proceseisen

Proceseisen, a Dutch term meaning process requirements, refers to the set of criteria that a process must satisfy to reliably produce a product or deliver a service. They translate customer needs, regulatory obligations, and internal quality policies into concrete, process-level criteria.

A proceseisen defines the expected capabilities of a process, including its purpose, scope, inputs and outputs, performance targets, acceptance criteria, and the controls that ensure consistency. It typically covers resources such as equipment, personnel, and the environment, as well as the steps and sequencing, measurement methods, data recording, and traceability. It also includes requirements for safety, environmental impact, and compliance with applicable laws and standards.

In practice, proceseisen are used in design and development, production, and service delivery, as a basis for process validation, qualification, and audits. They often form part of procurement documents or supplier qualification, and they are aligned with broader quality management systems such as ISO 9001 and sector-specific standards.

The implementation cycle involves documenting the proceseisen, validating that the process can meet them, monitoring performance, and managing changes through formal change control. Regular reviews and improvement actions help keep them up to date with technology, customer needs, and regulatory changes.

Example: In a manufacturing line, proceseisen might specify a maximum defect rate, target cycle time, required calibration intervals, and operator training needs, all verifiable by measurements and records.

See also: quality management, process validation, standard operating procedure, ISO 9001.