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.

ISO 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 management principles:

  1. Customer focus.
  2. Leadership.
  3. Engagement of people.
  4. Process approach.
  5. Improvement.
  6. Evidence-based decision making.
  7. Relationship management.
ISO 9001 is a life-cycle of improvement

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 elements include:

ISO 9001 QMS model
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
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 organisation.

See an example ISO 9001 Quality Manual, titled process manual, here. Powerpoint presentaion on the process approach here.