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TSEK assessment: check the test conditions and production evidence
TSEK assessment follows the accepted criterion and actual programme. A favourable result under different sample conditions does not automatically answer the required test.
Translate the criterion into an assessment plan
Confirm the accepted criterion, product configuration and manufacturing scope with TSE before fixing an assessment plan. Identify the required product examination and the manufacturing controls that support continuing conformity. Ask which samples, methods and production records the programme requires; this guide does not prescribe a universal test package, visit sequence or sampling frequency.
Check that the proposed evidence addresses the stated requirement rather than a similar property under unrelated conditions. Read sample preparation, conditioning, measurement method and reported result together. Keep the actual laboratory work and manufacturing assessment distinct; a laboratory report supports the recorded result, while TSE evaluates its relevance within the certification programme.
A favourable unconditioned result may leave a gap
Conditional example: the confirmed criterion requires assessment after a specified conditioning process, but the available report tested the product without it. Compare the report’s actual preparation and test conditions with that requirement. Do not claim that a favourable unconditioned result demonstrates performance after conditioning, or invent the missing conditioning duration in a preparation document.
Present the mismatch to TSE and arrange the evidence it requires, including genuine sample preparation and testing where applicable. Keep the original report and new work traceable to the actual configuration. A laboratory can clarify what it performed or correct a genuine reporting error; it cannot retrospectively perform conditioning by adding a sentence to the report.
Close findings with evidence the programme can accept
For a manufacturing-control gap, identify the affected product, the missing control and actual corrective action. Retain records that show implementation and the resulting product decision. A drafted procedure alone does not establish that the control operated, and a corrected test result does not by itself show that future manufacture remains consistent.
TSE decides whether the programme requirements have been met, whether the corrective evidence is acceptable and whether certification can proceed. The applicant supplies truthful information and operates controls; the laboratory accounts for its work. Kayra can compare the criterion with the evidence and coordinate agreed preparation. Record unresolved questions and acceptance milestones instead of promising a pass or a fixed completion date.
Related service guides
- ← Return to the main document guide
- 01Documents and Records Required for TSEKOpen guide →
- 02TSEK Cost and TimescaleOpen guide →
- 03TSEK Enquiry and ValidityOpen guide →
- 04TSEK Renewal and SurveillanceOpen guide →
- 05Is TSEK Mandatory? Requirements ExplainedOpen guide →
- 06Frequently Asked Questions About TSEKOpen guide →
- 07TSEK Scope and Key DifferencesOpen guide →
- 08How to Obtain TSEKOpen guide →
- 09Who Manages the TSEK Process?Open guide →
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The exact records for TSEK Audit Process depend on the confirmed scope. Current, consistent and traceable information reduces avoidable revisions.