BERGER is currently certified to DIN EN ISO 9001:2015. Certification to ISO 13485 is in preparation. The currently valid certificate is available in the download section of this page.
Quality & Certifications
Certified Quality Management
BERGER’s quality management system is certified to ISO 9001. Certification to ISO 13485 is currently in preparation.
Defined processes and responsibilities provide the basis for transparent project and series production management. Deviations and complaints are systematically assessed, root causes investigated, and required corrective actions documented and followed through.
Quality-relevant changes to products, materials, moulds, processes or documentation are assessed and implemented in a controlled manner. Depending on their impact, the necessary inspections, approvals and further measures are defined.
The currently valid certificate is available in the download section of this page.
Inspection Planning and Approval
Drawings, specifications and other agreed requirements form the basis for inspection planning. From these, relevant inspection characteristics, inspection methods, inspection scope and acceptance criteria are defined for sampling and series production.
The scope of inspection and documentation depends on the component, application and customer requirements. Additional quality-related and risk-based requirements are incorporated into project planning and series production assurance as required.
Quality Data and Traceability
Inspection planning, inspection results and quality-relevant records are managed in an in-house developed CAQ system. The system is an integral part of our quality planning and series monitoring.
Material batches, production lots and associated quality data are documented on a product- and order-specific basis. The scope and depth of traceability are defined according to the requirements of the respective product and project.
Process Validation
Where required by the product, application or customer, we perform process validations for injection moulding and cleanroom processes in accordance with IQ, OQ and PQ. Scope, acceptance criteria and documentation requirements are defined on a project-specific basis.
The results of the individual validation phases are documented and consolidated in a final validation report. Following approval, the validated process is maintained through defined routine monitoring.
In the event of changes or predefined triggers, the continued validated state is assessed. Revalidation is performed where required.
Cleanroom and Quality-Critical Processes
For components with specific cleanliness requirements, BERGER offers automated cleaning as well as inspection, assembly and packaging in an ISO Class 7 cleanroom.
Quality and validation requirements for these process steps are incorporated into the project-specific documentation. Further technical information is available in the Cleanroom section.
Questions About Quality and Certifications
Yes. BERGER supports projects with increased requirements for quality, documentation, traceability and process reliability. Specific requirements are assessed on a project-specific basis and incorporated into quality planning and documentation.
Yes. Where required by the project, we perform process validations for injection moulding and cleanroom processes in accordance with IQ, OQ and PQ. This includes a final validation report, defined routine monitoring and, where required, revalidation.
Depending on the application, these may include PFMEA and other risk-based process assessments, additional inspection and approval requirements, specific traceability requirements, monitoring, change assessments, and agreed quality and documentation requirements.
The specific scope is defined according to the product requirements and the agreements made with the customer.
Depending on the project, BERGER can provide first article inspection reports, inspection records, measurement reports, declarations of conformity, approval documentation and traceability information.
3.1 inspection certificates can be issued on a delivery-specific basis where agreed. The type and scope of documentation are defined on a project-specific basis.