The importance of
standards
Standards are tools developed to help companies to
ensure the quality and/or safety of their products, services and activities. Standards
are voluntary, which means that businesses and other organizations are not
legally obliged to apply them.
By providing
organizations with a common basis for mutual understanding, standards enable
companies to access markets and sell to customers in other countries. They are
especially useful for communication, measurement, commerce and manufacturing.
They enable compatibility between products and/or components and help
companies/organizations to comply with relevant legislation.
To be useful and accepted
by interested parties they need to be high quality standards, easily understandable
and conveying accurate and relevant provisions. They should enable companies to
achieve
better levels of performance and reliability. The process undertaken for
the standard development should be underpinned by the principles of “credibility”,
“transparency”, “alignment” and “consistency”.
Credibility can be
achieved by following international reference documents providing credible
practices. Transparency is achieved by making procedures available to the
interested parties. Alignment can be achieved by adopting a structure that
enables the integration with other standards. Consistency within the standard
and with other standards can be achieved by being in accordance with the
provisions from documents issued by european or international standardization
organizations such as CEN or ISO Directives for standard development.
Consistency within
the entire body of the document is also needed and can assured by clearly identifying
the link between the standard objectives and the principles of the activity and
the link between each requirement and the relevant objective.
Standard development procedures
The procedures
undertaken for the standard development can be described according to figure 1.
Figure
1- Procedure for the standard
setting activities.
Terms of reference
Terms of reference
include the following elements:
(1) A
justification study, to avoid standard duplication or overlap;
(2) The objectives
that the standard aims to achieve;
(3) The scope;
(4) A risk
analysis on the implementation, identifying the risks and how to mitigate for
these.
In order to
establish the objectives, the principles that govern the activity should be
identified. These principles provide the foundation for the establishment of the
provisions. They can also serve as an anchor for guidance on decisions that
companies need to make in unexpected situations.
The objectives
should be clearly established and justified, defining the outcomes that the
standard seeks to achieve. Clear objectives, aligned with the principles of the
activity are crucial since they are the pillars upon which the standard will be
built.
The risk analysis
should include (a) the identification of factors that could have a negative
impact on the ability of the standard to achieve its goals, (b) unintended
consequences that could arise from its implementation and (c) preventive
actions that could be taken during the standard development to address these
potential risks.
Establishing the
type of standard, structure and rules for drafting
The type of
standard is defined regarding the established structure (main clauses) and
provisions. The technical provisions found during draft should be documented and
their relevance to the attainment of the objectives evaluated.
The structure
should be defined looking for alignment with other standards with overlapped
scope enabling the integration of different disciplines.
Drafting should
follow European or international provisions ensuring the uniformity of
structure and style within the document and among ISO standards: identical
structure and clause numbering, and the use of analogous and identical words to
express analogous and identical provisions.
Establishing the
provisions
The standards
provisions are classified into “requirements”, “recommendations” and
“statements” (ISO/IEC 2011). This facilitated the use of the correct terms
within each provision, ensuring that all the requirements convey criteria and
that the method to evaluate the fulfillment of the criteria is identified. This
also make the standard easy to understand and facilitate the translation to
other languages.
The requirements
should be established in order to be clear, objective and verifiable. They
should be expressed in terms of process management and performance criteria
giving space for innovation and flexibility. When necessary explanations are
added in order to facilitate transposition of pure performance requirements
into practical solutions.
The use of terminology
must be consistent with ISO or CEN terms and definitions.
In order to assure
that (1) all requirements clearly contribute to the attainment of the standard
goals, (2) only requirements that are relevant to meet these outcomes are
included and (3) all the necessary requirements to address the defined goals
are included, the link between the requirement, the leading objective and the
related principle was identified.
To facilitate the
link between the requirement and the appropriate objective, an intention
declaration should be made for each requirement or set of requirements,
defining the desired outcome.
Public
consultation
Interested parties
are invited to participate providing appropriate opportunities for valuable
contributions in a transparent process whose different steps are identified in
figure 2. Comments are registered according to the respective clause. They are analysed and discussed
within the assigned commission for decision. Comments that are not accepted
will be justified and recorded. These records are made available to
participants.
Figure
2 - Procedure for the
interested parties consultation/participation.
Final remarks
European and international standards are
developed by teams of experts from different countries, nominated by the
national standards organizations, who share their knowledge and expertise in a
particular field. Thus users can benefit from having access to the best
available knowledge and state-of-the-art solutions.
These technical committees are expected to take
account of the opinions and interests of all the relevant interested parties
including business and industry, research institutes, consumer and
environmental organizations. All of these interested parties are invited to
express their views on draft standards by responding to public consultations or
enquiries that are organized at national level in each country.
After publishing standards are reviewed on a
regular basis to ensure that they take account of the latest scientific,
technological, regulatory and market developments.
References
ISO/IEC (2011), ISO/IEC
Directives, Part 2 - Rules for the structure and drafting of International
Standards, International Organization for Standardization and International
Electrotechnical Commission, Geneva,
Switzerland.
Anabela Martins
PhD Student
Research Group on
Quality and Organizational Excellence
University of Minho
