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A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). [1]
[1] [2] Quality policy management is a strategic item. [3] Section 5.2 of the ISO 9001:2015 standard requires a written, well-defined quality policy that is communicated and understood within an organization. Section 5.2 also sets out some of the requirements for quality policies. [4]
The ISO 9000 family is a set of international standards for quality management systems.It was developed in March 1987 by International Organization for Standardization.The goal of these standards is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service.
ISO created Quality Management System (QMS) [31] standards in 1987. They were the ISO 9000:1987 series of standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of industries, based on the type of activity or process: designing, production or service delivery.
The international standard ISO 9000:2015 (Title: Quality management systems - fundamentals and vocabulary) defines the term in chapter 3.5.3 as a "set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives".
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1] This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): [2] [3]
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard, ISO 9001 .
The plan–do–check–act cycle is an example of a continual improvement process. The PDCA (plan, do, check, act) or (plan, do, check, adjust) cycle supports continuous improvement and kaizen. It provides a process for improvement which can be used since the early design (planning) stage of any process, system, product or service.
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