Frequently asked questions about the accreditation of CleanControlling
What does accreditation according to DIN EN ISO/IEC 17025 mean?
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 our laboratory:
- is technically competent,
- delivers valid and comprehensible results,
- operates an effective quality management system.
This accreditation is awarded by the national accreditation body (in Germany: DAkkS) and is regularly verified by audits.
What are regular audits and why are they important?
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.
Why is the DAkkS certificate not time-limited?
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 surveillance therefore replaces a static expiration date.
The DAkkS publishes a list of accredited testing laboratories on its website. The current accreditation status can be viewed on the DAkkS website via the following link.
Why is it possible that the latest version of the standard is not always mentioned in our reports?
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 are only allowed to state 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, so that new standards may only be referenced after an accreditation change with verification by the DAkkS.
Processing times: The scope of application is only updated after successful assessment and approval by the accreditation body - a process that takes several months.
Legal certainty: Compliance with these requirements serves to legally safeguard our customers and to ensure traceability vis-à-vis authorities and notified bodies.
As soon as the new version of the standard is officially included in our scope of application, we will of course use it in our reports.
How do I get the current accreditation certificates?
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 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 accreditation as well as a list of all accreditation certificates for all specialist areas.
Accreditation Technical
- DAkkS certificate D-PL-18080-01-00: Laboratory for technical cleanliness
Accreditation Medical
- DAkkS certificate D-PL-19887-01-00: Medical devices
- DAkkS certificate D-PL-19887-03-00: Hygiene/hospital hygiene
Accreditation Chemical
- DAkkS certificate D-PL-19887-02-00: Chemical laboratory
- DAkkS partial certificate D-PL-19887-02-01: Analysis of water
- DAkkS partial certificate D-PL-19887-02-02: Chemical characterization of medical devices
- DAkkS partial certificate D-PL-19887-02-03: Analysis of soil and waste
What does recognition by the ZLG mean in the context of the MDR?
In Germany, the ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten) is responsible for the recognition of testing laboratories within the framework of the EU Medical Device Regulation (MDR). Such recognition is required if test reports are to be used as part of conformity assessments for medical devices.
Recognition by the ZLG means that our test reports can be recognized by notified bodies in the MDR context. This is an important proof of quality for our customers in the medical technology sector.
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