Quality Management

Certification. Validation. Traceability.

For over twenty years we have ensured that our management system and our products comply with the demanding regulatory requirements in medical technology. The first certification according to ISO 9001 was already obtained at the beginning of the 90s. If you are interested in finding out more about our certifications and our management of standards as well as other quality topics, then you have come to the right place!

  • Certification and applied standards
  • Audits
  • Process validations
  • Documentation and traceability
  • Contracts: confidentiality and quality agreements.

Do you have questions on these topics or do you require additional information? Do not hesitate to contact us.

Certifications and Standards

Due to our diversified certifications and our standards management we are always abreast of state-of-the-art technology. This allows to adjust quickly to new technologies and procedures in our projects and makes us a reliable partner for our customers.

  • In 1993 we successfully passed the first certification according to ISO 9001. Maintaining a management system was, of course, a given here. This standard forms the basis for the continuous improvement of the management system as well as the process management and lowers costs. This benefits our customers and partners.
  • In 1996 the conformity of our own dental products enabled us to realize first certification according to ISO 13485 and the EU certificate according to MDD 93/42/EEC. The result is the entitlement for CE-labeling and marketing authorization of own products on the European market. The certification is also a major element for good cooperation with our medical customers and partners. It guarantees consistent high quality of our services and products.
  • In 1997 we had our testing laboratories accredited to the Standard ISO/lEC 17025. The focus of the standard is on the accuracy, reproducibility and comparability of measured results. The applied inspection processes are also an important part of goods receiving inspection and the analysis of materials.
  • In 2005 we introduced an environmental management system with the certification according to ISO 14001. This standard forms the basis for optimizing environment-relevant processes and for minimizing the risks of environmental pollution in companies.
  • For the American market we follow the strict requirements of Law 21CFR820. As many of our customers are active on the US market and as our own products are also marketed in the USA, compliance with this law is an essential factor.
  • In 2006 we certified our quality management according to jPAL. Here we are regularly audited by an approved body.

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Audits

Audits are permanent companions in our line of business. Internal audits serve to check our processes for compliance and to improve them continuously. On the basis of risk classification, we also audit our suppliers regularly and can thus ensure that our network of partners continues to develop and improve. In the same vein, we are audited annually by various approved bodies. These confirm their findings in appropriate certificates which you are welcome to view in our Download Center.

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Process Validations

Process validation serves documented proof and ensures that a process permanently meets the previously defined requirements and thus leads to reproducible results. It is an essential and important part in the manufacturing of medical devices and must be based on a process-based risk analysis.

Cendres+Métaux has considerable experience in the process validation for medical devices and can offer customers individual advice and support in specific questions. If possible, we also apply our validated equipment and processes to customer products. This needs to be checked carefully when providing a feasibility assessment. If the scope of our standard validations is not sufficient, we can either conduct special process validations for the manufacturing of your products or coordinate this together with competent partners.

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Documentation and Traceability

Project management supported by a wide range of skills and comprehensive, competent advice - this is what distinguishes us. Interdisciplinary project work is guaranteed by the close cooperation between sales, production, development, technical project managers and quality management and is a given for us. This allows us to advise you in the preparation of your product documentation and provide you with important input on the topics of risk management and technical documentation:

  • Based on your requirements, we would be pleased to assist you in the technical documentation for the certification and marketing authorization of your medical device.
  • On the basis of the specification sheet, we can execute the necessary tests and validations according to applicable standards and requirements with competent partners
  • Based on our many years of experience and on validated packaging, we can already offer you some of the components for your product master file.
  • We live a process-oriented risk management, check our processes continuously to let you focus on the design and function of the medical devices.
  • Traceability from development to delivery is the law for us
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Contracts

Our aim is to ensure that our customers and partners and their ideas and projects feel well served and understood by our company. To build up this relationship of understanding requires an open exchange of information on behalf of both parties. Therefore, a contractually agreed protection of mutually exchanged information is essential as it forms the basis for a functioning and trustworthy partnership. We therefore view it as an important part of our daily work to establish and/or conclude confidentiality and quality agreements.

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