Quality management & quality assurance systems
Your benefits on the European and global market
In a QM/QA system certification a neutral and independent certification body assesses whether your QM/QA system complies with the relevant standards and directives. In case of conformity a certificate is issued and compliance is monitored during its validity period.
A QM/QA system certification opens up a wider market potential since it is a sign of the company’s business quality and efficiency. A successful certification creates confidence and is in many cases an essential requirement for awarding of contracts.
In addition to the voluntary system certification (e.g. according to DIN EN ISO 9001), a certification may also be required within the area regulated by law. Certification of your quality management/quality assurance system by a notified body is a possible way for obtaining the CE mark (e.g. for medical devices).
Manufacturers/distributors of medical devices with higher risk potential are obligated according to MDD 93/42/EEC to involve a notified body in the conformity assessment procedure. Depending on the product classification and the selected procedure, the manufacturer may also apply for an assessment and recognition of his QM or QA system according to MDD, annex II, V or VI conducted on the basis of the harmonised standard DIN EN ISO 13485. The notified body’s recognition and surveillance of the QM or QA system authorise the manufacturer to mark his product with the CE mark in combination with the notified body’s identification number. CE marking is a prerequisite for placing a product on the market.
SLG Prüf- und Zertifizierungs GmbH is a Notified Body (identification number 0494).
Manufacturers and especially suppliers of medical devices may apply to the certification body/notified body for a certification in accordance with DIN EN ISO 13485, voluntarily or within the area regulated by law.
On request and provided that all relevant requirements are met, multiple certifications, e.g. according to MDD 93/42/EEC, DIN EN ISO 13485:2003 and/or DIN EN ISO 9001:2000 are also possible.
Our services:
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QM system certification according to DIN EN ISO 9001 |
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QM system certification according to DIN EN ISO 13485 |
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QA system certification according to App. II, V, VI of Directive 93/42/EEC (Medical Device Directive) |
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QA system certification according to App. X of Directive 2006/42/EEC (Machinery Directive) |
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QA system certification according to App. VIII of Directive 2000/14/EEC (Outdoor Directive) |
Do you have any questions? We are happy to give you further information on the certifications required and applicable for your particular case. To make an enquiry, please, use the questionnaires available under Downloads.
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