, while
N/A responses identify questions that are not applicable in your situation.

Once you’ve answered all the audit questions, you’re ready to summarize your internal audit, calculate policy performance scores, draw general audit conclusions, and make and implement recommendations to address your policy performance problems.

ISO 9001 Procedures Audit Program

Overview of ISO 9001 Procedures Audit Program
Our ISO 9001 Procedures Audit covers the following topics:
  1. Management
  2. Documentation
  3. Content
  4. Compliance
  5. Usability
  6. Training
  7. Control
  8. Records
  9. Changes

Start by selecting a procedure that you want to audit. Then prepare your Procedures Audit Profile. Define the scope of your audit, identify the participants, and prepare a brief audit plan.

Before you begin answering procedures audit questions, please record the name of this procedure at the top of the Audit questionnaire. This will help auditors to maintain the focus of their audit.

Three response options are provided: YES, NO, and N/A. NO answers point to procedural performance problems, YES answers identify positive areas, while N/A responses identify questions that are not applicable in your situation.

Once you’ve answered all the audit questions, you’re ready to summarize your audit, calculate procedural performance scores, draw general audit conclusions, and make and implement recommendations to address your procedural performance problems.

ISO 9001 Process Audit Program

Overview of ISO 9001 Process Audit Program

Our ISO 9001 Process Audit covers the following topics:

  1. Develop Process >>> SAMPLE PDF
    1. Organization
    2. Documents
    3. Outputs
    4. Inputs
    5. Information
    6. Monitoring
    7. Measurement
    8. Training
    9. Resources
  2. Implement Process
    1. Management
    2. Competence
    3. Communication
    4. Infrastructure
    5. Records
  3. Maintain Process
    1. Management
    2. Competence
    3. Information
    4. Communication
    5. Infrastructure
    6. Records
  4. Control Process
    1. Management
    2. Outputs
    3. Inputs
    4. Monitoring
    5. Measurement
  5. Evaluate Process
    1. Scope
    2. Focus
    3. Methods
  6. Improve Process
    1. Information
    2. Methods
    3. Implementation
    4. Management

Clause 4.1 of ISO 9001 makes it clear that organizations must identify and manage the processes that make up their quality management systems. Therefore, the process approach is now a requirement.

The process approach is a management strategy. When managers use a process approach, it means that they manage the processes that make up their organization, the interaction between these processes, and the inputs and outputs that “glue” these processes together.

But, what’s a process, and what are inputs and outputs? Briefly put, a process uses inputs to generate outputs. Or, more precisely, a process is an integrated set of activities that uses resources to transform inputs into outputs. A system exists whenever several processes are interconnected using such input-output relationships.

Processes are interconnected because the output from one process becomes the input for another process. In effect, processes are “glued” together by means of such input-output relationships. And because the output of one process becomes the input of another process, inputs and outputs are really the same thing. In general, there are three basic types of inputs/outputs: products, services, and information.

Below you will find a list of some of the processes that can
be audited using our Process Audit Program:

  1. Production process
  2. Assembly process
  3. Purchasing process
  4. Design process
  5. Delivery process
  6. Marketing process
  7. Management process
  8. Maintenance process
  9. Manufacturing process
  10. Service provision process
  11. Communications process
  12. Document control process
  13. Record keeping process
  14. Administrative process
  15. Measurement process
  16. Monitoring process
  17. Planning process
  18. Training process

Of course, this does not exhaust the list of possible processes that could be audited using our approach. Your organization’s processes will certainly include many more processes that we have failed to mention.

Start your audit by selecting a process. Then prepare your Process Audit Profile. Define the scope of your audit, prepare a brief audit plan, and identify the inputs that are used by this process and the outputs that are generated.

Before you begin answering process audit questions, please enter the name of your process at the top of the Process Audit questionnaire. Three response options are provided: YES, NO, and N/A. NO answers point to process performance problems, YES answers identify positive areas, while N/A responses identify questions that are not applicable in your situation.

Once you’ve answered all the audit questions, you’re ready to summarize your audit, calculate process performance scores, draw general audit conclusions, and make and implement recommendations to address your process performance problems.

ISO 9001 Records Audit Program

Overview of ISO 9001 Records Audit Program
Our Records Audit Program is partly based on the ISO 15489-1 records management standard and covers the following topics:
  1. Management
  2. Initiation
  3. Recording
  4. Revisions
  5. Access
  6. Maintenance
  7. Retention
  8. Destruction
  9. Reporting
  10. Usability
  11. Authenticity
  12. Protection
  13. Continuity
  14. Training
  15. Auditing
  16. Compliance

Start by selecting a set of records. Our Audit Program can be used to audit virtually any type of record keeping system. Examples that you may wish to consider include the following: training records, design records, production records, service delivery records, measurement records, product traceability records, audit records, manufacturing records, management review records, and calibration records.

Once you’ve chosen which records to audit, you’re ready to prepare your Records Audit Profile. Specify the scope of your audit, its location, the participants, and prepare a brief audit plan.

Before you begin answering record keeping audit questions, please enter the name of the records being audited at the top of the audit questionnaire. This will help to ensure that the focus of the internal audit is maintained. Three response options are provided: YES, NO, and N/A. NO answers point to record keeping performance problems, YES answers identify positive areas, while N/A responses identify questions that are not applicable.

Once you’ve answered all the audit questions, you’re ready to summarize your audit, calculate record keeping performance scores, draw general audit conclusions, and make and implement recommendations to address your record keeping performance problems.

Praxiom

SAMPLE AUDIT QUESTIONS

A. COMPLIANCE AUDIT PROGRAM

3. COMPLIANCE AUDIT QUESTIONS

6. RESOURCE AUDIT QUESTIONS

6.1 PROVIDE QUALITY RESOURCES
Q IDENTIFY QUALITY RESOURCE REQUIREMENTS   NOTES AND OBSERVATIONS  
1 Has your organization identified the resources that your quality management system needs? YES NO    
2 Have you identified the resources that are needed to support the quality management system? YES NO    
3 Have you identified the resources that are needed to implement the quality management system? YES NO    
4 Have you identified the resources that are needed to maintain the
quality management system?		 YES NO    
5 Have you identified the resources that are needed to improve the quality management system? YES NO    
6 Have you identified the resources that are needed to improve customer satisfaction? YES NO    
7 Have you identified the resources that are needed to meet customer requirements? YES NO    
Q PROVIDE QUALITY SYSTEM RESOURCES  

NOTES AND OBSERVATIONS

  
8 Does your organization provide
quality system resources?		 YES NO    
9 Do you provide the resources that are needed to support the quality management system? YES NO    
10 Did you provide the resources that were needed to implement the quality management system? YES NO    
11 Do you provide the resources that are needed to maintain the quality management system? YES NO    
12 Do you provide the resources that are needed to improve the quality management system? YES NO    
13 Do you provide the resources that are needed to improve customer satisfaction? YES NO    
14 Do you provide the resources that are needed to meet customer requirements? YES NO    

6.2 PROVIDE QUALITY PERSONNEL
Q 6.2.1 USE COMPETENT PERSONNEL  

NOTES AND OBSERVATIONS

 
15 Does your organization ensure
that the people who influence
product quality are competent?		 YES NO    
16 Do you ensure that personnel have the right experience? YES NO    
17 Do you ensure that personnel have the right education? YES NO    
18 Do you ensure that personnel have the right training? YES NO    
19 Do you ensure that personnel have the right skills? YES NO    
Q 6.2.2 SUPPORT COMPETENCE

 

NOTES AND OBSERVATIONS

  
20 Does your organization takes steps to ensure that the people who influence product quality do in fact achieve an acceptable level of competence? YES NO    
21 Have you defined acceptable levels of competence? YES NO    
22 Have you identified training and awareness needs? YES NO    
23 Do you deliver appropriate training programs? YES NO    
24 Do you deliver appropriate awareness programs? YES NO    
25 Do you evaluate the effectiveness of your training programs? YES NO    
26 Do you evaluate the effectiveness of your awareness programs? YES NO    
27 Does your organization maintain a record of competence? YES NO    
28 Can your records prove that your personnel are trained? YES NO    
29 Can your records prove that your personnel are educated? YES NO    
30 Can your records prove that your personnel are experienced? YES NO    
31 Can your records prove that your personnel are skilled? YES NO    
32 Do you make your personnel aware of how their activities and attitudes influence product quality? YES NO    
33 Do you help your personnel to understand how they can help your organization to achieve its quality objectives? YES NO    

6.3 PROVIDE QUALITY INFRASTRUCTURE
Q IDENTIFY INFRASTRUCTURE NEEDS  

NOTES AND OBSERVATIONS

N
34 Has your organization identified the infrastructure that it needs in order to ensure that products meet requirements? YES NO    
35 Has your organization identified
quality building needs?		 YES NO    
36 Has your organization identified
quality workspace needs?		 YES NO    
37 Has your organization identified
quality equipment needs?		 YES NO    
38 Has your organization identified
quality hardware needs?		 YES NO    
39 Has your organization identified
quality software needs?		 YES NO    
40 Etcetera ...        
 

If you would like to see the rest of this audit
 questionnaire, please consider purchasing the 
complete ISO 9001 2000 Internal Audit Program.
 

Praxiom

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you may make as many copies as you need for use
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Title 22: ISO 9001 Internal Audit Program

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 program looks like, please consider purchasing
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ISO 9001 Internal Audit Program

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ISO 9001 Auditing Program