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Quality at our Heart Our Quality Policy: Brenner Fiedler is committed to exceeding customer expectations through regulatory compliance and continuous improvement of our Management System. Our goal is to become an extension of our customers’ teams through effective communication. Your customers depend on the quality of your products, just as you depend on ours. That’s why everything we sell, from components to fully assembled products, undergoes rigorous testing before leaving our shipping dock. From our engineering department to our production department, you can be assured of the quality process and are informed at every step from schematics and 3D renderings to final testing. We work with you at the prototype stage to determine acceptable testing requirements. Our assembly technicians follow a strict inspection procedure and checklist. Each unit is tested at multiple stages of the assembly process to ensure the highest quality results for you. Outside the doors of our quality department, the quality mentality pervades Brenner-Fiedler. The organization as a whole is dedicated to quality, so much so that it is the first thing employees see when they walk through the door. From our detailed processes to our employee training, we offer you a high commitment to quality. Our Certifications: To Establish and maintain best practices for our customers, we have certified our Riverside, California facility to ISO 9001:2008 and ISO 13485:2003. ISO 9001:2008 is an international standard that specifies requirements for a quality management system to promote customer satisfaction and continuous improvement. Our ISO 13485:2003 certification is used to standardize and demonstrate the ability to meet requirements for the design, development, and production of medical devices. In addition to our ISO 9001:2008 and ISO 13485:2003 certifications, we offer a dedicated UL508A panel shop as well as helping customers like you achieve FDA approval for your medical devices. While our certifications require a process, it means much more at Brenner-Fiedler: It is an uncompromising commitment to quality. We continuously improve our processes, training, and products to ensure our work meets your requirements – the first time -every time.
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Visoka kvaliteta naših proizvoda i usluga posljedica je suradnje s našim partnerima, od faze razvoja do završne kontrole. Kvaliteta proizvoda i proizvodnih procesa provjerava se kontinuirano, korištenjem vrhunskih mjernih uređaja te ispitivanjima u akreditiranim laboratorijima i tvrtkama. Svijest o potrebi kontinuiranog poboljšavanja i održavanju visoke razine kvalitete proizvoda rezultirala je certificiranjem sustava upravljanja kvalitetom Instrumentarie d.d. 1997. godine prema normi ISO 9001:1994. Slijedom daljnjeg razvoja tvrtke i usklađivanja s međunarodnim normama i direktivama, u srpnju 2007. uspješno smo zadovoljili ocjenjivanju kriterija normi: ISO 9001, ISO 13485 te MDD 93/42/EEC, smjernice EU za proizvodnju medicinskih proizvoda. Krajem 2009. godine Instrumentaria je usvojila zahtjeve prelaska s norme ISO 9001:2000 na ISO 9001:2008. Funkcioniranje sustava kvalitete ocjenjuje se svake godine višednevnim nadzorima od strane certifikacijske kuće. U srpnju 2013. godine uspješno je recertificiran sustav upravljanja kvalitetom te je valjanost certifikata sustava kvalitete produžena do 2018. godine. Najveće mjerilo kvalitete naših proizvoda predstavlja zadovoljstvo naših kupaca. Njihova se mišljenja i prijedlozi marljivo bilježe te se, sukladno procedurama sustava, analiziraju više puta tijekom svake godine. Kako bismo zadovoljili visoke zahtjeve u proizvodnji naših proizvoda, surađujemo s brojnim renomiranim akreditiranim tvrtkama iz cijeloga svijeta, a proizvodni proces se redovito ocjenjuje i kontrolira. Kvalitetu provodimo i živimo na više razina, u skladu sa sljedećim normama: - ISO 9001:2008 Quality management system - ISO 13485:2012 Requirements for a comprehensive management system for the design and manufacture of medical devices - MDD 93/42/EEC Council directive concerning medical device Kontrolu kvalitete naših proizvoda provjeravaju iskusni i educirani zaposlenici na vrhunskim mjernim uređajima, u svakoj fazi proizvodnog procesa. Kako bi razina kvalitete dostigla još višu razinu, uz 100%-tnu kontrolu proizvoda, redovito se provode ispitivanja čistoće proizvoda i prostora s kontroliranom atmosferom, mehanička testiranja proizvoda, provjera učinkovitosti metode sterilizacije, ispitivanja kvalitete proizvoda od dobavljača, mjerenja zadovoljstva kupaca. Kontrolira se svaka faza proizvodnog procesa, od ulaska materijala u skladište sirovina do predaje proizvoda u skladište gotovih proizvoda. Instrumentaria d.d. ulaže značajna sredstva i napore u kvalitetu, koja se provjerava na vrhunskim, mjernim uređajima.