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 Processbased 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? Do you use your planning process to plan the realization of your organization's products? Do you use your product realization planning process to set product quality objectives? Do you use your product realization planning process to specify product quality requirements? Do you use your product realization planning process to identify product realization needs? Do you identify the processes that you will need to use in order to realize products? Are your product realization processes integrated with other QMS processes? Do you identify the documents that you will need to use in order to realize products? Do you identify the records that you will need to use in order to realize products? Do you identify the records that you will need in order to be able to prove that your products meet requirements? Do you identify the records that you will need in order to be able to prove that your product realization processes meet requirements? Do you identify the product acceptance criteria that you will need to use in order to decide whether or not products meet requirements? Do you identify the methods that you will need to use in order to control product quality during the product realization process? Do you identify the verification methods that you will need to use in order to control product quality? Do you identify the validation methods that you will need to use in order to control product quality? Do you identify the monitoring methods that you will need to use in order to control product quality?

YES NO N/A

YES NO N/A

YES NO N/A

YES NO N/A

YES NO N/A

YES NO N/A

YES NO N/A

YES NO N/A

YES NO N/A

10

YES NO N/A

11

YES NO N/A

12

YES NO N/A

13

YES NO N/A

14

YES NO N/A

15

YES NO N/A

16

YES NO N/A

17

Do you identify the measurement methods that you will need to use in order to control product quality? Do you identify the inspection methods that you will need to use in order to control product quality? Do you identify the testing methods that you will need to use in order to control product quality? Do you identify the resources that you will need to use in order to realize your products? Do you prepare planning outputs that are suitable and consistent with your organization's methods? Do you develop the processes that you will need to use in order to realize products?

YES NO N/A

18

YES NO N/A

19

YES NO N/A

20

YES NO N/A

21

YES NO N/A

22

YES NO N/A

7.2 CONTROL CUSTOMER-RELATED PROCESSES

23

Do you identify the requirements that your customers want you to comply with? Do you identify your customers' product requirements? Do you identify your customers' delivery requirements? Do you identify your customers' post-delivery requirements? Do you identify warranty requirements? Do you identify contractual requirements? Do you identify maintenance requirements? Do you identify supplementary service requirements? Do you identify recycling requirements? Do you identify final disposal requirements? Do you identify the requirements that are dictated by your products' intended use or purpose? Do you identify the requirements that are imposed on your products by external agencies? Do you identify product requirements that are imposed by regulators? Do you identify product requirements that are imposed by statute?

YES NO N/A

24

YES NO N/A

25

YES NO N/A

26 27 28 29 30

YES NO N/A YES NO N/A YES NO N/A YES NO N/A YES NO N/A

31 32 33

YES NO N/A YES NO N/A YES NO N/A

34

YES NO N/A

35

YES NO N/A

36

YES NO N/A

37

Etcetera ...

YES NO N/A