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ISO 9001 – Quality Management System

The ISO 9000 family of quality management system standards is designed to support organizations in their efforts to ensure that they meet the needs of their customers and other stakeholders while complying with relevant legal and regulatory requirements.

ISO 9000 refers to the basic principles of quality management systems, including the eight management principles on which this series of standards as a whole is based.

ISO 9000, and all related QMSs, focus on continuous improvement processes in achieving objectives related to the overall performance of the organization such as service delivery, production lines, customer service, administration, etc.

 The process of organizing a business under ISO 90001 and all the related principles and requirements of the implemented QMS follow the basic approach – Plan-Do-Check-Act (PDCA)

 

The 4 phases of the PDCA cycle

01

Plan

The overall responsibility for the design and implementation of the quality management system is assigned to the upper management. The specific responsibility for its supervision and implementation is assumed by the Quality Manager and the Quality Team. In addition, as part of the design of the QMS, the organisation must articulate the Quality Policy in the form of a written statement outlining management’s intentions and commitment to the implementation of the System. The Quality Policy shall be communicated within the organisation. The Quality Team is the link between management and employees regarding compliance to the principles of the Quality System. This phase should identify the important operating processes of the organisation, the requirements that govern them (legal, technical specifications, customer requirements) as well as the quality objectives and the possibilities for improving the quality of the operations.
02

Do

In this phase, the defined procedures and the designed policies are put in place. The resources available and the responsibilities of the staff are defined. It is ensured that employees and other stakeholders are aware of and able to assume their responsibilities for the implementation of the quality management system in the organisation. This is how the implementation and application of the system begins.
03

Check

Every quality management system requires the existence of compliance control procedures with regard to its stated principles and documented procedures. Internal audit can help to confirm that the quality management system is operating correctly and effectively and producing the desired or intended results. Processes regarding compliance with legal and other requirements (customer, legal-regulatory, etc.) and the achievement of the organisation’s quality objectives must be observed. The results shall be documented and reported to management.
04

Act

The upper management prepares a written assessment based on the conclusions – findings of the internal audit. This document is called the Management Review. The results will be evaluated regarding the level of performance of the audited functions. If required, corrective or preventive actions are planned. Based on the above conclusions, new strategic or quality objectives are established and, at the same time, by implementing the required corrective measures, the processes as well as the quality outcome of the organisation’s functions are optimised.

Swiss Approval International guarantees

Swiss Approval International guarantees the accredited certification of Quality Management Systems, giving companies the appropriate passport to the international market, ensuring with accuracy and independence the compliance with the principles and rules defined by the ISO 9001: 2008/2015 standard.

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