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ABOUT LEJA LEJA公司介绍
初级会员第17年
代理商leja公司介绍的详细介绍 |
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. |