CISS key terms

A predefined condition used to judge a result against the intended requirement, distinct from inventing a passing limit after observing the data.

Documented evidence about equipment installation, operation or performance under defined conditions, whose scope must match the intended product and process.

Documented evidence that the defined process can consistently meet specified requirements under its intended conditions, rather than one convenient passing result.

A documented assessment and authorization process for a proposed change, including its effects on existing evidence, specifications and responsibilities.

A departure from an instruction, specification or expected condition that requires assessment rather than concealment or automatic acceptance.

An action directed at the supported cause of a detected problem, distinguished from merely correcting the individual affected record or item.

A planned evaluation of whether the implemented action achieved the intended result and controlled the identified problem under relevant conditions.

The documented connection among materials, equipment, process versions, product lots and decisions, supporting investigation and identification of affected output.

Comparison of a measurement system with an appropriate reference under stated conditions, including interpretation of error and relevant uncertainty.

The maintenance of trustworthy records throughout their lifecycle, including their origin, completeness, accuracy and appropriate handling of corrections.

A specified requirement used to compare objective evidence during an audit, distinct from an auditor personal preference or unsupported opinion.

Relevant information supporting a conclusion through observation, measurement, records or other examinable means, rather than assertion alone.

The population of viable microorganisms associated with a defined product or material at the specified point before a sterilization process.

A specified probability concept used in sterilization process design and validation, distinguished from proof obtained by examining every finished unit.

A defined challenge used to assess relevant sterilization performance, whose suitability depends on the process, product and intended challenge.

A characterized microbiological challenge used under specified conditions to provide evidence about a process, without independently proving every product unit sterile.

A device responding to defined process conditions, whose response must be interpreted according to its type and intended application.

A justified grouping of products sharing relevant characteristics for a defined assessment, rather than any convenient collection with a common label.

A controlled status preventing unintended use or release while the required evaluation or disposition remains incomplete, with appropriate physical or system controls.

A structured examination of hazards, likelihood, consequences and controls within the stated context, supporting decisions without removing every uncertainty.