BSH Group | Quality & Management

The strategic orientations of the BSH group are deployed through a Quality Management System focused on processes and based on a quality policy that demands performance and efficiency.

The Quality Management System guarantees customer satisfaction by fully satisfying their needs. In this framework, the Quality approach includes a full development process, from the requirements assessment to the full qualification of processes using QI (installation), QO (operation) and QP (Performance) protocols.
To ensure the objectives defined in a Quality improvement plan are achieved, each process is managed using a continuous improvement approach with constant monitoring of performance indicators. The involvement and motivation of personnel is a key point in the success of the Quality approach and is materialised by the annual training plan.
In 2011, the BSH Group will go even further in its performance quality policy, by initiating an approach to secure its IT system as part of the Ulysse 2.0 program, launched by the Rhône-Alpes regional authority and the DIRECCTE (Regional Authority for Business, Competition, Consumption and Employment). The aim is to achieve ISO 27001 certification, which guarantees the security of Information Systems for customers.

Plasturgiste secteur médical, conception pièces thermoplastiques, pièces plastiques pharmaceutique,ISO 13485, Transformateur en salle blanche, Injecteur en salle blanche.

Infiplast Biomedical quality certifications

  • NF EN ISO 14644 – Cleanrooms and associated controlled environments
    Infiplast Biomedical guarantees that the production, control and conditioning environments are compliant with this standard. The level of cleanliness of a cleanroom environment (e.g. ISO 5/ ISO 7) satisfies a classification defined by ISO 14644-1 and specifies a maximum number of particles per cubic meter at a specified particle size and class.

  • ISO 13485:2004
    Standard applicable to manufacturers of medical devices, specifying the regulatory requirements associated to European Directives 93/42/CE and 2007/47/CE.

  • NF EN ISO 15883 - Standard applicable to instrument sterilisers-disinfection equipment
    For the medical sector, the BSH Group confirms its desire to propose a full range of tools with the installation of a laboratory accredited under ISO 17025, to perform microbiological analyses in compliance with ISO 11737.

  • Other BSH Group certifications
    ISO TS 16949, an international standard applicable to automobile makers. Quality is an essential component of our policy: Material vigilance, qualification, product control, traceability.

iso 9001 iso ts 16949iso 13485

- ISO 9001 version 2008,
- ISO TS 16949 version 2009,
- ISO 13485 version 2012.

In brief

6th & 7th of February 2019

PHARMAPACK 2019 Exhibition

Please visit us on our stand E46

Du 12 au 15 Novembre 2018

MEDICA - COMPAMED 2018 Hall 17 Stand A24

Avec le soutien de la Région Auvergne-Rhône-Alpes et de I-CARE Health Technology Auvergne Rhône-Alpes CLUSTER, INFIPLAST sera présent au salon MEDICA-COMPAMED à DÜSSELDORF STAND A24 HALL 17. Votre contact commercial: Alain LECOMTE Mob:

> View all news


Infiplast I BiomEdical
Infiplast : A word from the chairman I Quality & Management I Biomedical Engineering I
Infrastructures I Laboratory
News / Press
Ophtalmology / Neurology

Infiplast I Groupe BSH
Infiplast : A word from the chairman I Quality & Management I Infrastructures

Legal notice • Design : artenium