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What does it mean to have a quality system under Module D/D1?
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Is ISO 9001 required?
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When must I inform the Notified Body of a change in my system, and do you do another audit?
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Can unwritten, or informal procedures be used?
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Does a quality system (D1) just cover production, or does it mean I need to assess the design of products before they are placed onto the market?
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Module D/D1 context to legal requirements
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How to ensure quality assurance of a laboratory?