Quality - Stevanato Group
Home - Stevanato Group > About - Stevanato Group > Quality - Stevanato Group
page-wrapper

医薬品容器は医薬品の一部であり、患者様にとって最高の品質を保証できるものである必要があります。

StevanatoGroupの使命は非経口医薬品の完全性を保証する包装資材を製造、提供し続けることです。

Stevanato Groupでは、GMP基準をベースにしたグループ全体の品質マネジメントシステムの原則一覧表を作成しました。

Stevanato Groupは常に下記を保証致します:

01

患者様の安全

02

製品適合性

03

お客様重視

04

ISO15378準拠

05

品質マネジメントシステム適合性

06

「最初から適切な方法で」

CERTIFICATES

Nuova Ompi (IT-PD)
Nuova Ompi (IT-LT)
Medical Glass
Ompi of America (IN-U.S.)
Ompi N. America
Ompi of China
Ompi do Brasil
Balda Medical (DE)
Balda C. Brewer (CA-U.S.)
Spami,
Stevanato Group Denmark
EMEA TEC,
U.S. TEC

ISO 15378
Primary packaging material for medicine products - particular requirements for the application of ISO 9001:2015 with reference to Good Manufacturing Practice (GMP)

n/a

n/a

n/a

ISO 13485
Medical devices - Quality management systems

n/a

 

n/a

n/a

n/a

ISO 9001
Quality management systems

 

ISO 45001
Occupational Health and Safety Management System

n/a

n/a

n/a

ISO 14001
Environmental management systems

ISO 50001
Energy management systems

Local law

Local law

No

 

No

No

No

No

n/a

 

ISO 17025
General requirements for the competence of testing and calibration laboratories

n/a

n/a

n/a

 

n/a

n/a

n/a

n/a

n/a

n/a

ISCC PLUS
International Sustainability and Carbon Certification

n/a

n/a

 

n/a

n/a

n/a

n/a

n/a

n/a

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