Approximately 90 days remain to meet the December 15, 2003, deadline for transitioning from the 1994 version of ISO 9000 to the 2000 version. While customer requirements is the most frequently cited reason for making the transition to ISO 9001: 2000, the benefits a company reaps from using a process-based approach, a key underlying element of the new version, provide an even stronger case for making the transition. By undergoing an 8-step program, manufacturers can quickly adopt the process-based approach and be ready for certification by the deadline.
Step 1. Identify the key differences in ISO 9001: 2000
The most significant change in ISO 9001: 2000 is moving from a procedure-based approach to a process-based approach. Other changes include:
- Establishing measurable objectives
- Defining competencies required for personnel
- Assessing the effectiveness of actions to establish and maintain competencies
- Additional identification of qualifications and monitoring of suppliers
- Increased evidence of management involvement
- Systematic evaluation of the results of the monitoring and measurement
- Monitoring that indicates customers’ perceptions that requirements have been met
- Achieving continual improvement
The minimum number of documented procedures is reduced to six, and they are document control, records control, control of nonconformities, internal audits, corrective action and preventive action. However, it is a company’s responsibility to ensure that they have the necessary documentation for effective planning, operation and control of the business. This affords the opportunity to eliminate procedures in place “just for the standard” and ensures the procedures are meaningful to the requirements. In general, the changes to the standard focus on achieving results and improving processes, rather than simply having procedures.
Step 2. Understand the process-based approach
A step that many companies overlook is to make sure that everyone on the management team understands the process-based approach. Figure 1 shows the essential difference between the procedure-based approach used in the 1994 standard, and the process-based approach used in ISO 9001: 2000.
For example, in the receiving area of a company, it is common to find the process carved up into a number of separate procedures based on the sections of the 1994 standard including: incoming inspection; customer-supplied material; in-process inspection for materials sent out for secondary processing; inspection and test status; identification and traceability; process control; storage and handling; and handling of nonconforming material.
A process-based approach considers the activities that follow a “trigger event” and the interactions among those various activities. A process is not limited by departmental boundaries.
The activities that are carried out depend on the trigger event. For instance, how identification and traceability is handled in receiving may be different if the material is
customer-supplied, received from secondary processing or conforms to a company’s inspection.
A simple document—visual, text or a combination of the two—can describe what is to be accomplished, what actions are required, what to look at, and what to look for, as part of receiving, the facilities and equipment used, what actions to take based on the situation identified, the documentation involved and who has responsibility for those actions.
This approach and documentation also meets the requirements of Section 4.1 of ISO 9001: 2000, which is the essence of the process-based approach.
- Identify the objectives to be achieved—key elements that indicate success
- Identify the activities involved—what is started with, what is done and the results
- Identify the measuring and monitoring that is done—product measures and process monitoring and measurement
- Identify what is done to establish effective planning, monitoring and control
- Make sure the needed resources are available, which include competent personnel, facilities and equipment
- Identify how it is known that the planned results are being achieved, and identify the actions to be taken if they are not achieved.
Step 3. Assess the specific situation
A company should take a thorough look at its procedures. The procedures may be working as described, and may already include the interactions that are part of a process-based approach. If they are not, the transition offers numerous benefits.
Be aware of “sand in the gears” when it comes to how the system’s elements work together. Though the deadline for certification is approaching, time and money can be saved and the system simplified by examining how activities in key areas work together. Key areas to consider include:
- Sales, customer service and production handoffs
- Engineering and production handoffs
- Material receiving
- Product completion and shipping
For example, a single order may go through sales, credit review and engineering before it gets to production. Each department has its own activities and procedures to perform, but they are all part of an overall process that gets the product made. It is common to find sand in the gears in this process. Orders may be promised for a certain date, which cannot be met because some factor unknown to the order processing personnel. Handling of special requests or changes may not be effective. Special materials may be required, involving yet other areas, such as purchasing, in the process.
The reduction in problems, errors and costs from resolving the sand in the gears can more than pay for the transition efforts, in addition to simplifying the transition.
Step 4. Lay out a step-by-step plan
There is an old equation that says:
1+59 > 60, meaning that one minute deciding how the next 59 will be spent gives a much better results than simply charging off to action.
A step-by-step plan will help identify what has to be done and ensure that nothing is left out; a logical sequence for the transition plan prevents duplication of effort.
A practical plan should include:
- Review of the quality policy and objectives
- Assessment of the results from monitoring and measurement
- Identifying processes and interactions
- Integrating the objectives, processes and measurements for improvement
- Incorporating specific elements that are new for the business
- Updating documentation
- Performing audits and completing a management review
After a timeframe for completing the transition activities is developed, confirm when the registrar will be available to do a recertification audit, if one has not already been scheduled. Many companies will be trying to schedule their ISO 9001: 2000 upgrade audits prior to the December 15, 2003, deadline, so an audit may be difficult to arrange with a registrar.
Step 5. Ensure management is on board
Top management commitment, always critical for success, is even more important to achieve the desired results in a short time period. Consider a management review meeting to make sure that everyone understands the actions and commitment required.
Step 6. Break the project into pieces
Everyone will need to participate to complete the work in the required time frame. Identify specific tasks that can be assigned to people in their area of responsibility. Give clear direction on the changes respective to their area. Include a specific timeline and hold status meetings to ensure that each piece of the puzzle stays on track.
Step 7. Apply project management principles
The key principles include:
- Identify the tasks to be done
- Identify who is responsible for what
- Determine expected start and end dates
- Track progress against the plan
- Communicate where the company is in the transition process
An easy-to-learn, easy-to-use project tracking tool will help track the necessary information, improve communication and address problems before they become critical.
Step 8. Establish a revised quality manual
Consider how the quality manual and related documentation can help minimize the cost of transition. This documentation should help avoid re-numbering the system—a nonvalue-added activity—as well as reduce the cost of ongoing compliance.
A structure found to be useful is a quality management system directory (QMSD). The relationship among the standard, the quality manual and the QMSD are shown in Figure 2.
The quality manual mirrors the requirements in ISO 9001: 2000 and includes reference to the documented procedures and an overall description of the interaction of the elements of the quality management system. Appendix A to the quality manual specifically lists the QMSD procedures.
The QMSD procedures define top-level objectives based on the requirements of ISO 9001: 2000. The QMSD also identifies how to meet those objectives based on specific operating procedures and processes. One process may meet the requirements of multiple areas of the standard. At the same time, a single requirement of the standard may be met in multiple areas of a system. The QMSD is quickly completed from the documentation of the system.
This approach makes it easier for employees, including internal auditors, and the external auditors to understand the system:
- the quality manual defines the requirements the system meets
- the QMSD procedures describe, in general terms, where in the system those requirements are met and the types of activities involved
- the processes and procedures describe in detail what is actually done
The QMSD is written so that it does not require updating unless major changes are made to a business.
While time is short, 90 days is still long enough for a company to get ready for ISO 9001: 2000 certification. The most important things to consider are to clearly assess the changes that need to be made, plan the efforts and follow the plan. Using this step-by-step approach will help companies stay on target to reach the certification deadline.
4aBetterBusiness Inc. (Northfield, IL) helps companies improve productivity and profitability with collaborative consulting services, and computer-based training and tools including electronic toolkits for transition to from the 1994 version to ISO 9001: 2000 and from QS-9000 to ISO/TS 16949: 2002. See free demos at www.4abetterbusiness.com/seeall.htm.