The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on this International Standard are:

the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;

facilitating opportunities to enhance customer satisfaction;

addressing risks and opportunities associated with its context and objectives;

the ability to demonstrate conformity to specified quality management system requirements.
This program employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

The process approach enables an organization to plan its processes and their interactions. The PDCA cycle enables an organization to ensure that its processes are
adequately resourced and managed, and that opportunities for improvement are determined and acted on.

Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise
Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.

Quality management principles

The quality management principles are: customer focus;
leadership;
engagement of people;

process approach;
improvement;
evidence-based decision making; relationship management.

Process approach

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer

requirements.
Understanding and managing interrelated processes as a system contributes to the
organization’s effectiveness and efficiency in achieving its intended results. This
approach enables the organization to control the interrelationships and
interdependencies among the processes of the system, so that the overall
performance of the organization can be enhanced.
The process approach involves the systematic definition and management of
processes, and their interactions, so as to achieve the intended results in accordance with the qual ity policy and strategic direction of the organization. Management of
the processes and the system as a whole can be achieved using the PDCA cycle
(see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking

advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:

understanding and consistency in meeting requirements;
the consideration of processes in terms of added value;
the achievement of effective process performance;
improvement of processes based on evaluation of data and information.

The PDCA cycle can be briefly described as follows:
Plan: establish the objectives of the system and its processes, and the

resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities;

Do: implement what was planned;

Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results;

Act: take actions to improve performance, as necessary. Risk-based thinking

-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.

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.

can arise as a result of a situation favourable to achieving an
intended result, for example, a set of circumstances that allow the
organization to attract customers, develop new products and services, reduce
waste or improve productivity. Actions to address opportunities can also
include consideration of associated risks. Risk is the effect of uncertainty
and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.