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OVERVIEW OF GAP ANALYSIS PROCESS

PHASE ONE: IDENTIFY GAPS

ANSWER EACH GAP ANALYSIS QUESTION

ANSWER"YES"

REQUIREMENTHAS BEEN

MET

NO ACTIONREQUIRED

ANSWER "NO"

GAP HAS BEENIDENTIFIED

REMEDIAL ACTIONSHOULD BE TAKEN

ANSWER "N/A"

REQUIREMENT ISNOT APPLICABLE

JUSTIFYEXCLUSIONS

FOR EACH "NO" ANSWER SELECT THE QUALITYPROCESSES THAT NEED FURTHER DEVELOPMENT

PHASE TWO: FILL GAPS

PREPARE PROCESS DEVELOPMENT PLANSUSING OUR PROCESS DEVELOPMENT FORMS

IMPLEMENT YOUR PROCESS DEVELOPMENTPLANS 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 questionnai res (4 to 8) to carry out youranalysis. 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.

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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: YESandNO.A YESanswer means that your organization has already met one of ISO's

requirements while aNOanswer points to a gap that should be filled.

However, whenever a requirement may be excludedor ignored, we offer

a third option:N/A. SelectN/Aif the requirement is not applicable in your

situation. TheN/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 NOto a question,

you are stating that at least one process fails to meet an ISO 9001 2008

requirement. A NOanswer 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 answerNOto 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 ofISO 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 process3. Training and awareness process

4. Product purchasing management process

5. Design and development process

6. Production management process7. Service management process

8. Product management process

9. Customer management process

10.Internal communication process11.Document management process

12.Records management process

13.Internal quality audit process14.Monitoring and measuring process

15.Compliance management process

16.Management review process

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17.Continual improvement process

Of course, this does not exhaust the list of possible processes thatcould 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 differentfrom the ones we have listed.

Phase Two: Fill Gaps

Once you've identified all of your gaps (NOanswers), you can begin

to fill them. In general, you fill your gaps by preparing and implementing

Process Development Plansusing the following Process Development

Forms:

1. Quality Management Process Development Form

2. Resource Management Process Development Form

3. Training and Awareness Process Development Form4. Purchasing Management Process Development Form

5. Design and Development Process Development Form

6. Production Management Process Development Form7. Service Management Process Development Form

8. Product Management Process Development Form

9. Customer Management Process Development Form

10.Internal Communication Process Development Form11.Document Management Process Development Form

12.Records Management Process Development Form

13.Internal Quality Audit Process Development Form14.Monitoring and Measuring Process Development Form

15.Compliance Management Process Development Form

16.Management Review Process Development Form17.Continual Improvement Process Development Form

18.General Systemic Process Development Form

Use theseProcess Development Forms to prepare yourProcess

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 formrecognizes 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

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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 turningour gap analysis questions into simple action statements.

For example, a gap analysis question might ask: "Do you protect yourmonitoring 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 DevelopmentForm (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 aRemedial Action Number (RAN)to each action,and record cross references to the corresponding ISO clause numbers

(see theISOcolumn) and gap analysis question (see the Qcolumn).

Also, specify who was given the responsibility to ensure that theremedial action is carried out. Then use these forms to monitor

and control implementation.

Once youve done this for all gaps, you will have severalProcessDevelopment Planswhich, taken together, make up a detailedProcess-

based Quality Management System Development Planthat will be uniqueto your organization. And once youve implemented yourProcess-basedQMS Development Plan, you will have an ISO 9001 2008 compliant

process-based quality management system.

You can also use yourProcess-based QMS Development Planto 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 ourGap Analysis Tool looks like. It is taken fromPart 7: Reali zation Gap Analysis Tool.

ISO 9001 2008 GAP ANALYSIS TOOL

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7. PRODUCT REALIZATION GAP ANALYSIS QUESTIONNAIRE

7.1 CONTROL PRODUCT REALIZATION PLANNING

1 Did your organization establish aproduct realization planning process?

YES NO N/A

2 Do you use your planning process to plan therealization of your organization's products?

YES NO N/A

3 Do you use your product realization planningprocess to set product quality objectives?

YES NO N/A

4 Do you use your product realization planningprocess to specify product quality requi rements?

YES NO N/A

5 Do you use your product realization planningprocess to identify product realization needs?

YES NO N/A

6 Do you identify the processesthat you willneed to use in order to realize products?

YES NO N/A

7 Are your product realization processesintegrated with other QMS processes?

YES NO N/A

8 Do you identify the documentsthat you willneed to use in order to realize products?

YES NO N/A

9 Do you identify the recordsthat you willneed to use in order to realize products?

YES NO N/A

10Do you identify the records that you willneed in order to be able to prove thatyour produc tsmeet requirements?

YES NO N/A

11

Do you identify the records that you will need

in order to be able to prove that your produc treal ization proc essesmeet requirements?

YES NO N/A

12Do you identify the prod uct acceptance cri ter iathat you will need to use in order to decidewhether or not products meet requirements?

YES NO N/A

13Do you identify the methods that you willneed to use in order to control product qualityduring the product realization process?

YES NO N/A

14Do you identify the veri f icationmethodsthat you will need to usein order to control product quality?

YES NO N/A

15Do you identify the val idationmethodsthat you will need to usein order to control product quality?

YES NO N/A

16Do you identify the moni tor ingmethodsthat you will need to usein order to control product quality?

YES NO N/A

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17Do you identify the measurementmethodsthat you will need to usein order to control product quality?

YES NO N/A

18Do you identify the inspect ionmethodsthat you will need to use

in order to control product quality?

YES NO N/A

19Do you identify the test ingmethodsthat you will need to use in orderto control product quality?

YES NO N/A

20 Do you identify the resourcesthat you willneed to use in order to realize your products?

YES NO N/A

21 Do you prepare planning outputs that are suitableand consistent with your organization's methods?

YES NO N/A

22 Do you develop the processes that you willneed to use in order to realize products?

YES NO N/A

7.2 CONTROL CUSTOMER-RELATED PROCESSES

23 Do you identify the requirements that yourcustomers want you to comply with?

YES NO N/A

24 Do you identify your customers'produc trequirements?

YES NO N/A

25 Do you identify your customers'del iveryrequirements?

YES NO N/A

26 Do you identify your customers'post-del iveryrequirements?

YES NO N/A

27

Do you identify warrantyrequirements? YES NO N/A28 Do you identify contractua lrequirements? YES NO N/A

29 Do you identify maintenance requirements? YES NO N/A

30 Do you identify supplementaryserv icerequirements?

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 dictatedby your products' intended use or purpose?

YES NO N/A

34 Do you identify the requirements that are imposedon your products by external agencies?

YES NO N/A

35 Do you identify product requirementsthat are imposed by regulators?

YES NO N/A

36 Do you identify product requirementsthat are imposed by statute?

YES NO N/A

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37 Etcetera ... YES NO N/A