Quality assurance a) Initial sampling If the delivered part has already been approved by the OEM with the initial sample test report, the supplier will send us a copy of the approval. Otherwise, the commissioning of tools or their provision includes the initial sampling. In the event of fixture corrections, the initial sample inspection shall be carried out again in full. If the initial sample is rejected, Handtmann is entitled to reimbursement of the initial sample inspection costs.
b) New samples for purchased parts In the case of design changes only to the delivery part, only the changed sub-areas/lots shall be re-sampled. In the event of any technical modifications (in particular to the machine, the device, the cutting tools), a complete re-sampling must be carried out. The costs of a new sample are borne by the respective responsible party alone.
Quality assurance. The Contractor undertakes to apply the principles of quality assurance in accordance with the relevant ISO 9000 to ISO 9004 standards in the provision of Contractor’s Supplies and Services and to impose the same obligation on its subcontractors. Principal and Final Customer shall be entitled to audit the quality assurance systems, specifications and plans of the Contractor and its subcontractors at any time.
Quality assurance. 5.1. The vendor shall establish and maintain an effective quality assurance system and shall provide evidence thereof to XSYS on request. The vendor shall, at XSYS’ request, use a quality assurance system in accordance with DIN ISO 9000 ff. or of an equivalent nature. XSYS shall be entitled to inspect this quality assurance system.
5.2. If the vendor changes the manufacturing process, it shall notify XSYS of this in all cases, even if the change has no effect on the specification of the goods to be supplied. The vendor shall inform XSYS of the composition and/or origin of the goods supplied, and shall provide proof thereof as soon as XSYS requires such information and/or such proof for forwarding to the authorities, public institutions, works medical officer etc.
Quality assurance. 7.1. The Supplier is obligated to perform effective quality assurance and to maintain a corresponding, effective quality assurance/quality management system, and to prove this to the respective Sanofi company upon request. At the request of the respective Sanofi company, the Supplier shall use a quality assurance/quality management system according to DIN ISO 9001 and/or ISO 14001 and/or DIN EN ISO 13485 or equivalent nature according to the recognized policies for GMP and GLP (“quality assurance system”).
7.2. The Supplier agrees that we have the right to review its quality assurance system.
7.3. For this purpose, we or a third party commissioned by us and under an obligation of confidentiality, may perform an audit on the business premises of the Supplier during its usual business hours, in order to review the Supplier’s compliance with quality regulations. Insofar as separately agreed between the parties, the respective Sanofi company may conduct regular audits of the Supplier after prior notice.
7.4. For this purpose, the Supplier shall, among other things, grant access to certification and auditing reports as well as to testing and manufacturing procedures carried out, including all records and documents relating to supply.
7.5. We and any third party commissioned by us to perform an audit will ensure that the audit is carried out in such a manner, taking the applicable data protection and other statutory regulations into account, as to disturb the business operation of the Supplier as little as possible and that there is no infringement of confidentiality agreements of the Supplier with third parties.
7.6. The costs arising from performance of the audit will be borne by us and by the Supplier itself, respectively.
7.7. The inspection can also occur by means of a questionnaire provided by us.
Quality assurance. 13.1 The Supplier undertakes to implement and maintain an appropriate quality assurance system which is state of the art. The Supplier shall ensure through appropriate quality assurance measures that the Goods and the Services comply with quality requirements and specifications agreed.
13.2 Furthermore, the Supplier undertakes to provide a proof of the existence of a quality assurance system and showing the quality standards applied to the Purchaser upon the Purchaser’s request, and to inform the Purchaser without delay in writing if changes to the quality assurance system occur. If the quality assurance system of the Supplier is certified, the Supplier shall provide a copy of the certificate upon the Purchaser’s request and to inform the Purchaser without delay in writing if changes to the certificate occur or the certification expires. The Purchaser shall have access to audit reports on quality carried out by the independent auditors.
13.3 The Supplier shall only transfer its delivery or service obligations to subcontractors or third parties with the Purchaser’s prior written consent. In case of transfer of delivery or service obligations to subcontractors or third parties, the Supplier shall procure that its subcontractors and third parties shall comply with all legal and contractual obligations.
13.4 If the Supplier procures production or test equipment, raw materials, software, services, material or other basic material or services from sub-suppliers (sub-supplies) for the production or quality assurance of the Goods or Services, the Supplier shall include such sub-suppliers in its quality assurance system or to assure through appropriate measures the quality of such sub-supplies. Upon request the Purchaser, the Supplier shall provide a proof showing that the Supplier has assured oneself of the efficiency of the quality assurance system of its sub-suppliers.
13.5 The Supplier allows the Purchaser to conduct audits in order to check whether the Supplier’s quality assurance measures comply with the Purchaser’s requirements. Upon the Purchaser’s written notice an audit can be executed as a system or a process audit. The Supplier allows the Purchaser to enter the factories, laboratories, testing centres, warehouses and other facilities which are production relevant and to examine documents which are quality relevant. The Purchaser accepts reasonable audit restriction which are necessary to secure business secrets of the Supplier or third parties.
13.6 The...
Quality assurance. 6.1. Die gelieferte Ware muss den jeweils geltenden in- und ausländischen gesetzlichen Bestimmungen, den Vorschriften und Richtlinien von Behörden, Berufsgenossenschaften und Fachverbänden, dem neuesten Stand der Technik sowie den in der Bestellung vorgegebenen Spezifikationen und Qualitätsanforderungen entsprechen. Der Lieferant ist verpflichtet, SKELETON auf etwaige Verwendungsbeschränkungen und Deklarationspflichten für die gelieferte Ware schriftlich hinzuweisen.
6.1. The goods supplied must correspond with the respective domestic and foreign statutory provisions which are in force, regulations and directives of public authorities, government safety organizations and trade associations, and with the latest technology as well as the specifications and quality requirements set out in the purchase order. The Supplier is obliged to advise SKELETON in writing of possible limitations on use and declaration duties for the supplied goods.
6.2. Jede Produktionsänderung oder Verlagerung der Bezugsquellen der gelieferten Ware sowie der Einsatz von Subunternehmern bedarf der ausdrücklichen schriftlichen Zustimmung von SKELETON.
6.2. Any production modification or change in the source of the goods to be supplied as well as the involvement of any sub-contractors requires the express written consent of SKELETON.
Quality assurance. 5.1 Der Lieferant hat bei seinen Lieferungen die anerkann- ten Regeln der Technik, die geltenden Sicherheitsvor- schriften und die vereinbarten technischen Daten, insbe- sondere diejenigen aus der Bestellung einzuhalten. Dies gilt auch bei der Durchführung von Arbeiten auf dem Be- triebsgelände von HQM.
5.1 Supplier shall comply with the recognised rules of technology, the applicable safety regulations and the agreed technical data, in particular those set forth in the purchase order, for its deliveries. This shall also apply when carrying out work on the premises of HQM.
5.2 Zur Sicherung der Qualität, seiner an HQM zu liefern- den Waren verpflichtet sich der Lieferant, in eigener Ver- antwortung ein wirksames Qualitätsmanagement-System (QM-System) gemäß DIN EN ISO 9000 ff. einzuführen, an- zuwenden und aufrecht zu erhalten. Der Lieferant kann stattdessen ein alternatives System einführen, das jedoch mindestens alle inhaltlichen Anforderungen das mindes- tens den gültigen Normen der ISO 9001/2002 entspricht. Anzustreben ist die Erfüllung der Anforderungen der ISO/TS 16949:2002. Auf Ziffer 4.10 wird verwiesen. 5.2 In order to ensure the quality of the Goods to be delivered to HQM, Supplier shall introduce, ap- ply and maintain an effective quality management system (QM system) in accordance with DIN EN ISO 9000 et seq. Supplier may instead introduce an al- ternative system which, however, meets at least all the content requirements of the applicable stand- ards of ISO 9001/2002. Supplier shall undertake to meet the requirements of ISO/TS 16949:2002. Ref- erence is made to section 4.10.
5.3 Art und Umfang der Prüfungen sowie die Prüfmittel und Methoden sind vom Lieferanten mit dem Auftragge- ber abzustimmen. Sind die Art und der Umfang der Prü- fungen sowie die Prüfmittel und Prüfmethoden zwischen dem Lieferanten und HQM nicht fest vereinbart, ist HQM auf Verlangen des Lieferanten bereit, im Rahmen ihrer Kenntnisse, Erfahrungen und Möglichkeiten, die Prüfun- gen mit dem Lieferanten zu erörtern, um den jeweils er- forderlichen Stand der Prüftechnik zu ermitteln. 5.3 The type and scope of the tests as well as the testing equipment and methods are to be agreed between Supplier and the customer. If the type and scope of the tests as well as the test equipment and test methods are not firmly agreed between Sup- plier and HQM, HQM shall, at Supplier's request, discuss the tests with Supplier within the scope of its knowledge, experience and possibilities in order...
Quality assurance. 1. Supplier shall carry out quality assurance which is suitable to the scope and extent of the deliv- ery, and in accordance with the latest technol- Im Bedarfsfall wird der Lieferant eine entspre- chende, gesonderte Qualitätssicherungsverein- barung mit uns abschließen. ogy, and provide us with evidence thereof on re- quest. If needed, Supplier shall make an appro- priate, separate quality assurance agreement with us.
2. Auf die für bestimmte Produkte (vollständige Maschinen im Sinne der Maschinenrichtlinie 2006/42/EG und weitere Produkte, die z. B. den EG-Richtlinien 2004/108/EG - elektro-magneti- sche Verträglichkeit, 2006/95/EG - elektrische Betriebsmittel, 97/23/EG - Druckgeräte oder 2009/105/EG - einfache Druckbehälter) geltende CE-Kennzeichnungspflicht wird der Lieferant hin- gewiesen. Mit der Anbringung des CE-Zeichens am Produkt bestätigt der Lieferant in eigener Verantwortung, dass sein Produkt alle geltenden rechtlichen Anforderungen der EU erfüllt. Die EG-Konformitätserklärung ist in diesem Fall - in deutscher Sprache abgefasst - Bestandteil des Lieferumfangs. 2. Supplier shall refer to the CE labelling require- ment for certain products (complete machines as defined by machine guideline 2006/42/EC, and additional products, such as those defined by EC guidelines 2004/108/EC - electromagnetic compatibility, 2006/95/EC - electrical equip- ment, 97/23/EC - pressure equipment, or 2009/105/EC - simple pressure containers). By affixing the CE label to the product, Supplier af- firms, at their own responsibility, that their product fulfils all applicable legal requirements of the EU. In this case, the EC Declaration of Con- formity, drawn up in the German language, is considered a component of the delivery con- tents. Handelt es sich um eine im Sinne der Maschinen- richtlinie 2006/42/EG unvollständige Maschine, gilt die CE-Kennzeichnungspflicht nicht. In die- sem Fall ist Bestandteil des Lieferumfanges die Einbauerklärung sowie die Montageanleitung, beide ebenfalls in deutscher Sprache abgefasst. The CE labelling requirement will not apply to in- complete machines as defined by the machine guideline 2006/42/EC. In this case, the installa- tion declaration and assembly instructions, both in German, will be components of the delivery contents. Sofern der Lieferant auch Hersteller und damit verpflichtet ist, für vollständige und unvollstän- dige Maschinen sowie sonstige unter Absatz 1 dieser Ziffer beispielhaft genannte Produkte Risi- kobeurteilungen anz...
Quality assurance. The Contractor must have a suitable Quality Assurance system, which corresponds to the state of the art. ERGO is entitled to carry out quality audits during the Contractor's normal office hours for the purpose of quality assurance or arrange for such audits to be carried out by third parties who are not competitors of the Contractor.
Quality assurance. 4.1 The Supplier must ensure that he has access to suitable test equipment to test all the characteristics laid down in the specification.
4.2 The manufacturability and feasibility is to be documented and submitted to SCHRAG on request.