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Introduction |
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The
ISO
9000
series
was
developed
as
an
international
standard
to
confirm
manufacturers
establish
and
maintain
a
uniform
quality
management
system
to
better
meet
the
customer's
needs.
The
standard
addresses
design,
development,
production
and
service
and
can
be
used
in
any
business
in
any
industry.
In
order
to
successfully
prepare
for
the
requirements
of
the
standard,
companies
will
need
to
have
a
solid
awareness
and
demonstrated
objective,
evidence
of
an
effective
management
system.
The
ISO
9001:2000
standard
provides
a
focus
on
system
processes
as
opposed
to
elemental
areas.
The
layout
of
ISO
9001
and
9004
have
a
new
consistent
structure.
The
twenty
elements
of
the
ISO
9001:1994
have
been
restructured
in
four
major
areas
or
clauses
of
ISO
9001:2000.
This
restructuring
was
done
to
provide
a
better
and
more
logical
sequencing
of
the
requirements
and
is
intended
to
make
the
documents
easier
to
use.
The
standard
is
now
divided
into:
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Clause 5.0 - Management Responsibility |
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Clause 6.0 - Resource Management |
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Clause 7.0 - Product Realization |
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Clause 8.0 - Measurement, analysis and improvement |
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Download
"ISO
9001:2000
Interpretations"
For
organizations
still
seeking
to
achieve
ISO
9001/2:1994
registration,
TÜV
Rheinland
will
continue
to
provide
registration
audits
until
December
31,
2002.
At
that
point,
we
will
no
longer
register
new
organizations
to
the
1994
revision
of
the
standard.
It
is
important
for
an
organization
to
review
the
TÜV
Rheinland
transition
policy
(see
below)
to
better
understand
these
requirements.
To
help
you
benefit
from
the
implementation
of a
complete
quality
system
and
ISO
9001:2000
certification,
TÜV
Rheinland
of
Iran,
offers
experienced,
professional
service.
As
an
ISO
9001:2000
registrar,
we
can
work
with
you
to
make
registration
easily
attainable
and
a
reality
for
your
company.
As
one
of
the
leading
registrars
in
North
America,
we
have
the
skills
and
expertise
to
meet
your
distinctive
needs.
We
are
committed
to
quality
and
to
guiding
you
through
the
registration
process.
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ISO
9001:2000
TÜV
Rheinland
Transition
Policy |
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This
policy
defines
and
documents
the
transition
from
the
1994
version
to
the
2000
version
of
ISO
9001:2000.
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Scope of
Policy |
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The scope of this policy includes all ISO 9001:2000 assessments services offered by TÜV Rheinland of Iran, worldwide.
Note: there will be no immediate effect on QS-9000:1998 certificates. However, the prudent customer may wish to begin to examine the ISO 9001:2000 standard.
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Acceptance
of
applications
for
assessments
services |
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On
January
1,
2002,
TÜV
Rheinland
of
Iran,
started
accepting
applications
to
the
1994
revision
on a
case-by-case
basis
for
the
remainder
of
the
transition
period.
Applications
will
be
reviewed
by
the
Operations
Manager
and
a
determination
on
rejecting
or
accepting
the
request
will
be
made
within
five
business
days.
Note:
any
certificate
issued
to
the
1994
version
of
the
standard
will
have
a
validity
date
up
and
until
December
14,
2003
only.
While
the
transition
period
is
from
December
15,
2000
to
December
14,
2003,
TÜV
Rheinland
of
Iran,
strongly
advises
that
you
do
not
wait
until
the
final
year
to
convert
to
the
2000
revision.
We
accept
applications
to
the
ISO
9001:2000
standard
and
are
conducting
audits
to
these
new
requirements.
TÜV
Rheinland
of
Iran,
has
adopted
the
ISO-issued
guidance
on
the
application
of
ISO
9001:2000.
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TÜV
Rheinland's
transition
timing
and
process
from the
1994
revision
to the
2000
revision
for all
existing
and
future
customers |
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TÜV
Rheinland
converted
the
vast
majority
of
it's
client
registrations
to
the
2000
revision
no
later
than
the
end
of
2002
and
used
the
remaining
year
to
assist
those
clients
that
need
the
full
three
years
to
transition
over
to
the
new
standard.
Note:
Any
organization
that
did
not
convert
by
12/14/03
will
have
their
current
registration
to
ISO
9001/9002:1994
withdrawn.
Any
company
that
has
not
converted
by
12/14/03
will
have
to
complete
the
entire
registration
process
before
a
new
certificate
can
be
issued.
TÜV
Rheinland
will
offer
a
Gap
Analysis
to
the
new
version
of
ISO
9001:2000
to
any
customer
that
would
like
to
take
advantage
of
this
service.
This
can
be
performed
as
an
add-on
to a
regularly
scheduled
surveillance,
or
as a
separate
visit.
The
Gap
Analysis
can
be
provided
with
verbal
and
written
feedback
on
site,
or,
at
an
additional
cost,
with
a
comprehensive
report
describing
in
detail
the
requirements
of
the
new
standard
and
the
findings
of
the
Gap
Analysis.
Similarly,
formal
upgrade
audits
to
the
new
standard
can
be
performed
as
an
add-on
during
a
scheduled
surveillance
audit,
or
at a
separate
visit.
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Registration
of
multiple
sites |
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The
existing
assessments
policy
for
multiple
site
registrations
is
applicable.
A
sample
of
sites
will
be
assessed
over
the
two-year
transition
period
(2001/2002)
and,
once
conformance
to
the
new
standard
is
verified
for
the
organization
and
sites
visited,
registration
will
be
recommended
and
granted
for
all
sites.
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Classification
of
findings |
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During
the
transition
process,
the
following
classifications
of
findings
could
be
documented
during
an
assessments:
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Non-Conformance (major, minor) against the 1994 revision of the standard |
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Non-conformance (major, minor) against the 2000 revision of the standard once the transition process has been started. |
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Observations or Opportunities for improvement against the 1994 or 2000 standard. |
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Transition
Plans |
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Customers currently registered to ISO 9001/2:1994 must request a quote for the upgrade process of their choice.
Although we will customize our audit plan to meet your unique needs, our upgrade audit will generally follow the sequence outlined below. We will assume based on previous audit history that your system is in compliance to the requirements that have not changed although it may be necessary to look at these areas as part of the process. As in the past, at least one full cycle of internal audits and a formal management review must have been completed prior to the registration of your quality management system to the new standard. We have defined the process in this manner because we feel it identifies a natural sequence of events in transitioning from the 94 to the 2000 standard.
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Generic
Audit
Plan for
ISO
9001:2000
Upgrade |
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Review of QMS documentation, including review of any exclusions |
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Elements 1.2, 4.1, 4.2 |
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Product realization |
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Elements 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, as applicable |
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Measurement Analyses & Improvement |
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Elements 8.1, 8.2, 8.3, 8.4, 8.5 |
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Management Responsibility |
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Elements 5.1, 5.2, 5.3, 5.4, 5.5, 5.6 |
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Resources Management |
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Elements 6.1, 6.2, 6.3, 6.4 |
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The
issuance
of
certificates
to ISO
9001:2000
conforming
systems |
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Once
your
organization
has
been
found
to
be
in
conformance
with
ISO
9001:2000
you
will
receive
a
new
certificate
of
registration.
Please
note
your
new
certificate
of
registration
will
have
a
period
of
validity
until
the
current
expiration
date.
If a
full
registration
audit
to
ISO
9001:2000
is
performed,
the
certificate
will
be
valid
for
three
years.
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Registrar
training
of staff
personnel
to the
requirements
of ISO
9001 &
ISO 9004 |
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All TÜV Rheinland assessors/auditors and administrative staff have received and will receive ongoing training that is necessary for their activities and that are in accordance with IRCA and TÜV CERT assessor qualification requirements, as applicable. TÜV Rheinland has already begun this training process and it has been reviewed by some of our accreditation bodies already and found to be in compliance with the requirements.
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ISO
9001:2000
"Top
Management"
Responsibilities |
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ISO
9001:2000
introduces
the
term
"Top
Management"
into
the
standard
for
the
first
time.
Top
Management
is
defined
within
ISO
9001:2000
as
the
"person
or
group
of
people
who
direct(s)
and
control(s)
an
organization
at
the
highest
level."
TÜV
Rheinland
has
defined
for
its
clients
"Top
Management"
as
the
individual
or
group
with
the
final
decision
making
responsibility
for
all
activities
related
to
the
QMS
at
the
facility.
This
chart
illustrates
the
responsibilities
of
Top
Management
during
the
design
and
implementation
of
the
quality
system,
and
during
the
maintenance
and
improvement
of
the
system.
As
per
the
requirements
found
in
Control
of
Records
(4.2.4),
you
will
need
to
provide
evidence
to
registration
auditors
to
demonstrate
your
role
in
fulfilling
each
of
these
responsibilities.
Note
that
Top
Management
responsibilities
cannot
be
delegated.
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ISO
9001:2000
Responsibilities
of Top
Management |
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Design
and
Implementation |
Maintenance and Continual Improvement |
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Establish the quality policy. |
Communicate the importance of meeting customer, statutory and regulatory requirements. |
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Ensure that quality objectives are established at all relevant levels of the organization. |
Conduct management reviews. |
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Ensure availability of resources. |
Ensure availability of resources. |
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Ensure that the planning of the quality system is carried out to meet the requirements of the standard and the quality objectives. |
Ensure that customer requirements are determined and fulfilled. |
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Ensure that responsibilities, authorities and their interrelation are defined and communicated. |
Ensure that the integrity of the quality management system is maintained when changes are made. |
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Ensure that appropriate communication is established within the organization and effectiveness of the quality management system is communicated. |
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ISO
9001:2000
Documentation
Requirements |
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ISO
9001:2000
provides
the
opportunity
for
many
organizations
to
examine
their
current
documented
quality
management
system.
It
is a
commonly
held
belief
that
the
latest
revision
of
ISO
9001
only
requires
six
documented
procedures.
Although
the
new
standard
explicitly
states
requirements
for
six
"documented
procedures"
when
reviewing
the
quality
system
it
is
essential
to
ensure
that
the
organization
has
reviewed
two
specific
areas
for
documentation.
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I.
Specific
procedures
required
by the
standard |
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II.
Documentation
requirements
(Section
4.2) |
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It
is
important
to
note
that
4.2.1d
places
emphasis
on
the
organization's
need
to
ensure
that
the
level
of
documentation
should
take
into
consideration
the
size
of
organization,
type
of
activities,
complexity
of
processes
and
their
interactions
and
the
competence
of
personnel.
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Effectiveness
of
Training
in ISO
9001:2000 |
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Scope of
Accreditation |
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TÜV
Rheinland
of
Iran,
offers
accredited
ISO
9001:2000
certification
to
manufacturing
and
service
organizations
in
the
regulated
and
unregulated
industries.
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Aircraft and Spacecraft |
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Automotive
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Business Machines |
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Chemical Products |
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Data Processing Equipment and Systems
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District Heat, Gas, District Heat, Water |
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Electro-technical Products |
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Glass and Ceramic Products |
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Iron, Steel and other Metal Products
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Machine Construction Products
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Marine Craft |
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Medical Devices |
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Mining Products |
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Nuclear Fuel (Fission and Fertile Material) |
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Paper and Cardboard Products |
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Petroleum Products |
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Plastic and Rubber Products |
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Precision Mechanical and Optical Products
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Software Development |
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Textiles and Leather Products
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Transportation and Logistics |
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Wood Products |
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ISO
9001:2000
Accreditation |
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TÜV
Rheinland
of
Iran,
offers
accredited
ISO
9001:2000
registration
services
through
TÜV
CERT.
We
are
a
member
of
the
Bonn,
Germany,
based
TÜV
CERT
which
is
accredited
by
the
German
Accreditation
Council,
DAR/TGA.
The
certification
system
offered
by
TÜV
Rheinland
of
Iran,
satisfies
the
requirements
of
EN
45012
and
ISO
10011.
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ISO
9001:2000
Registration
Process |
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1. |
Fixed Price Quotations
We will evaluate the scope of registration, location, and number of facilities and employees to be audited. Our fixed price quote includes the costs incurred over the first three years of your ISO 9001:2000 registration. |
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2. |
Auditor Selection
Based on the evaluation, we select the members of the industry-specific audit team. Our auditors are experienced professionals with strong engineering backgrounds. With auditors throughout the United States, we are always nearby. |
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3. |
Pre-Audit Option
TÜV Rheinland of Iran, offers an optional pre-audit, which is separate from the registration audit. This pre-audit can be a tool to determine the readiness of your quality system for the registration audit. The pre-audit includes a documentation review, an on-site audit and a report. |
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4. |
On-Site Registration Audit
The on-site registration audit will be performed after a documentation review. Depending on the scope of registration, the on-site audit takes two to four days. After successful completion of the audit and review of the corrective action proposals, your company will be recommended for registration. |
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5. |
Issuance of Certificate
Once the independent review is completed, we will issue your ISO 9001:2000 registration certificate. |
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6. |
Surveillance Visits
Surveillance visits maintain the integrity of the quality system. ISO 9001:2000 surveillance visits are performed every 6 or 12 months. Re-audits are performed only if applicable. |
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Together,
We Can
Achieve
Quality |
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Our
goal
is
to
team
with
you
and
help
your
company
achieve
a
certified
quality
system.
We
also
realize
that
timely,
cost-effective
ISO
9001:2000
registration
is
important
to
you.
By
working
as a
team,
we
can
meet
your
objectives
and
deadlines.
First,
TÜV
Rheinland
of
Iran,
listens
to,
interprets
and
understands
your
company's
needs.
Then,
we
select
and
assign
an
audit
team
that
knows
your
industry
and
will
continually
strive
to
provide
you
with
the
best
service
possible.
Our
in-house
auditors
come
from
a
variety
of
engineering
and
technical
backgrounds,
and
they
are
known
for
their
professionalism
and
expertise.
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