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WHAT'S ISO9001?
 
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
 
 
  • WHAT IS QUALITY MANAGEMENT SYSTEM (QMS)?

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  • A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

    ISO 9001:2015, the international standard specifying requirements for quality management systems, is the most prominent approach to quality management systems. While some use the term "QMS" to describe the ISO 9001 standard or the group of documents detailing the QMS, it actually refers to the entirety of the system. The documents only serve to describe the system.

ELEMENTS AND REQUIREMENTS OF A QMS:
 
  • Each element of a quality management system helps achieve the overall goals of meeting the customers’ and organization’s requirements. Quality management systems should address an organization’s unique needs; however, the elements all systems have in common include:

  1. *The organization’s quality policy and quality objectives
  2. *Quality manual
  3. *Procedures, instructions, and records
  4. *Data management
  5. *Internal processes
  6. *Customer satisfaction from product quality
  7. *Improvement opportunities
  8. *Quality analysis