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,
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 FDAs 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
So, in your relaxed state, you thought that you would just surf the web
and see what was new at mdis website. Maybe, you said to yourself,
"let me see what is new on mdis 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 dont 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
its 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
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
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
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.
"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 doesnt 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.
"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
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
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 Months 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.