Iso 9000 iso 9001

Iso 9000 iso 9001

This document describes the means by which compliance to the ISO 9000 series of
standards will be determined as registered companies change from their current revision
(1994) to the year 2000 revision. Bear in mind that transition criteria may vary slightly
from Accreditation Body to Accreditation Body (and therefore from Registrar to
Registrar), just as the interpretation of the current requirements varies somewhat.

Six Registrars were surveyed regarding the transition. The following questions were
asked of them:

• Assuming that a company is currently registered to ISO 9001:1994, how and
when will a Registrar determine if the company's quality system meets the
requirements of ISO 9001:2008?
• What criteria or guidelines have been established to make this determination?

The Registrars surveyed were among those known to have an active presence in the area:
ABS, BSI, BVQI, NSAI, Orion and TUV. Some background for each Registrar is
provided below, as are any specific thoughts offered in response to the above questions.
Three Accreditation Bodies were also queried: RAB, RvA, and UKAS. Their responses
are addressed later.

Despite the uncertainty felt by many companies faced with changing standards, registrars
feel that they know basically how their organizations will handle the transition.

Although the specific language of the standard is uncertain, the Registrars' auditing
approach will probably be affected very little. Orion seemed to capture the sentiment of
the of the group: "It's really no big deal..." Not to imply that the Registrars are
unconcerned, but rather they are confident that the transition will not be difficult-even
with the uncertainty surrounding the details.

There is a distinct possibility that some transition guidance will emerge from TC 176,
from the International Accreditation Forum (IAF) and/or from Accreditation Bodies. If
no such guidance is produced, however, the year 2000 transition would most probably be
like the 1994 transition.

According to that scenario, here's what's likely to happen:

• Each Registrar, as an organization, will adopt a set of internal criteria for handling
the transition. These criteria will address not only the changes to the requirements
of the standard, but they must also include a scheme by which they recommend
existing clients for certification to the revised standard.
• The Registrars will then create a plan for achieving the changeover. They will
document this plan (a quality plan) as required by their own quality system, just

as a company certified to ISO 9001 will "define and document how the
requirements for quality will be met". (Certainly at this juncture, as part of
planning, Registrars would consider any advisement of their Accreditation Bodies
or other authorities, if any is provided.)

Certainly this planning will address the revision of checklists to incorporate the new or
revised requirements. It will also include plans for training the organizations' auditors to
interpret and assess the new requirements. Most Registrars also plan to provide their
clients with guidance for how to address the new criteria.

For companies that are already registered, the Registrar may plan to audit them to the
new requirements during a surveillance audit, or perhaps over the course of two or three
surveillance audits. Some Registrars re-certify their clients every three years anyway, so
they might plan to audit entire systems for compliance to the new requirements as part of
a re-certification audit. For those companies pursuing certification for the first time, they
will be audited to the new standard.

• Registrars will then submit their transition plans to their respective Accreditation
Bodies. Accreditation Bodies ensure that Registrars' auditing activities remain in
compliance with ISO Guide 62, the guide applying to, you guessed it, the auditing
activities of Registrars. Just as a Registrar determines compliance of a quality
system to ISO 9001, the Accreditation Body determines compliance of a
Registrar's system to ISO Guide 62. So, Accreditation Bodies will review the
Registrars' plans to ensure that systems are in place to handle the transition and
that the systems remain compliant with the guidelines of ISO Guide 62. (If the
Accreditation Body provided a Registrar with guidance earlier, the body would
also here determine if the guidance was properly addressed.) As plans are
approved by the Accreditation Bodies, Registrars will return to their business of
determining compliance to quality standards.
• The Registrars' auditors will then assess their clients' quality systems according to
their revised checklists. As mentioned earlier, this may be done during
surveillance audits or during recertification audits. The Registrar might assess
compliance to just one of the new elements, planning to capture the balance of the
new requirements during subsequent surveillance audits, or the entire system may
be audited for compliance to all of the new elements at once.
• When an audit is concluded, the Registrar will send the Audit Report to the
Accreditation Body (or Bodies). The Accreditation Body will review the Audit
Report (and will occasionally conduct audits) to ensure that the Registrar is
sticking to the stated plan. If everything is in order a certificate will be issued,
much like business as usual.

As can be seen from this account, Registrars have successfully ushered in transitions to
new revisions of standards with little or no guidance from external bodies. So, any
guidelines or directives provided to them (supplemental to any Accreditation Body
advisement) will be more guidance than they had with the 1994 transition. Perhaps this is

partially the basis for the Registrars' confidence that the transition will not be difficult to
achieve.

THE REGISTRARS:
Registrar: ABS (American Bureau of Shipping) - Over 3,100 registrations worldwide to
various standards
Services/Courses Offered: ISO, 9000, ISO 14000, AS 9000, QS 9000, TE supplement
RAB
Accreditations: RAB, RvA, INMETRO
Ongoing Assessment Scheme: 6-month or 12-month surveillance without re-
certification at the 3-year mark*

ABS had very little to say about the transition. They believed that a transition guideline
would be published by TC 176, but a draft of the document would not be available for "a
few months". To their knowledge, the document is not yet titled.

Registrar: BSI (British Standards Institute) - Over 32,000 registrations worldwide to
various standards
Services/Courses Offered: ISO 9000, ISO 14000, AS 9000, QS 9000, CE Marking,
TickIT, TL 9000, Kitemark, TE Supplement, VDA 6.1, BS 7799, EN 46000
Accreditations: UKAS, RvA, INMETRO
Ongoing Assessment Scheme: RAB 6-month surveillance without renewal or
recertification*

BSI says that they will allow their clients two years to complete the transition. They will
determine compliance during surveillance audits.

Registrar: BVQI (Bureau Veritas Quality International) - Over 17,000 registrations
worldwide to various standards
Services/Courses Offered: ISO 9000, ISO 14000, AS 9000, QS 9000, SA 8000, CE
Marking, EN 46000, TickIT, TL 9000, TE Supplement, TSSA
Accreditations: RAB, UKAS, RvA, SCC, Cofrac, Sweda, Belcert, Swiss, DAR, Sincert,
Danak, JAS-ANZ, INMETRO ENAC, JAB
Ongoing Assessment Scheme: A 3-year certificate is issued.* Surveillance audits are
usually conducted every 6 months, but they may be done at 9 or 12 months, if
appropriate. There is a recertification audit after 3 years.

BVQI speculated that they will offer their clients a choice. They will either audit the
system for compliance to the new requirements during a client's three-year recertification
audit, or, they will audit the new requirements during surveillance audits. They will
recommend the client for certification to the year 2000 revision (or whatever year it
happens to be) only after compliance to all of the new elements has been verified. This
latter option may take a year or two to complete.

Registrar: NSAI (National Standards Authority of Ireland) - Over 2,000 registrations
worldwide to various standards

Services/Courses Offered: ISO 9000, ISO 14000, QS 9000, CE Marking, EN 46000
Accreditations: RAB, NAB
Ongoing Assessment Scheme: NAB 6-month surveillance without recertification at the
3-year mark*

NSAI said that they will complete the transition with their clients within one year after
the new standard is adopted officially. NSAI will also determine compliance during
surveillance audits.

Registrar: Orion - Over 160 registrations worldwide to various standards
Services/Courses Offered: ISO 9000, ISO 14000, QS 9000, TE Supplement, AS 9000,
CE Marking
Accreditations: RvA, SCC
Ongoing Assessment Scheme: 6-month or 12-month surveillance without recertification
at the 3-year mark *

Orion says that they will offer their clients a choice for for handling the change-over.
Either it will be done in one audit prior to a three-year renewal or it will be done in
increments during surveillance audits. They said it may take a year to a year and a half to
implement the change according to the latter option.

Registrar: TUV Management Services - Over 9,000 certificates issued worldwide to
various standards
Services/Courses Offered: ISO 9000, ISO 14000, QS 9000, AS 9000, TE Supplement,
EN 4600, VDA 6.1, CE Marking
Accreditations: RAB DAR
Ongoing Assessment Scheme: Surveillance audits are conducted either every 6* or 12
months. When it is done every 12 months, a recertification audit is conducted after three
years.

TUV said that to his knowledge, TUV handled the 1994 transition in a unique fashion.
TUV honored the validity of the expiration date for all ISO certificates. So they gave
their clients until the expiration date on the (three-year) certificate to be compliant to the
revised standard. TUV said that, barring any external direction, the year 2000 transition
will be handled just like the 1994 transition.

* Some Accreditation Bodies require Registrars to renew or recertify clients every three
years, especially if the Registrar performs annual surveillances. Therefore some
Registrars (like ABS, Orion or NSAI) may, at the end of the 3-year mark, review the
client's quality system documentation and examine any trends in surveillance audit
results over the 3-year period. If no major negative trends are discovered, the certificate
will be re-issued or renewed. Some Registrars (like BVQI) will conduct a full system
audit after a 3-year certificate expires, and then will recertify the client. Other Registrars
(like BSI) will conduct surveillances every 6 months and will not ever require renewal or
recertification. Still other Registrars (like TUV) will offer a choice between these options

or some combination thereof. Of course all of the above depends upon the requirements
of the Registrar's Accreditation Body.

THE ACCREDITATION BODIES:

Registrar Accreditation Board (RAB):

RAB described the "normal process" for handling the transition between one revision of a
standard to another. They described the methods by which Accreditation Bodies will
usually handle a transition:

• The first way that transition guidance may be established for an Accreditation
Body is through the direction of an external organization, such as the body who
promulgated the standard, in this case TC 176. They said that the external
organization might also establish a date by which the transition must be complete.
• If no direction is provided as described above, Accreditation Bodies may
determine how the transition will be accomplished according to the direction of
the IAF, a group of (currently sixteen) Accreditation Bodies.
• The IAF may prescribe an implementation plan that will be communicated to all
Accreditation Bodies, who will flow down the requirements to Registrars.
Accreditation Bodies may also directly contact each other to ensure that their
courses of action are consistent. If the IAF provides no direction, the scenario
described earlier for what happened in 1994 takes precedence. In this case, the
Accreditation Body will often provide Registrars with a "Letter of Advisement"
outlining any necessary transition guidance, sometimes including a date by which
the transition must be complete.

RAB speculated that guidance for the year 2000 transition will be developed according to
the first method described here, although they declined to speculate as to whom this
guidance would apply. If it applies to Accreditation Bodies, the guidance may be
incorporated in a Letter of Advisement, which would be sent to Registrars as described
above. Or, if it applies to Registrars, the Registrars will include the guidelines or
directives as part of their quality planning. Then the process described for the 1994
transition could then be followed again, except the Accreditation Body would not only
verify the Registrar's internal plans for the transition, but the body would also verify that
the Registrar's plans incorporate any applicable external guidance or directives.

Raad Voor Accreditatie (RvA)

RvA said that they have not yet set a policy for handling the transition, as they are
awaiting final acceptance and translation of the standard. They expect that the RvA will
not have an official policy until mid-2001. They said that normally when a new or revised
standard is adopted, the RvA will establish a policy and procedure for how to proceed
with assessing and recommending clients for certification. The procedure will be flowed
down to Registrars, who will normally give their clients one year to comply.

United Kingdom Accreditation Service (UKAS)

UKAS said that the year 2000 revisions will require more auditor training than the 1994
transition did. This is so because the year 2000 standard will be more geared toward
improvement, whereas the 1994 standard is more concerned with compliance. So they
believe that some extensive, skill-based training will be in order. UKAS is also awaiting
publication of the final draft before making any definitive statements about how they will
handle the transition. They surmised that the transition will be similar to the 1994
transition, except that they, too, expect some guidance from the IAF or TC 176. They
said that UKAS will develop a transition plan, including a completion date, and will
communicate the plan to all of its Registrars. UKAS will likely allow one year to
complete the transition (as they did in 1994).

TWO FINAL NOTES:

1. According to a document posted on ISO's website, "A major requirement of the
ISO 9000 revision process is that organizations which have implemented the
current ISO 9000 standards will find it easy to transition to the revised standards...
transition planning guidance is being produced." The nature of this "transition
planning guidance" is not addressed, but this entry may well be alluding to the
guidance being developed by TC 176.TC 176 is indeed developing transition
guidance. The level at which such guidance will be introduced is as yet
undetermined. Its method of publication has not yet been determined and neither
has its content been finalized. As mentioned before, RAB would not speculate as
to whom this guidance would apply-the Accreditation Bodies, the Registrars, or
the end users. Being "close to members of TC 176″, RAB said that they do "not
expect final answers to these questions anytime this year". RvA and UKAS felt
that the guidance document will most probably be geared toward Registrars
and/or users of the standard and not Accreditation Bodies. The publication of such
a guidance document represents a difference from the transition between the 1987
and the 1994 version. No guidance document was ever published by ISO to
facilitate the change-over from 1987 to 1994. However, the 1994 revisions to the
standard were relatively minor when compared to the proposed year 2000
revisions.
2. The year 2000 revisions to the ISO 9000 series of standards will most likely have
some effect on other ISO 9000-related standards like ISO 14000, QS 9000 and AS
9000.ISO TC 207 (the committee responsible for ISO 14000) has considered
revising ISO 14000 to accommodate the revision to ISO 9000. However, further
consideration is pending the official publication of ISO 9000:2008. Since QS
9000 recently underwent revision to the 3rd Edition (last year), not much is being
said yet about how it will be revised to accommodate the change in ISO 9000.
According to representatives from SAE the body responsible for revising AS
9000-the American Aerospace Quality Group (AAQG)-met two weeks ago.
During the meeting, two major suggestions for revision to AS 9000 were
considered. The first came from Boeing, who presented 17 specific proposed
revisions to the standard. The second source of proposed revisions dealt with the

goal to harmonize AS 9000 with EN 9000 (the European standard containing
requirements for the Aerospace industry above those contained in ISO 9000).
Currently the group is most concerned with addressing these two bodies of
revisions. The committee is not speculating about how or if AS 9000 will
accommodate the year 2000 revisions to ISO 9000. Scott suggested that the
committee would most likely harmonize AS 9000 with EN 9000 and incorporate
the Boeing suggestions first, and then when the official revisions to ISO 9000 are
adopted they will consider revising the harmonized AS/EN 9000 standard to be
aligned with the new ISO 9000 standards.

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Iso 9000 iso 9001

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