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Welcome ICS Accreditation Services
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How we help Manufacturers & Clinical Laboratories
We have holistic approach to improve patient care in diagnostic healthcare
Our team will support you as a medical laboratory in your adjustment to the IVDR and help ensure that you comply with the requirements for using LDTs whilst maintaining accreditation against the ISO 15189 standards.
Knowing the clinical context of these requirements, effective application and dissemination of knowledge is critical to ensuring minimal harm to patient on an ongoing basis.
We train on the 'why' the standards are important in clinical context, providing case studies on how non-compliance leads to detrimental healthcare.
We also focus on training clinical teams to ensure they fully understand laboratory governance requirements.
Accreditation Assistance for Diagnostic Laboratories
Validation documentation
Validation documentation
Validation documentation
Send us the your data and we will analyse the data and compile the report to ISO 15189 requirements.
Audit/review
Validation documentation
Validation documentation
Review and or audit your processes before submitting for accreditation.. Perform jap analysis.
The Full works
The Full works
The Full works
Feature product. Full assay/instrument implementation;
From planning and testing to full report write up. This is the hassle free product to the entire process enabling you to concrete on your day to day activities.
Guide Price for individual evaluation types & Part number
Assay/device verification
Straight verification to meet ISO 15189, 2022 requirements
User requirements and verification plan
Price from £250
Design verification documentation to confirm that the design output meets the design input requirements.
Part number:1501
Sample requirements
Price from £500
Identifying sample requirements as per verification plan and sourcing them for the study.
Part number:1502
Conducting Verification and writing report
Price from £2900
Conducting full testing for the customer & writing full verification report as required for ISO15189 requirements.
Part number:15VER
In-house Assay validation of assay- Full service Part Number 180101
Bringing inhouse products to clinical use using relevant essential requirements of the IVD Directive 98/79 EC or Regulation 2017/746
Phase 1: Feasibility
Price from £3000
- Clinical application research
- Establishment of intended use
- Scope utility: comparison to other methods
- Validate Specificity claims
- Initial Quality program design
- Product application sheet construct
- Feasibility data publication
- Validation action plan write up
Phase 2: Design qualification
Price from £3000
- Assay optimization plan
- Establishment of best practice. Pre-analytical, sample types, sample stability, sample rejection criteria
- Instrument maintenance / critical operational elements identification
- Identify reagent best practice; reagent source, stabilities
- Finalize Quality program/SOP
- Estimation of margin of error (MU)
Phase 3: Performance Qualification
Price from £4500
Clinical verification
- Reproducibility & Accuracy
- Analytical Specificity
- Identify Interferences; i.e. concurrent drugs
- Est. Normal range
- Linearity analysis
- Method Comparison
- Standard operating manual construct
- Validation document written up for clinical sign off
Assay/device validation- deviation from intended use/ Part number: 180701
Applicable for assays used outside 'intended use' specified in manufacturers kit inserts
Deviation clinical approval process
Price from £900
Sort supporting evidence and publications to support change in 'intended use' of assay or device
Assay optimization
Price from £3100
Validation and data analysis of assay operational qualification requirements
Conduct validation to support changes
Price from £3500
Performance Qualifications (PQ)
Full validation with report submissions to regulators
Price from £6500
Report written to meet required regulator requirements (i.e. UKAS, FDA, CE marking, UKCA, IVDR)
Prices are dependent of study size and complexity of requirements
featured Innovative Solutions for Tomorrow's Challenges
ISO15189 Accreditation solutions for Clinical laboratories
Lead times for implementation of devises or instruments in clinical laboratories can be an overwhelming task to incorporate within already busy schedules.
One of our specialist to take the hassle of the ISO 15189 accreditation process of any equipment or processes you require!
We provide from tailored solutions to full 'end to end' verifications or validations to ensure your laboratory meets the necessary standards and regulations to fulfil the requirements of ISO 15198,2022.
Training and Development
- Introductory Haemostasis to Advance Haemostasis
- Quality assurances procedures.
- Assay development methods.
- Blood Morphology
- Specialized Haemostasis methods- practical laboratory sessions
Validation solutions
Premade validations sample packs delivered to conduct location evaluations of your procedure /instrument
- Normal Serum or plasma for normal ranges establishment
- Pathological samples for method comparison studies
- Spiked samples to evaluate treatment efficacy of methods
- Samples with interference substances to evaluate assay limitations