Operational Qualification and Accreditation

Packaging Qualification Principle

The packaging qualification is documented testing that demonstrates with a high degree of assurance that a specific system will meet pre-determined acceptance criteria (type of use, temperature and duration).

Qualification Process

In order to meet the high level of quality requirements expected from the healthcare community, the Kalibox qualification process follows a rigorous methodology.

The qualification protocol is the reference document for the realisation of the tests. It must be validated by both parties and define:

  • The objective of the qualification, reference regulatory documents and responsibilities
  • Operating conditions and testing procedures
  • Acceptance criteria

The Qualification report includes tests results and the calibration certificates of used equipment. The Qualification report aims at providing the comprehensive documentation to support your Quality Assurance system and at explaining the testing methodology.

ISO 17025 Accreditation

Kalibox testing laboratory is accredited by the COFRAC institute according to the ISO/CEI/17025 standard for the qualification of temperature-controlled packaging according to the normalised methodology NF S 99-700.

The Accreditation is a formal recognition, by an external and independent organism, of the laboratory staff’s competences, of the applied methodology, of the monitoring of the entire measure chain and of the management of the organisation (traceability, data management and software.) For our customer, accreditation represents a guarantee of impartiality recognized by official authorities. Indeed, these categorically acknowledge the independency of the laboratory when it expresses its judgement of conformity.