ISO 9001 is defined as the international standard that specifies requirements for a quality management system. Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard the standard that organizations can certify.
ISO 9001 was first published in 1987.
ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.
ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.
Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:
- Organize processes
- Improve the efficiency of processes
- Continually improve
- Cost saving
What topics does ISO 9001:2015 cover?
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 an organization. Specific sections of the standard contain information on many topics, such as:
- Context of Organization planning and determining process interactions
- Risk based Thinking
- Support process, including human resources and an organization’s work environment
- Operation, including the steps from design to delivery
- Performance evaluation, and improvement of the QMS through activities like internal audits and corrective action
How do I get started with ISO 9001:2015?
Whether you are beginning your ISO 9001 journey or transitioning to the 2015 revision, your first step is to purchase a copy of ISO 9001:2015.
ISO 9001 CERTIFICATION
ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001:2015 certification means that an organization has demonstrated the following:
- Follows the guidelines of the ISO 9001 standard
- Fulfills its own requirements
- Meets customer requirements and statutory and regulatory requirements
- Maintains documentation
- Certification to the ISO 9001 standard can enhance an organization’s credibility by showing customers that its products and services meet expectations. In some instances or in some industries, certification is required or legally mandated.
- The certification process includes implementing the requirements of ISO 9001:2015 and then completing a successful EFR audit confirming the organization meets those requirements.