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ABOUT LEJA LEJA公司介紹

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  • 公司名稱 自然基因科技有限公司
  • 品牌
  • 型號 ABOUT LEJA
  • 產(chǎn)地 德國
  • 廠商性質 代理商
  • 更新時間 2024/8/22 15:13:02
  • 訪問次數(shù) 2424

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  自然基因科技是一家長期致力于研究,生產(chǎn)及銷售生命科學儀器的企業(yè)。我們主要提供生化科研,醫(yī)學科研,生物工程,分子生物學及其他科研項目如生物化學,農(nóng)業(yè),環(huán)保及質量控制等方面的產(chǎn)品。多年來,憑借強大的技術力量,完善的軟硬件配置,自然基因科技為世界各地的大學、醫(yī)院、科學研究機構提供科研儀器,滿足各種研究領域的應用需求,并提供專業(yè)的的售后服務給客戶。自然基因科技用戶遍布全球,不少產(chǎn)品已在業(yè)界具有良好的口碑。
  公司主要代理法國IMSTAR圖像分析處理系統(tǒng),美國AAPPTEC多肽合成儀,IRIS甩片機和原位雜交儀器等。
 

多肽合成儀,德國耶拿ProgRes CCD系列,IMSTAR智能顯微圖像分析機,Makler精子計數(shù)板,動物呼吸機,動物麻醉機,動物行為學儀器,細胞融合儀,精密注射泵等

leja is a company and was founded in 1995. the head of the ivf clinic of the amsterdam free university thought that semen analyses could be done better. he invented the concept behind the leja slides. after a long period of testing, the first slides to be officially marketed were released in 2002. since then, a lot of product development has been taken place. new slide designs were developed. also a physical occurrence was noted: the segre-silberberg effect. a special slide design was developed in order to compensate for this effect. currently a lot of research to constantly improve our products is conducted by the r&d department.
leja公司介紹的詳細介紹

about leja.

leja is a company and was founded in 1995. the head of the ivf clinic of the amsterdam free university thought that semen analyses could be done better. he invented the concept behind the leja slides. after a long period of testing, the first slides to be officially marketed were released in 2002. since then, a lot of product development has been taken place. new slide designs were developed. also a physical occurrence was noted: the segre-silberberg effect. a special slide design was developed in order to compensate for this effect.
currently a lot of research to constantly improve our products is conducted by the r&d department.

quality standards.

you can also download this document here [59 kb].
download the iso certifcate here [296 kb].
download the declaration of conformity here (ce mark) [122 kb].

 

leja products bv is an iso 9001: 2000 certified company.

leja is audited annually by kema medical, arnhem, the netherlands.

our quality manual contains procedures and working instructions, providing a summary of the aspects important for the customer.

chapter 1 (policy & strategy & quality)

the board of leja aims at maintaining the quality system according to iso 9001:2000. the board regularly reviews the functioning of the quality system and new quality aims are formulated annually.
 

the board approves product specifications, handling information and promotion material.

 

the quality manager at leja is responsible for the functioning of the quality system in close cooperation with the representative of the board. leja performs an annual internal audit program, based on risk analysis.

 
chapter 2 (organization)
 

the organizational structure of leja is aimed at quality. working goal-directed is guaranteed by the system of goals and planning and by the leja personnel system. tasks and responsibilities are clear and limited.

 
chapter 3 (primary processes)
 

3.1 customer relations
 

leja sells its products via distributors or agents.

 

distributors are always informed about product changes (e.g. components, packaging) and the possible consequences.

 

complaints must be reported to the distributor, who immediay contacts marketing. the quality manager manages the complaint file containing communication, research, preventive/corrective actions and a follow-up. the distributor receives an explanation and a desc-ription of the actions taken within 3 weeks.

 

3.2 research & development

 

leja is focused on continuous improvement of its products and on developing innovative products.

 

every new product is reviewed by the board and a research team (r&d, production, marketing). all research activities are documented in the "project master file". every phase in the research plan (4 from idea to end product) is finished with a report.

 
3.3 production and warehouse
 

all materials for producing, checking, packaging, and designing the end product are purchased from approved suppliers (evaluated regularly).

 

all production-related incoming materials are checked and laboratory tested for various defined aspects using a "raw-material specification form". then they receive a sticker with the leja-code and an intern batch number.

 

all processes that influence the quality of the end product are described (all routine handlings in "working instructions") and subject to control. we perform extensive in process- and end controls on every produced batch at leja (for details see: product specification).

 

problems or aberrations found during production or end controls are reported to the board. when the problem cannot be solved directly, the products are placed in quarantine and a research team investigates the cause. the corrective actions (e.g. adaptation of the production process, new working instructions, teaching, external audit) are communicated to everyone involved.

 

during production, codes and internal batch numbers are registered, together with various process parameters. at the end, it is exactly clear which materials and process conditions are incorporated in one production batch.

 

proposed changes in a product and/or process are first investigated by a research team and then documented in a report together with a risk analysis. the proposition is evaluated by the board.

 

critical measuring instruments are calibrated regularly according to an annual calibration program (e.g. height measurement).

 
 
 

chapter 4 supportive processes

 
4.1 personnel process
 

this procedure describes the intake, development and departure of employees at leja. for each function there is a desc-ription with demands for that function. furthermore, the competences of each employee are placed on the record. in order to determine the capacities within the organization, the personnel process is passed through annually.

 

4.2 financial/administrative process

 

this procedure describes the dispatch of the purchase and sale processes and also contains a procuration schedule.

 
14.04.2004
 
chris dam

quality manager, leja products b.v.




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