Organisation must maintain a listing of main processes related to QMS, delivering it's products / services and maintaining its operations. Process owners are designated for each process and they are responsible for completing the related documentation and possible other quality actions directly related to the process.
Process documentation must include at least:
The organization has determined criteria and methods (e.g. monitoring actions, measurements or other related process metrics) needed to ensure the effective operation and control of its main processes.
These methods and criteria are being actively applied to have condifence that processes are being carried out as planned. Organization regularly documents the carried out monitoring / metering actions to have documented information about process monitoring.
The organization has defined the actions to identify and control outputs that do not conform to their requirements to prevent their unintended use or delivery. The organization takes appropriate actions based on the nature of the non-conformity and its effect on the conformity of products / services.
All non-conforming outputs are treated in one or more of the following ways:
Conformity to the requirements shall be verified when nonconforming outputs are corrected.
The organization maintains documentation about non-conforming outputs, actions taken, concessions obtained and the authority deciding the action in respect of the non-conformity.
The organization documents relevant externally provided processes, products and services similarly as others in the quality management system. The organization needs to similarly ensure these processes conform to requirements.
Externally provided processes, products and services are relevant when:
The organization has determined the general criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements.
The organization documents these externally provided processes, products and services in the quality management system and logs any evaluation activities and necessary actions arising in the documentation cards.
The organization needs to evaluate the suitability of its processes continually to make sure they achieve their intented results. When any significant changes to processes are deemed necessary, they are documented in the quality management system.
In systematic quality work, all significant changes to processes are implemented in a controlled manner. The impact of changes is first assessed, their ownership is assigned and the execution is monitored.
The organization needs to document process sequences for each process related to the quality management system, which illustrates the sequential flow of activities within a process.
Sequences should display the interactions of different processes and they should be detailed enough, so that the organization can use them for monitoring and having confidence that the processes are being carried out as planned.
The organization has defined how it clearly communicates quality requirements to relevant external providers.
The organization ensures that externally provided processes, products and services do not negatively affect the ability to deliver conforming products and services to its customers.
To enable this, the organization documents in its quality management system for each externally provided process, product or service:
The controls should be proportionate to the potential impact of the related activities on organization's quality and take into account the effectiveness of the controls applied by the external provider themselves.
When organization uses monitoring and measurement resources to verify product / service conformity, the organization has determined:
The organization shall ensure that monitoring and measurement resources provided:
The organization has documented relevant monitoring and measurement resources in the quality management system and shall document all relevant evidence when verifying their fitness for purpose is on the related documentation cards in the QMS.
The organization has determined suitable operating environments for its processes, to be able to produce and deliver its products and services conforming to their quality and other requirements. The organization has also defined how it provides and maintains such an environment.
A suitable environment significantly depends on the type of products and services delivered. Usually it can involve a combination of human and physical factors, such as:
In Cyberday, all frameworks’ requirements are mapped into universal tasks, so you achieve multi-framework compliance effortlessly.
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