9001

ISO 9001, commonly referred to as 9001, is the international standard that specifies the requirements for a quality management system (QMS). It is part of the ISO 9000 family and is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements, while also aiming to enhance customer satisfaction.

The standard is built around a process approach and the Plan-Do-Check-Act (PDCA) cycle and is grounded in seven quality management principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and mutually beneficial supplier relationships. It is designed to be applicable to any organization, regardless of type or size or the products and services offered.

Key requirements cover establishing the context of the organization, leadership and commitment, planning to address risks and opportunities, resource support, operational controls, performance evaluation through monitoring and measurement, internal audits, management review, and continual improvement. Documentation is referred to as “documented information,” allowing flexibility in how information is maintained and controlled.

Certification to ISO 9001 is achieved through independent external audits conducted by accredited certification bodies. Successful audits lead to a certificate, with surveillance audits typically conducted annually and a full re-certification every three years. The standard can be integrated with other management system standards due to its common high-level structure (Annex SL).

History traces ISO 9001 back to the 1987 adoption of the former BS 5750 standard. The 2015 revision introduced risk-based thinking, greater emphasis on leadership, and alignment with other management systems. The standard remains widely adopted across industries as a framework for consistent quality and process improvement.