OEM / Quality Management & Regulatory Affairs Contract
Between
AAA
Reprented by XXX – CEO, owner, called Own Brand Labelling, hereinafter referred to as "OBL”,
西红柿英文And
Name of manufacturer:
Adress:
Reprented by 五人制足球规则XXX, CEO, called OEM manufacturer, hereinafter referred to as "OEM"
1.Preface
The products manufactured by OEM ( designing, material, packaging instruction for u, labeling and final control) are sold by OBL under the responsibility of OBL. Thus, OBL is the manufacturer in the n of the Directive 93/42/EEC and is conquently obliged to maintain a documented quality management system which meets the current requirements for manufacturers of medical devices in Europe. This system is certified by an accredited body.
2.Scope of application黑芝麻薄脆饼干
This contract only applies to the products specified in annex 1 of this agreement. Annex 1 shows the correspondence of OEM’s products with OBL’s products including the classification information according to Directive 93/42/EEC . Versions of annex 1 of this agreement are only valid when signed by both parties. The agreement shall be effective for all orders prent and future that will be confirmed before the termination of this agreement.
3.Contractual obligations of OEM
Apart from the above mentioned obligations, OEM is obliged to the following:
a) Definition of product purpo
OEM declares that the products specified in annex 1 of this agreement are according to the defined purpo and the ur instructions in effect. The purpo of the product will not change.
b) Conformity to the Directive 93/42/EEC
OEM declares that the products specified in annex 1 of this agreement meet the esntial requirements of annex I of the Directive 93/42/EEC and regarding the specific products the additional requirements according to annexes V of this directive. Furthermore, all other required standards, particularly European harmonized standards, are met.
实践评语
c) Quality management system
OEM maintains a quality management system according to ISO 13485, and annex V of th
e Directive 93/42/EEC for the products specified in annex 1 of this agreement including the departments of rearch, production and transport. QMS must be certified by Notified Body.
OEM is obliged to provide OBL with the valid certificates on this behalf and to inform OBL about changes concerning tho certificates unsolicitedly
d) Technical documentation
OEM creates and maintains a complete technical documentation according to annex VII of the Directive 93/42/EEC. OEM will provide OBL with all relevant documentation about the products specified in annex 1 of this agreement regarding OBL’s certification and sales process such as label information, ur instructions and material safety data sheets. In cas of incidents or reasonable suspicion in this regard, OEM grants access to this documentation to the notified body or the competent administrative authority of OBL, including the access to the full documentation of relevant products and their production.
比划猜词游戏
Particularly nsitive product information, for example formulations, does not have to be granted access to and not handed out by OEM. If necessary, OEM will grant access to the accordant production site on an individual basis.
Potentially raid costs by checking the documentation of OEM will be charged from OEM to OBL.
e) Suppliers and sub-contractors
家常粉丝OEM contractually obliges his suppliers and subcontractors for important materials, resources, parts, systems, components or rvices to maintain and cure the flow of information as above mentioned.
f) Label information and ur instructions
OEM creates and prents all label information including inscriptions and ur instructions etc. of the products specified in annex 1 of this agreement to OBL for approval before the manufacturing. All changes of label information relevant to safety, sp
ecification or function by each party require approval by the other party.
OEM guarantees, that all esntial information from the point the sights of the safety of the device were required by the NB become considered in the pasd on instruction of the rvice and different documents concurrent
g) Changes of product specifications
OEM is obliged to inform OBL about all changes in product specifications relevant to safety, specification or function of the product and in production process in written form and unsolicitedly and ask for approval. Deliveries after major changes must not be carried out without written approval of OBL. In order to establish complete traceability, OEM is obliged to document all changes and approvals regarding the products specified in annex 1 of this agreement.
h) Final product inspections
OEM inspects all outgoing products before delivery to OBL and provides certificates thereof with delivery by request.
h) Market monitoring
凤凰怎么画OEM will communicate to OBL all relevant information on the products specified in annex 1 of this agreement and to similar products that OEM will obtain by its market monitoring. 抗日烈士
