ISO 9000

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"ISO 9000 " (ISO 9000:2015)
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ISO 9000 is a set of international standards for quality management and quality assurance established 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.

Overview[edit | edit source]

The ISO 9000 family of standards is based on several quality management principles, including a strong customer focus, the involvement of top management, a process approach, and continual improvement. The standards provide guidance and tools for companies and organizations that want to ensure their products and services consistently meet customer’s requirements, and that quality is consistently improved.

History[edit | edit source]

The ISO 9000 series was first published in 1987. The standards have been updated several times, with the most recent version being ISO 9000:2015. The 2015 revision introduced a greater emphasis on risk-based thinking and aligned the structure with other ISO management system standards.

Key Standards in the ISO 9000 Family[edit | edit source]

  • 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
  • ISO 19011:2018 - Guidelines for auditing management systems

Principles of ISO 9000[edit | edit source]

The ISO 9000 standards are based on the following seven quality management principles:

  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]

Organizations can be certified to ISO 9001, which is the standard that sets out the criteria for a quality management system. Certification is performed by external certification bodies, and many organizations around the world are certified to ISO 9001.

Benefits[edit | edit source]

Implementing ISO 9000 can offer numerous benefits, including:

  • Improved product quality
  • Enhanced customer satisfaction
  • Increased efficiency and reduced waste
  • Better compliance with regulations
  • Enhanced marketability

Related Standards[edit | edit source]

ISO 9000 is part of a broader family of standards, including:

See Also[edit | edit source]

References[edit | edit source]

External Links[edit | edit source]

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Contributors: Prab R. Tumpati, MD