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Each instrument begins as a so-called “blank”. There are only a few certified forge shops capable of meeting our demanding specifications in terms of materials, shape and dimensions.
As a starting material, only European stainless steel is used, and a recognized test certificate must accompany each steel batch. The blanks created from this raw material are documented as well. To ensure traceability as stipulated by law, the quality management systems of our suppliers are closely interlaced with our own QM system.
The technical documentation is the basis on which each product is manufactured. All manufacturing specifications are integrated into our quality management processes, thus enabling us to verify and locate product changes anytime.
Manufacturing is a batch-based process because the great variety of instruments does not permit serial production. Thus, almost all instruments are hand-made. All intermediate checks and tests are defined as steps in the process and, consequently, meticulously documented.
As regards instrument functionality and reprocessing, tempering is usually the most vital step in the manufacturing cycle. At this stage, instruments made from hardenable chromium steels receive their hardness, tenacity (toughness) and corrosion resistance. Nickel-chromium steels, in contrast, are not hardenable and therefore can be used only for special instruments.
Instruments are given their final shape, function and surface finish only after the tempering stage. High-qualified instrument-makers now fit each instrument to its function in a purely manual process. Not surprisingly, Tuttlingen is the only place in the world that has a technical school and training system tailored to the needs of the industry.
On its way through the manufacturing cycle, each instrument must continuously pass prescribed and documented tests. Despite these rigid in-process requirements, KLS Martin insists on traditional final inspection. Each instrument enters this stage with written test instructions and a test drawing against which the manufacturing batch is checked. Every step of this process is carefully documented. Only instruments that have passed this test are allowed to go on – to be marked and cleaned and then released for packing and storage.
Marking the instrument also includes affixing the valued CE-mark as a guarantor of quality. All products carrying this mark satisfy the essential requirements stipulated in the EU Directive relating to medical devices and comply with KLS Martin’s documented and validated internal product profile.
As we are convinced of the high quality of our surgical instruments, we offer our customers an unlimited warranty. Should a product exhibit a defect in material or workmanship despite our most careful inspection and testing, we will repair or replace it free of charge.
Of course, this life-long warranty presupposes that the instruments are used for their intended purpose, reprocessed correctly and left unchanged. Normal wear and tear is also exempted from the warranty.
