What is ISO 9001?
An International Standard specifying a set of descriptive requirements
for what is universally recognised should be contained in a management
system that seeks to achieve and enhance quality.
9001 belongs to a family of standards, including ISO 9000 on quality
fundamentals and vocabulary; and the ISO 9004 guidance standard on a
quality approach to managing for the sustained success of an
organisation. The family of standards is based on seven quality
- Customer focus.
- Engagement of people.
- Process approach.
- Evidence-based decision making.
- Relationship management.
ISO 9001 is not a one-off project, but
assumes a life-cycle of improvement
ISO 9001 defines a
quality management system (QMS) as “coordinated activities to direct and
control an organisation with regard to quality”. The standard
describes a model, centred on the
Plan-Do-Check-Act (PDCA) cycle, for achieving an organisation’s policy
and objectives, and for managing risks and opportunities. Its system
- Leadership, driving the PDCA cycle.
- Operations and support.
- Performance evaluation.
QMS model. The cycle parallel arrows indicate that PDCA occurs at both
strategic and tactical levels
ISO 9001 does not prescribe how its requirements shall be met. It is
for the organisation self to determine how it will meet them, in a way
that best suits its particular situation. The standard promotes a generic end-to-end process approach
(as opposed to a functionally divided approach). It defines a product
simply as the
“result of a process”, which makes the standard universally applicable to any type
of organisation, regardless of size and product or service provided.
Process-based PDCA organisation
The term ‘process approach’ refers to the “systematic definition and
management of processes and their interactions so that to achieve the
intended overall results in accordance with policies and strategy
direction of the organisation”. The process approach enables the
organisation managing its system and its value creation as an integrated
whole, including the risks and opportunities that span across the
See an example ISO 9001 Quality Manual, titled process manual,
Powerpoint presentaion on the process approach