Quality
One concept, numerous / several facets / aspects.
For delivering process devices and systems in the pharmaceutical, biotechnological and chemical industry, the concept ‘quality’ consists of numerous/several facets/aspects.
Quality management system ISO 9001
According to ISO 9001, our quality management system is entirely adjusted to the engineering, production and installation of process components and systems within the pharmaceutical, biotechnological and chemical industry.
A realistic schedule, well-structured consultation and the essential engineering, specification and verification documents for different project phases will lead to a coordinated delivery, installation and maintenance. Het Noorden’s Project quality.
Standards and guidelines
We wield applicable standards and guidelines for the engineering of the different parts of the process system, such that every individual component of the installation will satisfy the legal requirements for cGMP and safety.
PED
The European guideline for the engineering and production of pressure equipment, whereby the conformity assessment, carried out by a NoBo, an extra independent quality guarantee is.
ASME BPE
The design guideline for devices in the bioprocess and pharmaceutical industry, such that construction details, material component selection and the required finish are verifiable.
GAMP 5
The guidelines of ISPE for designing, producing, testing and verifying the operating systems. An all-embracing structured approach will ensure the ultimate quality of the process and therefore the quality of the process.
ISPE
The guidelines for designing and qualifying water and steam systems in the pharmaceutical industry regarding equipment, dimension and process choice.
Knowledge
Through realizing our projects, we accumulated a great amount of knowledge on the great diversity and applications of materials, appendages, fittings and instrumentation. We know the right fabricants and suppliers. Our knowledge for a practical solution and a reliable process.
Craftsmanship
Through realizing our projects, we accumulated a great amount of knowledge on the great diversity and applications of materials, appendages, fittings and instrumentation. We know the right fabricants and suppliers. Our knowledge for a practical solution and a reliable process.
