Revising ISO 14001 and ISO 14004

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					collection of statistical data for electron-
                                                A MONTH OF ISO STANDARDIZATION
ic information resources and electronic
delivery as well as for traditional library
services. This ISO standard gives library
managers with performance indicators           Revising ISO 14001 and ISO 14004
which can be used as a base for strategic
                                               by Oswald A. Dodds, Chair TC 207, Environ-       SC 1 decided to survey the national
planning, decision-making and funding,         mental management, Subcommittee SC 1,          delegations that make up the subcom-
review and formulating policy.                 Environmental mamagement systems
                                                                                              mittee about the need for and possible
   ISO 2789 will also help libraries and
                                                                                              approach to a revision of both standards
information services in the compilation        To ensure that ISO                             and this took place in 1998. Thirty-
of statistics at the regional, national and    standards represent the                        one of the then 47 participating “ P ”
international levels so that they can be
truly comparable between countries and         state of the art, ISO’s                        members (ISO technical committees
                                                                                              also have observer “ O ” members, who
over time.                                     rules require its technical
                                                                                              do not vote) of ISO/TC 207/SC 1 sup-
   This third edition, which replaces ISO      committees to review                           ported revising the standards with most
2789:1991, has been updated to take into
account new methods of sampling for
                                               the standards they have                        of them preferring to see a wide-ranging
library services, and gives an account         developed within five years
of new developments in library practice,       of their publication and to
particularly those concerned with elec-        decide whether to revise,
tronic resources and automation.
   “ The main challenge linked to the          confirm or withdraw them.
revision was to identify and define sta-
tistics for the ‘digital library’,” said Dr.   ISO’s environmental management system
Poll, convenor of the working group            (EMS) standards ISO 14001 (EMS
that developed the new standard. “ The         specification and guidance for use)
solution was to add those data and defi-       and ISO 14004 (general guidelines on
nitions of new electronic information          EMS principles, systems and supporting
                                                                                              ISO/TC 207, SC 1 decided to limit
services which will hopefully remain           technologies) are no exceptions to the
                                                                                              the revisions to the following:
stable over several years.”                    rule. Published in 1996, they are now          “Enhancing compatibility between
   The new standard is likely to be used       being revised by Subcommittee (SC) 1           ISO 14001 and ISO 9001:2000 ”...
by all types of libraries and information      of ISO technical committee ISO/TC 207,
services, regardless of setting, user group    Environmental management, which devel-         revision.
and characteristics (e.g. structure, fund-     oped the original versions.                      At the same time, concerns existed
ing, governance, etc.)                            In addition to ISO’s five-year review       (and still do) that such an early revision
   ISO 2789:2003 is the work of ISO tech-      requirement, the following issues came         could cause confusion or uncertainty
nical committee ISO/TC 46, Informa-            into play during the discussions preced-       among the potential users of the stand-
tion and documentation, subcommittee           ing the review :                               ards. Therefore, SC 1 decided to limit the
                                                                                              revisions to the following :
SC 8, Quality – Statistics and perform-        • the overwhelming desire of the writ-
ance evaluation, working group WG 2,               ers of the standards to ensure com-        − enhancing compatibility between
International library statistics.                  patibility with the ISO 9000 series          ISO 14001 and ISO 9001:2000, and
                                                   standards, which were undergoing a         − improving the clarity of the 1996
                                                   major revision at the time ISO 14001         texts.
                                                   and ISO 14004 were first published ;
                                                                                                This decision was designed to reassure
                                               • the need to ensure that the standards are    the marketplace, assist existing users
                                                   clear in their requirements and content;
                                                                                              and help countries only recently becom-
                                               • the need to reflect experience in the        ing aware of and involved in the develop-
                                                   use of ISO 14001 and ISO 14004 ;           ment and use of the standards.
                                                                                                In the case of ISO 14004, the scope of
                                               • the need to ensure that the stand-           the revision was defined as follows :
                                                   ards can be used and understood by
                                                                                              − follow and remain consistent with
                                                   all types and sizes of organization
                                                                                                the revisions of ISO 14001,
           ISO BULLETIN JUNE 2003
− improve the clarity of the text,            cooperation of our colleagues from ISO/      • the Legal and other requirements
                                              TC 176/SC 2 – the subcommittee respon-          clause is to include an explicit provi-
− reflect and integrate the experience
                                              sible for ISO 9001:2000. Several years          sion “ to ensure that legal require-
  of users,
                                              ago, during their own revision activity, a      ments are considered in developing,
− ensure that the document can be             joint group was established to deal with        implementing and maintaining (an
  used by and is relevant to small and        compatibility issues and participants in        organization’s) EMS ” ;
  medium enterprises (SME’s).                 that group (the Joint Task Group) have       • the clauses in the 1996 edition that
                                              attended each other’s meetings, offering        refer to Objectives and Targets and
   Terms of reference for the revisions
                                              comments to aid the compatibility im-           Environmental Management pro-
were agreed and the work got underway
                                              provements of ISO’s quality and environ-        gramme are to be combined in order
in 1999-2000. The original work plan
                                              mental management system standards.             to aid understanding ;
showed that the task should be complet-
ed during 2003. It is now seen as more                                                     • the clauses on Structure and respon-
likely that the task will be completed            “ We have had the                           sibility, and Training, awareness and
during 2004.                                                                                  competence have been revised to
                                                  full support and
                                                                                              clarify their purpose and make them
The revision process                              cooperation of our                          more understandable for users ;
Two working groups have been set up,              colleagues from
each assigned the revision of one of the          ISO/TC 176/SC 2 –
standards. They use many techniques,              the subcommittee
ranging from general brainstorming
sessions to specific issue discussions in
                                                  responsible for
small and large groups, not to forget             ISO 9001:2000 ”
focussed task groups looking at a
particular element (or even phrase) in
                                              Key revisions
one of the standards.
  We have been through rough drafts,          Examples of key changes proposed to ISO
working drafts, editing groups, and           14001 include the following :
many more ! We have had our “mo-              • changes to the diagram (Figure 1) to
ments” en route to the present position,                                                   ... and “improving the clarity of the
                                                 show the Plan-Do-Check-Act meth-
but that is all part of the process of con-                                                1996 texts”.
                                                 odology and the addition of a note
sensus-building, which is at the core of         of explanation and reference to the
the ISO process.                                                                           • the requirement for specific docu-
                                                 process approach used in ISO 9001:
  Currently, we are in the middle of a                                                        mented procedures is to be reduced to
                                                 2000 ;
four-month (approximately) period for                                                         that required for operational control
                                              • amendments to and the addition                purposes. In all other cases, the need
Committee Draft (CD) ballot/comments
                                                 of new definitions for compatibil-           for documentation is to be covered by
that will hopefully lead to a Draft Inter-
                                                 ity, and enhancement and clarity of          a revised Documentation clause that
national Standard (DIS) for both revised
                                                 meaning ;                                    includes requirements for
documents following meetings scheduled
to take place in Bali, Indonesia in late      • the explicit requirement to define            − documented environmental policy,
June/early July 2003.                            the scope of the EMS has been moved            objectives and targets,
  I should point out that through this           from the Introduction of the exist-
                                                 ing version of the standard to clause        − a description of the main ele-
activity we have had the full support and
                                                 4.1 ;                                          ments of the EMS and their in-
                                                                                                teraction and reference to related
    “ To ensure that ISO                      • the requirement “ for the Policy to be
                                                 appropriate to the nature, scale and
    standards represent                          environmental impacts ” will now             − documents required by this Inter-
    the state of the art,                        apply to the “ activities, products and        national Standard,
    ISO’s rules require                          services that are within the defined         − documents determined by the
                                                 scope of its EMS ” ;
    its technical com-                                                                          organization to be necessary to
    mittees to review the                     • the phrases “ employees ” and “mem-             ensure the effective planning,
                                                 bers” are to be replaced by the phrase         operation and control of proc-
    standards they have                          “ all persons working for or on behalf         esses that relate to its significant
    developed ”                                  of the organization ” ;                        environmental aspects, and

                                                                                                      ISO BULLETIN JUNE 2003
     − records required by this Interna-
       tional Standard.                                                                A MONTH OF ISO
                                                      About the author                 STANDARDIZATION
• the requirement to evaluate legal com-
     pliance periodically is to be separated
     from the monitoring and measure-
     ment clause to ensure that it receives                                           ISO 9000
     appropriate attention by users ;
                                                                                      guidelines for
• the EMS audit clause will be amend-
     ed to emphasize that the requirement
     is for an internal process (not to be
     confused with other audit-type ac-
     tivities) ;                                                                      ISO has published guidelines for medical
• Annex A: the guidance offered on the                                                laboratories for implementing quality
     use of ISO 14001, has been revised to     Oswald A. Dodds, MBE, is chair-        management systems based on ISO 9001:
     fit with the changes to the require-      man of ISO technical committee         2000.
     ments and to provide guidance based       ISO/TC 207’s Subcommittee 1,              “ The new standard will guide lab-
     on experience and need, and               which is revising ISO 14001 and ISO    oratories to organize their operation
                                               14004, and a member of the work-       efficiently ”, said John Zlockie, Secre-
• Annex B: informative tables show-            ing group dealing specifically with    tary of the technical committee which
     ing links between ISO 9001:2000 and       ISO 14001. He is co-leader of the      developed the new standard. “ It will
     ISO 14001:200X will be updated as         ISO/TC 207 Group on Corporate          help them to comply with regulatory
     the revision progresses.                  Social Responsibility, TC 207 liai-    requirements, to meet the expectations
                                               son representative to ISO/CASCO,       of their clients and customers and, most
  Space limitations preclude a more de-        Committee on conformity assess-        importantly, to improve or maintain
tailed explanation of proposed changes,        ment, and leader of the United         their service to patients.”
as they are many and detailed. All of          Kingdom delegation to ISO/TC 207.         ISO 15189:2003, Medical laboratories
them are designed to :                         He is also active in standardization   – Particular requirements for quality
− improve the clarity of the 1996 text,        at all levels within the British       and competence, provides a framework
                                               Standards Institution (BSI) and the    for the design and improvement of proc-
− improve further compatibility be-
                                               European Committee for Standardi-      ess-based quality management systems
  tween ISO 9001:2000 and ISO 14001:
                                               zation (CEN). Former executive di-     by medical laboratories. It contains
                                               rector of a large British local gov-   much of the text of ISO 9001:2000, sup-
− ensure easier translation and use            ernment authority, Oswald Dodds        plemented by specific guidance for its
  around the world, and                        now runs his own business support      implementation in laboratories based on
− avoid new requirements being intro-          company, Osanda.                       ISO 17025:1999, General requirements
  duced (beyond any changes needed                                                    for the competence of testing and cali-
                                               Oswald A Dodds, MBE, Director,
  to implement the other bullet points                                                bration laboratories.
                                               Osanda Support Services,
  above).                                                                                The new standard is intended to pro-
                                               19 Shepperton Close, Great Billing,
                                                                                      mote a common approach to the qual-
                                               Northampton NN3 9NT,
  Clearly, with both ISO 14001 and ISO                                                ity management of medical laboratories
                                               United Kingdom.
14004, the views of ISO national member                                               and to all aspects of its operation, from
institutes will have to be accommodated        Tel.   + 44 1604 401726.               patient preparation and identification to
as we move to finalize the revised stand-      Fax    +44 1604 414366.                the collection and examination of clini-
ards – and clearly too, the ballot results     E-mail oad.osanda@                     cal samples.
will be significant in how and when we                           According to John Zlockie, ISO 15189
move to finalize the process and ask ISO                                              will prove useful to accreditation bodies
to publish the new editions.                                                          engaged in the recognition of the compe-
  I am optimistic that we can achieve                                                 tence of medical laboratories as a basis
publication during 2004 – later than                                                  for their activities.
originally expected, but given the nature                                                “ ISO 15189 will be an important tem-
of the task and the considerable interest                                             plate for assessing and recognizing the
and involvement in our discussions, per-                                              competence of medical laboratories in
haps not entirely unexpected.                                                         their technical capacity and the effective

            ISO BULLETIN JUNE 2003