Quality management

   Quality at  Medi TECH is not only orthographically capitalized. 
Since 1999 we have implemented a Quality-Management-System , which is anually audited, evaluated and improved by an independent notified body. 
  Our company is currently certified in accordance with DIN EN ISO 13485:2016 (for medical device manufacturers).

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We pursue the following quality policy:

 

We make sure that our quality policy 

  • is appropriate for the purpose of our company,

  • contains an obligation to fulfil requirements and to continuously improve the effectiveness of our QM system, 

  • provides a framework for setting and evaluating quality objectives,

  • is mediated and understood in our company, and 

  • is assessed for continuing appropriateness.

Fundament

We use the quality policy as a means to continuously improve the actions and performance of our company. The quality policy is an equal and consistent component of the overall policy and strategy of our company.

When defining our quality policy, we take the following points into account

  • Measurable customer expectations and wishes.

  • the nature and quality of the improvements required for the success of our enterprise, 

  • Clear and measurable level of customer satisfaction and its increase 

  • The further development of our employees (promotion of competence and motivation)

  • Requirements and expectations of other interested parties 

  • Resources needed to go beyond the requirements of the underlying standards 

  • Regional and international market leadership 

  • Increasing the profitability of our company 

  • Continuous improvement of our services, as well as the use of instruments to maintain the effectiveness of our QM system in accordance with Directive 93/42/EEC Annex II and DIN EN ISO 9001 and 13485.


The quality policy can be used for improvements provided that it 

  • is compatible with the vision and future strategy of the management board 

  • ensures that quality objectives are understood and implemented throughout the company 

  • outlines the management's commitment to quality and the provision of adequate ressources to achieve the objectives 

  • promotes a commitment to quality at all levels under clear management,

  • includes continuous improvement in terms of meeting customer wishes and requirements 

  • is effectively formulated and efficiently communicated. 

We have also set ourselves the following quality targets:

 

Global goals

Creating trust

  • through market-driven and qualitatively mature products

  • through competent advice and fulfilment of the promised quality requirements

  • through products that offer good value for money 

  • through on-schedule processing of orders 

  • through a professional and transparent company structure with a fixed structure and process organisation 

  • by maintaining high standards and striving for continuous improvement of products and services 

Facilitating team spirit

  • through internal "customer-supplier" relationship 

  • by clearly defining responsibilities and responsibilities 

  • through a management style that promotes the individual responsibility of each employee. 

Special goals

The management considers the following quality objectives

  • Goals to increase customer satisfaction (quality, complaint rate, readiness to deliver, adherence to schedules, service, customer gain and loss),

  • Leadership goals (corporate culture, communication with employees, information, praise, suggestion scheme),

  • precautions to protect health and safety at work,

  • Targets for reducing liability risks and minimizing risk.

The following results of previous evaluations will continue to be taken into account when setting quality objectives

  • Results of the management review 

  • Results in terms of product quality 

  • Results of investigations to the satisfaction of all interested parties (customers and end users, employees, owners, suppliers and partners)

Testing

  • Management shall identify and provide the means necessary to achieve the quality objectives. All employees are obliged to provide the necessary information. The quality objectives, responsibilities and key figures are documented in the report of the top management. The report documents the measures taken and future measures taken to achieve the quality objectives.

  • The degree of fulfillment is determined and documented in regular performance reviews in which the entire workforce participates. Necessary changes and planning are documented in the corresponding meeting minutes.

  • Changes in the QM system are defined in cooperation with the employees involved; the QM system must be maintained during these changes. 

  • Concrete objectives are defined and their achievement monitored as part of the regular management evaluation.


Information obligation in accordance with MPG


As a manufacturer of medical products, we at MediTECH are legally obliged to inform our customers and partners clearly and publicly about

  • safety relevant problems concerning products

  • product recalls

  • revocations of registrations, certifications and certificates by official authorities

 

In the past - i.e. since the foundation of MediTECH Electronic GmbH in 1996 - there has been no need for such information. We are making every effort and using the latest knowledge to maintain this standard and to ensure that recalls are never necessary.  

However, should any of the above problems occur or recalls be necessary, you can find information about them here.

You can inform yourself about registrations and certifications regarding MediTECH and our products at www.dimdi.de .

Declaration of conformity

Here you can find the current declaration of conformity to our currently available products manufactured by us. For this reason we refrain from printing the declaration in the operating instructions / user manuals enclosed with our devices.

Quality management

Since 1998 is our company, as a manufacturer of medical products, in possession of a quality management system, originally in accordance with the Guidline 93/42/EWG. Since 2007 the certification is valid in accordance with ISO 13485.

The suitability and maintenance of the certification is examined in annual audits by an organisation independent of us - a so-called notified body.