Accreditation Services

Is your laboratory facing any of these challenges?

“We're not sure whether this requires verification or validation.”

“We've completed the validation, but we're not confident the evidence is sufficient.”

A new examination method does not always require the same level of evaluation.

The appropriate approach depends on factors such as the method, manufacturer's claims, intended use, modifications and how the examination will be performed within your laboratory.

We can help you determine the appropriate approach and develop a proportionate study plan.

“We've completed the validation, but we're not confident the evidence is sufficient.”

We can review:

Study design
Acceptance criteria
Sample selection
Performance data
Statistical analysis
Conclusions
Supporting documentation

Our aim is to identify gaps before they are identified during assessment.

“We're introducing a new analyser or examination method.”

Implementation of a new platform or method requires more than simply demonstrating that the analyser works.

Your laboratory needs evidence that the examination procedure is suitable for its intended clinical application within your own environment.

ISOCHECKS can support method verification, comparison studies, performance evaluation and implementation documentation.

“We've modified the manufacturer's method.”

“We're introducing a new analyser or examination method.”

Changes to an established method can alter its performance characteristics.

Examples include:

Different specimen types
Modified sample preparation
Different extraction procedures
Changes to analytical parameters
Different instrumentation
Use outside the manufacturer's intended purpose

We can help assess the impact of the modification and determine an appropriate validation strategy.

What we can support

Method Verification

Precision & Reproducibility

Method Verification

Support for laboratories introducing established examination procedures into their own laboratory environment.

We can help with study design, performance requirements, data interpretation and documentation.

Method Comparison

Precision & Reproducibility

Method Verification

Structured comparison of a new examination procedure with an existing or comparator method.

Depending on the application, this may include assessment of:

Bias
Agreement
Precision
Range
Clinically relevant concentrations
Statistical performance

Precision & Reproducibility

Assessment of repeatability and reproducibility under appropriate conditions.

We can help develop study designs that provide meaningful evidence of analytical performance

Analytical Performance

Clinical Performance & Clinical Relevance

Precision & Reproducibility

Depending on the method, we can support evaluation of areas such as:

Precision
Accuracy / trueness
Linearity
Measuring range
Detection capability
Analytical specificity
Interference
Carryover
Reproducibility

Clinical Performance & Clinical Relevance

Analytical performance is only part of the picture.

Where appropriate, validation should consider the clinical application of the examination procedure and whether the evidence supports its intended use.

We can help laboratories incorporate clinical considerations into their validation strategy

From validation to implementation

Clinical Performance & Clinical Relevance

Validation shouldn't sit in isolation.

Once the study is complete, your laboratory may need to incorporate the findings into:

Standard operating procedures
Quality documentation
Method implementation records
Training
Competency assessment
Quality control processes
Reference intervals
Measurement uncertainty
Ongoing performance monitoring

Most Popular Practical support for Clinical laboratories

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 15189,2022.

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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

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Validation documentation review

Already completed your study?

You don't necessarily need to start again.

ISOCHECKS can review your existing validation package and provide an independent assessment of:

Study design
Was the study appropriate for the intended use?
Sample selection
Were the samples and concentrations appropriate?
Acceptance criteria
Were appropriate performance requirements established before testing?
Data analysis
Has the data been analysed and presented appropriately?
Conclusions
Do the conclusions logically follow from the evidence?
Documentation
Can another competent person understand what was done, why it was done and what was concluded?

The objective is to help you turn technical data into a clear, defensible validation package.

Frequently Asked Questions

Please reach us at Info@isochecks.co.uk if you cannot find an answer to your question.

What is the difference between verification and validation?

The appropriate approach depends on the examination method, intended use, manufacturer's claims and any modifications made by the laboratory. We

can help you determine the appropriate strategy for your specific situation.

Can you review validation work completed by our laboratory?

Yes. We can provide an independent review of existing validation or verification evidence and identify potential gaps.

Can you help if we have already received UKAS findings?

Yes. We can help laboratories understand validation-related findings and develop an appropriate response and improvement plan.

Can you help if we have already received UKAS findings?

Yes. We can help laboratories understand validation-related findings and develop an appropriate response and improvement plan.

Can you work with our existing laboratory team?

Yes. We can work collaboratively with laboratory scientists and quality teams or provide more independent project support, depending on your requirements.

ISO 15189 & UKAS Validation Support

Is your laboratory facing any of these challenges?

“We're not sure whether this requires verification or validation.”

“We've completed the validation, but we're not confident the evidence is sufficient.”

“We've completed the validation, but we're not confident the evidence is sufficient.”

“We've completed the validation, but we're not confident the evidence is sufficient.”

“We've completed the validation, but we're not confident the evidence is sufficient.”

“We've completed the validation, but we're not confident the evidence is sufficient.”

“We're introducing a new analyser or examination method.”

“We're introducing a new analyser or examination method.”

“We're introducing a new analyser or examination method.”

“We've modified the manufacturer's method.”

“We're introducing a new analyser or examination method.”

“We're introducing a new analyser or examination method.”

“We're preparing for a UKAS assessment.”

What we can support

Method Verification

Precision & Reproducibility

Method Verification

Method Comparison

Precision & Reproducibility

Method Verification

Precision & Reproducibility

Precision & Reproducibility

Precision & Reproducibility

Analytical Performance

Clinical Performance & Clinical Relevance

Precision & Reproducibility

Clinical Performance & Clinical Relevance

Clinical Performance & Clinical Relevance

Clinical Performance & Clinical Relevance

From validation to implementation

Clinical Performance & Clinical Relevance

Clinical Performance & Clinical Relevance

Most Popular Practical support for Clinical laboratories

ISO15189 Accreditation solutions for Clinical laboratories

Validation solutions

Validation documentation review

Express Implementation

Frequently Asked Questions

Need help with UKAS accreditation?

Is IVD validation becoming a challenge for your laboratory?

New IVD implementation

New IVD implementation

New IVD implementation

Modified IVD

New IVD implementation

New IVD implementation

UKAS preparation

New IVD implementation

UKAS preparation

LDT development

Limited resources

UKAS preparation

Limited resources

Limited resources

Limited resources

Clinical samples

Limited resources

Limited resources