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AT THE CORE

THIS ARTICLE DISCUSSES

How records and information managers can participate in their organizations' quality
management processes

Why the revised standard is more accessible and applicable to RIMS beyond the
manufacturing industry

What changes have been incorporated in ISO 9001:2000

ISO 9001:2000 is an internationally recognized quality management system (QMS)


standard affecting thousands of organizations around the world. A new version, which
is scheduled for publication in late 2000, will replace ISO 9001:1994 and will have
both a new look and a new scope as its image as a purely manufacturing standard is
eclipsed and it becomes more acceptable to other sectors. Late 2000 will be the start
of a busy period for anyone directly involved in an organization's ISO 9001
certification activities. One of the disciplines affected will be records and information
management (RIM).

Provided they take a proactive role, information management professionals will find
significant new opportunities to participate more fully than ever before in their
organization's quality management processes. The focus of these opportunities lies in
the area of documentation of an organization's processes and its related information
and records systems.

This overview of the new standard should be a call to information managers in all
sectors to look carefully at the standard to begin to understand its implications for
them.

The final draft of ISO 9001: 2000, Quality Management Systems Requirements, was
issued on February 22, 1999. Its adoption will continue to have a major influence on
the manufacturing industry where it has long been accepted as the benchmark of
quality management. The standard's most significant change is its potential
applicability to industries other than manufacturing.

This article has a dual focus. First, it outlines the main elements of the agreement
reached on a new version of ISO 9001. Second, it examines the new standard's impact
on information management professionals.

While some service and software industries had already adopted ISO 9001, most
organizations in these industries declined in the beginning to treat ISO 9001 seriously.
They justified their lack of interest on the grounds that the standard was applicable
only to manufacturing quality management systems.

The more generic and expanded character of ISO 9001:2000 clearly challenges this
view. The strong manufacturing bias reflected in the content and structure of both the
original 1987 standard and its 1994 revised version is now a thing of the past. Service
and software organizations are likely to face increasing pressure to measure the
quality of their organizations against the benchmarks outlined in ISO 9001:2000.

Background and Future of ISO 9001:2000

ISO 9001 serves as the basis for benchmarking an organization's quality management
system. Quality management should not be confused with terms such as quality
assurance" or quality control. Quality management measures the overall management
function in determining the organization's quality policy, its objectives, and its
responsibilities, as well as the quality policy implementation through means such as
quality assurance and quality control. Quality assurance measures all planned and
systematic activities implemented within the organizations quality system. Quality
control is the operational techniques and activities used to fulfil quality requirements
(e.g., meeting a customer's specifications or requirements for a given product or
service).

Revision of the ISO 9000 standards has been under discussion for a number of years.
Soon after the 1994 revisions, ISO Technical Committee 176 began the task of
overcoming the standard's manufacturing bias while, at the same time, overcoming
other persistent criticisms that the standard did not adequately cover all aspects of the
QMS.

The development of ISO 9001:2000 has been a particularly interesting process to


behold. It is an object lesson in consensus building. ISO Technical Committee 176,
with the participation of various national standards bodies, has actually managed to
overcome criticisms from apparently opposite directions and written a document that
appears to be acceptable to the great majority of ISO's member bodies.

The manufacturing industry criticized the older versions of ISO 9001 for its failure to
include a large range of quality management requirements in the standard. Some
manufacturing industries considered ISO 9001 to be so inadequate that they
developed their own expanded, industry-specific versions of the ISO 9001 standard.
ISO was also criticized by non-manufacturing industries for catering to the
manufacturing industries. Everything about the older versions of ISO 9001 seemed
overwhelmingly rooted in a manufacturing environment.

The ISO technical committee found itself in a dilemma and then found a way out. ISO
9001:2000 appears to have actually reached a satisfactory compromise in which the
language is generic enough to be applicable to industries other than manufacturing yet
specific enough to satisfy the particular concerns of the manufacturing industry.

ISO Technical Committee 176's objective was to overcome the apparent conflict
between the manufacturing industry's specific requirements and the demand to make
the standard more accessible and more clearly applicable to other industries. This
objective also led to changes in the structure and organization of what used to be a
series of standards and guidelines. ISO 9001:2000 will replace all three 1994
standards (9001, 9002, and 9003). Once ISO 9001:2000 is published, ISO 9002 and
ISO 9003 will become obsolete.
All organizations will have to fulfill all the requirements in ISO 9001:2000. A
requirement is now inapplicable only if the function or activity it describes is not
performed at all. In other words, organizations that may have certified under ISO
9002 to avoid including design and development activities in the scope of their
certification can no longer do so. If they perform design and development activities,
these activities must be included as part of the ISO 9001:2000 certification.

ISO 9001:2000 will have a structure that resembles ISO 14001:1996, an international
standard that specifies the requirements for the certification of an organization's
environmental management system (EMS). Titled Environmental Management
Systems - Specification with Guidance for Use, ISO 14001 measures adherence to
legislative requirements and information about significant environmental impacts.
Like the EMS standard, the ISO 9001:2000 standard will be divided into five broad
management principles. In part, this approach is intended to suggest that common
subjects between ISO 9001:2000 and ISO 14001:1996 may be implemented in a
shared manner to avoid duplication of effort.

As far as actual implementation of the new standard was concerned, ISO Technical
Committee 176 recommended that implementation of ISO 9001:2000 could begin as
early as the fourth quarter of 1999 -- one full year in advance of the standard's
scheduled publication. The ISO technical committee made this recommendation
because ISO works through a lengthy consultative process to achieve a consensus.
Once a consensus was obtained (in early 1999), further changes became improbable.

New Elements and Emphases

What has actually changed in ISO 9001:2000 that makes it so new and improved?
While ISO 9001:2000 retains most of the content of the 1987 and 1994 versions, it
also contains substantive additions. Most of the specific changes fall under two broad
categories: 1) customer satisfaction and 2) the quality management function. Some
changes are quite broad in character.

In ISO 9001:1994 the scope declares the achievement of customer satisfaction as the
standard's primary aim, but it was not then a requirement. In ISO 9001:2000, however,
the achievement of customer satisfaction becomes an explicit requirement that finds
expression in several sections of the standard. One requirement, for example, is that
the organization must identify and review customer requirements. Another new
paragraph focuses on management's responsibility to ensure that customer
requirements are met. Yet a third requires the measuring and monitoring of customer
satisfaction.

Customer satisfaction and conformity to customer requirements will also play a major
role in determining where improvements can be made in an organization. Clearly,
there are opportunities here for information managers to show the centrality of their
work to the organization in areas of documentation.

ISO 9001:2000 also places a much stronger emphasis on the quality management
function of the organization as distinct from its quality assurance activities. Although
the 1987 and 1994 versions of the standard intended to measure the quality
management function, large portions of the standard were focused solely on quality
assurance.

Even the titles reflected the earlier emphasis on quality assurance almost at the
expense of quality management. The title of ISO 9001:1994 was Quality Systems -
Model for Quality Assurance in Design, Development, Production, Installation and
Servicing. In ISO 9001:2000, the title changes to Quality Management Systems -
Requirements. According to the foreword to the 2000 standard, the new title reflects
the fact that the QMS requirements not only address quality assurance of products and
services but also address the need for an organization to demonstrate its capability to
achieve customer satisfaction.

Almost all the new elements in the 2000 standard (e.g., meeting customer and legal
requirements, involving people and training, managing information, continuous
improvement) address overall quality management issues as distinct from quality
assurance activities.

ISO 9001:2000 is more strongly influenced by specific industry standards that were
developed because the older versions were inadequate to a given industry's specific
needs. Requirements for infrastructure, work environment, process monitoring,
continuous improvement and customer satisfaction show the influence of these
industry-specific standards, especially on the automobile, aerospace, and medical
devices industries.

A number of supplementary standards and guidelines have also been consolidated or


restructured. ISO 9004 guidelines used to be published in four parts; one was generic
and the other three addressed the concerns of specific industries. There will now be a
single generic guideline: ISO 9004: 2000. Its structure will parallel ISO 9001:2000.

The purpose of the structural change to the guideline, titled Quality Management
Systems - Guidance for Performance Improvement, is to enhance its use as a
supplement and aid to ISO 9001:2000. It parallels the standard not only in structure
but also in content, including, for example, an even more explicit focus on customer
satisfaction.

ISO 8402:1994, the standard that defines the terms and vocabulary used in the ISO
9000 series of QMS standards, and those parts of ISO 9000:1994 that pertain to
definitions, will be consolidated into a single document (ISO 9000:2000) for defining
terms and vocabulary. ISO 10011, ISO 10012, and the three EMS auditing standards
are being revised and consolidated; they should be ready in the first quarter of 2001.

The Five Quality Management Principles

To facilitate a clearer understanding of the differences between ISO 9001:1994 and


ISO 9001:2000, tables are used at various points in this article. In each table, the
column on the left summarizes the requirement, by number and title, found in ISO
9001:2000. The column on the right lists the corresponding requirements, by number
and title, in ISO 9001:1994.
Some comparisons, which are italicized, are derived from Technical Committee 176's
(draft) Transition Planning Guidance, published in May 1999. The remaining
comparisons between the 1994 and 2000 versions include those between ISO
9001:2000 and QS-9000. QS-9000 requirements are preceded by the letters "QS" and
have been added to illustrate QS-9000's influence on ISO 9001based industry
standards.

(It is not the intention of this article to suggest that the automotive industry's QS-9000
is the only, or even the main, influence on the development of ISO 9001:2000. It
happens to be the one with which the author is most familiar.)

In the standards, the scope, normative reference, terms, and definitions account for the
first three numbered sections of the ISO 9001:2000 standard. The first quality
management principle is numbered four. The remaining four principles are numbered
sequentially.

Quality Management System Requirements

In ISO 9001:1994, this title was used to include all 20 main requirements against
which the organization had to be evaluated. It had no independent content. In ISO
9001:2000, it is the title for the first of five quality management principles.

The QMS principle states that the organization shall implement, maintain, and
improve a QMS and that it prepares QMS procedures describing the processes
necessary to ensure that the organization meets the customer's requirements. It
incorporates parts of the Quality System section of the 1994 standard (see Table 1).

This principle also highlights the understanding that a QMS has to be analyzed from
two aspects: the processes that ensure customer requirements are met and their
description in the form of documentation. In essence, this principle embodies the
concept and practice that "you say what you do and you do what you say." This
concept is not new to ISO 9001. The 2000 standard makes explicit what had been
implicit in the previous versions.

Management Responsibility and Information

Management

This ISO 9001:2000 principle (see Table 2) includes most of the following ISO
9001:1994 requirements: management responsibility, document and data control, and
control of quality records. It also has several new clauses pertaining to customer
requirements, legal requirements, the establishment of quality objectives, and the
maintenance of internal communications. Portions of this principle, specifically those
pertaining to control of documents and records, have special significance for RIM
professionals.

In ISO 9001:1994, both the document control and records control were, from a
structural standpoint, treated as equals with the other 18 general requirements such as
management responsibility. (Document and record have distinct meanings in the ISO
9001 standard. Documents are prescriptive and instructional, such as the quality
manual, procedures, work instructions, and unused forms. Records are objective data
recorded in a predetermined structured format, such as a form or a database.)

Now document control and records control are subsections of "Quality Management
System," one of seven general requirements that constitute the principle of
management responsibility. At first glance, their new position appears to have
diminished their role in the ISO 9001 standard. This is not the case.

First, it should be noted that the requirements for the control of documents and
records remained essentially the same between the 1994 and 2000 versions of the
standard. Organizations will still have to maintain as rigorous control over documents
and records as they have in the past. This is particularly significant for information
managers in sectors where initially there was interest in certification to the standard.

Second, it has already been noted that documents constitute one side of the
processes/documents dichotomy that lies at the core of the "Quality Management
System Requirements" (not to be confused with the section entitled "Quality
Management System," which is part of the the second principle, "Management
Responsibility").

In the management responsibility principle, documents and records have been placed
in a more appropriate and accurate context. If documents describe the QMS, then their
control is essential to ensuring that this description accurately reflects the
organization's processes. This explains why the control of documents (as distinct from
the documents themselves) have been included under the QMS section of this
principle. The description of processes through documents also requires the support of
objective evidence in the form of records. Records control therefore enjoys equal
status with document control.

Given that control of documents and records is so vitally important to the QMS, it is
appropriate that management should take a direct interest in it. Indeed, making the
control of documents and records through information managers - a management
responsibility has elevated information managers' status. It is another way of
explicitly indicating management's active role in the documentation of the QMS.

This shift from apparent independence to subordination reflects 12 years of practical


experience. The success or failure of a QMS (and its documentation) depends directly
on the role played by management. In the corporate world, and in most other
organizations, management has the power, means, and ultimate responsibility for the
decisions an organization makes, including its document, information, and records
management systems.

Resource Management

This principle pulls together parts of several requirements of the 1994 standard, most
notably training (see Table 3). It also includes several new requirements on the
management of information necessary to control processes, the provision for and
maintenance of an infrastructure, and maintenance of an appropriate work
environment.
Particularly significant for RIM professionals are the requirements affecting
information management. A brief note disingenuously defines information as process,
product and/or service knowledge and/or experience, and data from suppliers and
customers. There is a requirement to develop system-level procedures for managing
this information. This requirement opens the door to expanding the role and
responsibilities of records managers and administrators in the QMS.

First, procedures must be put in place to ensure access to (and protection of) this
knowledge and experience. The requirement has knowledge management overtones,
and it strongly implies that the organization must document currently unrecorded
information that may have an impact on the QMS. At the very least, it calls on the
organization to include quality-related informal knowledge and experience into the
corporate memory.

Second, there must be procedures to handle data from customers and suppliers. This
requirement, an explicit recognition of the role of external data in evaluating the QMS,
has the potential of putting organizational functions that had hitherto played only
marginal roles in the QMS (e.g., the finance, information technology, and systems
development departments) into the spotlight.

Only time will tell how the requirement for managing information will be interpreted
when ISO 9001:2000 is implemented. If this analysis is correct, organizations may
find it challenging to meet this requirement.

Product and Service Realization

This quality management principle (see Table 4) incorporates almost half (nine) of the
20 requirements that originally constituted the ISO 9001:1994 standard. The sequence
of the first five sections parallels the processes involved in the realization of a product
or service. It begins with the determination of the customer's requirements and ends
with the customer's final acceptance of the product or service. The sixth section
applies to measuring and controlling devices that are used in the other requirements
covered by this management principle.

Measurement, Analysis, and Improvement

This principle incorporates five of the 20 original ISO 9001:1994 requirements (see
Table 5). These requirements pertained to quality assurance, internal auditing, and
corrective and preventive action.

Here ISO 9001:2000 substantially reduces the quality assurance requirements


originally found in ISO 9001. However, it does have new requirements. The
organization must show evidence that measuring and monitoring of the QMS
processes, products, and services leads to an analysis of the data and to continual
improvement. It must also measure, monitor, and analyze customer satisfaction.
Corrective and preventive action constitutes the mechanism through which continual
improvement can be made when non-conformities take place. Here, documentation
and recordkeeping are of paramount importance.
Transitional Activities

According to ISO's Technical Committee 176, existing documents will remain valid
for the purposes of ISO 9001:2000. During the organization's transition from the 1994
standard to the 2000 one, existing documents that make references to specific sections
of ISO 9000:1994 will have to be changed to reflect the numbering scheme used in
ISO 9001:2000.

In addition, organizations should perform a gap analysis to determine what areas of


their QMS do not comply with the revised requirements. Depending on local
conditions, they will have to revise the quality manual and some procedures, or write
new documents, where appropriate, to conform to the new ISO 9001:2000
requirements.

Each organization should consult its ISO certification body before any of the steps
above are taken and should establish, in conjunction with that certification body,
when the organization begins and completes the transition from the 1994
requirements to the 2000 requirements. The certification bodies will define the
transition period for each organization. Technical Committee 176 anticipates a
transition period of one to two years.

What ISO 9001:2000 Means to RIM Professionals

In describing ISO 9001:2000, there are clear indicators that the standard may have a
significant impact on information management professionals. As stated earlier, four
requirements are particularly important:

documented procedures

control of documents

control of records

information management (e.g., external data, knowledge, and experience)

Because of the nature of their functions and expertise, information management


professionals will be directly or indirectly affected by these requirements. How the
requirements affect these professionals and the extent of the impact is contingent on
the willingness of informaiton professionals to face the challenge and seize the
opportunities. Information managers could play a very important role in their
organization's QMS. Sadly, however, it is equally possible for them to become
marginalized in this area.

Information management professionals in the ISO-certified manufacturing sector have


already had their opportunity. In some organizations, their role has been restricted to
the control of records. In others, they play a much more significant role in the
management and control of documents and information. This latter group is well
placed to take advantage of the new information management requirements in the
standard. As long as they are proactive, they should see an enhancement of their role
in their organization's QMS.
The ISO 9001:2000's generic character will lead to its extension and application to
industries other than manufacturing. It is a real possibility that manufacturing
organizations will act as catalysts to this development by requiring their
nonmanufacturing suppliers to become ISO 9001 certified as a price for doing
business with them.

ISO 9001 was and continues to be a customer-driven standard. In the future, service
and software industries will not be able to so easily escape scrutiny of their quality
management systems.

Information professionals in the service, software, and other nonmanufacturing


industries may be faced with the same essential choice faced by their colleagues in the
manufacturing industry in the 1990s. They can allow others to make the decisions, or
they can become proactive and show management that they have skills vital to the
successful implementation of an internationally recognized QMS in their
organizations.

ABOUT THE AUTHOR: Gerry van Houten, M.L.S., is the Web and documentation
administrator for BASF Canada Inc. In Toronto. Benchmarking company
documentation against various quality management systems is an integral part of his
job. He has eight years' experience in the information management field. He has
participated in several successful ISO 9000 certifications and is a certified ISO 9001
auditor. He holds a master's degree from the Faculty of Information Studies,
University of Toronto and is a member of ARMA International as well as the Special
Libraries and the Canadian Library Associations. He may be reached at
vanhoug@basf-corp.com. The author dedicates this manuscript to the memory of his
very much loved son, Adrian, who died accidentally in December 1999. His parents
miss him.

Copyright Association of Records Managers and Administrators Inc. Apr 2000


Provided by ProQuest Information and Learning Company. All rights Reserved

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