3/2/2024 0 Comments Iso en 13485Question 3: How long does it take to establish and certify a QM-System? Pay attention that you do not pick a certification body that "only" may certify ISO 13485 complianceīoth, the EU but also national authorities publish lists of "accredidated" notified bodies as for example the German ZLG. They have to have the accreditation for "Annex Certificates". Only notified bodies my certify your QM-system. ![]() Question 3: Who may certify my QM-system? If you need a certified QM-system (see question 1), only a ISO 13485 certification is sufficient to prove compliance with regulatory requirements. Question 2: I already have a ISO 9001 certificate. But this QM-system does not have to be certified. If your product is in class I, there is QM-system demanded by MDR and by IEC 62304. ![]() However, this approach is rather the exception. Only conformity assessment procedures based on MDR Annex IV (EC verification) respectively MDR Annex XI part B do not require a certified QM-system. If your product is NOT in class I, you most probably need a certified QM-system.
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