Volume 5 · Issue 12 · December 2000
Contents
Page 1...
A Look at Some Details
Provided by Registrars
As Transition Begins, Survey Points Out Some Issues
By the time you read this,
the 3-year transition period for ISO 9001:2000 will have begun,
with ISO having published the standard and made it available
for purchase by December 15, 2000.
Three questions your organization
needs to answer in light of the transition period are:
- When will our quality management
system (QMS) be ready to make the transition or obtain initial
registration to ISO 9001:2000?
- What assistance has/will our
registrar provide?
- What are the challenges ISO
9001:2000 represents?
In November 2000, THE
OUTLOOK published an initial analysis of survey results
from 10 of the 23 largest accredited QMS registrars in terms
of certificates of registration to ISO 9001/2/3 in North America.
The key fact from that analysis was that all 10 registrars
are or will soon be ready to assess and register the QMSs
of existing or new clients for conformance with ISO 9001:2000.
In addition, they are
communicating with their clients about the transition period
and plan to follow the guidelines established for the transition
period but are not pressuring existing clients to upgrade
their QMSs as soon as possible or refusing to assess new clients
against ISO 9001/2/3:1994 (see "Registrars Ready But
Not Pushing Transition", THE OUTLOOK, November
2000).
A more in-depth
review of the analysis and a few follow-up questions to the 10 registrars
that responded (see Table 1) reveals the following
additional facts:
- There is a correlation between
the types of communication a registrar has provided
to its clients and the client response rate.
- A possible concern is a glut of
organizations seeking to upgrade their registrations late
in the transition period.
- Registrars expect the majority
of transition assessments to be done by December 2002.
- It will be difficult to draw simple
conclusions about calculating transition costs.
- The process auditing-procedural
auditing issue points out an assessment shift with ISO
9001:2000.
- Permissible exclusions may be
an issue with some registrars.
What follows is a more detailed examination
of the survey results, with occasional post-survey comments
from the registrars. However, to avoid turning the survey
and reporting on the survey into a promotion for one or more
registrars or a disclosure of proprietary information by those
registrars that responded to the survey, the sources of any
statements in this analysis and any references to a registrar
have been removed.
Type of Communication More Important
Than Amount
The registrar responses concerning the types
and amounts of communications they have done with their clients
on the transition, the number of clients that contacted the
registrars in response and the nature of those contacts have
been analyzed. There is a correlation between the types and
level of communication a registrar provided to its clients
and the percentage of clients that have contacted the registrar
about scheduling a transition assessment.
The following forms of communication were specified
as having been used by the respondents, with the percentage
that mentioned this form listed after each:
- Registrar publications (magazines, newsletters, books,
etc.) (50%)
- Informational fact sheets and pamphlets (30%)
- Letters to clients (30%)
- Verbal communication from auditors (30%)
- Conferences, seminars and/or public training courses offered
by a registrar (20%)
- Registrar web site (20%)
- Exhibitions (10%)
- Memoranda and other registrar mailings (20%)
- Training courses provided to clients (10%).
These various forms of communications addressed
the following subject matters with regard to the transition:
the registrar’s upgrade requirements (40%); changing/additional
requirements in ISO 9001:2000 (30%); the International Accreditation
Forum (IAF) policy and registrar position on IAF policy (30%);
frequently asked questions (20%); timing/timetables (20%);
issuance date of ISO 9001:2000 (10%); registrar readiness
(10%); and registration options (10%). "We have tried
to explain the key content of the DIS [Draft International
Standard] and FDIS [Final Draft International Standard] of
ISO 9001:2000," explained one of the registrars that
had one of the most active programs.
The response rates of existing clients to these
communications ranged from approximately 25.0% to less than
0.1%, and there was no single message or form of communication
that elicited the greatest response. The lowest response rates
were among those registrars that had relied on informal and
indirect forms of communication–verbal information from
a registrar’s auditors during a surveillance audit and
information buried in newsletters and other registrar mailings
not exclusively on the transition–and among those waiting
to launch a full communications campaign once ISO 9001:2000
was published.
"There has been much communication to our
clients via newsletters, written memos, informational pamphlets,
etc., to provide them all with pertinent information relative
to the changing/additional requirements, timing, options,
etc.," explained the registrar with the highest percentage
of responses.
Another registrar that has already promoted
to its clients that it is offering public courses on ISO 9001:2000
and the transition period also saw high response rates.
However, what the results show is that it is
the type of information conveyed as well as the format used
that made a difference. A combination of serious message and
"serious" format seemed to make a difference.
What does this mean to ISO 9001/2/3:1994-registered
organizations that have not yet been adequately motivated
to contact their registrars? Very little in the short term,
assuming your organization is not eager to upgrade its QMS.
But it does mean that you should contact your organization’s
registrar early in 2001 to ask when information will be provided
and what type of information is the registrar going to provide.
If for some reason your registrar has sent information
that you missed, you may be at a disadvantage or may risk
missing a free training course or free informational materials
that must be ordered from the registrar.
Among registrars, there seems to be a lack of
consistency in terms of timing or best approaches to communication,
although this may reflect the nature of the organizations
that are using one registrar rather than another. The registrars
that are not planning as intense an informational drive may
be wise to consider what they can effectively do to communicate
pertinent information in the next few months.
Is a Registration Upgrade Glut Ahead?
One question asked of the registrars was, "Is
your organization encouraging its clients to upgrade their
QMSs to conform with ISO 9001:2000 as soon as possible?"
A registrar responded affirmatively, but added the following
in its answer that raises separate issues:
We would like clients to begin reviewing and understanding
the [ISO 9001:2000] requirements. This would allow them
the opportunity to implement the requirements over time.
In addition, this would avoid a glut of clients trying to
upgrade with the expiration of the 1994 versions of ISO
9001/2/3 looming.
While no other registrar explicitly raised the
issue of a glut of clients rushing to upgrade as the transition
period comes to a close, there is some concern in the QMS
field that the lack of interest and preparations by the vast
majority of organizations in the United States might lead
to a last-minute stampede or leave many organizations out
of the competition for future contracts once customers require
ISO 9001:2000 registration. Such contractual specifications
have not yet occurred, but it would not be surprising if deadlines
for registration to the 2000 edition begin to appear in early
2001.
Clearly, there is an impact from the delay and
limited interest in the automotive, aerospace, medical device
and other business sectors, which are linked to the updating
of sector-specific requirements based presently on ISO 9001:1994.
Until the industry original equipment manufacturers
(OEMs) in these sectors have completed work on revisions to
their sector-specific requirements and revised sector registration
schemes/requirements, suppliers to these industries are not
likely to move to upgrade their QMSs.
Some organizations will wait until their registration
renewals–as suggested by several registrars–or until
a customer or trade association requires ISO 9001:2000 registration
by a set deadline. But this creates a potential danger that
many organizations will confront deadlines that they will
not be able to meet once other organizations begin moving
to transition.
Some registrars in the survey also indicated
that they had received calls even before ISO 9001:2000 was
published asking about new registrations to the 2000 edition.
There are no projections for new registrations once ISO 9001:2000
is available, although the leveling off of ISO 9001/2/3 registrations
in the past two years despite strong interest in quality management
issues makes a rise in new registration a distinct possibility.
While some organizations may be motivated to
revise their QMSs now and update their registrations because
of the risk of a pending glut, the survey responses do not
paint a picture of registrars expecting a last-minute rush.
Table 2 presents
the responses from the registrars when asked to project when they estimate
their existing clients will make the transition to ISO 9001:2000 conformance.
They show that most registrars expect the vast majority of registrations
to be updated well before the transition period concludes.
In fact, only one registrar projects that more
than one-third of its clients will seek registration updates
to ISO 9001:2000 during the final year of the three-year transition.
This shouldn’t be taken as a sign that
your organization should not worry about getting its QMS upgraded
and registered for conformance before the ISO 9001/2/3:1994
standards are obsolete, because there is no guarantee a registrar
will be able to meet your schedule due to any number of reasons,
including a growing market for new registration assessments.
One registrar advised, however, that "we
will continue to accept applications to only ISO 9001/2:1994
for a 12-month period ending December 31, 2001, unless agreed
otherwise on a case-by-case basis. This is to ensure new clients
that still opt for the old standard for their initial registration
assessment will still have two years to transition to the
new standard. We will make it clear to clients that go beyond
the date defined above that there is a real risk in not meeting
the final transition date and hence lose their registration."
This registrar is not necessarily refusing outright
to register a new client to ISO 9001/2/3:1994 after 2001,
but it will be actively discouraging the practice simply to
avoid having too many clients become comfortable with a standard
that is about to become obsolete.
Most registrars are planning to advise existing
and future clients repeatedly that their registrations to
the 1994 editions will expire toward the end of 2003 as far
as the accreditation bodies the registrars follow are concerned,
in the hope most will begin to transition well in advance.
How Long Will Transition Upgrade Audit
Take?
Some have asked what the cost of upgrading a
QMS from ISO 9001/2/3 to ISO 9001:2000 will be and whether
that cost will be recovered by most organizations in the form
of QMS improvements over time.
The most quantifiable transition cost is that
associated with registrar assessments. This is due to the
fact that what two organizations will spend on actual QMS
revisions will vary depending on whether an organization had
already been pursuing continual improvement of its quality
system before ISO 9001:2000 or had a bare-bones ISO 9002:1994-based
system that avoided inclusion of design elements.
For this reason, registrar costs may be the
only measurable expense that should be comparable for all
organizations. Even then, costs will vary depending on the
registrar used, whether the transition assessment is being
conducted in connection with or separate from a surveillance
audit or registration renewal and the scope of the new registration
compared with the previous 1994 certificate. It is also difficult
to compare the responses of the registrars, since they did
not all quantify their estimates in the same way.
As a result, below are the verbatim responses
from the 10 registrars, which appear in random order to avoid
comparison of these responses with the projections in Table
2.
Registrar A
Approximately 4-8 additional hours per client.
Registrar B
Approximately 2 days for a mid-size, one-location
facility.
Registrar C
An upgrade will require 1-2 days more than a surveillance
audit.
Registrar D
It is not possible to give a general estimate at this
time. We are dealing with this on a case-by-case basis.
Registrar E
We are estimating to add 50% of the audit days as
specified in the IAF Guidance to ISO/IEC Guide 62.
Registrar F
This is currently being evaluated by a group within
our operations. They are interviewing auditors who have done
some of our first audits to the new standard.
Registrar G
The extra time involved will be around 1 day per location.
However, the final determination will be made on a case-by-case
basis, depending upon site size and complexity.
Registrar H
The IAF requires that the upgrade to ISO 9001:2000
be the same length as a renewal audit. Therefore, we would
expect that, on average, the upgrade will add 2-3 audit days
to a surveillance audit.
Registrar I
As a rule, provided your registration is in good standing,
a complete re-registration will not be required. However,
although the elements from ISO 9001:1994 are recognizable
in the 2000 version, the structure of the standard, level
of detail and organization of the elements will mean that
more time may be required than the time usually allotted for
a surveillance or re-registration visit.
Registrar J
It depends on several factors, including:
- The maturity of the quality system
- How well the organization used ISO 9004:1994 in setting
up its system
- The number of employees
- Complexity of operation.
For most registered companies, it would take
less than a day to upgrade their system’s registration,
which could be accomplished during a regularly scheduled surveillance
audit. No extra time would be needed for new registrations.
Auditing and Permissible Exclusions
What about changes organizations should expect
to see as a result of the revisions contained in ISO 9001:2000?
Two changes identified by a few respondents that will affect
the nature of a QMS and its registration are:
- Auditor training for ISO 9001:2000 registration assessments
involved preparing auditors to conduct process audits, compared
with the procedural audits conducted for ISO 9001/2/3 conformance
in the past. This represents a significant shift in how
a QMS is examined. Auditors will need to adapt their auditing
approach from looking at ISO 9001 requirements and system
elements as stand-alone items to looking at them as part
of a whole system. ISO 9001:2000 is based on the process
approach model, and it anticipates having an organization
rely on a QMS that ties all processes into a single flow
of activities related to the organization’s overall
business or a specific product line. The result is a linkage
of related events that previously were treated as separate
operations that shared only the same product or production
line. It will be interesting to see if auditors will conduct
audits of the QMS as if they were looking at the entire
organization every time or if there will be efforts to isolate
QMS elements that are expected to conform to one or more
requirements in ISO 9001:2000.
- Permissible exclusions is an issue where there is likely
to be varying interpretations by different auditors. Only
one registrar mentioned permissible exclusions, but the
circumstances of that mention raise the possibility that
some registrars and their auditors may not yet fully understand
how this ISO 9001:2000 feature works. The registrar noted
that, for auditors who had taken an accredited auditor transition
course, 1 of the 4 benefits of the course was an improved
understanding of the application of ISO 9001:2000 and permissible
exclusions. While an organization registered to ISO 9001:1994
that has a QMS that covers its design processes will not
face any difficulties in applying the scope of ISO 9001:2000,
an organization registered to ISO 9002:1994 but that engages
in design activities may face significant difficulties in
applying the scope. In the case of the ISO 9001-registered
organization, its QMS already meets all the requirements
of Section 7, Product Realization, and it will simply update
its QMS to conform to any minor modifications. There is
no need for the registrar’s auditors to determine whether
it appropriately excludes any requirements. An organization
that excluded design activities and relied on ISO 9002:1994
will have to either expand its QMS to cover all processes
within its operations or will have to justify the limitation
of the QMS’s scope to its registrar’s auditors.
The auditors will need to determine whether an organization
that excludes activities from its QMS or defines the scope
of its QMS to exclude activities it does not engage in has
done so in conformance with the requirements of ISO 9001:2000.
Beginning the Transition
This survey was conducted to provide you with
a snapshot of the status of some of the largest registrars
at the start of the transition period for ISO 9001:2000, not
to be a comprehensive survey of registrars or provide responses
that represent the perspective of all registrars.
What it makes apparent is that not all registrars
or all clients are at the same point or are taking the same
view when it comes to making the transition to ISO 9001:2000.
There are three factors that all organizations
registered to ISO 9001/2/3 need to consider in the months
ahead:
- Your organization’s registrar remains a valuable
source of information and is responsible for providing your
organization with its registration update.
- Registrars are encouraging clients to pursue QMS upgrades
to conform with ISO 9001:2000 as soon as possible, even
if a client is not interested in updating its registration
for now. The reason is that, although no changes to ISO
9001:2000’s requirements are "earth-shattering",
the reorganization of the requirements and the additions
may take time to conform with, and it is helpful to have
the revised system in place for a while before undergoing
a transition assessment.
- Three years may seem like a long time, but upgrading your
organization’s QMS to conform with ISO 9001:2000 is
not the only task you face, and three years can slip by
easily. In addition, upgrading sooner will not only benefit
your organization by providing an improved QMS earlier,
but it will allow your organization to undergo the transition
assessment by its registrar before the demand for audits
increases.
THE OUTLOOK will continue to provide
information and guidance on making the transition to ISO 9001:2000
and on implementing a brand-new QMS in conformance with ISO
9001:2000 in those organizations just beginning the process
of managing quality with a formal system. If you have any
questions, send them to INFORMintl@aol.com.
Table 1. Respondents
Among the Top 23 QMS Registrars in North America
*Canadian & US operations combined.
NOTES: Responses received as of 11/14/00: 10 of
23 registrars (43.5%), representing 25,354 of 41,947 certificates
(60.4%) reported for North America by World Preferred Registry
as of October 31, 2000, with some updating based on registrar
reports to THE INFORMED OUTLOOK. Due to delays in
registrar submission and data entry of reports of certificates
issued, the World Preferred figures do not reflect all certificates
issued through October 2000. Registrars are listed in alphabetical
order and represent a range of certificates issued from
566 to 6,924.
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Table 2. Registrar
Estimates of Transition Timing at Key Points
| (Percentage of existing
ISO 9001/2/3:1994 certificates updated at a given time) |
| Registrar No. |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9* |
10 |
| Transitions Will Occur |
|
|
|
|
|
|
|
|
|
|
| ASAP |
A |
10% |
10% |
B |
5% |
5% |
B |
5% |
5% |
B |
| 6/01 |
A |
20% |
15% |
B |
5% |
25% |
B |
5% |
5% |
B |
| 12/01 |
A |
50% |
25% |
B |
20% |
25% |
B |
10% |
15% |
B |
| Post-Sector Supplements |
A |
10% |
20% |
B |
10% |
15% |
B |
25% |
NA |
B |
| 12/02 |
A |
10% |
15% |
B |
35% |
15% |
B |
45% |
25% |
B |
| 12/03 |
A |
0% |
15% |
B |
25% |
15% |
B |
10% |
40% |
B |
A = Did not offer estimate, but expects most companies
will transition to ISO 9001:2000 at their registration renewals.
B = Did not provide estimate, based on lack of feedback
from clients.
*Did not provide sector projection nor do figures add up
to 100%.
NOTE: The numbering of registrars is random and
used only to permit the reader to see how different registrars
estimate the transition will unfold.
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