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Checklist for Auditing Sterilization with Radiation Mobile App

The Checklist for Auditing Sterilization with Radiation mobile app serves for the evaluation of audit results. Every audit requirement should be evaluated separately. This checklist shall be used for assessment of operators of the corresponding sterilization facilities. Where sterile products are to be included in the company’s product spectrum, a sterilization assessment (including assessment of design and validation of sterilization processes) must be carried out based on at least one product file of a sterile product. For sterile products of risk class III, the documentation of design and validation must be examined. Where an assessment of sterilization procedures validation is necessary as a part of the QM assessment for medical products, the present checklist should be applied in case of radiation used as the sterilizing agent.

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Ref:
Device:
Date:
Manufacturer:
Auditor:
Signature:
Documentation
Have procedures for the design, validation, routine control and product release from sterilizatio...
Are all documents and records that are necessary according to ISO 11137-1 reviewed, approved and ...
Management Responsibility
Are responsibilities and authorities for all the requirements of ISO 11137-1 specified and assign...
Is there a contract agreement about the responsibilities and authorities, in case several organiz...
Product Realization
Are procedures for purchasing, identification*) and traceability*) specified?
Is a system for calibration of all equipment and testing instruments specified**)?
Is the metrological aspect of the dosimetry traceable to national or international standards and ...
Measurement, Analysis and Improvement — Control Of Nonconforming Product
Are procedures for the control of nonconforming products, corrections, corrective actions and pre...
(*) respective applicable parts of ISO 13485
(**) respective applicable parts of ISO 13485 or ISO 10012-1
Comments
Corrective Actions
Sterilizing Agent
Has the type of radiation to be used been specified?
For electrons or X-rays: has the energy of electrons been specified?
Is the electron beam energy >10 MeV (accelerated electrons) resp.
Microbicidal Effectiveness
(No normative requirements)
...and More!