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:
- 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 can be thought of as a system model that contains 5 internal elements and 1 external elements, all evolving around the Plan-Do-Check-Act (PDCA) cycle, for achieving an organisation’s policy and objectives, and for managing risks and opportunities.
QMS model. The cycle parallel arrows indicate that PDCA occurs at both strategic and tactical levels
The PDCA cycle in fact occur at multiple levels, represented here by the two parallel arrows; where the outer arrows may represent senior management taking a strategic view and where the inner circle represents self-managing teams taking a tactical/procedural view on the system. Senior managers plan and operate in outline terms, whereas the teams will plan and operate the related details. The successful outcome for the organisation and its customers depends on the effectiveness of both the ‘strategic’ and the ‘tactical’ PDCA cycles.
The purpose of the 5+1 system elements can be summarised as:
Leadership: Drives the effective implementation and ongoing execution of the PDCA cycle across the system. Sets a unified direction and promotes the coherence to planned objectives. Unblocks any obstacles and maintains conditions for achieving the objectives.
Planning: Determines the customer input, mandatory requirements and the organisational context, for translation into objectives. The context will influence the objectives for making use of opportunities for improvement and efficiencies as they arise. Planning also considers and incorporates countermeasures to any risks of deviation from the objectives.
Operation and support: Organise and control the multiple activities and linkages in the processes-chain and resources, for purpose of producing the planned result – e.g. transform the input requirements into a corresponding output. The support element develops and maintains the appropriate competencies, capability and capacity in people, equipment, infrastructure and work environment.
Performance Evaluation: Measures, investigates and analyses the processes, product and outcomes, including customer satisfaction, for purpose of verifying that planned results are met and for identifying new risks and opportunities. Periodic audits objectively measure effectiveness and verify conformity to requirements.
Improvement: Reactive and proactive activity for assuring the ability to meet requirements and for enhancing the satisfaction of customers and other interested parties. Improvement relies on evidence-based decision making.
Suppliers: Suppliers are not part of the organisation, but they can influence outcomes and can thereby be considered as part of the wider system. In some industries, suppliers are equally or more important to the results than the organisation’s own resources are. Suppliers should therefore be engaged with similar attentiveness as given to the organisation’s own resources.
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 organisation.