ISO 9001 is a set of international standard and guidance documents for quality management and quality assurance. The standard represents an international consensus on good management practices with the aim of ensuring that the organization can, time and time again, deliver the product or services that meet the client’s quality requirements.
These good practices have been distilled into standardized set of requirements for a quality management system, regardless of what your organization does, its size, or whether it’s in the private, or public sector. The standard helps businesses define and document their own quality procedures for production and/or services. It can be used in any type of business and accepted around the world as proof that a business can provide assured quality.
The quality system requirements defined by ISO 9001 are general in nature, allowing companies to develop their own procedures, policies, and work instructions. Each company defines, in detail, what standards and procedures are needed. ISO 9000 quality system standards were primarily intended for manufacturing, but have been adapted for services and other specialized businesses.
The ISO 9000 series of standards and guidance consists of one document, ISO 9001, which details the requirements, and two guidance documents, ISO 9000 and ISO 9001. The standard ISO 9001 is based on the “process approach.” The “process approach” is to examine each of the processes defined by the organization, and the interaction of the inputs and outputs of each process.