To meet the ISO 9001 standard, businesses need to implement and maintain a number of practices, processes and specific standards. In particular, they need to put concrete quality management processes in place, and also adopt intangible values such as a customer-centric focus. Responsibility for quality control also needs to be taken on by upper management and employees down through the business hierarchy. The most general and overarching requirement for ISO 9001 certification can be expressed like this:
“Organizations must establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of the International Standard”.
In essence, this directive boils down to a few key requirements under eight primary headings, a sample of which are detailed below:
4. Products and Services
The essence of the ISO 9001 standard is the implementation of the core quality control processes. These will vary widely from business to business, and depend largely on the specific product, service and value-creation process. Examples of quality management processes are the systematic checking of raw materials as they arrive at a plant, and randomised spot-checks of component quality at an intermediate manufacturing stage. Specialised ISO consultants are often called upon to plan and implement the quality control systems that a given business needs.
ISO 9001 requires businesses to thoroughly document relevant processes. This involves creating written procedural documents for all steps in the major quality management processes that have been implemented. The organization needs to produce a quality manual that can be easily referenced by all employees who are involved in quality management.
There are several customer-facing requirements of ISO 9001. Firstly, the business is required to actually determine customer requirements for their offer, and establish a solid product-market fit. The company must also create systems for engaging and communicating with customers, and be able to deal effectively with enquiries, complaints and customer feedback.
As you can see, the ISO 9001 requirements are fairly thorough and impact all stages of a business from value creation through to shipment and customer service. Although the focus of ISO 9001 is quality management, it actually often provides the foundation for a functional and profitable business.