The Relamatrix Group, in partnership with MDI consultants, Inc., provides frequently updated content on breaking news and events in the Medical Device Industry. We regularly review the market for issues and situations that are not only revelant to our clients, but manufacturers worldwide. When we see such an issue, we prepare an INSIGHT REPORT and publish it here for your review. Please visit this section often to see the latest updates.

September Issue:    ISO 9000-2000 "Problems, Problems, Problems"

What would life be without a little spice now and then. But, this is getting a ridiculous. First you have to assure FDA GMP compliance. Then you have to go out and adjust your entire quality system to make sure that you could achieve ISO certification to sell to the European Union (EU). Then the FDA comes back and changes the GMP to the Quality System Requirement and you have go back and make sure the quality system that you prepared to meet the ISO9000 standard now meets the FDA’s revised system.  At least now for two or three years you would expect to sit back with your hands behind your head, your legs up on your desk, take a deep breathe and finally get to R-E-L-A-X.

Sorry, no chance! Not in this ever-changing and regulated industry. Now the ISO group has decided that for the year 2000 they would pull off their own Y2K scare and come out with a revised ISO9000 standard (which will be called the ISO9000-2000 standard).

That is not the worst of it. The powers to be want to incorporate some very interesting concepts that may provide some interesting scenarios as to how the FDA will look to continue their road to harmonization with the EU.

So, in your relaxed state, you thought that you would just surf the web and see what was new at mdi’s website. Maybe, you said to yourself, "let me see what is new on mdi’s Insight Report", and you decide to glance at it. All of a sudden you start to feel a little anxiety and you start to twitch and your shoulders start to get tight and that tension headache is building in the back of your head. You now know that you press the mouse and close this window and tell yourself that you are never coming back here again.

Before you do, remember, I am just the messenger and don’t blame this on me.

"So, what is going on with this new ISO 9000-2000 Standard?" you ask. As you have probably been aware, the FDA has been trying to harmonize it’s GMP with the ISO standard making compliance to both standards easier to comply with.

It appears that this new standard has caused some concern with the both FDA regulators and the device industry quality managers. There are four changes that are to be incorporated into the ISO9000-2000 that are drawing objections:

1.Requirements for "continual improvement" in quality systems

2."Customer satisfaction" should be a quality goal

3.Include a "quality model" that would allow requirements to be added or deleted

4.Leeway to drop some elements of the standard when they are not considered applicable

Continual Improvement

The ISO draft states, "organizations shall continually improve the quality management system," and goes on," the quality objectives shall be consistent with the quality policy and the commitment to continual improvement."

This idea of continual improvement in reality does not fit with the FDA requirements which for the most part states, "that you are either in compliance or your are not." For the most part the FDA could understand that you are looking to improve an operation but no matter what you product must meet specifications before it is released from the facilities. If you want to improve your operations to reduce cost that is not an FDA concern unless it could affect the quality of the product.

Customer Satisfaction

"Quality management system requirements are aimed primarily at achieving customer satisfaction by meeting customer requirements through application of the system, continual improvement of the system and the prevention of nonconformity." "Customer satisfaction shall be used as one measure of system output and internal audit shall be used as a tool for evaluating ongoing system compliance."

The draft guideline also states that that, "Organizations shall monitor information on customer satisfaction and/or dissatisfaction." It was never a FDA concern to determine customer satisfaction. As a matter of fact, the FDA doesn’t really care about whether your customer is satisfied with your product or not. Of course if a customer makes a complaint, the FDA is very concerned as to what the complaint was and what was done to investigate that complaint. If your customers are satisfied, well, that is nice but of no concern to the agency. The work to be done to achieve customer satisfaction may at times go against the FDA regulations. This has to be considered when attempting to obtaining certification to this revised ISO standard.

Process Model

"The systematic identification and management of various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the process approach to management."

This would have to be measured using an integration of the following areas of the standard - management responsibility, resource management, product realization and management review. By using these areas you would be required to determine what changes have to be made to make the appropriate improvements.

If properly used, this would then look to continual improvement as a basis of determining if Process Model is properly functioning.

Reduction in Scope

This revision of the ISO standard will combine the ISO-9001 with the 9002 and 9003 standards. This is being done because of the way these standards have been interpreted as ISO-9001 being the highest level of certification while 9002 and 9003 being a lower level of certification. In reality the certification to the standard means the same but the capabilities of the operations are different.

To eliminate this perception, there will only be one certification, ISO-9000 for all companies and in your compliance to the stand you will determine which sections of the standard apply to your operations and which do not allowing you the flexibility to reduce the scope of the standard when necessary.

This could create a problem for manufacturers. There have been many instances where a company could have achieved ISO-9003 certification but to meet FDA GMP compliance there would be additional requirements. Reducing the scope of the ISO standard to meet your operations may at times not be congruent with the FDA GMP and thus you could meet the ISO standard but fall out of compliance with the FDA regulations.

So, now what do you have to look forward to.?

If you are already certified to the ISO standard, you will have to go back to your quality system once the final draft is announced and revised your system to meet the new standard. You will probably have a period of time to do this. You should be in contact with your certified body to determine when this new standard will be in effect and what will the potential problems be if you are not meeting that standard during the surveillance audit.

For companies not presently ISO certified but who want to move towards certification, I would not put off starting your project waiting for this final draft. I recommend that you initiate the project and then as you get close to the completion of the project and certification look to assure that as the new draft is finalized you adjust your quality system to implement these changes. Waiting for the final changes to the standard could cause you undue delays and a waste of valuable time.

As the saying goes, "when you think things are going well, that is then you have to be on guard." There never seems to a dull moment.

Next Month’s Insight Report – The QSIT goes into effect

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.

Copyright 1998 mdi Consultants, Inc.