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ISO 9001 Requires a Compliant QMS
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New employees use an SOP to answer questions without having to interrupt supervisors to ask how an operation is performed. The international quality standard ISO 9001 essentially requires the determination of processes (documented as standard operating procedures) used in any manufacturing process that could affect the quality of the product. [6]
The ISO 9001 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes. Butterworth-Heinemann and other publishers have offered several books which provide step-by-step guides to those seeking the quality certifications of their products.
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.
The ISO 9004:2009 document gives guidelines for performance improvement over and above the basic standard (ISO 9001:2000). This standard provides a measurement framework for improved quality management, similar to and based upon the measurement framework for process assessment. The last major revision was published 15 September 2015.
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".
The simplest form of quality control was a sketch of the desired item. If the sketch did not match the item, it was rejected, in a simple Go/no go procedure. However, manufacturers soon found it was difficult and costly to make parts be exactly like their depiction; hence around 1840 tolerance limits were introduced, wherein a design would ...
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