The 9000 Resource

ISO 9001 Gap Analysis Report

Summarize the audit findings in the form of a task list.

You will usually identify several categories of tasks.

1. Processes that comply with the standard and are documented.
2. Processes that comply with the standard and must be documented.
3. Processes that do not comply with the standard and must be redesigned.
4. Processes required by the standard that are not currently in place.

For each requirement (or set of requirements) of the standard you will want to identify the status of the current system. The ISO 9001:2000 Steering Team will use this information as they assign responsibility and timelines to Teams. Task Teams will be assigned responsibility for development of a procedure.

Conducting a Gap Analysis

1. Follow the schedule that you have prepared. Go into each area of the facility to evaluate the current quality system.
2. Focus on what is in place, and what is not in place. Remind auditors that you are not focusing on compliance or non compliance to the current system, but on the design of the current system, and how it matches the ISO 9001:2000 requirements.
3. Take notes on what is in place, and what will need to be developed and changed. Take complete notes, reference documents and examples.

Next: Gap Analysis Report

Scheduling the ISO 9001 Gap Analysis

Review the project plan

1. Schedule the Gap Analysis, and communicate to all employees what is being done, and why.
2. You will want to be able to make the employees comfortable with answering your auditor's questions.You may want to consider sending out a newsletter to inform employees that the Gap Analysis will be performed, by whom, when and why the Gap Analysis is being performed. Use the Employee Newsletter which is included in the Gap Analysis Checklist Toolkit.
3. Determine whether you will audit by process/procedure or by area of the facility. Our approach is usually to audit by area of the facility.
4. Divide the facility into manageable areas.
5. Schedule time to audit each section of the standard that applies to the area.
6. If you are using an audit team, assign the team to cover the various areas of the facility.
7. Arrange your Gap Analysis checklists so each auditor will have the sections of the standard that are applicable in the areas they will cover.

Next: Conducting the Gap Analysis

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

ISO 9001 Task Teams

Visit our page on Using Teams to Implement ISO 9001:2000 for a description of the Team Approach and an overview of the functions and make up of the ISO Steering Team and Task Teams.

Task Teams

The team leader is responsible for scheduling the first team meeting according to the plan on the Gantt chart.

Team Leader: Create a Task Team First Meeting Agenda, include:

• Discussion of the Responsibilities of the ISO 9001:2000 Steering Team and Implementation steps. Use the PowerPoint presentation “Implementation of ISO 9001:2000”
• Give out the Task Team Handout
• If you are using The 9000 Store Procedures, hand out the Quality System Procedure that the team will be responsible for.
• Explain to the team that the Procedure and your process must match. Some of your processes (the way you do things) will need to be changed to meet requirements of the standard, and parts of the procedure will need to be edited to accurately describe what you do.
• If you are not using the prepared procedures this team will be responsible for developing and documenting the new procedure for thier section of the standard. The completed Gap Analysis will show the team what requirements are not being met by your current process.
• You will need to make changes to your current process to conform with the requirements.
• List the requirements from the Gap Analysis that you are meeting.
• Identify the requirements of the standard that you will need to address to be in compliance.
• Schedule next meeting. During the next meetings you will work on the tasks that you have listed above.
• Once the process has been determined the procedure will need to be finalized and sent for approval by the ISO 9001:2000 Steering Team.

Agendas for the next meetings should include:

• Read The 9000 Store Procedure (Or for the team responsible for the quality manual read The 9000 Store Quality Manual and compare to current processes.)
• If not using The 9000 Store procedures, outline a new process to meet the requirements of the standard.
• Assign tasks for implementing changes in your processes and editing prepared procedure.
• Set next agenda
• Schedule next meeting

ISO 9001 Steering Team

ISO 9001Steering Team

Visit our page on Using Teams to Implement ISO 9001:2000 for a description of the Team Approach and an overview of the functions and make up of the ISO Steering Team and Task Teams

Determine who will be on the team. Include top management. Answer these questions:

• Who will be able to decide which employees will be assigned tasks?
• Will they know whether the employees' workload will be able to accommodate the assigned tasks?
• Who is responsible for resources and can make resources available to the ISO 9001:2000 project?
• This group should continue meeting as the “ISO 9001:2000 Steering Team”

Use the downloads listed at the bottom of this page to prepare for your ISO Steering Team Meetings.

Prepare your Agenda:

• Explain the Implementation Steps to the team
• Download and use the PowerPoint presentation ISO 9001:2000 Implementation
• Use the PowerPoint presentation “ISO 9000 Implementation Tips and Techniques” to give the team an overview of the dos and don’ts of implementation.
• Assign the tasks to individuals or teams. Complete the Task Team Assignments Table
• Review the responsibilities to make sure that they are well dispersed, not assigned heavily to one group or one individual.
• For each team identify a team leader. It works very well to have a member of the ISO Steering Team as a leader for each of the Task Group teams. It provides good communication between the teams and the ISO Steering Team throughout the project.
• Determine resources required for completion of the tasks.
• Will teams or individuals need assistance with other responsibilities during the ISO 9001:2000 project?
• What kind of technical guidance will be needed to allow these teams or individuals to complete the tasks efficiently and effectively?
  Assistance from the management representative?
  Prepared materials?
  Special Training?

Assign dates to tasks. Complete the Gantt Chart

• Complete the Gap Analysis before starting the Task Teams. They will use information from the Gap Analysis.
• Stagger start dates according to resources available.
• Determine which tasks you need to complete in the beginning to allow others to build on, for example: Management Responsibility. Complete the Quality Policy and Quality Goals as well as identifying key processes and their interrelation early on in the project.
• Estimate the amount of time needed to complete each task based on the amount of resources available to the task.

ISO 9001:2000 Steering Team Responsibilities

• Identify team members for each procedure.
• Assign target start date and completion date for each team.
• Identify training needs for employees and schedule training sessions:
• Meet on a regular basis to evaluate progress, answer questions for the teams and evaluate resource needs for the implementation.
• Review and approve procedures as they are finalized.
• Evaluate and choose a Registrar

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

We finished our documentation, now what?

Congratulations on completing your QMS design and documentation! This is a good time to celebrate, and to communicate appreciation and kudos to everyone involved!

The next step in your project is to use and improve your QMS:

Follow documented procedures and work instructions

Everyone in your organization should be performing processes following your documented procedures and work instructions, complying with the QMS requirements.

Make improvements to the processes
Many of these procedures may be new to your organization, or have changed significantly during your ISO 9001 project. Now that they are actually in use, you will most likely find areas that can be improved. Make improvements using the Corrective and Preventive Action process and the document revision process.

Conduct Internal Audits
Schedule internal audits to cover all areas of the organization before your Registration Audit. Allow time to take corrective action on any findings. A robust and effective internal audit program is one of the best tools to finding and correcting shortcomings in the QMS before your Registration Audit. You willll need to train a team of internal auditors. Internal Auditor Training Materials Package allows you to do that yourself, in-house.

Hold frequent Management Review meetings
Management Review is another key factor in getting the new QMS ready for a Registration Audit. Review information from Internal Audits, Corrective and Preventive Action and results of measuring and monitoring of the QMS. Initiate corrective actions and preventive actions to fix problems and make improvements to the QMS.

Keep records
During the Registration Audit, the auditor will be looking for evidence that you are complying with the requirements of ISO 9001 and of your QMS. This evidence is in the form of records that you generate as you run your QMS. Be sure that you are following all of the records requirements that you set up in the QMS. Run your system for several months before your Registration Audit so there are sufficient records for the auditor to evaluate.