ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Companies use the standard to exhibit the ability to consistently provide products and services that meet customer and regulatory requirements. To be certified to the ISO 9001 standard, a company must follow the conditions outlined in the ISO 9001 Standard.

To become ISO 9001 certified, a company have to:

  • Follow the steps to implement an ISO 9001 quality management system.
  • Then a Certification Body (CB or Registrar) audits the performance of your organization against the latest version of the ISO 9001 Requirements. If the company passes this audit, the Registrar issues an ISO 9001 Certificate demonstrating that the company is Registered to ISO 9001 for three years.
  • Finally, the company must be re-certified every three years to maintain its ISO 9001 certification status.

ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in a company. Specific sections of the standard contain information on topics, such as:

  • Requirements for a QMS, including documented information, planning and determining process interactions
  • Responsibilities of management
  • Management of resources, including human resources and an organization’s work environment
  • Product realization, including the steps from design to delivery
  • Measurement, analysis, and improvement of the QMS through activities such as internal audits and corrective and preventive action.