TheEuropean union is China's most important trading partner. Even ifexports still have many barriers to overcome, machinery and cars fromEurope, electrical goods and textiles, even kitchen modules arehighly prized. And now even standards - European standards.
DQS审核员MaximilianMay，身为工商管理硕士(MBA)，以及经过专业培训的医护专家，近期作为代表DQSGmbH公司的审核员组长来到中国。他要面对的客户是一家外科整形美容中心。在他的行装中还带有一份DINEN 15224:2016——通行于全欧洲的，专业医疗保健质量管理(QM)要求的标准文件。请阅读下面这份可谓令人耳目一新的审核报告。
DQSAuditor Maximilian May, MBA, trained paramedic and health careexpert, has recently travelled to the People's Republic as a leadauditor on behalf of DQS GmbH. His customer: a center forreconstructive and cosmetic surgery. In his baggage: DIN EN15224:2016, a standard valid throughout Europe for the specific QMrequirements of health care. Read now an audit report of a slightlydifferent kind.
“以极其精细和周到的高品质护理，作为独一无二的卖点”——这是美联致美整形医院自2015年创立以来，为自己设定的企业形象。该企业是一家外科整形美容中心，同时还是中国一家大型化妆品制造企业的下属分支机构。美联致美下设十家医学美容疗法的门诊中心，在中国各大城市，包括北京和天津，都有业务开展。该企业现已设立开展外科手术治疗的首个门诊分部。
"Highlysophisticated care with quality as a unique selling point" -that is the self-image of Mege union Medical Beauty, and has beensince its founding in 2015. The organization is the center forreconstructive and cosmetic surgery and a subsidiary of a majormanufacturer of cosmetics in China. With ten outpatient centers formedical beauty therapies, Mege union Medical Beauty is represented inChina's major cities, including Beijing and Tianjin. It has nowestablished the first branch for outpatient surgical procedures.
采用欧盟标准能够使企业拥有竞争优势
EuropeanStandards supply a Competitive Advantage
中国的保健行业竞争激烈。仅就上海这座2500万人口的大都市而言，为开展业务而激烈竞争的门诊性医疗美容中心就有450家。品质，通常是决定着优劣高下的首要因素;采用国际性标准——包括在中国颇负盛名的ISO9001标准——则意味着拥有实质性的竞争优势。
TheChinese health care industry is marked by strong competition. In the25-million metropolis of Shanghai alone, 450 outpatient medicalbeauty centers are competing for business. Quality usually enjoys thehighest priority, a certification according to an internationalstandard - including ISO 9001, which is well-known in China - is anessential competitive advantage.
应DQS(中国)的请求，为了遴选出适用的标准，还组成了国际项目组。相比于美国标准JCI与德国的KTQ，EN15224 被认定为最合适的标准。该标准在设计上以高级体系为依据，且与ISO9001:2015 标准完全符合。尤其值得一提的是，由于EN15224 标准在临床风险管理上，即涉及患者在医疗过程中的特殊风险的管理上具有优点，该标准能够在医疗保健的特殊要求方面达到理想化的平衡。
Followinga request by DQS China, an international project group needed toweigh the options for a suitable standard. In comparison with the USstandard JCI and the German KTQ, EN 15224 was found to be mostsuitable. The standard is designed according to the High-LevelStructure and fully compatible with ISO 9001:2015. In particular, EN15224 is ideally balanced for the special requirements of health caredue to its clinical risk management, i.e. the specific risks frompatient-related medical processes.
选定了适用的标准之后，还必须规划好接下来的相应步骤。具体包括培训出20名DQS(中国)的审核员。其目标在于：要使这些审核员能够在中国独立应对今后的审核工作。首次的现场审核于2017年8月实施，其间，审核组长根据ISO9001:2015 标准与EN15224标准的“合并审核进度”，成功完成了文件审评工作(书面审评)(第I阶段审核)。由于全部文件是采用中文象形文字(汉字)书写，要确保审核工作在如此短的时间内快速完成，极具挑战性。DQS(中国)聘请的译员为此做出无可估量的杰出贡献。她在后期还有极其出色的再度表现。
Afterchoosing the standard, further steps had to be planned. This includedtraining 20 auditors of DQS China. The goal: they were to be able tohandle future cases in China independently. The first on-site auditwas conducted in August 2017, during which the lead auditorsuccessfully evaluated the documentation (Stage I Audit), based on acombined schedule for ISO 9001:2015 and EN 15224. This was made morechallenging by the fast that the entire documentation was written inChinese ideographs. The interpreter hired by DQS China deliveredinvaluable work here. She was to reappear later in a most remarkablefashion.
在2017年10月，即第II审核阶段期间，具体的流程在实践中得到再现应用，微创治疗(采用透明质酸进行局部整形治疗)和手术治疗(采用种植体进行鼻整形、颊部自体脂肪移植)均有涉及。“实践”一词在此毫无夸张。原因是，在全体一致同意的前提下，DQS(中国)的译员担当了一名要求接受特殊美容手术的患者的角色。
Duringthe Stage II Audit in October 2017, the specific processes werepractically reproduced, both regarding minimally invasive therapy(local treatment with hyaluronic acid) as well as invasive surgicaltherapy (rhinoplasty with implant, buccal autologous fatre-transplantation). And "practically" was nearly literalin this case. Because with everyone's agreement, the interpreter ofDQS China took the role of a patient with a specificsurgical-cosmetic request.
从进入接诊区的一刻起，直到进行医疗咨询和治疗规划，再到接受医疗性及非医疗性的处置以及后期护理，陪伴她走完了所有分段流程的审核员都严格遵循相关的过程步骤，并随时备妥相应的文件。相关的介入治疗是在相应的治疗场所(介入治疗室、手术室，还设有出入规程)通过示范完成的，当然不会在实际上完整实施。
Fromthe reception area to the medical consultation and therapy planningto the medical and non-medical treatment as well as aftercare, theaudit followed her through all the subsidiary processes, with therelevant process steps as well as corresponding documentation.Interventions were hinted at in the appropriate treatment theatres(intervention room, surgical theatre, including entrance and exitprocedures), but of course were not carried through.
欧盟质量管理理念的重大意义
EuropeanQuality Mindset as Enrichment
作为伴随进行的月度性内部质量管理(QM)检查的组成部分，对于美联致美的所有辅助性流程都进行了仔细检查，质量经理每月还要根据一份全面检查表(254条录入)，对结构、流程或结果的所有相关参数进行检查。全方位的卫生管理——有几点还超出了德国标准对门诊医护的要求——以及对肉毒杆菌毒素一类的神经毒素的应用实施的明确监管和控制，这些不过是美联致美严格的一般性日常质量管理做法的几个例证。
Aspart of an accompanied monthly internal QM check, all supportprocesses were observed. At Mege union Medical Beauty, all parametersrelevant to structure, processes or results are examined monthly bythe quality manager on the basis of a comprehensive check list (254entries). A comprehensive hygiene management - in some points goingbeyond German standards for outpatient care - as well as a clearlyregulated and controlled handling of neurotoxins like Botox are justexamples of a daily common quality practice at Mege union MedicalBeauty.
美联致美的员工在其上海分部创立了全方位的质量管理体系，并推行了许多切实的、以确保质量为导向的解决方案。在所有“转换点”上进行深入细致的交叉检查，尤其反映出他们具有高度的质量意识和风险意义。总之，审核组长在整个审核过程中能够对ISO9001:2015 与EN15224:2016 两大标准的合规性做出确定。存在的个别不符合标准之处，已经在审核的第I和第II阶段之间得到弥补和消除。
Thestaff at Mege union Medical Beauty has created a comprehensivequality management system at their Shanghai branch office, andimplemented many practical, quality-oriented solutions. The thoroughcross-checking at all transfer points in particular demonstrates ahigh degree of awareness of quality and risk. In conclusion, the leadauditor was able to determine the conformity with both standards, ISO9001:2015 as well as EN 15224:2016 during the entire audit process.Non-conformities were already closed between Stage I and Stage II.
在审评期间，所有参与者都注意到，所付出的巨大努力，尤其是在推行过程管理方面付出的巨大努力，获得了效果显著的回报。所有人都认为：采用欧盟标准EN15224:2016 益处良多——该标准所体现的，欧盟的质量管理理念，对于中国保健专业人士树立质量意识，必然产生巨大的促进作用。
Duringreview, all participants noted that the great efforts, especiallyregarding the implementation of process management, have paid offconsiderably. The European standard EN 15224:2016 was felt byeveryone to be helpful - the European quality mindset recognizable inthe standard was seen as a gain for the understanding of quality ofthe Chinese health experts.
