By : Yasuhiko Yoneto
Yasuhiko Yoneto discusses the Japanese view of ISO 9001
and his suggestions for the revised version of the standard in 2015
When ISO 9000 was first published in 1987, many Japanese
companies showed a strong resistance to the requirements of western-style
documentation. ISO 9001:2000 was expected to breathe new life into Japanese
companies that were suffering from the collapse of the bubble economy, and to
help restore their competitiveness. However, we found out that the quality
management system on its own was not enough to strengthen the economic results
of Japanese companies' operations. The revision in 2008 was not a full-scale
one and there were only minor modifications. With this in mind, from a personal
point of view, expectations are high for the revised version of ISO 9001
(expected to be released in 2015).
Today, you would be hard pressed to find an organisation
that is unaffected by the wave of globalisation. It is now common to
procure materials, components for products, and even services, from abroad. For
example, a company in the US
might be continuously carrying out around-the-clock development work on
computer software in collaboration with an Indian company. Despite this
situation, the only wording that reflects this in the current version of the
standard is "evaluation of suppliers". So it is difficult to say that
the standard places enough emphasis on the management of suppliers. Many
companies have responded by creating a supplier qualification process using
their own rating criteria, such as supply capability and quality control level.
There has been a host of challenges for international supply chains recently,
which demonstrate the need for supply chains to be strengthened. It's therefore
desirable that a clear statement about the requirement for supplier evaluation
is made in the revised ISO 9001 standard, addressing the presence or absence of
supply chain management and need for periodical second-party auditing.
According to a recent ISO survey on the relationship
between financial results and the concept of zero defects, a financial
disadvantage can surface when the management system for the manufacturing
process aims to achieve a zero-defect product infinitely through the principle
of 'quality first'. The survey also found that many companies are seeking
economic benefits through the utilisation of the ISO 9001 quality management
system. In Japan
it is not as prevalent as the rest of the world, but some companies do seek
third-party certification of their management system for the sole purpose of
increasing their commercial advantage. This is a particularly strong pattern
among small and medium-sized companies. To avoid such improper trends, one
option for the revised ISO 9001 standard would be that 'management review'
requires organisations to discuss investment efficiency as well as cost
reduction.
Due to advances in information technology, it's become
common practice for management systems and various documents to be digitalised.
This practice encourages the internal sharing of various documents so that they
can be facilitated at every level of an organisation. Today, many organisations
use information technology to strengthen their internal communications and
share knowledge of customer information and personal experiences. However, the
current international standard does not specifically mention the utilisation of
information technology, other than referring to "documents containing
digital data". An active utilisation of information technology could be
encouraged in the standard, by adding a requirement regarding documentation.
The difference between corrective and preventive actions
is not so clear, although these are major requirements in the current
international standard. Not only that, but the requirement for preventive
action cannot be described as a proactive approach, but rather a reactive
approach. In addition, 'preventive action' is often synonymous with risk
assessment, hence it has to be positioned at the 'plan' stage in Deming's
plan-do-check-act cycle. Very fortunately, the newly proposed high level
structure for international standards follows this direction and emphasises
risk management in the planning stage as a part of the management system. The
risk-based approach adopted for another standard – PAS 99:2006 – might be one
of options to encourage organisations to carry out a simple risk assessment.
Therefore, my final suggestion for the revised ISO 9001 standard is to add a
note referring to the risk-based approach of PAS 99.
Yasuhiko Yoneto is a quality commentator, former employee of
ExxonMobil Chemical, and former quality improvement engineer in Japan, the US
and Singapore
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