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.
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.
"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.
EuropeanStandards supply a Competitive Advantage
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 被认定为合适的标准。该标准在设计上以*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.
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.
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.
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.
EuropeanQuality Mindset as Enrichment
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.
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.（文章来源：互联网）