The revised standards incorporate several concepts that will tend to bring the standard into better alignment and harmony with what are generally considered "best practice" strategies for quality management systems.

The new revisions at first look like a complete rewrite, but don’t throw out your old quality manual yet. The standards are undergoing a reorganization to a process oriented structure. All the current requirements are still there, with a several new ones. The two most obvious of these for ISO 9001 are more of a focus on customer satisfaction and continuous improvement. This is driven by a process model for quality management.  Most companies are probably practicing many of the new requirements, they just aren’t formally in your quality system yet.   You can view the table for a comparison of the 1994 to the 2000 revision.  ISO 13485 replaces "customer satisfaction" with "maintaining customer requirements" and "continuous improvement" with "improvement to regulatory requirements" driven largely by USA and EU medical device quality system regulations.

There are three standards that form the basis of ISO 9001:2000:
• ISO 9000 - Fundamentals and vocabulary
• ISO 9001 - Requirements
• ISO 9004 - Guidance for performance improvement

The old ISO 9002 and 9003 standards were withdrawn. Under the new system companies will implement the elements of the ISO 9001:2000 that apply to their business. Thus if you do not design products, you do not apply that part of the standard.

The 20 elements that form the soon to expire ISO 9001 standard are folded into a new structure with four sections:

1. Management responsibility
2. Resource management
3. Product and/or service realization
4. Measurement, analysis, and improvement.

ISO 9001 and ISO 9004 now form what ISO calls a "Consistent Pair" of quality management standards. It is intended that the 9001 document will define the minimum requirements and that 9004 will provide guidance for companies to go beyond the minimum requirements by a process of continual improvement. The old Customer Complaint, Self-Audit, and Corrective and Preventive Action requirements were pointed in the direction of continual improvement, but now it will be a fundamental theme.

Another major difference is a requirement for actual measurement of customer satisfaction. The concept of customer satisfaction is a fundamental feature of most modern quality management philosophies.

The new standard will also place more emphasis on the need to provide and make available specific types of resources. The required resources will include such elements as information, communication, infrastructure and work environment protection.

If your company is currently certified to one of the existing ISO 9000 standards, you may be wondering what happens now?. Those of you certified to the soon-to-be-obsolete 9002 or 9003 standards may be especially concerned.

The ISO 9001:2000 is intended to build on the requirements of the old system. So, you have the foundation already in place to make the transition to the new 2000 standard. Most of your existing systems and documentation will simply fold into your new ISO 9001:2000 system. There will be a need for some new procedures, and the quality systems manual may need to be reorganized or at least re-indexed.

The revision of the ISO 9000 standards is needed to take the standards to the next level of achievement. The new standards build on the old requirements, with the goal of encouraging continual improvement of quality performance, resulting in enhanced customer satisfaction.

The two-year transition period after the adoption of the revised standard is almost over. Now is a good time to begin discussions with your notified body or registrar, to plan a transition based for your particular situation. We can support you in this through training, ISO9001:2000 gap analysis and planning, and for ISO 13485:2003 which follows the same revisions as ISO 9001:2000..