The Road to ISO 9001:2000 Certification
You've decided that earning your ISO
9001:2000 certification will contribute to the success and
profitability of your business. Where do you go from there?
ISO 9001:2000 is an international standard for a quality management system that addresses all of the elements of quality management that a company must have in place for an effective system to manage and improve the quality of its product or service. Part 1 (January/February) examined what ISO 9001 certification encompasses and the business benefits of becoming certified.
Let.s assume now that you've decided that earning your ISO 9001:2000 certification will contribute to the success and profitability of your organization. What happens next? Implementation can seem like a daunting task, but understanding the process will make earning certification manageable for any organization.
Hire Help or DIY?
Some companies will hire outside consultants to lead them through the
certification process. This is the most expensive option, but it can
work well if an organization has a very limited amount of time
available to complete the process.
Another option is to purchase product software. Buying a software package is less expensive than hiring an outside consultant, and will give you a "roadmap" to follow in building your system, as well as a technical resource to answer questions. It is a good balance between the high cost of a consultant and going through the process completely on your own.
Some companies build their system from scratch. This will take the most time and internal resources, but it can work if there is expertise in the company. If no one has experiences with the certification process, time can be wasted by taking off in the wrong direction.
Once your company is prepared, a registration audit will be conducted by a registrar. The auditor will compare your system to the requirements, and write up non-conformances if there are discrepancies. Some non-conformances are categorized as minor, some are major, but most registration audits will result in some non-conformances. For a minor nonconformance, the organization will correct the problem and send the registrar a description of the action taken. If the registrar approves, the organization will then receive registration. If a major nonconformance is identified, or if there are many minor non-conformances, the registrar will schedule another audit of the organization after the company has had sufficient time to correct the problems. The registrar will come back every six months or every year to conduct an audit to maintain your certification.
The Preparation Process
Project Plan
Regardless of which option you take to prepare, the first step is to
put together a project plan. Determine the date that you want to have
your certificate, and work back from that date. Schedule a date three
months before your certification date to have your system complete and
running so you have sufficient records to show your auditor. Document
this date on your plan. The time between today and that date is the
time that you have to get your system designed and running.
Gap Analysis
You will start by planning a date for a gap analysis. A gap analysis is
simply an audit using the standard requirements as a checklist and
evaluating your company against it. This will tell you how much you
already have in place, and what you need to work on. When you complete
the audit, you will have a list of things that need to be developed and
documented in order to complete your system.
Identify one or more people to conduct the gap analysis; it is helpful if they have some quality system experience or audit experience. Next, prepare a gap analysis checklist. 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 auditor's questions. (The auditor is the person conducting the gap analysis. It may be an audit team or one individual, depending on the size of your company.) Conduct the gap analysis by evaluating current practices in each department against the requirements in the standard. Keep a list of requirements that are not currently being met in the organization.
Project Team
Next you will want to put together a team of people that will lead and
coordinate the project. The team should be made up of management
representing the different areas of your company. They will be
responsible for assigning people from their area to work on the system,
providing resources to the project, and coordinating the system
development with the other managers on the team.
Using the gap analysis results, this team will assign responsibility for development of procedures needed to document the quality management system. For example, a small team of individuals (a task team) might be responsible for determining a process for document control, and writing a procedure for the process. This task team would also develop any forms or work instructions required for document control. Once the process is designed and documented, the team would train employees and make sure the process is implemented throughout the organization. A team is required for each of the quality system processes that must be developed and documented.
Evaluate Current Practices These task teams will each look at the requirements for their process and procedure. They will use information from the gap analysis to compare the current system to the requirements of ISO 9001:2000. The team will design a new process, or modify the current process so the company will be meeting ISO 9001:2000 requirements. This is where a software package or consultant can be a great help. The new process will be documented as a procedure. Once the procedure is approved by the management team, 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 management team will want to prepare a timeline and assign start and end dates for these task teams. A Gantt chart is a useful tool for scheduling the task teams; spread the teams out over the time between the gap analysis and the date you identified as the date your system would be complete. The management team will watch the progress of the task teams, help resolve any issues that arise, and provide coordination between the different teams as they work.
Keep Lines of Communication Open
Communication and training are important throughout the implementation.
The project leader and management team should be trained early in the
project. Individuals assigned to be on task teams need training on the
requirements before they begin their work, and all employees must be
trained on or around the date the system is complete. Look for online
resources or local training sessions for your project leader. Once this
person is trained they can use prepared materials to conduct training
for the organization.
Communicate to employees so they understand why the organization is implementing ISO 9001:2000, and what it means to them in their jobs. The more you communicate and educate throughout the project, the better the organization will transition to the new system. Use tools such as newsletters, e-mail bulletins, meetings, and celebrations to keep everyone informed and involved.
Plan your project, and manage the project step by step. The project can take anywhere from three months to over a year, but your organization will start benefiting early on in the project and at the end of the project you will have your certificate in hand and continuous improvement built into your organization.
Cynthia Weber is president and founder of The 9000 Store (Minneapolis, MN) an ISO 9000 resource company that has developed tools, documents, and techniques that we use to assist customers with their quality management systems projects. The 9000 Store has assisted more than 4,000 companies worldwide achieve registration. Visit the Web site at www.the900store.com.
