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Quality - Stevanato Group
Pharmaceutical containers are integral to the pharmaceutical product itself, they must ensure maximum quality for patients. Quality.
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Quality

Pharmaceutical containers are integral to the pharmaceutical product itself. Together they must ensure maximum quality for patients: this is our main goal, every day.

Since Stevanato Group’s mission is to create systems that enhance the integrity of parenteral medicines, ensuring maximum quality of the primary packaging is the primary goal for everyone involved in the process.

Stevanato Group has defined a list of principles as the basis of GMP (Good Manufacturing Practices), representing the quality management system orientation of the whole Group.

The aim is to always guarantee:

01

Patient safety

02

Product conformity

03

Customer-focused orientation

04

ISO15378 conformity

05

Quality Management System conformity

06

“Right first time”

Read our Quality Policy


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Certificates

ISO 15378 ISO 13485 ISO 9001 ISO 45001 ISO 14001 ISO 50001 ISO 17025
Nuova Ompi (IT-PD)

Local law

n/a
Nuova Ompi (IT-LT)

Local law

n/a
Medical Glass

n/a

No

n/a
Ompi of America (IN-U.S.)

n/a

n/a
Ompi N. America

n/a

No

n/a
Ompi of China

n/a

No

n/a
Ompi do Brasil

n/a

No

n/a
Balda Medical (DE)

n/a
Balda C. Brewer (CA-U.S.)

n/a

n/a

n/a

No

n/a
Spami, Stevanato Group Denmark

n/a

n/a

n/a

n/a

n/a

n/a
EMEA TEC, U.S. TEC

n/a

n/a

n/a

n/a
Certificates
Iso Type
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Legal Entity
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ISO 14001 - ISO 45001 - Stevanato Group S.p.A.
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ISO 14001 - ISO 45001 - Nuova Ompi S.r.l. Unipersonale
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ISO 14001 - ISO 45001 - Medical Glass A.S.
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ISO 14001 - ISO 45001 - Ompi N. A. S. de R. L. de C. V.
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ISO 14001 - ISO 45001 - OMPI DO BRASIL INDÚSTRIA E COMÉRCIO DE EMBALAGENS FARMACÊUTICAS LTDA
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ISO 14001 - ISO 45001 - OMPI Pharmaceutical Packing Technology (China) Co., Ltd.
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ISO 14001 - ISO 45001 - Ompi of America Inc.
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ISO 14001 - ISO 45001 - ISO 9001 - Balda Medical GmbH
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ISO 50001 - Balda Medical GmbH
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ISO 15378 - Stevanato Group S.p.A.
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ISO 15378 - Nuova Ompi S.r.l. Unipersonale
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ISO 15378 - Medical Glass A.S.
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ISO 15378 - Ompi N. A. S. de R. L. de C. V.
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ISO 15378 - OMPI DO BRASIL INDÚSTRIA E COMÉRCIO DE EMBALAGENS FARMACÊUTICAS LTDA
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ISO 15378 - OMPI Pharmaceutical Packing Technology (China) Co., Ltd.
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ISO 15378 - Ompi of America Inc.
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ISO 15378 - Balda Medical GmbH
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ISO 9001 - Stevanato Group S.p.A.
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ISO 9001 - Nuova Ompi S.r.l. Unipersonale
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ISO 9001 - Medical Glass A.S.
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ISO 9001 - Ompi N. A. S. de R. L. de C. V.
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ISO 9001 - OMPI DO BRASIL INDÚSTRIA E COMÉRCIO DE EMBALAGENS FARMACÊUTICAS LTDA
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ISO 9001 - OMPI Pharmaceutical Packing Technology (China) Co., Ltd.
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ISO 9001 - Ompi of America Inc.
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ISO 9001 - Balda/C. Brewer
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ISO 9001 - S.P.A.M.I. S.r.l. Unipersonale
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ISO 9001 - Stevanato Group Denmark A/S
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ISO 9001 - US TEC - Ompi of America Inc.
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ISO 9001 - EMEA TEC - Nuova Ompi S.r.l. Unipersonale
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ISO 9001 - EMEA TEC Analytics - Nuova Ompi S.r.l. Unipersonale
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ISO 17025 - Accredia - EMEA TEC Analytics - Nuova Ompi S.r.l. Unipersonale
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ISO 13485 - Balda/C. Brewer
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ISO 13485 - Balda Medical GmbH
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ISO 13485 - Ompi of America Inc.
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ISO 13485 - Nuova Ompi S.r.l. Unipersonale
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ISO 13485 - US TEC - Ompi of America Inc.
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ISO 13485 - EMEA TEC - Nuova Ompi S.r.l. Unipersonale
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ISO 13485 - EMEA TEC Analytics - Nuova Ompi S.r.l. Unipersonale
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