ISO 9001 2008*GAP ANALYSIS TOOL
* Based on final version of ISO 9001 2008 published November 15, 2008. |
The following material will introduce
our ISO 9001 2008 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 ISO 9001 2008 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 ISO 9001 2008 Gap Analysis Tool is easy to understand
and
ready to use. It is focused, detailed, and complete. We guarantee
it!
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|
ISO 9001 2008 GAP ANALYSIS TOOL |
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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 |
<SAMPLE |
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|
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 ISO 9001 2008 Gap Analysis
Tool has two phases.
The following material will introduce these two phases.
|
OVERVIEW OF GAP ANALYSIS PROCESS |
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PHASE ONE: IDENTIFY GAPS |
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| ANSWER EACH GAP ANALYSIS QUESTION | ||||
|
ANSWER
"YES"
REQUIREMENT NO ACTION |
ANSWER
"NO"
GAP HAS BEEN REMEDIAL ACTION |
ANSWER
"N/A"
REQUIREMENT IS JUSTIFY |
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|
FOR
EACH "NO" ANSWER SELECT THE QUALITY |
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|
PHASE TWO: FILL GAPS |
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|
PREPARE
PROCESS DEVELOPMENT PLANS |
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|
IMPLEMENT YOUR PROCESS DEVELOPMENT |
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| Phase One: Identify Gaps |
|
Phase One asks you to identify gaps by performing a gap
analysis. Each gap analysis question has either two or three
possible answers. However, whenever a requirement may be excluded
or ignored, we offer NO answers reveal gaps that exist between the
ISO 9001 standard and
We use a process
approach, not only because it makes good sense Since the process approach is now central to ISO 9001,
we have
Of course, this does not exhaust the list of possible
processes that |
| Phase Two: Fill Gaps |
|
Once you've identified all of your gaps (NO
answers), you can begin
Use these Process Development Forms to prepare
your Process While we have identified 18 processes, you don’t have
to agree with the Of course, before you can list your remedial actions,
you need to formulate For example, a gap analysis question might ask: "Do you
protect your As you list your remedial actions using our 18 process
development Once you’ve done this for all gaps, you will have
several Process You can also use your Process-based QMS Development
Plan to help |
The
following example will show you what our
Gap Analysis Tool looks like.
It is taken from
Part 7: Realization Gap Analysis
Tool.
| 7. REALIZATION GAP ANALYSIS QUESTIONNAIRE | |||||||||
|
7.1 CONTROL PRODUCT REALIZATION PLANNING |
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| 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 |
Do you use your product realization planning process to specify product quality requirements? |
YES | NO | N/A | |||||
| 5 |
Do you use your product realization planning 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 need to use in order to realize products? |
YES | NO | N/A | |||||
| 9 |
Do you identify the records that you
will need to use in order to realize products? |
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 methods that you will need to use in order to control product quality? |
YES | NO | N/A | |||||
| 16 |
Do you identify the monitoring methods that you will need to use in order to control product quality? |
YES | NO | N/A | |||||
| 17 |
Do you identify the measurement methods that you will need to use in order to control product quality? |
YES | NO | N/A | |||||
| 18 |
Do you identify the inspection methods that you will need to use in order to control product quality? |
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 need to use in order to realize products? |
YES | NO | N/A | |||||
|
7.2 CONTROL CUSTOMER-RELATED PROCESSES |
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| 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 |
Do you identify your customers' delivery requirements? |
YES | NO | N/A | |||||
| 26 |
Do you identify your customers' 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 Ó 2009 PRAXIOM RESEARCH GROUP LIMITED. ALL RIGHTS RESERVED. | EDITION 4.0 |
| PART 7 | GAP ANALYSIS QUESTIONNAIRES | PAGE 35 |
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Now
that you know what our Gap Analysis
If you purchase our ISO 9001 2008 Gap Analysis Tool, you'll find
Title 21
can be delivered to you on CD or as an email attachment. |
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