CleanControlling's test laboratories are accredited in accordance with DIN EN ISO/IEC 17025:2018. The Technical, Medical and Chemical divisions are each accredited and certified in their own accreditation areas. The test methods included in the respective accreditation areas are defined in the annex to the corresponding accreditation certificates.
DIN EN ISO/IEC 17025 is the internationally recognized standard for the competence of testing and calibration laboratories. Accreditation in accordance with this standard confirms that the laboratory is technically competent, delivers valid and comprehensible results and operates an effective quality management system.
This accreditation is awarded by the national accreditation body (in Germany: DAkkS) and is regularly verified by audits.
Regular audits (also known as surveillance or reaccreditation audits) are mandatory checks by the accreditation body. These audits check whether we continue to meet all the requirements of the standard. These audits usually take place annually or in the reaccreditation cycle (every five years) and ensure the continuous quality of our work.
The laboratories and quality management of CleanControlling's various corporate and specialist divisions are audited independently of each other and fall under different accreditations.
The respective current accreditation certificates are available for download in the Infothek on the homepage in the categories Technical, Medical and Chemical. Below you will find the direct links to the accreditation as well as a list of all accreditation certificates for all specialist areas.
Accreditation Technical Accreditation Medical Accreditation Chemical
Unlike many other certificates, the DAkkS accreditation certificate does not have a fixed expiration date. The validity of the accreditation is linked to the continuous fulfillment of the requirements, which is ensured by regular surveillance and reaccreditation audits.
As long as a laboratory fulfills the requirements of the standard and successfully passes the audits, the accreditation remains valid. However, DAkkS can suspend or withdraw accreditation at any time if serious deviations are detected. Ongoing monitoring therefore replaces a static expiration date.
CleanControlling conducts surveillance audits every 18 months. The recertification audit takes place every five years. As long…
In the transitional period between the publication of a new version of a standard and its formal inclusion in our accredited scope by the DAkkS, we may still have to refer to the previous version of the standard in our final reports. The reasons for this are as follows:
- Formal accreditation obligation: In our reports, we may only cite standards that are officially listed by the DAkkS in our scope of application.
- Flexible accreditation of the scope of application is excluded for medical devices, meaning that new standards may only be referenced after an accreditation change with verification by the DAkkS.
- Procedure times: The scope is only updated after successful assessment and approval by…
The testing facility of CleanControlling Medical GmbH & Co. KG for testing medical devices for biological, chemical, particulate and toxic impurities is subject to the national GLP monitoring procedure and is regularly monitored for compliance with the GLP principles in accordance with the Chemicals Act and 2004/9/EC.
Good Laboratory Practice (GLP) is a quality assurance system for test facilities that carry out non-clinical tests in the health and environmental sectors. GLP recognition enables the mutual recognition of tests carried out in accordance with the principles of GLP by the regulatory authorities of OECD member states.
GLP regulates the organizational processes and conditions under which non-clinical health and environmental studies are planned, conducted, monitored, recorded, archived and reported.
GLP-approved test facilities are integrated into the national official GLP monitoring procedure and are regularly checked for compliance with the GLP principles in accordance with the Chemicals Act and 2004/9/EC by the responsible monitoring authorities.
GLP-compliant testing is recommended when seeking approval of medical devices in the U.S. market (or in markets aligned with the U.S. FDA). The U.S. Food and Drug Administration (FDA) favors testing that is GLP compliant. GLP-compliant trials offer stringent quality controls and comprehensive documentation, which can facilitate their acceptance by the FDA.
The decision whether to conduct GLP-compliant or non-GLP-compliant testing is highly dependent on the market in which the products are to be approved.
GLP-compliant tests are generally recognized in Europe, USA, Canada, Japan, Mexico and Australia.
For the European market and CE approval, non-GLP-compliant tests are often sufficient. In certain cases or special regulatory requirements, however, GLP conformity may be necessary.
The responsible ZLG (Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices) has recognized the competence of the laboratory for biological and microbiological-hygienic testing of medical devices of CleanControlling Medical GmbH & Co. KG in accordance with the applicable EU regulation.
Recognition in accordance with Section 18 of the Medical Devices Law Implementation Act (MPDG) by the ZLG (Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices) is confirmation of compliance with the requirements for a testing laboratory in accordance with Regulation (EU) 2017/745 [MDR] and DIN EN ISO/IEC 17025:2018.
The Central Authority of the Federal States for Health Protection of Medicinal Products and Medical Devices recognizes that CleanControlIng Medical GmbH & Co. KG has the competence according to Regulation (EU) 2017/745 and DIN EN ISO/IEC 17025 for biological, chemical and microbiological-hygienic testing of medical devices, sterile barrier and packaging systems and substances as integral parts with adjuvant function of medical devices according to Article 1(8) of Regulation (EU) 2017/745 as well as for physical testing of sterile barrier and packaging systems and for environmental monitoring.
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