Example of table of contents covering what our team will do
We use a range of templates picked out by expect assessors that cover all requirements for ISO 15189 accreditation.
Additional requirements can be added or removed depending on the assay/ device being investigated.
(Example below is from an analyzer verification. Part number 151201 below).
Bringing inhouse products to clinical use using relevant essential requirements of the IVD Directive 98/79 EC or Regulation 2017/746
Reproducibility & Accuracy
Analytical Specificity - identify interferences; i.e.
concurrent drugs
Est. Normal range
Standard operating manual construct.
Qualification and validation document written up for clinical
sign off.
Applicable for assays used outside intended use specified in manufacturers kit inserts
Supporting evidence and publication to support change in intended use of assay or device
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Validation and data analysis of assay operational qualification requirements
Report written to meet required regulator requirement (i.e. UKAS, FDA, CE marking, UKCA, IVDR)
Straight verification to meet ISO15189 requirements
Documentation write up and approval
Identifying sample requirements as per verification plan and sourcing them for the study.
Conducting testing for customer and writing full report as required for ISO15189 requirements
Prices are dependent of study size and complexity of requirements
ISOChecks.co.uk