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QM-System Certification

The conformity assessment of quality management systems (module D or E) for the production of type tested and approved products (module B) is based on two elements:

  1. The quality management system maintained by the manufacturer (manufacturer defined as responsible party for the placing on the market; maybe not the producer), which should meet the requirements of ISO 9001. This is mostly shown by an ISO 9001 certification. Alternatively it can be approved by BSH-Cert with additional efforts. BSH-Cert is accredited for the relevant standard EN ISO/IEC 17021, but BSH-Cert can not submit a ISO 9001 certificate. The ISO 9001 certification is subject to the free market.
  2. Specific processes to improve the applicable product specifications, which are required by the relevant standard (according to annex A.1 of the MED) as minimum criteria’s and general processes to improve these requirements for lifetime of the product.
    This is the essential element of the conformity assessment which requires an additional certification.
    The verification of the product safety and required product specifications can be handled as a part of the production (module D). Only if there is the chance to verify all parameters at the end of production (the relevant criterias can not be reduced), this can be done by a product end test (module E).

The process (more details in Not barrier-free file.  Certification rules, quality assurance (PDF, 89 KB, Not barrier-free file.), only in german):

  1. With or after application the manufacturer sends all documents to BSH-Cert, which shows the quality management system and all product quality related documents according to the safety and documents improving the minimum requirements of the product.
  2. BSH-Cert checks the document and if necessary performs a pre-audit. Before BSH-Cert can submit a certificate it is mandatory to perform a on-site certification audit and the removal of all non-conformities.
  3. A yearly surveillance audit by BSH-Cert is needed to verify the product conformity during the certification cycle (upto 5 years).

The audits are performed in a team of two auditors. The audit time is calculated according to international guidelines. The fees based on the time needed are fixed in the BSH cost regulation (BSH-Kostenverordnung - BSHKostVO). Additionally the travel expenses will be charged according to the Federal travel regulations (Bundesreisekostengesetzt - BRKG).

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