ISO 9001 2000

GAP ANALYSIS TOOL

 

OTHER GAP ANALYSIS TOOLS

ISO 22000 Food Safety Gap Analysis Tool

ISO 13485 Medical Device Gap Analysis Tool

ISO IEC 27001 2005 Information Security Gap Analysis Tool

ISO 14001 2004 Environmental Management Gap Analysis Tool

OHSAS 18001 2007 Occupational Health and Safety Gap Analysis Tool

ISO 9001 Gap Analysis

Please note that ISO 9001 2000 replaces ISO 9001 1994,
ISO 9002 1994, and ISO 9003 1994.  The old ISO 9002 and
ISO 9003 series of quality standards has been dropped!

If you're now ISO 9002 or ISO 9003 certified, you're
going to have to become ISO 9001 2000 certified!

If you need to develop a Quality Management System that meets
 the NEW ISO 9001 2000 Standard, you need our Gap Analysis Tool.
Our Tool will tell you what you need to do to meet the new Standard.
 It will do so by showing you how to pinpoint and fill quality gaps.

More precisely, our Tool will help you to identify the gaps that exist
between the new standard and your organization's actual processes.
Once you know exactly where your gaps are, you can take steps to
fill them. By using this approach, you will not only meet the new
ISO 9001 Standard, but you will also improve the overall
performance of your quality management process.

Our ISO 9001 2000 Gap Analysis Tool is easy to understand and
ready to use. It is focused, detailed, and complete. We guarantee it!

ISO 9001 Gap Analysis

Overview of Gap Analysis Tool
The following material will introduce our ISO 9001 2000 Gap Analysis Tool.
However, we will not present the complete product.  Instead, we will show
you how our Gap Analysis Tool is organized and how it is used. In addition,
we will show you some examples of our approach. Once you've examined
our approach, we hope you'll consider purchasing our complete
ISO 9001 2000 Gap Analysis Tool.

The following is based on the final version of ISO 9001:2000

ISO 9001 2000 Gap Analysis Tool

TABLE OF CONTENTS

PART

INTRODUCTION

PAGE

A Table of Contents 2
B Profile of Gap Analysis Project 3
C Explanation of Gap Analysis Process 4
D Contact Information and Legal Notices 10

TOOL

GAP ANALYSIS TOOLS

PAGE

4 Quality Management System Gap Analysis Tool 11
5 Management Responsibility Gap Analysis Tool 15
6 Resource Management Gap Analysis Tool 21
7 Product Realization Gap Analysis Tool 25
8 Remedial Gap Analysis Tool 41

PLAN

QUALITY SYSTEM DEVELOPMENT PLANS

PAGE

QM Quality Management Process Development Plan 51
RM Resource Management Process Development Plan 52
RR Regulatory Research Process Development Plan 53
MR Market Research Process Development Plan 54
PD Product Design Process Development Plan 55
PU Purchasing Process Development Plan 56
PP Production Process Development Plan 57
SP Service Provision Process Development Plan 58
PT Product Protection Process Development Plan 59
CN Customer Needs Assessment Process Development Plan 60
CC Customer Communications Process Development Plan 61
IC Internal Communications Process Development Plan 62
DC Document Control Process Development Plan 63
RK Record Keeping Process Development Plan 64
PL Planning Process Development Plan 65
TR Training Process Development Plan 66
IA Internal Audit Process Development Plan 67
RV Management Review Process Development Plan 68
MM Monitoring and Measuring Process Development Plan 69
NC Nonconformance Management Process Development Plan 70
CI Continual Improvement Process Development Plan 71
GS General Systemic Process Development Plan 72
FEB 2001 COPYRIGHT Ó PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. VER 2.0
PART A TABLE OF CONTENTS PAGE 2

Our ISO 9001 2000 Gap Analysis Tool has two phases.
The following material will introduce these two phases.

 

OVERVIEW OF OUR GAP ANALYSIS PROCESS

 
PHASE
ONE

IDENTIFY GAPS

USE
TOOLS
ANSWER EACH GAP ANALYSIS QUESTION
ANSWER "YES" 

REQUIREMENT
HAS BEEN MET

NO ACTION
REQUIRED

ANSWER "NO"

GAP HAS BEEN
IDENTIFIED

REMEDIAL ACTION
SHOULD BE TAKEN

ANSWER "N/A" 

REQUIREMENT IS
NOT APPLICABLE

NO ACTION
REQUIRED

FOR EACH "NO" ANSWER SELECT THE QUALITY
PROCESSES THAT NEED FURTHER DEVELOPMENT
 
PHASE
TWO

FILL GAPS

USE
PLANS
PREPARE QUALITY SYSTEM DEVELOPMENT PLANS
 USING OUR QUALITY SYSTEM DEVELOPMENT FORMS
IMPLEMENT QUALITY SYSTEM DEVELOPMENT
PLANS AND TRACK IMPLEMENTATION USING
OUR QUALITY SYSTEM DEVELOPMENT FORMS
 

Phase One: Identify Gaps

Phase One asks you to identify gaps by performing a Gap Analysis. In order to do so, you would use our five Gap Analysis Tools. These five tools list the five sets of requirements that make up the ISO 9001 2000 Standard. However, instead of listing ISO's requirements in the form of statements, they are listed as questions.

Each Gap Analysis question has three possible answers: Yes, No, and N/A. A Yes answer means that your organization has already met one of ISO's requirements, a No answer points to a gap, while an N/A answer says that the question is not applicable in your situation.

No answers reveal gaps that exist between the ISO 9001 2000 Standard and your organization's processes. Whenever you answer No to a question, you are stating that at least one of your organization's processes fails to meet an ISO 9001 2000 requirement. A No answer tells you that a process needs further development. It tells you that a process needs to be modified, improved, or created.

Therefore, whenever you answer No to a question, you must consider your processes, and decide which ones need to be changed. To help you out, we've identified 22 processes. Taken together, these 22 processes make up a complete ISO 9001 2000 Quality Management System. These 22 processes, and the associated abbreviations, are listed below. All you have to do is choose from this list of 22 processes.

And to help you out even more, we've provided our own suggestions in the far right column of every Gap Analysis Tool. This column will tell you exactly which processes need to be changed whenever you answer No to a question (see the column entitled: IF NO, GO TO).

For example, whenever you see the abbreviation QM, it means that the Quality Management Process needs to be changed, and whenever you see RM it means that the Resource Management Process needs to be changed, and so on for all of the following 22 processes:

1 QM Quality Management Process
2 RM Resource Management Process
3 RR Regulatory Research Process
4 MR Market Research Process
5 PD Product Design Process
6 PU Purchasing Process
7 PP Production Process
8 SP Service Provision Process
9 PT Product Protection Process
10 CN Customer Needs Assessment Process
11 CC Customer Communications Process
12 IC Internal Communications Process
13 DC Document Control Process
14 RK Record Keeping Process
15 PL Planning Process
16 TR Training Process
17 IA Internal Audit Process
18 RV Management Review Process
19 MM Monitoring and Measuring Process
20 NC Nonconformance Management Process
21 CI  Continual Improvement Process
22 GS General Systemic Process

Please take special note of the abbreviation GS (number 22). GS refers to the General Systemic Process, and recognizes the fact that the Quality Management System as a whole is also a process. Whenever you see the abbreviation GS, it means that the Quality Management System must be changed at a general or holistic level.

Once you've decided which processes need to be changed, you would record your processes in the space provided on our Gap Analysis Forms (shown below). We suggest that you use our abbreviations in order to save space (use QM for Quality Management Process, RM for Resource Management Process, and so on).

As you've probably noticed, our Gap Analysis Tool uses a process approach. We use a process approach, not only because it makes good sense to do so, but also because ISO has made it mandatory. Clause 4.1 of ISO 9001 2000 makes it very clear that organizations must identify and manage the processes that make up their Quality Management Systems.

Phase Two: Fill Gaps

Now that you've identified all of your gaps and you've figured out which processes need to be changed, you can begin to fill your gaps. In general, you fill your gaps by preparing and implementing System Development Plans using the following System Development Forms:

1 QM Quality Management Process Development Form
2 RM Resource Management Process Development Form
3 RR Regulatory Research Process Development Form
4 MR Market Research Process Development Form
5 PD Product Design Process Development Form
6 PU Purchasing Process Development Form
7 PP Production Process Development Form
8 SP Service Provision Process Development Form
9 PT Product Protection Process Development Form
10 CN Customer Needs Assessment Process Development Form
11 CC Customer Communications Process Development Form
12 IC Internal Communications Process Development Form
13 DC Document Control Process Development Form
14 RK Record Keeping Process Development Form
15 PL Planning Process Development Form
16 TR Training Process Development Form
17 IA Internal Audit Process Development Form
18 RV Management Review Process Development Form
19 MM Monitoring and Measuring Process Development Form
20 NC Nonconformance Management Process Development Form
21 CI  Continual Improvement Process Development Form
22 GS General Systemic Process Development Form

Notice that we have developed a System Development Form for each of the 22 processes listed in Phase One. Please use these 22 Forms to prepare 22 System Development Plans. These System Development Forms are used to list the remedial actions that should be taken to fill your gaps. Of course, before you can list your remedial actions, you need to formulate them. In general, remedial action statements are formulated by turning our Gap Analysis questions into action statements.  That's all there is to it.

As you list your remedial actions using our 22 System Development Forms, you will assign Remedial Action Numbers to each action, and record cross-references to the corresponding ISO clause numbers and Gap Analysis questions. In addition, you will specify who is given the responsibility to ensure that the remedial action is carried out.

Finally, as actions are performed and gaps are filled, you will record the date the gap was filled. Once all remedial actions have been performed and all System Development Plans have been implemented, you will have an ISO 9001 2000 compliant Quality Management System!

The following example will show you what our Gap
 Analysis Tools look like. This example is taken from
  Tool 7: Product Realization Gap Analysis Tool.

ISO 9001 2000 GAP ANALYSIS TOOL

SPECIAL METHODOLOGICAL NOTE
At first glance, our gap analysis questions look a bit repetitive. It looks like we're asking the same question over and over again. If fact, we're not. If you look more closely, you'll notice that each question is unique. However, some questions only vary by one word. This may look odd, but we've taken this approach in order to ensure that each question contains only ONE question, and not several. We have taken this approach in order to avoid complex questions that require complex "YES, NO, and YES" type answers.

7 PRODUCT REALIZATION GAP ANALYSIS FORM

7.1 CONTROL REALIZATION PLANNING

RECORD
ANSWERS
IF NO, RECORD QUALITY
PROCESSES THAT NEED
FURTHER DEVELOPMENT
IF NO
GO TO

PLAN PRODUCT REALIZATION PROCESSES

1 Does your organization plan
its product realization projects?
YES NO N/A   PL PD MR RR
2 Does your organization set quality objectives whenever it plans to realize a product? YES NO N/A   PL PD MR RR
3 Does your organization define requirements whenever it plans to realize a product? YES NO N/A   PL PD MR RR
4 Does your organization identify
product realization needs whenever
it plans to realize a product?
YES NO N/A   PL PD MR RR
5 Do you identify the processes that
you will need to use whenever
you plan to realize a product?
YES NO N/A   PL PD
6 Do you identify the documents that
you will need to use whenever you
plan to realize a product?
YES NO N/A   PL DC PD
7 Do you identify the records that you
will need to use whenever you plan
to realize a product?
YES NO N/A   PL RK PD
8 Do you identify the records that
you will need to use to prove
that realization processes
meet requirements?
YES NO N/A   PL RK PD
9 Do you identify the records that you
will need to use to prove that your
products meet requirements?
YES NO N/A   PL RK PD
10 Do you identify the methods that it
will need to use to control product
quality during product realization? 
YES NO N/A   PL PD
11 Does your organization identify the
product acceptance criteria that it will
need to use in order to decide whether
its product has met requirements? 
YES NO N/A   PL PD
12 Does your organization identify the
resources that it will need to use in
order to realize its products? 
YES NO N/A   PL RM PD
13 Does your organization prepare product realization planning outputs that are appropriate to its method of operation?  YES NO N/A   PL PD
DEVELOP PRODUCT REALIZATION PROCESSES

ANSWERS

RECORD PROCESSES

TO

14 Has your organization developed the processes that it will need to use in
order to realize its products?
YES NO N/A   PL PD
15 Have you implemented the processes
that you will need to use in order to
realize your products?
YES NO N/A   PL PD
16 Have you designed the documents
that you will need to use in order
to realize your products?
YES NO N/A   PL DC PD
17 Have you set up the records that you will need to use in order to realize your products? YES NO N/A   PL RK PD
18 Have you set up the records that you will need to use in order to prove that your realization processes meet requirements? YES NO N/A   PL RK PD
19 Have you set up the records that you will need to use in order to prove that your product meets requirements? YES NO N/A   PL RK PD
20 Have you established the methods that you will need to use in order to control product quality during product realization? YES NO N/A   PL PD
21 Have you established product
verification methods?
YES NO N/A   PL PD
22 Have you established product validation methods? YES NO N/A   PL PD
23 Have you established product monitoring methods? YES NO N/A   PL PD
24 Have you established product inspection methods? YES NO N/A   PL PD
25 Have you established product testing methods? YES

NO

N/A   PL PD

7.2 CONTROL CUSTOMER PROCESSES

RECORD
ANSWERS

IF NO, RECORD QUALITY
PROCESSES THAT NEED
FURTHER DEVELOPMENT

IF NO
GO TO

7.2.1 IDENTIFY CUSTOMERS' REQUIREMENTS
26 Does your organization identify
the customers' product-oriented
requirements and obligations?
YES NO N/A   MR CN CC
27 Do you identify your customers' product requirements? YES NO N/A   MR CN CC
28 Do you identify your customers' delivery requirements? YES NO N/A   MR CN CC
29 Do you identify your customers'
post-delivery requirements?
YES NO N/A   MR CN CC
30 Do you identify requirements that
are dictated by your product's
intended use or purpose? 
YES NO N/A   MR CN CC
31 Does your organization identify
product-oriented requirements that are imposed by external authorities? 
YES NO N/A   RR
32 Do you identify product obligations
imposed by regulators?
YES NO N/A   RR
33 Do you identify product obligations
imposed by statute?
YES NO N/A   RR
34 Do you identify product-oriented requirements that your own organization wishes to meet? YES NO N/A   PD QM
7.2.2 REVIEW CUSTOMERS' REQUIREMENTS

ANSWERS

RECORD PROCESSES

TO

35 Does your organization review customers' product-oriented requirements? YES NO N/A   CN CC
36 Does your organization review product requirements before it agrees to supply products to customers?  YES NO N/A   CN CC
37 Do you review requirements before you submit a tender? YES NO N/A   CN CC
38 Do you review requirements before you accept a contract? YES NO N/A   CN CC
39 Do you review requirements before you accept contract changes? YES NO N/A   CN CC
40 Do you review requirements before you accept an order? YES NO N/A   CN CC
41 Do you review requirements before you accept change orders? YES NO N/A   CN CC
42 Do you verify that product requirements
are specified before you agree to supply products to customers?
YES NO N/A   CN CC
43 Etcetera ...          

 

If you would like to see the rest of this Gap Analysis
questionnaire, please consider purchasing the
complete ISO 9001 2000 Gap Analysis Tool.

 
ORGANIZATION: PROJECT SCOPE:
PREPARED BY: DATE PREPARED:
REVIEWED BY: DATE REVIEWED:
FEB 2001 COPYRIGHT Ó PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. VER 2.0
TOOL 7 PRODUCT REALIZATION GAP ANALYSIS TOOL PAGE 25

COPYRIGHT AUTHORIZATION
If you purchase our ISO 9001 2000 Gap Analysis Tool,
you may make as many copies as you need for use
at one site or location within your own organization!

Now that you know what our Gap Analysis
Tool looks like, please consider purchasing
 
Title 21: ISO 9001 2000 Gap Analysis Tool.
Check our PricesPlace an Order.
Contact Praxiom Research.

 

ISO 9001 2000

 

If you purchase our ISO 9001 2000 Gap Analysis Tool, 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 product.
In fact, we
guarantee the quality!

 
CONTACT INFORMATION
 
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Alberta, T5K 0V7, Canada
Phone: (780)461-4514
Fax: (780)463-6034

info@praxiom.com
 

ISO 9001 2000

ISO 9000 2000 NAVIGATION GUIDE

       
Home Page Table of Contents Alphabetical Index Site Map
       
How to Order Our Products Our Prices Our Guarantee
       
OTHER ISO 9001 WEB PAGES

ISO 9000 2000 Introduction

ISO 9000 2000 Principles

ISO 9001 2000 versus ISO 9001 1994
Plain English Overview of ISO 9001 2000
ISO 9001 2000 Translated into Plain English
How to Develop a Process Oriented Quality Management System
ISO 9001 2000 Quality Management System Development Plan
How to Upgrade to the New ISO 9001 2000 Standard
ISO 9001 2000 Internal Audit
 ISO 9001 2000 Tutorial
ISO's Process Approach
ISO 9000 2000 Definitions
FAQ: Frequently Asked Questions
OTHER GAP ANALYSIS TOOLS
ISO 22000 Food Safety Gap Analysis Tool

ISO 13485 Medical Device Gap Analysis Tool

ISO IEC 27001 2005 Information Security Gap Analysis Tool

ISO 14001 2004 Environmental Management Gap Analysis Tool

OHSAS 18001 2007 Occupational Health and Safety Gap Analysis Tool

 

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ISO 9001 2000