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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Collaborations
CCKL collaborates with the Accreditation Council. Just as CCKL, the task of this institution is the accreditation of laboratories. CCKL is focused specifically on medical laboratories in the human healthcare sector. The Accreditation Council is active in all other fields. When requested by a laboratory, both organisations carry out a collective assessment. This assessment then leads to accreditation by both CCKL and the Accreditation Council.
Dutch Institute for Hospital Accreditation
The Dutch Institute for Hospital Accreditation (NIAZ) is yet another body with whom CCKL collaborates. This institute accredits hospitals or parts of hospitals. The NIAZ recognizes accreditations granted by CCKL. This means that a laboratory need not be assessed a second time by the NIAZ. At the most, the NIAZ may still check the interfaces between the laboratory and the hospital.
Ministry of Health, Welfare and Sport
The Ministry of Health, Welfare and Sport is also a government body with whom CCKL has considerable contact. In this case, specifically the Public Health Inspectorate. This inspectorate inspects the health care sector in the Netherlands on behalf of the state. When an institution is accredited, the Inspectorate can conduct its inspections somewhat more remotely. This is also referred to as 'inspection of inspection'. The Inspectorate mainly acts during disasters and thematic investigations. For certain laboratories it is mandatory to obtain a permit from the Inspectorate, for example pharmacies and IVF clinics. In such cases, besides fulfilling the CCKL requirements, these centres also have to comply with such standards as the GMP-Z (for hospitals) and GLP.
Federation of Dutch Thrombosis Services
The CCKL works closely with the Federation of Dutch Thrombosis Services (FNT). Both medical laboratories and thrombosis services, or a combination of these, are accredited in conformance with ISO 15189, as specified in detail in the CCKL Code of Practice and the Thrombosis Service Accreditation Policy Committee (TAB) guideline.
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