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Who can I
contact for answers to technical or ISO standards-related
questions?
You can talk to
your auditors or contact our technical support team at 203
877-8088 M-F, 8:00am - 7:00pm EST. You can also click on the link to
the right to email us and we will respond ASAP to any/all of your
quality or business systems management
questions/concerns.
Questions about
transitioning (and registering) to ISO 9001:2000
How is ISO
different from
TQM?
ISO 9000:2000 is total
quality management. It requires management of every process in an
organization that impacts quality.TQM is not quality management, but
process management -- the process of improvement. And it is
not total since it only addresses one aspect of quality management
-- improvement. While ISO-9000 is a clearly defined
system, TQM is a philosophy. ISO is by far superior to TQM because
it offers a set of guidelines for quality management and can stand
alone, while TQM can not.
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How
long does it take to transition a company from ISO 1994 to ISO
2000?
That
depends on the size of the company and the complexity of the system.
On average, RH Andersen's "TEAM ISO" can transition a small (less
than 50 people) company to certifiable (ready for certification
audit) in 120 days.
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Can the transition
audit be done in conjunction with a periodic or re-certification
audit?
Yes, the most cost
effective way to conduct the transition audit is in conjunction with
a regularly scheduled periodic or re-certification audit. The
transition audit can also be conducted independently from the
periodic and re-certification audits.
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Can I have my
regular auditor do the transition audit?
Yes, subject to the
auditor's availability. We would encourage you to get the transition
audit dates on the schedule as soon as possible. This will increase
the likelihood that your auditor will be available.
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What happens if I
am ready to have the transition audit and my registrar does not have
any auditors available?
Most registrars will
have adequate resources to meet the demand. The key thing is to
schedule with your registrar as far in advance as possible. If the
audit is not put on the schedule early enough the auditor assigned
may not necessarily be your regular auditor.
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How
much extra time is involved for the transition and what is the
cost?
The extra time required
is generally a function of the number of employees under the scope
of the audit. Where there are multiple shifts the number of
employees on the largest shift will be used to determine the audit
duration. The cost will be based on the required number of audit
days times your regular audit day rate. Contact your registrar for
the specific days required.
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Why is extra time
needed?
There are new
requirements in ISO 9001:2000 which were not previously found in ISO
9001/2/3:1994. The additional time is required to verify compliance
with these requirements. If the transition is conducted in
conjunction with a periodic audit this time will be in addition to
the time required for the periodic audit.
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Do I have to send
internal auditors for training on ISO 9001:2000?
It is not a requirement
of the standard. However, as with any other function within your
organization, you do have to define appropriate skills and training
in order to ensure that the auditors are competent to conduct the
audits.
What happens
if I did not complete the transition audit by December 15th
2003?
The International
Accreditation Forum (IAF) which consists of most of the world's
major accreditation bodies, has mandated that accreditation schemes
for ISO 9001/2:1994 will cease on December 15th,
2003. You can maintain ISO compliance without certification until
December 15th, 2004, but must transition to 2000 during that time
period. If you have not completed transitioning by December
2004, you may get a waiver from your customers, if they see yo being
pro-active in persuing regitration...
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Do I have to do a
complete internal audit cycle based on ISO 9001:2000 prior to a a
registration audit?
As a minimum you will have to have performed one
internal audit of all the elements to verify the effectiveness of
the implementation of the new requirements in ISO 9001:2000. This
applies whether you are transitioning to ISO or geting registered
for the first time .
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Do I have to
complete a management review prior to a registration
audit?
Yes, there needs to be
evidence that management has reviewed the new requirements of ISO
9001:2000 to verify that they are implemented and are effective. As
your Quality Objectives are your degree of success in actually
obtaining them is still hard to measure, that will be taken into
consideration by the certification auditor.
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Will additional
document review be required?
Yes, the auditor will
have to verify that the Quality Manual addresses the requirements of
ISO 9001:2000.
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Do I have to
re-write the quality manual if I already have one for the 1994
standard?
No, but the manual will
have to address all of the requirements of ISO 9001:2000.This will,
at the very least, mean some additions and reorganization of your
manual's content.
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Where can I get
copies of the ISO 9000:2000 standards?
Among other
places the standards can be purchased from the American Society for
Quality www.asq.org or the
International Organization for Standardization in Geneva,
Switzerland www.iso.ch
We strongly
recommend that you purchase both ISO 9001 Requirements for Quality
Management Systems and ISO 9004 – Guidelines for performance
improvements.
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Do I have to
re-number documents and procedures from my current 1994 "element"
structure to the 2000 "Clause" structure to make it easier for the
auditor?
No, you do not have to
do anything to make it easier for the auditors. However it will make
your system easier to manage internally if there is at least a cross
reference table somewhere in your system that maps procedures and
documents from the 1994 element structure to the 2000 clause
structure. ISO 9001:2000 does have a table which will show you the
basic mapping. Re-numbering would be an option but would be a
decision that you would make based on your system.
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Can I discard my
current procedures and just keep the six now required by ISO
9001:2000?
In theory yes, however,
from a practical point of view if you have procedures and work
instructions that are in place today, and are effective in managing
your process, then they should probably be retained.
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Will the periodic
audit schedule change after a successful transition or registration
audit?
If the transition audit
is conducted at the same time as a regular periodic audit, the
periodic audit schedule will continue on the same cycle. If the
transition audit is conducted separately from the periodic audit
then the new periodic cycle will be calculated from the date of the
last day of the audit. In both cases a successful transition audit
will result in a new certificate which will be valid for a period of
three years.
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Will my certificate
expiration date change after a successful transition
audit?
Yes, the old certificate
will be withdrawn and a new certificate will be issued with a
three-year validity.
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What happens if I
get nonconformities during a retgistration or transition
audit?
If there are
minor (category 2) nonconformities issued to either the existing
requirements of ISO 9001/2:1994 or the new requirements of ISO
9001:2000, corrective actions will be required but a recommendation
will be made by the lead auditor that certification be granted to
ISO 9001:2000. If there is a major (category 1) non-conformity
against the existing requirements of ISO 9001/2:1994 and compliance
is found to the supplemental requirements of ISO 9001:2000,
corrective actions will be required and generally a return visit
will be made to verify effective implementation of the corrective
actions before a recommendation for certificate issuance to ISO
9001:2000 is made.
Can RH Andersen
perform my pre-assessment audits?
Yes. We have been
perfroming pre-assessment ausits for more than ten years and for
more than 100 satisfied customers.
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Can RH Andersen
help me with my documentation?
Yes. We can help you
with your manual, SOPs and work instructions. We can help you with
you quality plan, process mapping, etc. Just ask!
What is RH
Andersen's success ratio in getting a company through the ISO
certification process?
100%. We
have never had a customer fail a certification audit. While we do
not perform the actual certification audits ourselves, we can take
any company that wants to get there from zero quality management to
ISO compliant in 3 to 6 months.
Find out more...
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