ISO certification for pharma, cosmetics & medical devices
ISO 13485 is not one option among several for a medical-device manufacturer — it is a baseline requirement, at the core of market-access schemes like MDSAP and CE/UKCA marking. In cosmetics, ISO 22716 (GMP) plays the equivalent role. Greek pharmaceutical manufacturers already apply it at industrial scale — this is not a theoretical standard.
ISO 13485: the basis for CE and MDSAP
It applies to anyone designing, manufacturing, maintaining or distributing medical devices. It does not just certify "good quality" — it is the evidence base underpinning EU CE marking and the international Medical Device Single Audit Program (MDSAP). Without it, access to many markets simply does not open.
ISO 22716: GMP for cosmetics
It covers production, control, storage and distribution of cosmetic products under good manufacturing practice. It is the scheme European distributors and large retail chains recognise before adding a new cosmetics supplier to their list.
When ISO 9001 or ISO 14001 gets added
In units with a broader product range (not only devices/cosmetics), ISO 9001 provides a wider organisational base. Where production has a significant environmental footprint (chemicals, waste), ISO 14001 documents its management — also important for licensing.
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