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Volume 5 · Issue 12 · December 2000

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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

Registrars Contact Name Phone E-mail
ABS Quality Evaluations Bernadette Martinez 440-878-9000 bmartinez@eagle.org
BSI Reg Blake 703-464-1908 reg.blake@bsiamericas.com
BVQI Greg Swan 716-484-9002 gswan@bvqina.com
DNV Earl Hudspeth 281-721-6746 earl.hudspeth@dnv.com
ITS Intertek Services Lisa Hartley 800-810-1195 lhartley@itsqs.com
NSF Intern. Strategic Registrations Ltd. Christian Lupo 800-673-9000, ext. 6866 lupo@nsf-isr.org
Perry Johnson Registrars Rachel Douglas 800-800-7910 rdouglas@pjr.com
QMI     bfrost@qmi.com
Quality Systems Registrars Kim Miceli 703-478-0241 kimm@qsr.com
SGS ICS* Lois O’Brien 800-747-9047

lois_obrien@sgsgroup.com

sgsicslob@aol.com

*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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