Enter returns or RMAs into the system

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...

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...

At suitable stages the organization carries out the arrangements it has planned for checking that products and services meet their requirements. Products and services are released to the customer only once those arrangements are satisfactorily complete, unless a relevant authority, and the customer where applicable, approves otherwise. Documented information...

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 shall define and document quality requirements for data and ensure they are met.

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...

The organization identifies, provides and maintains the infrastructure its processes need to run and to make products and services conform. Infrastructure may cover buildings and utilities, equipment (hardware and software included), transport resources, and information and communication technology.

When it plans its QMS, the organization takes into account the issues from 4.1 and the requirements from 4.2 and identifies the risks and opportunities it needs to address so that it can be confident the system will achieve what it is meant to, strengthen wanted effects, prevent or lessen unwanted ones, and bring about improvement. It plans the actions it wi...

Where the organization decides its QMS needs to change, it makes the change in a planned way, taking into account why the change is being made and what it could lead to, whether the system stays intact, whether resources are available, and how responsibilities and authorities are allocated or reallocated.

The organization keeps improving how suitable, adequate and effective its QMS is. It uses what analysis and evaluation show, together with what management review decides, to find out whether there are needs or opportunities that continual improvement should take up.

The organization shall establish a process to assess the potential consequences of the AI system for individuals or groups and societies.

As part of identifying resources, the organization shall document information about the data resources utilized for the AI system.