Inquiry by the customer
Possibilities of inquiry:
Feasibility evaluation of the desired test method by CleanControlling Medical
- Clarification of the feasibility of the desired test
Clarification of testing details
- By phone or by e-mail
- During a visit to our house in connection with a laboratory tour
Quotation
- Quotation 1 to 2 days after request
- The offer is accompanied by a Test Item Characterization Sheet, which has to be filled out and sent with every order to ensure a smooth process. Please use the form attached to the offer or download it from the following links:
Ordering by the client and shipment of the test items in our laboratory
Packageing by the client and shipment to our facilities:
- Packaging Variant 1: The test items should be packed in such a way that no further contamination (biological, chemical or particulate) can get onto the products during transport (eg in a closed polybag, better still sealed).
- Packaging variant 2: Simulation of customer delivery with original packaging and removal of the test items from CleanControlling Medical.
Goods receipt of samples at CleanControlling
- The packaging is visually inspected and photographed and documented in case of possible transport damage or inadequate packaging.
- Inspection of the analysis information when receiving the order
- Creation of a laboratory order from information from the client
Start of the analysis
- Preparation of the samples (e.g. sterilization)
- Provision of the necessary sterile working materials
After completion of the analysis
- You will receive the test items after completing the tests, unless otherwise agreed. The test items are not contaminated.
- We do not archive any reference samples.
Handling of Decision Rules at CleanControlling
1. Standard Requirements:
If decision rules are specified in specifications or standards, we apply only those rules.
2. Client Requirements:
If the client requests a specific decision rule (e.g., safety band, risk assessment according to ILAC G8), this must be communicated in writing in advance. Implementation and documentation will follow after consultation.
3. Standard – Simple Acceptance:
If no specifications are provided, conformity assessment is conducted according to the principle of simple acceptance (ILAC G8, 4.2.1): The result is considered compliant if it falls within the limit values, without taking measurement uncertainty into account.
A detailed description of our approach to assessing the conformity of test results, as well as the decision rule applied in this process, can be found here.