[Self assessment grid for the post-analytical phase].

This document is a proposal of questionnaire for a self-assessment of the post-examination phase: results validation, reporting and transmitting, post-examination samples keeping and documents archival storage. The questions allow to check that the laboratory fulfils the ISO 15189 Standard and COFRAC SH REF 02 document, French regulatory requirements and more generally, satisfaction of its clients. This document can be used as it is or can be adapted to implement internal audit grids.

[Guidelines for records control and documents retention].

The quality management system is based on records to maintain, according to the requirements of ISO 15189 standard and those of the French regulation as well, to ensure traceability of data. This article provides the nature of information and documents to be stored by the laboratory and the time they have to be maintained according to the French regulation. Moreover, it provides recommendations for the management and the control of records.

[Guidelines for advisory services and results interpretation of biological examinations].

The "medical biologist" has to play a role as a consultant for the relevant use of biological examinations and to provide comments for their interpretation, comprehensible and useful to physicians. Advisory activities of the medical laboratory may help physician in diagnosis or therapeutic algorithm, avoiding ordering incomplete or useless examinations. After presentation of regulation and requirements of the EN ISO 15189 standard, this paper gives proposals for recommendations to apply in the context of accreditation.

[Guidelines for validation of the results in laboratory medicine].

The validation of the results is defined as the review and verification of the coherency and likelihood of the whole results of the examination for a patient, taking into account needed clinical data, uncertainty of measurement and anteriority's as well. The signature of the authorized person certifies this validation according to the requirements of the French regulation and ISO standard as well. Recommendations are given for the organization of this step specially for duty periods and in case of utilization of an expert system software.

[Self assesment grid for pre-examination phase].

This document is a proposal of questionnaire for self-assessment of pre-analytical phase referring to the different steps described in the document SG1-01. The questions are aimed at verifying that what is examined fulfills ISO 15189 standard requirements or in general tends towards client satisfaction. This questionnaire has been elaborated using 5 M risk assessment tool for exhaustiveness purpose.