Setting up a quality management system, documenting how the system should work, writing a quality manual, controlling the documents and the system and managing records suitably are some of the criteria required to get an ISO 9001 quality management certification. There is a long list of requirements to achieve certification, including several categories for the specified criteria.
There are several requirements for managing the quality system, such as demonstrating commitment to it, focusing on customers, writing a quality policy and using it and planning for quality. The system needs to include objectives that can be measured and suitable plans to achieve these objectives. There needs to be a clear definition and communication about who has what responsibility and authority. This category includes review requirements, such as reviewing the system at regular intervals including customer feedback, performance, nonconformity, audits, actions raised, changes and any need to improve.
Another category of criteria are resource requirements. This category includes deciding what resources are needed for the system and providing them. Infrastructure decisions and work environment conditions are also part of this section.
Requirements for products or services are also part of the ISO criteria. These include planning, such as having effective customer-related processes and effective ways to communicate with customers, and controlling what is bought or outsourced if it affects services or products. Requirements on how to manage operations are also included in this category, for instance, having effective ways to control how products or services are provided, validating production and service provision, identifying and tracking services and products and controlling measuring and monitoring equipment.