General Terms and Conditions of LaboZert GmbH for the Certification of Medical Laboratories
Status: 26 April 2022
Unless otherwise expressly agreed in writing, these General Terms and Conditions ("GTC") shall apply exclusively to the performance of certification procedures by LaboZert GmbH ("LaboZert"). General terms and conditions of the client are not applicable, even if LaboZert has not objected to them in individual cases.
Subject of the Contract
The subject of the contract is the implementation of the certification procedure described in more detail in the offer. Part of the contract is the operating facility of the client listed in the offer.
The certification process consists of 5 phases:
1. Audit request/Contract
3. On-site Audit
The client initiates the certification procedure with the audit request on my.labozert.de. LaboZert prepares an offer based on the audit request and any preparatory discussions.
The contract is concluded by the acceptance of the offer on mein.labozert.de by the client. The GTC is an integral part of the contract.
LaboZert is entitled to postpone or cancel the certification audit if no qualified auditors are available to perform the certification.
On mein.labozert.de, it is listed which documentation (e.g., process and work instructions, etc.) the client has to submit to LaboZert for certification. The client has to upload the required documents at mein.labozert.de.
LaboZert uses qualified auditors to carry out the certification. They are given access to the documentation submitted by the client for accreditation.
In addition to the document review, an on-site audit is performed. The subject of the on-site audit is compliance with the certification requirements at the client's premises.
After the completion of the audit of the documentation and the on-site audit, the secondary audit check is carried out by the program manager of the audit. The result of the evaluation is summarized in an evaluation report.
If the client has fulfilled the certification criteria, he will receive a certificate.
If the client has not fulfilled the certification criteria, the client can rectify the deviations within 180 days after submitting the evaluation. After rectification, a post-audit can be carried out. In such a case, LaboZert shall submit a separate offer to the client for acceptance. After the post-audit has been carried out, the client will receive a further evaluation report. The certificate is issued if it is determined in the post-audit that the certification criteria are fulfilled. Otherwise, the certification procedure is completed without issuing the certificate.
LaboZert maintains a directory of all certified clients. In this directory are listed: Name, address, branches, if applicable, and the scope of the certificate. LaboZert is entitled to publish the directory. The client can object to the publication for an important reason. The important reason must be stated in writing.
The certificate has a limited term of 3 years after issuance. In each case, the client can extend the term by renewed certification(s) for a further three years. The application for renewed certification shall be submitted to LaboZert sufficiently early (at least three months in advance) to ensure a continuous certificate term. The provisions of Sections 3.1 to 3.5 shall apply mutatis mutandis to the renewed certification unless otherwise stated in the offer.
Obligations of the Client to cooperate in the Auditing Process
The Client shall perform all acts of cooperation specified in the offer or otherwise required for the performance of the auditing. In particular, it shall provide all information and documents within the set deadlines, enable the on-site audit to be carried out, and support it with suitable personnel.
Rights and Obligations of the Client after Issuance of the Certificate
Use of the LaboZert Trademark
After the certificate has been issued, the client is entitled to use the LaboZert trademark listed below.
The right of use is limited to the premises and the subject matter of the certificate.
The following information shall be provided in direct connection with the trademark:
- Subject of certification: [specify text from certificate].
- Certification year: [year]
- Audited facility: [indication from certificate]
- Audited by: LaboZert GmbH
The authorization to use the LaboZert trademark is granted non-exclusively and may not be transferred or licensed to third parties by the client. The right to use the LaboZert trademark is bound to the certificate's term. After the expiration of the right of use, the client will destroy all materials and objects bearing the LaboZert trademark immediately.
The LaboZert trademark is to be used in the representation specified above and is to be placed on a white background. The LaboZert trademark may be enlarged or reduced in size, but the graphic proportions must not be changed. The use of continuous text or in combination with other graphic elements is not permitted.
The LaboZert mark may be used on the stationery of the applicant as well as on the homepage of the client. All other uses require the separate written consent of LaboZert.
When using the LaboZert trademark, all legal requirements, in particular also the requirements of the law against unfair competition, must be observed by the client. In particular, no misleading statements may be made in the context of the LaboZert trademark.
LaboZert is the sole owner of the LaboZert trademark. The client does not obtain any own rights to the LaboZert trademark through the rights of use granted. Should any rights arise for the client from using the LaboZert trademark, these are transferred in full to LaboZert.
Compliance with the Conditions of Certification; Changes in the Basis for granting the Certificate.
The client must ensure that the conditions for granting the certificate are complied with during the term of the certificate. The client must inform LaboZert immediately of all changes to its operational processes that are relevant to the certificate. Suppose the changes lead to the fact that the primary conditions for granting the certificate no longer exist. In that case, the certificate shall become invalid, and the use of the LaboZert mark shall be discontinued immediately.
LaboZert has the right to check the client's compliance with the certification conditions at any time, particularly if LaboZert receives indications from third parties that the client no longer complies with the certification conditions.
After receipt of the evaluation report, a complaint is only possible within four weeks. After the expiry of this period, claims of the client due to a complaint are excluded.
In the event of an unsatisfactory performance by LaboZert for which LaboZert is responsible, LaboZert is entitled to rectify the performance. If the rectification fails, the client has the right to refuse further execution, withdraw from the contract, or demand a reduction of the agreed remuneration.
Claims for damages - irrespective of the legal grounds - against LaboZert due to negligent breaches of duty shall only exist if an essential contractual obligation/cardinal obligation has been breached. Liability is limited to typically foreseeable damages and is limited to a maximum of three times the agreed certification fee.
In all other respects, the liability of LaboZert is excluded. These limitations do not apply to injury to life, body, or health, and insofar as the damage is based on an intentional or grossly negligent breach of duty.
The prices for the auditing are specified in LaboZert's offer. Cost overruns of up to 10% of the amounts stated in the offer are permissible and will not be notified separately by LaboZert. LaboZert will report cost overruns of more than 10 % in good time to obtain the client's agreement.
All prices are subject to the addition of the statutory value-added tax.
The payment obligation arises at the time of the conclusion of the contract per section 3.1 of these GTC. It shall expire exclusively in the event of payment by the client per section 3.1 of these GTC or cancellation of the auditing by LaboZert per section 3.1 of these GTC. LaboZert can refuse the performance of the auditing and the delivery of the certificates if the client is in default with his payment obligations.
Invoicing shall occur as follows: 70% after the conclusion of the contract, 30% after submission of the evaluation report unless otherwise stated in the offer. LaboZert is entitled to demand advance payment.
Invoice amounts are due within ten days after receipt of the invoice. Invoices are issued exclusively in EURO. Any bank charges incurred shall be borne by the client.
The contract comes into force upon conclusion and runs until the end of the certificate term. In the event of recertification, the contract shall be extended by the extended certificate term.
The contract may be terminated without notice for a good cause. An important reason exists for LaboZert in particular if:
- the customer does not fulfill his obligations to cooperate after receiving a reminder;
- the client does not fulfill his payment obligations even after receipt of a reminder; or
Notice of termination must be given in writing.
Place of Performance
The place of performance is the registered office of LaboZert in Düsseldorf.
The contract is subject to the Federal Republic of Germany's law, except for international private law and the UN Convention on Contracts for the International Sale of Goods (CISG).
Suppose the participant is a merchant within the meaning of Section 1 (1) of the German Commercial Code, a legal entity (under public law), or a special fund under public law. In that case, the place of jurisdiction for all disputes arising from or in connection with the contract shall be Düsseldorf.
Should any provision of this contract be or become invalid or unenforceable in whole or in part, this shall not affect the validity of the remaining provisions of this contract. In place of the invalid or unenforceable provision or to fill the gap, an appropriate provision shall apply which, as far as legally possible, comes closest to or corresponds to what the contracting parties intended in economic terms or would have intended according to the meaning and purpose of this contract if they had considered this point. This shall also apply if the invalidity of a provision is based, for example, on a scope of performance or time (deadline or date) provided for in this contract; in such cases, a legally permissible scope of performance or time (deadline or date) that comes as close as possible to the intended economic purpose shall take the place of what was agreed. The same shall apply if and to the extent that a loophole should become apparent in this contract.