我院实施ISO9000族标准的具体操作

哈尔滨医科大学附属第二医院于１９９９年８月８日正式通过了由法国ＢＶＱＩ国际认证公司按ＩＳＯ９０００族质量标准对医院进行的全面质量审核与认证,医院在ＩＳＯ９０００族标准的具体操作过程中美经过了以下步骤：（１）领导决策,统一思想：（２）成立实施ＩＳＯ９０００族标准工作小组、制定细致的实施工作计划;（３）质量体系框架的设计,体系文件的编写,最重要的是《质量手册》的编写;（４）医院质量方针的确立;（５）质     

ISO 9000族标准与医院质量管理

ＩＳＯ９０００族标准体系，作为质量管理、质量保证的国际标准，为医院质量管理提供了重要的标准化形式。通过对ＩＳＯ９０００族概况的介绍，以及各质量保证要素与医院质量管理的关系的分析，意在帮助人们进一步了解ＩＳＯ９０００族标准的内涵，提高对ＩＳＯ９０００在医院质量管理标准化建设方面重要意义的认识 。     

2000版ISO9000族标准简介

和１９９４版ＩＳＯ９０００族标准相比，２０００版ＤＩＳ稿至少有如下的明显变化。１标准“族谱”的变化 １９９４版从术语、选择和使用、质量保证标准、质量管理指南、支持性技术指南等不下２０余个。２０００版精简成４个核心标准，即ＩＳＯ９０００“质量管理体系一基本原理和术语”； ＩＳＯ９００１“质量管理体系一要求”；ＩＳＯ９００４“质量管理体系一业绩改进指南”和ＩＳＯ１９０１１“质量管理和环境审核指南”。内容大量压缩精炼。有一部分转为其地标准或变化技术报告（ＴＲ）。２供应链使用术语的变化 由１９９４版的分供…     

国际标准化组织9000族标准2000年展望

国际标准化组织９０００族标准２０００年展望上海医用电子仪器厂（上海２０００３２）孔繁荣北京经济学院孙贞１全球性竞争趋势自国际标准化组织（ＩＳＯ）颁布ＩＳＯ９０００－８７版系列标准以来，其全球性推广已成为现实。目前ＩＳＯ９０００认证已成为国际上几乎所有...     

ISO9000族标准即将换版

日前 ,笔者作为技术专家参加了国家技术监督局中国质量体系认证机构国家认可委员会（ＣＮＡＣＲ）组织的２０００ＣＮＡＣＲ认可评审员／技术专家研讨会 ,在会上ＣＮＡＣＲ秘书处负责人称 ,ＩＳＯ９０００体系认证近年呈上升趋势。据不完全统计 ,全球通过认证的企业到１９９８年已达２７２０００余家。而在我国 ,１９９８年底８０００余家 ,１９９９年达１５０００家 ,２０００年４月达１７７００多家。从中可以看到 ,我国的认证也呈上升趋势。目前我国使用的ＩＳＯ９０００族标准是１９９４年发布的（简称９４版）,质量保证模式（标准）Ｉ…     

北京福田电子医疗仪器有限公司等六家企业通过质量认证

［本刊讯］我国医疗器械质量认证工作又取得新进展，航卫通用电气医疗系统有限公司、北京福田电子医疗仪器有限公司、上海麦迪逊医疗器械有限公司、陕西省医疗仪器厂、北京古莎生物材料有限公司、北京医疗器械研究所按照ＧＢ／Ｔ１９０００－ＩＳＯ９０００系列标准和ＹＹ／Ｔ０２８７—ＩＳＯ１３４８５或ＹＹ／Ｔ０２８８—ＩＳＯ１３４８８标准的要求建立和实施质量体系，贯彻相应产品的国家标准或行业标准，通过了质量认证，近日获得了中国医疗器械产品认证委员会及其中国医疗器械质量认证中心（以下简称ＣＭＤＣ）颁发的认证证书，这也…     

从“ISO9000”引发的思考——建立科研计划管理标准化工作程序

从“ＩＳＯ９０００”引发的思考——建立科研计划管理标准化工作程序曹也丁“ＩＳＯ９０００”是国际标准化组织（ＩＳＯ）所制定的一系列质量管理和质量保证的国际标准，自１９８７年正式颁布以来，截止到１９９４年底已被全世界７０多个国家所采用，成为迄今为止发展最...     

上海国家医疗器械质量监督检验中心通过质量体系认可审查

上海国家医疗器械质量监督检验中心通过质量体系认可审查１９９５年１月中旬由国家技术监督局组织的专家评审小组，按ＩＳＯ／ＩＥＣ导则２５─１９９０“标准和检验实验室资格的通用要求”和ＩＳＯ９０００．２对国家医疗器械质量监督检验中心（上海医疗器械产品认证检测...     

建立适宜的质量管理体系——学习医疗器械生产企业体系考核办法

１医疗器械生产企业体系考核（以下简称体系考核）是具有中国特色的监督管理方式１．１任何企业都有自己的质量管理模式 根据ＩＳＯ９０００体系的有关表述,质量是指产品、体系或过程的一组固有特性,满足顾客和其他相关要求的能力;管理是指指导和控制组织的相互协调的活动;体系（系统）是指相互关联或相互作用的一组要素;质量管理体系（或叫质量管理模式）是指建立质量方针和质量目标并实现这些目标的体系。很明显,企业为了实现既定的质量方针和质量目标：（１）需要相应组织结构,无论是行政管理组织还是生产管理组织,并有明确的相…     

ISO9000国际标准与医院质量管理

一、ＩＳＯ９０００标准概述ＩＳＯ系国际标准化组织 (ＴｈｅＩｎｔｅｒｎａｔｉｏｎａｌＱｒｇａｎｉｚａｔｉｏｎＦｏｒＳｔａｎｄａｒｄｉｚａｔｉｏｎ）的简称 ,ＩＳＯ９０００系列是国际标准化组织颁发的一套质量管理和质量保证国际标准。该标准自１９８７年公布实施以来 ,全世界已有１００多个国家和地区宣布等同①或等效采用。ＩＳＯ９０００标准是现代质量管理理论发展的结晶 ,是最基本的质量管理方法 ,它具有广泛的适用性 ,几乎覆盖了社会经济活动的各个层面 ,是工业发达国家在长期市场竞争中开展质量管理和质量保证 ,谋求最小经济…     

Die sogenannte Vinylchlorid-Krankheit—eine berufsbedingte Systemsklerose?

Zusammenfassung Es wurden 13 Arbeiter untersucht, die zwischen 1 3/4 und 18 Jahren in einem PVC-herstellenden Betrieb beschäftigt waren. 8 von ihnen wiesen sklerodermieartige Hautveränderungen (Abb. 2) auf, die histologisch charakterisiert sind durch Verbreiterung und Homogenisierung der kollagenen Faserbündel (Abb. 3 u. 4) sowie Fragmentation und Rarefizierung der elastischen Fasern (Abb. 5). Bei 7 Patienten bestanden trommelschlegelartige Auftreibungen einzelner Fingerendphalangen (Abb. 1). 11 Patienten zeigten Durchblutungsstörungen der Extremitäten (4 von diesen ein Raynaud-Syndrom) und 6 Patienten Acroosteolysen einzelner Fingerendphalangen (Abb. 6, Tabellen 1–3).Darüber hinaus bestand bei allen Patienten eine Thrombocytopenie, bei 12 Patienten eine Splenomegalie, bei 11 Patienten eine Einschränkung der Leberfunktion (erhöhte BSP-Retention). An der Leber ließ sich histologisch bei den 5 laparoskopierten Patienten eine deutliche Fibrosierung der Portalfelder nachweisen. Bei 4 Patienten bestanden Oesophagusvaricen (Tabellen 4 u. 5). 8 Patienten zeigten eine Partialinsuffizienz mit Hinweisen für vorwiegend restriktive Veränderungen.Die hier beschriebenen Veränderungen gehen weit über das bisher bekannte Acroosteolysesyndrom hinaus. Es wird der dringende Verdacht geäußert, daß langfristige Vinylchlorid-Exposition dieses komplexe Krankheitsbild verursacht. Daher wird für diese systemische Krankheit die Bezeichnung Vinylchlorid-Krankheit vorgeschlagen.Wir danken Frau E. Voigtländer für die Herstellung der klinischen und histologischen Abbildungen.     

Empathic processes: perception by medical students of patients'' anxiety and depression

Perceptions by medical students of patients' affective states were investigated, and the effect of the students' own emotions on such perceptions. One hundred and one fourth-year medical students rated the levels of anxiety and depression of three women patients presented on videotape, rated their own levels of anxiety and depression and completed a questionnaire on aspects of the rating process. Students had widely different and often inappropriate perceptions of patients' levels of anxiety and depression. Students who consistently overrated anxiety or depression in patients, compared to those who consistently underrated, were themselves significantly more anxious or depressed. These data suggest a need in medical education for systematic teaching of empathic skills and for recognition of potential bias in clinical decision-making arising from the clinician's own emotional state.     

The reported incidence of work-related ill-health in Scotland (2002-2003)

BACKGROUND: Although incidence data for work-related ill-health in the UK are available, more detailed information for smaller geographical areas has hitherto been unpublished. AIMS: To estimate the incidence of work-related ill-health reported by clinical specialists in Scotland, 2002-2003. METHODS: THOR (The Health and Occupation Reporting network) is a UK wide reporting scheme for work-related ill-health. In 2002-2003, 241 out of 2162 physicians in THOR were based in Scotland. We have summarized the reported cases and calculated incidence rates for categories of ill-health by age, gender and industry. The UK Labour Force Survey (2002) was used to provide denominator data, with comparisons made between rates for Scotland and the rest of the UK. RESULTS: In 2002-2003, 4043 estimated cases were reported from Scotland. Mental ill-health was most frequently reported (41%); followed by musculoskeletal disorders (31%), skin disorders (16%), respiratory disease (10%), hearing disorders (2%) and infection (1%). The reported average annual incidence rate per 100,000 employees for all work-related ill-health in Scotland was 86.0. The highest reported rate for mental ill-health was found for employees in public administration and defence (76.7 per 100,000), and health and social work (72.3 per 100,000). The construction industry had the highest reported rate of musculoskeletal disorders (41.6 per 100,000), while hairdressers appeared at most risk of developing occupational contact dermatitis (rate=86.4 per 100,000). CONCLUSIONS: Despite its limitations, THOR has indicated types of work-related ill-health and related industries for targeted disease prevention in Scotland.     

Function of the protein RPE65 in the visual cycle

A protein called RPE65 performs a key role in the trans-cis isomerization of retinol in the retinal pigment epithelium of the eye. The palmitoylation of RPE65 serves to switch off the visual cycle in darkness and to switch it on in the light.     

Acute symptoms following work with pesticides

BACKGROUND: Serious accidental poisoning by pesticides is rare in the UK, but more minor pesticide-related illness may be under-reported. Anecdotally, use of sheep dip has been linked with flu-like symptoms. AIM: To explore the frequency, nature and determinants of acute symptoms following work with pesticides. METHODS: A postal survey of men in three rural areas of England and Wales provided data on occupational use of five categories of pesticide, occurrence of 12 specified symptoms within 48 h of using pesticides and tendency to somatize. Risk factors for pesticide-related symptoms were assessed by modified Cox regression. RESULTS: Of 10 765 responders (response rate = 31%), 4108 had at some time used pesticides occupationally, including 935 (23%) who reported symptoms following such work on at least one occasion. In two areas, acute symptoms were most frequent following use of sheep dip (29 and 32% of users), but in the third area the rate was significantly lower (13% of users). The relative frequency of symptoms was similar for all five categories of pesticide, and flu-like symptoms did not cluster unusually among users of sheep dip. Risk of pesticide-related symptoms increased with somatizing tendency (prevalence ratio for highest versus lowest category 2.4, 95% confidence interval 2.0-3.0) and was higher in men who had used pesticides most often or handled concentrate. CONCLUSION: Acute symptoms are common following work with pesticides, but in many cases the illness may arise through psychological rather than toxic mechanisms.     

The Life Events Inventory: re-scaling based on an occupational sample.

The objective of this study was to compare the validity of the original weightings used by the Life Events Inventory (LEI) with those obtained from a contemporary occupational sample. Fifty male and 62 female manufacturing employees (age range 16-55 years) assigned scores to each item on a slightly modified version of the LEI scale. The current sample consistently assigned higher weights to events/items than did the original sample, but there was high agreement in terms of item ranking. Some distinct age and gender differences in scoring were apparent, and are discussed further. It was concluded that when separate weightings are employed for age and gender groups, the LEI remains a useful tool for quantifying background levels of stress in both workplace stress audits and epidemiological studies where statistical control for non-occupational sources of stress is required.     

Maxillofacial injuries related to work accidents: a new concept of a hospital-based full electronic occupational trauma surveillance system

The objective of this study was to investigate the occurrence of occupational maxillofacial injuries using a newly installed relational database. Twenty-six injuries were identified out of 28,624 patients admitted to the emergency unit during a 12 month period. Falls from height or being struck by moving objects were common causes of these injuries. Two-thirds of those identified were construction workers. This paper demonstrates the power of modern databases to identify specific occurrences that may provide the basis for prevention in the future.     

Rôles physiologiques des endocannabinoïdes dans le contrôle de l’homéostasie énergétique

Endocannabinoids are endogenous lipids which modulate the release of neurotransmitters and activate different signaling pathways, through the binding to cannabinoïd receptors, CB1 and CB2. Endocannabinoids are involved in the control of a variety of behavioural and neuroendocrine functions, including feeding behaviour. In the central nervous system, they essentially modulate the expression of orexigen or anorexigen neuropeptides thus resulting in the stimulation of food intake. Their peripheral targets are mainly the liver and the white adipose tissue where they stimulate lipogenesis, through the modulation of several enzymes and proteins expressions. Cannabinoïd receptor agonists are nowadays prescribed to improve appetite of people suffering from cancer or AIDS. In the same way, CB1 antagonist, such as Rimonabant, could provide efficient treatment of obesity.     

Stress in police officers: a study of the origins,prevalence and severity of stress-related symptoms within a county police force

BACKGROUND: High levels of stress-related illness are causing concern across industry. Against a background of impending legislative moves to try to improve this situation, there is a need to identify key work-related stressors. Police work tends to be regarded as inherently stressful because of the personal risk of exposure to confrontation and violence and the day-to-day involvement in a variety of traumatic incidents. As a result, high levels of stress-related symptoms might be expected in this population. OBJECTIVE: To examine the sources of stress-related symptoms within police officers and measure the prevalence of significant associated mental ill-health. METHOD: A cross-sectional questionnaire survey of a population of 1206 police officers was performed to assess levels of strain associated with a series of potential home and work related stressors. Participants were then split into low and high scoring groups on the basis of a General Health Questionnaire (GHQ) threshold score in order to identify those stressors most associated with mental ill-health effects. RESULTS: Occupational stressors ranking most highly within the population were not specific to policing, but to organizational issues such as the demands of work impinging upon home life, lack of consultation and communication, lack of control over workload, inadequate support and excess workload in general. The high scoring group constituted 41% of the population and differed significantly from those with low scores in perception of all stressors, ranking both personal and occupational stressors more highly, and from personality constraints appeared significantly more 'stress-prone'. A significant association between gender and mental ill-health was found, with females more likely to score more highly on the GHQ than males. CONCLUSION: This study confirms previous findings of organizational culture and workload as the key issues in officer stress. Given that the degree of symptomatology appears to be worsening, management action is required. Further research is indicated within the police population into a possible increased susceptibility in female officers.