ISO 9001 specifies a set of requirements for a Quality Management System where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction.
Quality Management System mainly suggests process approach means organization’s activities are segregated in to various processes, which will be helpful in monitoring and measurement of process and continual improvement of process.
To obtain this certification, Organization’s Process are to be documented and approved (Generally called as Planned Arrangement) by the Top Management and the relevant document should be distributed within the organization where the activities are performed. (Finance and Accounts is excluded from QMS).Organization should maintain Records for all the process defined in QMS.
Records are the evidence that the planned Arrangement is followed. Records are updated by the employee who carries out the process as per the planned arrangement (Document).Data captured in various records are real time data of the organization. Upon analysis it reveals a clear message to the Top Management for further planning and action.
|Plan||:||Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.|
|Do||:||Implement the processes.|
|Check||:||Monitor and measure processes and product against policies, objectives and requirements for the product and report the results.|
|Act||:||Take actions to continually improve process performance.|
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.
A desired result is achieved more efficiently when activities and related resources are managed as a process.
Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.
Continual improvement of the organization's overall performance should be a permanent objective of the organization.
Effective decisions are based on the analysis of data and information.
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
These eight quality management principles form the basis for the quality management system standards within the ISO 9000 family.