What is the ISO 9001 standard?

ISO 9001 is the world's most important standard for quality management. It defines requirements for processes, procedures and company management in order to ensure consistently high product and service quality. The standard is industry-independent and is used by small companies through to global corporations.

 

Requirements of ISO 9001

ISO 9001 defines the basic requirements for an effective quality management system. It does not define any technical specifications, but describes how a company must organise its processes so that quality is planned, monitored and continuously improved. The central requirements are

  • Process-orientated work: All relevant processes are defined, controlled and regularly evaluated.
  • Risk-based thinking: Risks and opportunities for processes, products and customers are systematically identified and addressed.
  • Responsibilities and competences: Responsibilities are clearly defined. Employees are trained and empowered to carry out quality-related tasks safely.
  • Documented information: Relevant processes, evidence and records are documented and maintained.
  • Suppliers: External partners are evaluated, monitored and included in quality management.
  • Quality deviations: Deviations are identified, documented and countermeasures initiated.
  • Internal audit and management review: The system is regularly reviewed, evaluated and adapted.
  • Continuous improvement: Measures to optimise processes, products and services are actively planned and implemented.

 

Scope of application of ISO 9001

ISO 9001 can be used in almost any organisation - regardless of sector, size or product. It is aimed at organisations that want to control, monitor and improve their processes in a structured manner in order to deliver reliable quality. The standard applies to manufacturers, service providers, trading companies and public organisations.

It also forms the basis for a large number of industry-specific quality standards, for example in the aerospace, medical technology and automotive sectors.