This
International Standard specifies requirements for a quality management system
where an organisation:
a) Needs
to demonstrate its ability to consistently provide product that meets customer
and applicable statutory and regulatory requirements, and
b) Aims to
enhance customer satisfaction through the effective application of the system,
including processes
For
continual improvement of the system and the assurance of conformity to customer
and applicable statutory and regulatory requirements
ISO 9001 is based on seven quality management principles.
-Customer focus
– Organisations
depend ontheir customers, and therefore need to shape activities around the
fulfillment of market need.
-Leadership –
Is needed to provide unity of purpose and direction
-Engagement of people –
Creates an
environment where people become fully involved in achieving the organisations
objectives.
-Process approach –
To achieve
organisational objectives, resources and activities need to be managed as
processes, with an understanding of how the outputs of one process affect the
inputs to another
-Continual improvement –
Adopting
this as a part of everyday culture is a key objective for an organisation
-Evidence based decision-making –
Effective decisions are based on the logical and intuitive analysis of data and
factual information
-Relationship management
– Such relationships will enhance the ability to create value.
Risk-based thinking
Risk-based thinking is
essential for achieving an effective quality management system. The concept of risk-based
thinking has been implicit in previous editions of this International Standard including,
for example, carrying out preventive action to eliminate potential nonconformities,
analysing any nonconformities that do occur, and taking action to prevent recurrence
that is appropriate for the effects of the nonconformity. To conform to the requirements
of this International Standard, an organization needs to plan and implement actions to address
risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing
the effectiveness of the quality management system, achieving improved results and preventing negative
effects.
Why an organisation should implement ISO 9001?
Without
satisfied customers, an organisation is in peril! To keep customers satisfied,
the organisation needs to meet their requirements. The ISO 9001standard provides
a tried and tested framework for taking a systematic approach to managing the
organisation's processes so that they consistently turn out product that
satisfies customers' expectations.
