The 9000 Resource

Step 4 Gap Analysis

What is an ISO 9001 Gap Analysis?

One of the first steps in your Quality Management System (QMS) transition or implementation project is to compare your current QMS to the requirements of the ISO 9000:2000 standard. This is most commonly called a Gap Analysis.

ISO 9001 Gap Analysis Checklist

• The most important tool for the Gap Analysis is the Gap Analysis Checklist. This is a list of the requirements in the standard, written in question format.
• The auditor will use this list to compare the QMS that is in place with the requirements of the ISO 9001:2000 Standard.
• The checklist provides the auditor with recommendations of what documents to look for, examples of what will meet the requirements and other guidance on auditing to the standard. The checklist also gives the auditor a specific place to document what they saw that did or did not meet the standard.
• Scheduling the Gap Analysis
• Conducting the Gap Analysis
• How to use the Results of the Gap Analysis: The Report

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The 9000 Store  sells a  Gap Analysis Checklist Toolkit for $39. The toolkit includes

• Gap Analysis Checklist: a detailed, 37 page checklist with guidance on what to look for to evaluate your current processes and their compliance to the ISO 9001:2000 Requirements.
• Project Plan
• Project Plan Template
• Employee Flyer to use to explain the Gap Analysis to employees
• Buy one now

Step 5: Documenting your system

Step 3 Develop your ISO Project Plan

Determine the project goals

In order to start planning, you will need to determine what your goals are for the project. Answer these questions:

1. When will you start your project?
2. Consider the start of your project as the date of the Gap Analysis. When will you be ready to conduct the Gap Analysis?
3. Recommended steps to be completed before conducting the Gap Analysis: Identify one or more people to conduct the Gap Analysis; it is helpful if they have some quality system experience or audit experience. You may also want to consider having assistance from a consultant. Create or purchase a checklist for the Gap Analysis Checklist.
4. Schedule the Gap Analysis, and communicate to all employees what is being done, and why. You will want to be able to make the employees comfortable with answering your auditors questions.
   
   The auditor is the person conducting the gap analysis. It may be an audit team or one individual
   
   Free planning template:Download Project-Plan-Template.doc
   

When does your company want to have an ISO 9001:2000 certificate in hand?

• The answer to this question will determine your timeline.
• The shorter time frame allowed for the project, the more resources the project will demand during implementation.
• It is important to know what your goal is because other dates will be determined by this information.
• Find out if there are company goals, are there clients that are requesting certification or other circumstances that will determine the date?
• Your date may be revised later. You will use this as a target date, and as we move along to the gap analysis and creating the task list you will be able to determine if the date is realistic. It will depend on what you currently have in place for your quality system, and how many resources you have available for the project.

Identify Project Responsibilities

It is important to determine who will be leading this project. Are you the person leading the charge? If so, you would be the project manager. You do not need to identify the management representative at this point. You will need to clarify who makes up "Top Management". The standard has requirements to be fulfilled by Top Management, and the sooner they are involved in this project the better.

• Who is your project manager?
• Who makes up Top Management at your organization?
• Who should be on the ISO 9001 Steering Team? This team will play an important role in planning, coordinating and providing resources for the ISO 9001:2000 project.
• What is the ISO 9001 Steering Team?

Begin to fill in the Project Timeline

1. When will you conduct your Gap Analysis and how long will it take to complete?
2. A Gap Analysis can typically take anywhere from 2 days to 5 days to perform. It will depend on the size of your organization, the number of auditors, the state of your current quality system and the experience of your auditors.
3. Planning Meetings to assign Task Teams.

This will take one or two meetings. Tips for Planning your Planning Meeting.The project manager and top management should be involved.
What are task Teams?

Target a date for Introductory training for all employees.

1. You will want your employees to be aware of the project, what will need to be done, who will be involved, and why you are implementing ISO 9001:2000. Choose a date that is after the planning meeting discussed above. That way you can decide if some people that will be involved in the project need more detailed training, and you can let employees know who will be working on the project.
2. Plan training before the Task Team meetings so individuals involved in the task groups are trained before their first meeting.
   
   Resource Tip: 3 Training options from The 9000 Store
   
   General ISO 9001:2000 Employee Training
   Implementating ISO 9001:2000
   Introduction to ISO 9000 Presentation Materials

Step 4: Perform a Gap Analysis

Step 2 Set up Teams

Using Teams to Design and Document your ISO 9001:2000 QMS

Our years of experience assisting companies with ISO 9001 Implementation has resulted in a very effective method of implementation using a Team Approach. As we discuss this method, think about how big your organization is; for smaller organizations we have used "teams" as small as one or two people. For larger organizations, teams are typically 5 to 7 people.

ISO Steering Team

• We use one Team to lead the project, and call this the ISO Steering Team. The name is not important, name yours to suit your company. The function of the team is very important. This team will meet on a regular basis during the project to monitor progress, resolve questions, allocate resources and coordinate the design of the new QMS.
• The ISO Steering Team should be made up of Management representing the areas of your company. For example, a manufacturing manager, a quality manager, an administrative manager, an engineering manager and an executive manager. This will give the team the knowledge and authority it needs to make decisions and devote resources to the project.
• The management representative and/or project manager for the implementation project should be the team leader. The team leader will schedule meetings, prepare agendas, and collect information to bring to the meetings.
• While the ISO Steering Team leads the project, "Task Teams" will develop processes and document procedures to address requirements of the standard. The ISO Steering team will review the processes and procedures, and monitor the progress of the Task Teams. Our approach is to set up a Task Team for each Quality System Procedure that needs to be developed and documented.
• ISO Steering Team Page…..

 

ISO Task Teams

• The Task Teams that are set up will each look at the requirements for their process and procedure. They will be responsible for comparing the requirements of the standard to the current process used at your company. They will design a new process, or modify the current process so the company will be meeting ISO 9001:2000 requirements. They will write a procedure for the new process, and give it to the ISO Steering Team to review. Once the procedure is approved, they will introduce it to employees, training as needed. The company will then start using the new process/procedure.
• It is important to remember that not all of the Task Teams need to start working at the same time. The ISO Steering Team will want to prepare a timeline and assign start and end dates for the Task Teams. Visit the ISO Steering Team Page for downloads of the Task Team assignments and a Gantt chart for the project.
• ISO Task Team Page...

Step 3: Develop your implementation plan

Learn about ISO 9001

Step by Step:
Leading your Company to Successful ISO 9001:2000 Registration

ISO 9001:2000 can be simplified by breaking the project down into manageable steps. Here is our 11 step process for a successful project. Visit this page as you start a new step and follow the links to free tools that will help you complete the task.

The 9000 Store offers some economical ways to do this:

• Free online tutorial "Basics of ISO"
• Free Quickstart Kit includes a detailed implementation guide and some PowerPoint presentations.
• Once you are ready for a more in-depth training that explains how to implement ISO in your company, try the  online "Implementation Training".

Step 2: Set up Implementation Teams