QMS (MBA_ZG_524)_Assignment_22018HB74067

Case study:

It is the case study of Implementation of ISO 9001:2015, Clause 8.5 in a Software Company

Problem Statement:
We are a small start-up software company developing some accounting software and sell the
software together with support. The accounting software is the main and most lucrative product
we develop, and requires constant updating to meet changes in legislation, but we also develop
other software solutions according to the requirements of our customers. In this case study we
will discuss the process of developing new software for individual clients.
Is it production or design and development?
This question may come as a surprise in other industries, but here it is hard to make a
distinction. Once the product is designed, it no longer requires production as in the
manufacturing industry, so the design and development is the production and the process needs
to meet the requirements of both clauses 8.3 and 8.5 at the same time.

Planning software development

Let’s assume that the requirements for the product are identified during the sales process.
Because all employees in the company had little experience with project management, one of
the challenges was to define the planning step in the design process. After consideration of the
requirements of the standard, the company developed a planning stage that included:
 the nature and complexity of the software production activities
 the required stages, including applicable reviews
 the required verification and validation activities
 the internal and external resources needed for software production
 the need to control interfaces between persons involved in the design and development
process
 the requirement for subsequent provision of products and services
 roles and responsibilities within the design project, including the project team
 Inputs for design and development, including functional and performance requirements,
statutory and regulatory requirements, etc.

Based on all of this information, the company later developed the project plan with defined
phases, inputs, outputs, relevant documents, roles, etc. This typically involved a preliminary
and high-level design of the main modules with an overall picture (such as a block diagram) of
how the parts fit together. Information about the language, operating system, and hardware
components are also defined at that time. Then, a detailed or low-level design was created, with
prototyping as proof-of-concept or to firm up requirements.

Executing software development, testing and documenting

Once the project stages were defined, the people involved in the design started with
programming the code for the project. Software testing was an integral and important phase of
the software development process. Our estimate was that 50% of the whole software
development process should be tested. The purpose of the testing, which included both
validation and verification, was to ensure that defects are recognized as soon as possible). The
company adopted the test-driven development process, meaning that the tests are developed
just before implementation and served as a guide for the implementation’s correctness. Early
discovery of errors and their remedywas the key to reliable software.

Deployment and maintenance

Deployment started directly after the code is appropriately tested, approved for release, and
sold or otherwise distributed into a production environment. This involved installation,
customization (such as by setting parameters according to the customer’s values), testing, and
an extended period of evaluation.

Maintaining and enhancing software to cope with newly discovered problems and requirements
took far more time than the initial development of the software. Not only it was necessary to
add code that does not fit the original design but just determining how software works at some
point after it is completed required significant effort by the software engineer. About 60% of
all software engineering work was maintenance, but this statistic can be misleading. A small
part of that was fixing bugs. Most maintenance was extending systems to do new things, which
in many ways was considered new work.

To prevent problems, followed “Go by book approach”

Many small software development companies have problems because they perceive planning
the projects and structuring the process to be redundant and time-consuming, but development
of the procedure with clear steps and responsibilities did a great deal in preventing problems
and avoiding rework of the code.

ISO 9001 is rarely a customer requirement for software companies, but the requirements of the
standard and especially clause 8.5 helped a lot in defining the software development process,
and improving the performance of the company by cutting time spent on rework due to
misunderstanding of product requirements, and other challenges that emerge in the design
process.

Tools and Techniques used

PDCA, PPQA (Process and Product Quality Assurance), V-model.

Documents
 Characteristics of product to produced and service provided
 Records about customer property
 Production/service provision change control records
 Record of conformity of product/service with acceptance criteria
 Procedure for production and service provision