ISO 9001 2000 Gap Analysis Tool

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!

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.

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.

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!

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		RECORD ANSWERS				IF NO GO TO
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		RECORD ANSWERS				IF NO GO TO
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:

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you may make as many copies as you need for use
at one site or location within your own organization!

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that it's integrated, detailed, exhaustive, and easy to understand.
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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


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ISO 9001 2000

GAP ANALYSIS TOOL