Fix a label, barcode or paperwork error

Top management makes sure that the responsibilities and authorities of relevant roles are allocated, made known and understood across the organization. This includes allocating who is responsible and has authority for: keeping the QMS in conformity with the standard; making sure processes produce the outputs intended for them; reporting to top management on ...

The organization makes sure that any output failing to meet its requirements is identified and controlled so that it is not used or delivered by mistake. It acts on the nonconformity in proportion to what the nonconformity is and how it affects whether products and services conform, and this applies also to outputs found to be nonconforming after delivery. P...

Whenever a nonconformity arises, complaints included, the organization responds to it: as applicable it acts to control and correct it and deals with what follows from it. It then judges whether action is needed to remove the causes, so the nonconformity does not happen again or somewhere else, by reviewing and analysing it, finding its causes, and finding o...

A process shall be established to enable reporting of concerns about AI systems' development, deployment, or use.

The organization shall determine and document a plan for communicating incidents to relevant interested parties.

The organization's communication with customers covers: giving information about its products and services; dealing with enquiries, contracts and orders, including changes to them; collecting customer feedback on its products and services, complaints included; handling or controlling property that belongs to customers; and, where relevant, agreeing specific ...

The organization makes sure that what external providers supply (processes, products and services) meets requirements. It decides what controls to apply in three cases: where an external provider's products and services will be built into the organization's own; where an external provider supplies products and services straight to customers on the organizati...

Before it passes requirements to an external provider, the organization makes sure they are adequate. It tells the provider its requirements on: what processes, products and services are to be supplied; how products and services, methods, processes and equipment are approved, and how products and services are released; competence, including any qualification...

Where needed to make products and services conform, the organization uses suitable means to identify its outputs. Throughout production and service provision it marks where each output stands against the monitoring and measurement requirements. Where traceability is required, it controls the unique identification of outputs and retains the documented informa...

The organization decides which internal and external communications matter to its QMS: what it will communicate, when, to whom, by what means, and who will do the communicating.

Establish a process ensuring that the organization's use of services, products or materials provided by suppliers aligns with its approach to the responsible development and use of AI systems.

Ensure the organization's approach to the responsible development and use of AI systems takes account of customer expectations and needs.

The organization makes sure that any output failing to meet its requirements is identified and controlled so that it is not used or delivered by mistake. It acts on the nonconformity in proportion to what the nonconformity is and how it affects whether products and services conform, and this applies also to outputs found to be nonconforming after delivery. P...

The organization decides what it will monitor and measure; which methods of monitoring, measurement, analysis and evaluation it will use so the results can be relied on; when monitoring and measurement take place; and when the results are analysed and evaluated. It evaluates how the QMS is performing and how effective it is, and retains suitable documented i...

The organization analyses and evaluates the relevant data and information that monitoring and measurement produce, and uses what it learns to judge: whether products and services conform; how satisfied customers are; how the QMS is performing and how effective it is; whether planning was put into effect well; how effective the actions on risks and opportunit...

Whenever a nonconformity arises, complaints included, the organization responds to it: as applicable it acts to control and correct it and deals with what follows from it. It then judges whether action is needed to remove the causes, so the nonconformity does not happen again or somewhere else, by reviewing and analysing it, finding its causes, and finding o...

The organization identifies and chooses opportunities to improve and carries out the actions needed to satisfy customer requirements and raise customer satisfaction. These include: improving products and services so they meet requirements and anticipate future needs and expectations; correcting, preventing or reducing unwanted effects; and making the QMS per...

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