ISO 9000

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ISO 9001 in Tsukiji

Family of standards for quality management systems


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ISO 9000 is a set of international standards for quality management systems (QMS) maintained by the International Organization for Standardization (ISO). The standards are designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of quality management systems, including the seven quality management principles upon which the family of standards is based. It is complemented by ISO 9001, which specifies the requirements that organizations wishing to meet the standard must fulfill.

History[edit | edit source]

The ISO 9000 family of standards was first published in 1987 by ISO, based on the BS 5750 series of standards from British Standards Institution (BSI) that were proposed to ISO in 1979. The standards have undergone several revisions, with the most recent being ISO 9000:2015, which was published in September 2015.

Structure[edit | edit source]

The ISO 9000 family consists of the following standards:

  • ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary
  • ISO 9001:2015 - Quality management systems - Requirements
  • ISO 9004:2018 - Quality management - Quality of an organization - Guidance to achieve sustained success

Quality Management Principles[edit | edit source]

The seven quality management principles are:

  1. Customer focus
  2. Leadership
  3. Engagement of people
  4. Process approach
  5. Improvement
  6. Evidence-based decision making
  7. Relationship management

Certification[edit | edit source]

While ISO 9000 provides the fundamentals and vocabulary, ISO 9001 is the standard that specifies the requirements for a quality management system. Organizations can be certified to ISO 9001 by undergoing an audit by a certification body. Certification to ISO 9001 is not a requirement, and organizations can implement the standard without seeking certification.

Benefits[edit | edit source]

Implementing ISO 9000 standards can provide several benefits, including:

  • Improved product quality
  • Increased customer satisfaction
  • Enhanced operational efficiency
  • Better compliance with regulations
  • Competitive advantage in the marketplace

Related Pages[edit | edit source]

See Also[edit | edit source]


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Contributors: Prab R. Tumpati, MD