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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Decision-making
The findings from the on-site assessment are divided into categories. CCKL uses the following categories:
- category 1: no observable deviations from the quality system;
- category 2: the observed deviations form no direct danger to the quality system. Nevertheless, they must be rectified, because a negative effect on the system can be expected in the long term;
- category 3: the observed deviations have a negative effect on the professional capabilities of the laboratory and its personnel, and/or the quality system. Considering the seriousness of the deviations, rectification must take place in the short term;
- category 4: the observed deviations have an immediate and critical effect on the professional capabilities of the laboratory and its personnel, and/or the quality system. The deviations therefore directly affect the delivered quality.
For deviations in category 2, the examination team supplies the CCKL board with a positive recommendation for accreditation. However, the laboratory must propose an action plan for eliminating the deviations within a year. This is referred to as the homework round. During a first assessment, applicants are allowed five months to complete their homework following the release of the assessment report, so that everything can be completed within six months. In the case of a reassessment, applicants are allowed two months to complete their homework following the release of the assessment report, so that everything can be completed within three months.
Deviations in categories 3 and 4 do not lead to a positive recommendation. The defects must first be demonstrably eliminated, before accreditation can be resumed.
Based on this categorisation, the recommendations of the assessment team and that of the CCKL director, the CCKL board will decide whether a laboratory is to be accredited.
Once the CCKL board gives a positive decision, a laboratory will be granted accreditation. The accreditation is announced by CCKL. The laboratory may then use the CCKL accreditation mark.
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