ISO 9001 2008 Gap Analysis Tool

7/14/2014 ISO 9001 2008 Gap Analysis Tool
http://www.praxiom.com/iso-gap.htm 1/10
The following material will introduce our Plain English 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 2008 Plain English Gap Analysis Tool (Title 21).
Our Plain English Gap Analysis Tool can help you to identify the gaps
that exist between the new standard and your organization's processes.
Once you know exactly where your gaps are, you can take steps to
fill them. By using this approach, you will not only comply with the
new ISO 9001 standard, but you will also improve the overall
effectiveness of your quality management system (QMS).
Our Gap Analysis Tool assumes that your organization
already has a functioning QMS and that you simply need
to upgrade it to comply with the new ISO 9001 standard. It
assumes that you only need to make incremental changes.
Our Plain English Gap Analysis Tool is easy to understand and
ready to use. It is focused, detailed, and complete. We guarantee it!
ISO 9001 2008 GAP ANALYSIS TOOL
PART TITLE 21 TABLE OF CONTENTS PAGE
1 Profile of Gap Analysis Project 3
2 Introduction to ISO 9001 2008 4
3 Explanation of Gap Analysis Process 9
4 General Gap Analysis Questionnaire 14
5 Management Gap Analysis Questionnaire 23
6 Resource Gap Analysis Questionnaire 30
7 Realization Gap Analysis Questionnaire <SAMPLE
8 Remedial Gap Analysis Questionnaire 57
9 Process-based QMS Development Plan 77
10 Quality Management Terminology 96
11 Legal and Contact Information 122
MAR 2009 COPYRIGHT 2009 PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. EDITION 4.0
Our Plain English Gap Analysis Tool has two phases.
The following material will introduce these two phases.
OVERVIEW OF GAP ANALYSIS PROCESS

PHASE ONE: IDENTIFY GAPS

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
JUSTIFY
EXCLUSIONS
FOR EACH "NO" ANSWER SELECT THE QUALITY
PROCESSES THAT NEED FURTHER DEVELOPMENT

PHASE TWO: FILL GAPS

PREPARE PROCESS DEVELOPMENT PLANS
USING OUR PROCESS DEVELOPMENT FORMS
IMPLEMENT YOUR PROCESS DEVELOPMENT
PLANS AND TRACK IMPLEMENTATION USING
OUR PROCESS DEVELOPMENT FORMS

Phase One: Identify Gaps
Phase One asks you to identify gaps by performing a gap analysis.
Use our five gap analysis questionnaires (4 to 8) to carry out your
analysis. These five questionnaires list the five sets of requirements
that make up the ISO 9001 2008 standard. However, instead of listing
ISO's requirements in the form of statements, they are listed as questions.
Each gap analysis question has either two or three possible answers.
Whenever a question refers to a requirement that must be met in order
to comply with ISO 9001, we offer two possible answers: YES and NO.
A YES answer means that your organization has already met one of ISO's
requirements while a NO answer points to a gap that should be filled.
However, whenever a requirement may be excluded or ignored, we offer
a third option: N/A. Select N/A if the requirement is not applicable in your
situation. The N/A option is added to every Part 7 question because you
may exclude or ignore any Part 7 requirement if you can justify doing so.
NO answers reveal gaps that exist between the ISO 9001 standard and
your organization's processes. Whenever you answer NO to a question,
you are stating that at least one process fails to meet an ISO 9001 2008
requirement. A NO answer tells you that at least one of your processes
needs some work. It tells you that at least one process needs to be
developed, modified, or improved. Therefore, whenever you answer
NO to a question, you must consider your processes, and decide
which ones need to be changed.
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 makes it very clear that organizations must identify and
manage the processes that make up their quality systems.
Since the process approach is now central to ISO 9001, we have
tried to identify the processes that make up a quality management
system (QMS). Some of these processes are listed below:
1. Quality management process
2. Resource management process
3. Training and awareness process
4. Product purchasing management process
5. Design and development process
6. Production management process
7. Service management process
8. Product management process
9. Customer management process
10. Internal communication process
11. Document management process
12. Records management process
13. Internal quality audit process
14. Monitoring and measuring process
15. Compliance management process
16. Management review process
17. Continual improvement process
Of course, this does not exhaust the list of possible processes that
could be used to establish a QMS, nor does it exhaust the many ways
in which processes can be grouped into larger processes or subdivided
into smaller ones. Your organizations list of processes may be different
from the ones we have listed.
Phase Two: Fill Gaps
Once you've identified all of your gaps (NO answers), you can begin
to fill them. In general, you fill your gaps by preparing and implementing
Process Development Plans using the following Process Development
Forms:
1. Quality Management Process Development Form
2. Resource Management Process Development Form
3. Training and Awareness Process Development Form
4. Purchasing Management Process Development Form
5. Design and Development Process Development Form
6. Production Management Process Development Form
7. Service Management Process Development Form
8. Product Management Process Development Form
9. Customer Management Process Development Form
10. Internal Communication Process Development Form
11. Document Management Process Development Form
12. Records Management Process Development Form
13. Internal Quality Audit Process Development Form
14. Monitoring and Measuring Process Development Form
15. Compliance Management Process Development Form
16. Management Review Process Development Form
17. Continual Improvement Process Development Form
18. General Systemic Process Development Form
Use these Process Development Forms to prepare your Process
Development Plans. Each form is used to list the remedial actions that
should be taken to fill your gaps. Also, please take special note of item
number 18, the General Systemic Process Development Form. This form
recognizes the fact that the quality management system as a whole is also
a process. Use this general systemic form to list the general remedial
actions that relate to your quality management system as a whole.
While we have identified 18 processes, you dont have to agree with the
way in which weve divided things up. If your list of processes differs from
ours, thats fine (weve provided a blank form for this purpose). Just make
sure that your list can accommodate every relevant ISO 9001 requirement,
and that it also meets your organizations needs.
Of course, before you can list your remedial actions, you need to formulate
them. In general, remedial action statements can be formulated by turning
our gap analysis questions into simple action statements.
For example, a gap analysis question might ask: "Do you protect your
monitoring and measuring equipment?" In order to prepare a remedial
action statement, all you have to do is re-write it as follows: "Protect
monitoring and measuring equipment". This remedial action statement
is then listed on our Monitoring and Measuring Process Development
Form (14 above). In most cases, that's all there is to it. However, in some
cases, you may need to be more specific, or you may need to formulate
a slightly different action statement for several different processes.
As you list your remedial actions using our 18 process development
forms, you will assign a Remedial Action Number (RAN) to each action,
and record cross references to the corresponding ISO clause numbers
(see the ISO column) and gap analysis question (see the Q column).
Also, specify who was given the responsibility to ensure that the
remedial action is carried out. Then use these forms to monitor
and control implementation.
Once youve done this for all gaps, you will have several Process
Development Plans which, taken together, make up a detailed Process-
based Quality Management System Development Plan that will be unique
to your organization. And once youve implemented your Process-based
QMS Development Plan, you will have an ISO 9001 2008 compliant
process-based quality management system.
You can also use your Process-based QMS Development Plan to help
you figure out how much time it will take and how much it will cost to
bring your QMS into compliance with the new ISO 9001 2008 standard.
The following example will show you what our
Gap Analysis Tool looks like. It is taken from
Part 7: Realization Gap Analysis Tool.
ISO 9001 2008 GAP ANALYSIS TOOL
7. PRODUCT REALIZATION GAP ANALYSIS QUESTIONNAIRE
7.1 CONTROL PRODUCT REALIZATION PLANNING
1
Did your organization establish a
product realization planning process?
YES NO N/A
2
Do you use your planning process to plan the
realization of your organization's products?
YES NO N/A
3
Do you use your product realization planning
process to set product quality objectives?
YES NO N/A
4
process to specify product quality requirements?
YES NO N/A
5
process to identify product realization needs?
YES NO N/A
6
Do you identify the processes that you will
need to use in order to realize products?
YES NO N/A
7
Are your product realization processes
integrated with other QMS processes?
YES NO N/A
8
Do you identify the documents that you will
YES NO N/A
9
Do you identify the records that you will
YES NO N/A
10
Do you identify the records that you will
need in order to be able to prove that
your products meet requirements?
YES NO N/A
11
Do you identify the records that you will need
in order to be able to prove that your product
realization processes meet requirements?
YES NO N/A
12
Do you identify the product acceptance criteria
that you will need to use in order to decide
whether or not products meet requirements?
YES NO N/A
13
Do you identify the methods that you will
need to use in order to control product quality
during the product realization process?
YES NO N/A
14
Do you identify the verification
methods that you will need to use
in order to control product quality?
YES NO N/A
15
Do you identify the validation
YES NO N/A
16
Do you identify the monitoring
YES NO N/A
17
Do you identify the measurement
YES NO N/A
18
Do you identify the inspection
YES NO N/A
19
Do you identify the testing methods
that you will need to use in order
to control product quality?
YES NO N/A
20
Do you identify the resources that you will
need to use in order to realize your products?
YES NO N/A
21
Do you prepare planning outputs that are suitable
and consistent with your organization's methods?
YES NO N/A
22
Do you develop the processes that you will
YES NO N/A
7.2 CONTROL CUSTOMER-RELATED PROCESSES
23
Do you identify the requirements that your
customers want you to comply with?
YES NO N/A
24
Do you identify your customers'
product requirements?
YES NO N/A
25
delivery requirements?
YES NO N/A
26
post-delivery requirements?
YES NO N/A
27 Do you identify warranty requirements? YES NO N/A
28 Do you identify contractual requirements? YES NO N/A
29 Do you identify maintenance requirements? YES NO N/A
30
Do you identify supplementary
service requirements?
YES NO N/A
31 Do you identify recycling requirements? YES NO N/A
32 Do you identify final disposal requirements? YES NO N/A
33
Do you identify the requirements that are dictated
by your products' intended use or purpose?
YES NO N/A
34
Do you identify the requirements that are imposed
on your products by external agencies?
YES NO N/A
35
Do you identify product requirements
that are imposed by regulators?
YES NO N/A
36
Do you identify product requirements
that are imposed by statute?
YES NO N/A
37 Etcetera ... YES NO N/A

ORGANIZATION: YOUR LOCATION:
COMPLETED BY: DATE COMPLETED:
REVIEWED BY: DATE REVIEWED:
MAR 2009 COPYRIGHT 2009 PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. EDITION 4.0
PART 7 GAP ANALYSIS QUESTIONNAIRES PAGE 35
Now that you know what our Gap Analysis Tool looks like, please
consider purchasing Title 21: ISO 9001 2008 Gap Analysis Tool.
If you purchase our Plain English 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 it.
Title 21 can be delivered to you on CD or as an email attachment.
Title 21 is 123 pages long and comes in pdf and MS doc file formats.
Check our Prices Place an Order Check our License
MORE ISO 9001 PAGES
ISO 9001 Introduction
Quality Management Principles
ISO 9001 2008 versus ISO 9001 2000
ISO 9001 2000 versus ISO 9001 1994
Plain English Quality Management Definitions
ISO 9001 2008 Translated into Plain English
How to Upgrade to the New ISO 9001 2008 Standard
How to Develop a Process-based QMS
Process-based QMS Development Plan
The Process Approach to Management
Quality Management Audit Program
Frequently Asked Questions
OTHER GAP ANALYSIS TOOLS
Food Safety Management Gap Analysis Tool
Environmental Management Gap Analysis Tool
Aerospace Quality Management Gap Analysis Tool
Information Security Management Gap Analysis Tool
Medical Device Quality Management Gap Analysis Tool
Occupational Health and Safety Management Gap Analysis Tool
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Updated on November 30, 2013. First published on December 4, 2000.
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7/14/2014 ISO 9001 2008 Gap Analysis Tool

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