顾客满意-ISO 9001与ISO 13485的区别

对比ISO 9001质量管理体系，ISO 13485医疗器械质量管理体系标准里没有“顾客满意”的要求，代之以“满足顾客要求”。标准中解释：“顾客满意”和“顾客感知度”在法规中作为要求来实施太过于主观。以“满足顾客要求”作为对质量管理体系绩效的测量，与ISO 13485反应当前监管法规和促进世界医疗器械监管法规协调的目标相一致。

所谓“良药苦口”，医疗器械在保证安全、有效的前提下，有时不得不对产品使用的舒适性作出折中甚至舍弃一致降低了顾客满意度。同时，一味地追求顾客满意也会对医疗器械产品的研发、制造产生不利的影响。

虽然现在的标准中未要求＂顾客满意＂，但个人认为在保证医疗器械产品安全、有效的前提下，顾客的使用舒适性应在产品研发阶段给予充分考虑。同时，对顾客使用舒适性的反馈信息的深入分析结果是下一步产品开发和改进的重要的参考。通过考虑结和最新科技成果、仔细分析和评估风险/受益及应用人因工程学原理等，提供产品的使用舒适性，才能更好的开发出顾客满意度高的、具有强大市场竞争力的产品。

Quality Assurance vs Quality Control

Quality assurance and quality control are two important aspects in quality management system. They often confuse R&D staffs especially scientists at the university who are not familar with the industry and manufacturing. Generally speaking, Quality Assurance (QA) is process oriented and focuses on defect prevention, while Quality Control (QC) is product oriented and focuses on defect identification. Good summary can be found: Difference of QA and QC. In my opinion, QA is to make sure do the thing right then naturally it lead to do the right thing. While QC focuses on investigate if we are doing the right thing.

Seven Basic Tools of Quality

I often utilize flow chart, check sheet in the project management in the academic research to improve the work efficiency, they are also used widely in quality management, so called Seven Basic Tools of Quality. Quality management is a field which is less involved in the academic research in universities. Total quality management needs to be considered in the initial stage in prodcut development to ensure excellent final products.