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The organization identifies the knowledge its processes need to run and to make products and services conform, keeps that knowledge, and makes it available as far as needed. When needs and trends change, it looks at what it knows already and decides how it will obtain, or gain access to, the further knowledge and updates it needs. Organizational knowledge ma...

The QMS holds two kinds of documented information: what the standard itself requires, and whatever else the organization decides it needs for the system to be effective. How much is needed varies with the organization's size, the kind of activities, processes, products and services it has, how complex its processes are and how they interact, and how competen...

The organization plans, carries out and controls the processes required to meet the requirements for supplying its products and services and to put into effect the actions from clause 6. It does so by identifying the requirements for those products and services; setting criteria both for the processes and for accepting the products and services; identifying ...

Production and service provision are carried out under conditions the organization keeps controlled. Where they apply, these include: documented information that defines the characteristics of the products, services or activities and the results to be reached; monitoring and measuring resources that are suitable, available and used; monitoring and measuremen...

The organization shall ensure that the AI system is used according to the intended uses of the AI system and its accompanying documentation.

Requirements and specifications shall be defined for new or substantially modified AI systems, including responsible AI requirements.

The organization shall define and document processes for the responsible use of AI systems, including processes for the use by employees of AI systems provided by third parties.

The organization shall identify and document objectives to guide the responsible use of AI systems.

The organization shall document a deployment plan and ensure requirements are met before deployment.

AI systems shall be operated and monitored according to organizational and operational requirements throughout their lifetime. Operational guidance shall be available to operators.

Event logs shall be generated and recorded during AI system operations to enable monitoring, accountability, and incident investigation.

The organization shall assess and document the potential impacts of AI systems to individuals or groups of individuals throughout the system's life cycle.

Production and service provision are carried out under conditions the organization keeps controlled. Where they apply, these include: documented information that defines the characteristics of the products, services or activities and the results to be reached; monitoring and measuring resources that are suitable, available and used; monitoring and measuremen...