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Quality

For us it's about more than good work - it's about people.

At wezi-med, quality policy and management, process competence, digital document and risk management are a long-standing tradition. These areas of expertise guarantee our customers the best solutions.

Certifications

Stay on the safe side with wezi-med. We also have that in writing.

To ensure that our products and solutions meet customers' highest demands, we have been certified several times over.

  • ISO 13485 (PDF)

    ISO 13485 (PDF)

    83 KB
  • ISO 9001 (PDF)

    ISO 9001 (PDF)

    267 KB

Quality policy

Good is not an option at wezi-med.

The reliable quality, processes and services of our products are key factors in our business' success. For us, quality means meeting the expectations and demands of our customers. This requires us to precisely match our arrangements and promises to customer need, and to consistently meet agreed upon quality standards.

For us, working with quality in mind also means handling valuable resources efficiently and sparingly. Every employee has both the right and duty to work towards eliminating circumstances that hinders the manufacture of products of impeccable quality. wezi-med views continuous improvements in quality with a focus on prevention as a medium- and long-term prerequisite for effectively reducing costs, and an important part of our effort to protect the environment. To produce quality products, it is first and foremost important to avoid errors at every stage of order processing, and to consistently eliminate potential sources of error. At wezi-med, preventive assurance and targeted improvement in quality takes top priority for all employees, regardless of their area of responsibility. It requires every employee's conscious commitment and active cooperation.

We make sure of it with frictionless organisation principles and advanced quality management methods. Managers undertake to apply applicable QM measures in their area of responsibility, to constantly monitor their effectiveness and to adapt them to the latest knowledge and requirements. This understanding and awareness of quality - as well as the attitude our employees take - create the preconditions for our customers' enthusiasm, and thus for the lasting success of our company.

Quality management

Our minimum requirements: The highest demands.

Since the foundation of the business unit, wezi-med has practiced preventive quality management . For us, this means learning before doing and not learning by doing.

The entire quality management framework is integrated into our networked business processes, ensuring a smooth and complete overall process and documentation. Each individual employee strives continuously to improve out of his own motivation and a sense of duty to other teams, departments and employees. We believe that despite any amount of expertise and quality, there is always room for improvement.

Elements of our QM system:

  • Certification according to ISO 9001 and DIN EN ISO 13485:2016
  • CAQ: SAP R/3, FMEA
  • Machine and process capability verification with qs-STAT

Our QM laboratory equipment guarantees fast and accurate testing procedures:

  • 3D measuring machine
  • 3D measuring machine with laser scan head
  • 2D measuring microscope
  • Material tests
  • Colour tests
  • Strength tests
  • Climate and condensation testing
  • Endurance/reliability tests, e.g. kinematics and shaker tests

Process competence

With us from the start to the finish line

How to produce products with the greatest possible user and patient benefit as well as the greatest possible safety? By constantly checking our progress. That's how we measure ourselves.

We bring many years of experience in the development and production of individual plastic components, complex assemblies and system products at our Dillenburg site to your advantage. As a full-service supplier, we offer our customers specific solutions that meet their requirements. Our process competence allows us to provide added value for our customers in all areas of product realisation by applying our expertise in a goal-oriented and networked fashion.

Our process competence begins before the "actual" work. We simplify relationships and structures in advance, in order to understand them before product implementation begins.

This enables us to identify solutions and the right designs from the initial stages, saving time and money. Our product realisation process is based on project-specific milestones. By setting individual milestones, binding tasks and goals are defined for a precisely specified period of time. In this way, we not only create transparency in-house, but also for our customers. Our process competence runs like a red thread through all projects, from design to series production. Our customers too stand to profit:

Digital document management

Transparency at one click

Our digital document management ensures the quickest possible access to data and highest data security, and meets all regulatory requirements for document control.

Electronic signature and audit trail according to 21 CRF Part 11? With our digital document management system, it's no problem. By organizing all technical documentation into digital product files, we guarantee the fastest possible access to data and the greatest possible data security. We also understand documentation competence to mean supporting our customers in their approval processes by providing them with the necessary documents.

In addition to document management itself, we also use other software functions to digitise our business processes, such as training and CAPA management. Integrating our document management system into the entire process chain makes results immediately visible and available. Security becomes transparent with the press of a button.

Risk management

We are predictable and consistent. Lucky for you.

Risk management in accordance with DIN EN ISO 14971 forms an integral part of our entire development and implementation process. Patient and user safety are always our highest priority.

We take a risk-based approach to all areas of our business processes, whether it is evaluating a product during development in order to identify and eliminate potential risks at an early stage or a risk-based determination of the scope of validity for our manufacturing processes.