Accreditatie en certificering
Accreditatie gaat verder dan certificering. Het verschil is als volgt:- Accreditatie is een procedure waardoor een gezaghebbend orgaan formeel kenbaar maakt dat een instelling of persoon competent is om specifieke taken uit te voeren.
- Certificatie is een procedure waardoor een onafhankelijke instelling schriftelijk verklaart dat een product, proces of dienst voldoet aan gespecificeerde eisen.
Bij accreditatie wordt een volledig werkproces getoetst. Bij certificering wordt alleen de dienst (of het product) zelf getoetst en niet de manier waarop dat tot stand komt.
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Audit
Een audit is een systematisch en onafhankelijk onderzoek om te bepalen of de kwaliteitsactiviteiten en de resultaten hiervan overeenkomen met vastgelegde regelingen en of deze laatsten doeltreffend ten uitvoer zijn gebracht, alsmede geschikt zijn voor het bereiken van de doelstellingen.
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Criteria
CCKL assesses the quality of laboratories against various international standards. The relevant standards are ISO 15189, ISO 17025 and relevant paragraphs of ISO 9001 and 9002. These standards also form the basis of CCKL’s own Code of Practice. In the CCKL Code of Practice, the international standards and requirements are specified in detail, in particular for laboratories serving the human healthcare sector. It also pays particular attention to the pre- and post-analytical phase, specimen collection, specimen preparation and consultation on the results and treatment plans that follow. The guide covers embedding within the Dutch situation (regulations).
As an aid to the implementation of a quality system compliant with CCKL standards, several professional associations have compiled model handbooks. These books elaborate further on the CCKL Code of Practice for certain specific laboratory disciplines. These model handbooks are available solely from the professional associations in question.
CCKL complies with the requirements stated in ISO/IEC/17011 for Conformity Assessment Bodies. However, CCKL imposes an assessment frequency which is non-standard, but commonplace in healthcare. This is because the individual pillars of a quality system are also validated by means of management reviews, quality control programmes, professional visitation (peer assessment) and training visitation.
The CCKL Code of Practice has been established in collaboration with all laboratory-related professional associations.
What makes the CCKL Code of Practice unique is that it has been compiled by representatives of all laboratory disciplines and sub-disciplines and organisations for external quality control. This pan-disciplinary approach, an English translation under the auspices of the World Health Organization (WHO) and a French translation, have contributed to the CCKL Code of Practice achieving widespread acceptance within Europe. CCKL and the CCKL Code of Practice have attained such international repute that in several European countries they now form the benchmark for the development of quality policy for medical laboratories.
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