Certification Standards - Using Event-B for Critical Device Software Systems - page 304

Appendix
Certification Standards
A.1 What Are Standards?
Standards are documented agreements containing technical specifications, which
produce precise criteria, consistent rules, procedures to ensure reliability, software
processes, methods, products, services and use of products are fit for their purpose in
this world. Standards include a set of issues corresponding to the product function-
ality and compatibility, facilitate interoperability, including designing, developing,
enhancing, and maintaining. A set of protocols and guidelines, which are produced
by the standards, are consistent and universally acceptable for product development.
Standards allow to understand the quality of different products for competing with
them and provides a way to verify the credibility of new products [ 13 , 18 ]. A basic
definition of standards is defined by ISO [ 18 ]asfollows:
Standards are documented agreements containing technical specifications or
other precise criteria to be used consistently as rules, guidelines, or definitions of
characteristics, to ensure that materials, products, processes and services are fit for
their purpose .
Different nations tend to have different views of what a standard is and what
standardisation is for. Standards are varied from nation to nation. For instance, UK
and Europe standards define a product. Implementation dependencies should be re-
duced, and rigorous testing of products should satisfy the standards. The standard is
a description of an artifact that is to be built precisely according to the provisions of
the standard.
Since software plays an increasingly important role in software-based products
related to medical, automotive and avionic systems. Because of the uncertainty of
the reliability and compatibility of these software-based products, different kinds of
national and international standards related to certification bodies (FDA's QSR and
ISO's 13485, etc.) need effective means for ensuring that the developed software-
based system is safe and reliable.
There is a wide variety of standards bodies. More than 300 software standards
and 50 organisations are developing software standards [ 8 ]. Standards come in many
different flavours, for example, de-facto standards, local, national and international