ISO 9001 2008 Gap Analysis Tool

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!

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 ISO 9001 2008 Gap Analysis Tool has two phases.
The following material will introduce these two phases.

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:

Quality management process
Resource management process
Training and awareness process
Product purchasing management process
Design and development process
Production management process
Service management process
Product management process
Customer management process
Internal communication process
Document management process
Records management process
Internal quality audit process
Monitoring and measuring process
Compliance management process
Management review process
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 organization’s 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:

Quality Management Process Development Form
Resource Management Process Development Form
Training and Awareness Process Development Form
Purchasing Management Process Development Form
Design and Development Process Development Form
Production Management Process Development Form
Service Management Process Development Form
Product Management Process Development Form
Customer Management Process Development Form
Internal Communication Process Development Form
Document Management Process Development Form
Records Management Process Development Form
Internal Quality Audit Process Development Form
Monitoring and Measuring Process Development Form
Compliance Management Process Development Form
Management Review Process Development Form
Continual Improvement Process Development Form
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 don’t have to agree with the
way in which we’ve divided things up. If your list of processes differs from
ours, that’s fine (we’ve 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 organization’s 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 you’ve 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 you’ve 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. 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		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
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

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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

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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Updated on September 7, 2009. On the Web since May 25, 1997.

ISO 9001 2008*