ISO 9000 is a set of standards for quality management systems. Perhaps, it is the most popular generic international standard today. First published in 1987 and modified in 1994, it is the true basis for businesses to develop or improve their quality assurance systems. Today, most international businesses document their quality systems according to the ISO 9001 elements.
There are a total of 20 elements (sections) in the overall ISO 9000 standard. Each section explains what a company has to do in order to show that it is abiding by the ISO 9000 rules. Each of these elements should be clearly and completely documented.
The twenty ISO 9000 elements include management responsibility, quality management system (QMS), contract review, design control, document control, purchasing, purchaser supplied product, process control, inspection and testing, inspection, measuring and test equipment, inspection and test status, control of non-conforming product, corrective action, handling, storage, packaging and delivery, control of quality records, internal quality audits, training, servicing, and statistical techniques and product ID and traceability.
Management responsibility addresses the responsibility of an organization to set up a system that frequently meets consumer requirements and expectations, even in times of managerial change. Quality management system defines general requirements, along with documentation requirements such as quality manual, procedures, work instructions and records.
Design control requires that all phases in the designing of products or services must be managed and conducted by qualified employees. The ISO element document control requires that all documents and data used must be controlled and authorized.
The section of statistical techniques includes data analysis, sampling methods, and SPC (statistical process control). These processes should be based on established procedures and sound statistical techniques.
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