Lmb Technologie GmbH

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Quality Management Systems - Lmb

Lmb Technologie GmbH has implemented Quality Management Systems that integrate compliance Quality System Regulations and applicable international standards ISO 9001 and ISO 13485 and Medical Device Directive 93/42/EEC.
Quality Management Systems are specifically intended for the Design and development, production, distribution and service of medical devices and systems to produce, handle, treat, store and transport blood and blood components as well as solutions of systems and software for applications in blood banks and industry.
Certificates are issued based on satisfactory audit results that Quality Management Systems are maintained in compliance with ISO 13485 and the Medical Device Directive.
Lmb products are labelled with the CE mark indicating that they are certified to meet the essential requirements of the Medical Device Directive.

 

Quality Management System (ISO 9001; ISO 13485) and EC Certificates: Certificates

ISO 13485 is a recognized standard prescribing quality assurance management for the manufacture of medical devices.
Certification of compliance to the Medical Device Directive is required to allow the manufacturer to create the Declaration of Conformity and affix CE mark for product.
The Lmb Quality Manual was designed such that when all of the requirements of standards and MDD are met, customers can be confident in the quality of products and services that they purchase.
Top Management of LMB actively supports achieving high quality of product and services through clearly defined Quality Policy and Quality Objectives while assuring mechanism for their fulfilment.

Lmb organisation relies on following basic quality principles:

  1. Customer focused organisation
  2. Leadership
  3. Involvement of people
  4. Process approach
  5. System approach to management
  6. Continual improvement
  7. Factual approach to decision making
  8. Mutually beneficial supplier relationships

The Lmb Technologie trough certified QMS requires:

  • Employees carry out the work in accordance with the written procedures considering that work affecting product or service quality
  • Software solution Quality Supervision System (QSP) assures complete traceability from material input until final delivery of complete product
  • In accordance with Yearly internal audit plan confirms compliance with procedures and regulations through internal auditing
  • Immediate correction of problems or weaknesses and revise the system to prevent the same problems from recurring in accordance with CAPA Process (Corrective and Preventive measures)
  • Continually raise employees knowledge and skills through regular training plans
  • Documented, objective evidence of quality-related activities as proof of compliance to Standards and Directives

Lmb Technologie have main goal to provide products that are safe and effective, meets all regulations, and satisfies our customers. We recognize that these needs are constantly changing, and therefore we are responsive and open to improve in order to achieve and maintain customer satisfaction on highest level. By using PDCA (Plan Do Check Act) principle we are learning each day in order to influence on product quality.
The satisfaction of our customers is one of our highest company principles. Only by a high quality of our products and services and strong commitment of all employees we can reach this. The customer sets the benchmark for the quality – so the judgement of the customer is decisive for our quality.

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