{"id":26916,"date":"2025-12-12T16:38:51","date_gmt":"2025-12-12T08:38:51","guid":{"rendered":"https:\/\/www.zdsztech.com\/blog\/qms-system-principles-complete-guide-small-medium-enterprises-improve-quality-management\/"},"modified":"2025-12-12T16:38:51","modified_gmt":"2025-12-12T08:38:51","slug":"qms-system-principles-complete-guide-small-medium-enterprises-improve-quality-management","status":"publish","type":"post","link":"https:\/\/www.zdsztech.com\/blog\/qms-system-principles-complete-guide-small-medium-enterprises-improve-quality-management\/","title":{"rendered":"QMS\u7cfb\u7edf\u539f\u7406\u5168\u89e3\u6790\uff1a\u4e2d\u5c0f\u4f01\u4e1a\u5982\u4f55\u7528\u5b83\u63d0\u5347\u8d28\u91cf\u7ba1\u7406"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/www.zdsztech.com\/wp-content\/uploads\/2025\/12\/1765528729-86ccb0dc1ca07f246fe537f322ac7fdd.jpeg\" alt=\"QMS\u7cfb\u7edf\u539f\u7406\u5168\u89e3\u6790\uff1a\u4e2d\u5c0f\u4f01\u4e1a\u5982\u4f55\u7528\u5b83\u63d0\u5347\u8d28\u91cf\u7ba1\u7406\"><\/p>\n<p>\u5728\u5f53\u524d\u5168\u7403\u4f9b\u5e94\u94fe\u6301\u7eed\u6ce2\u52a8\u3001\u5ba2\u6237\u5bf9\u4ea7\u54c1\u4e0e\u670d\u52a1\u7684\u671f\u671b\u65e5\u76ca\u4e25\u82db\u3001\u884c\u4e1a\u5408\u89c4\u538b\u529b\u4e0e\u65e5\u4ff1\u589e\u7684\u5e02\u573a\u73af\u5883\u4e0b\uff0c\u8d28\u91cf\u7ba1\u7406\u5df2\u4e0d\u518d\u662f\u4f01\u4e1a\u8fd0\u8425\u4e2d\u7684\u4e00\u4e2a\u53ef\u9009\u9879\uff0c\u800c\u662f\u51b3\u5b9a\u4e2d\u5c0f\u4f01\u4e1a\u751f\u6b7b\u5b58\u4ea1\u7684\u6218\u7565\u6838\u5fc3\u3002\u5b8f\u89c2\u6570\u636e\u663e\u793a\uff0c\u5236\u9020\u4e1a\u7684\u5e73\u5747\u4e0d\u826f\u54c1\u7387\u6bcf\u964d\u4f4e\u4e00\u4e2a\u767e\u5206\u70b9\uff0c\u4f01\u4e1a\u7684\u51c0\u5229\u6da6\u53ef\u80fd\u63d0\u53475%\u81f310%\uff1b\u800c\u5ba2\u6237\u6ee1\u610f\u5ea6\u4e0e\u590d\u8d2d\u7387\u7684\u5173\u8054\u7814\u7a76\u4e5f\u660e\u786e\u6307\u51fa\uff0c\u7531\u8d28\u91cf\u95ee\u9898\u5f15\u53d1\u7684\u5ba2\u6237\u6d41\u5931\u662f\u4f01\u4e1a\u589e\u957f\u7684\u6700\u5927\u969c\u788d\u4e4b\u4e00\u3002\u7136\u800c\uff0c\u8bb8\u591a\u4e2d\u5c0f\u4f01\u4e1a\u51b3\u7b56\u8005\u4ecd\u5c06\u8d28\u91cf\u7ba1\u7406\u89c6\u4e3a\u4e00\u4e2a\u88ab\u52a8\u7684\u3001\u9ad8\u6210\u672c\u7684\u201c\u6551\u706b\u201d\u90e8\u95e8\uff0c\u800c\u975e\u4e3b\u52a8\u521b\u9020\u4ef7\u503c\u7684\u5f15\u64ce\u3002\u8fd9\u79cd\u8ba4\u77e5\u504f\u5dee\uff0c\u6b63\u662f\u5236\u7ea6\u4f01\u4e1a\u53d1\u5c55\u7684\u5173\u952e\u74f6\u9888\u3002\u56e0\u6b64\uff0c\u73b0\u5728\u662f\u5ba1\u89c6\u5e76\u91cd\u6784\u4f01\u4e1a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u7684\u6700\u4f73\u65f6\u673a\u3002\u672c\u6587\u65e8\u5728\u4f9d\u6258\u5bf95000+\u4f01\u4e1a\u6570\u5b57\u5316\u5b9e\u8df5\u7684\u6d1e\u5bdf\uff0c\u4e3a\u4f01\u4e1a\u51b3\u7b56\u8005\u63d0\u4f9b\u4e00\u4e2a\u6e05\u6670\u7684QMS\u7cfb\u7edf\u8ba4\u77e5\u6846\u67b6\u548c\u4e00\u5957\u53ef\u6267\u884c\u7684\u5b9e\u65bd\u8def\u5f84\u56fe\uff0c\u5e2e\u52a9\u60a8\u5c06\u8d28\u91cf\u7ba1\u7406\u4ece\u4f20\u7edf\u7684\u6210\u672c\u4e2d\u5fc3\uff0c\u5f7b\u5e95\u8f6c\u53d8\u4e3a\u9a71\u52a8\u4e1a\u52a1\u589e\u957f\u3001\u6784\u7b51\u6838\u5fc3\u7ade\u4e89\u529b\u7684\u4ef7\u503c\u521b\u9020\u4e2d\u5fc3\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%80%E3%80%81%E6%8B%A8%E5%BC%80%E8%BF%B7%E9%9B%BE%EF%BC%9AQMS%E7%B3%BB%E7%BB%9F%E5%88%B0%E5%BA%95%E6%98%AF%E4%BB%80%E4%B9%88%EF%BC%9F\"><\/span>\u4e00\u3001\u62e8\u5f00\u8ff7\u96fe\uff1aQMS\u7cfb\u7edf\u5230\u5e95\u662f\u4ec0\u4e48\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5bf9\u4e8e\u8bb8\u591a\u4f01\u4e1a\u7ba1\u7406\u8005\u800c\u8a00\uff0cQMS\uff08Quality Management System\uff09\u7cfb\u7edf\u5e38\u5e38\u88ab\u8bef\u89e3\u4e3a\u4e00\u5957\u590d\u6742\u7684\u8f6f\u4ef6\u6216\u4ec5\u4ec5\u662f\u7528\u4e8e\u5e94\u4ed8ISO\u8ba4\u8bc1\u7684\u5de5\u5177\u3002\u5b9e\u9645\u4e0a\uff0c\u4e00\u4e2a\u73b0\u4ee3\u5316\u7684QMS\u7cfb\u7edf\u8fdc\u4e0d\u6b62\u4e8e\u6b64\u3002\u5b83\u662f\u4e00\u4e2a\u4f01\u4e1a\u7ea7\u7684\u7ba1\u7406\u5e73\u53f0\uff0c\u5176\u672c\u8d28\u662f\u5c06\u5148\u8fdb\u7684\u8d28\u91cf\u7ba1\u7406\u54f2\u5b66\u4e0e\u6570\u5b57\u5316\u6280\u672f\u6df1\u5ea6\u878d\u5408\uff0c\u5f62\u6210\u4e00\u5957\u6807\u51c6\u5316\u7684\u3001\u53ef\u8ffd\u6eaf\u7684\u3001\u6301\u7eed\u6539\u8fdb\u7684\u4e1a\u52a1\u6d41\u7a0b\uff0c\u4ece\u800c\u7cfb\u7edf\u6027\u5730\u63d0\u5347\u4ea7\u54c1\u4e0e\u670d\u52a1\u8d28\u91cf\u3002\u7406\u89e3\u5176\u6838\u5fc3\u539f\u7406\u4e0e\u6784\u6210\uff0c\u662f\u6210\u529f\u5e94\u7528\u7684\u7b2c\u4e00\u6b65\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"1_%E6%A0%B8%E5%BF%83%E5%8E%9F%E7%90%86%EF%BC%9APDCA%E5%BE%AA%E7%8E%AF%E7%9A%84%E6%95%B0%E5%AD%97%E5%8C%96%E5%86%8D%E7%8E%B0\"><\/span>1. \u6838\u5fc3\u539f\u7406\uff1aPDCA\u5faa\u73af\u7684\u6570\u5b57\u5316\u518d\u73b0<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6240\u6709\u6709\u6548\u7684\u8d28\u91cf\u7ba1\u7406\u6d3b\u52a8\uff0c\u5176\u5e95\u5c42\u903b\u8f91\u90fd\u9075\u5faa\u7740\u7ecf\u5178\u7684\u6234\u660e\u73af\uff08Deming Cycle\uff09\uff0c\u5373PDCA\u5faa\u73af\u3002QMS\u7cfb\u7edf\u7684\u6838\u5fc3\u4ef7\u503c\uff0c\u6b63\u662f\u5c06\u8fd9\u4e00\u201c\u8ba1\u5212\uff08Plan\uff09-\u6267\u884c\uff08Do\uff09-\u68c0\u67e5\uff08Check\uff09-\u5904\u7406\uff08Act\uff09\u201d\u7684\u7ba1\u7406\u54f2\u5b66\uff0c\u4ece\u5899\u4e0a\u7684\u6807\u8bed\u548c\u96f6\u6563\u7684\u6587\u6863\uff0c\u56fa\u5316\u4e3a\u53ef\u81ea\u52a8\u6d41\u8f6c\u3001\u95ed\u73af\u8fd0\u884c\u7684\u8f6f\u4ef6\u6d41\u7a0b\u3002\u8fd9\u786e\u4fdd\u4e86\u8d28\u91cf\u6539\u8fdb\u4e0d\u518d\u4f9d\u8d56\u4e8e\u4e2a\u522b\u5458\u5de5\u7684\u81ea\u89c9\u6027\uff0c\u800c\u662f\u6210\u4e3a\u7ec4\u7ec7\u7684\u4e00\u79cd\u5236\u5ea6\u5316\u80fd\u529b\u3002<\/p>\n<p>\u5728QMS\u7cfb\u7edf\u4e2d\uff0cPDCA\u5faa\u73af\u88ab\u6570\u5b57\u5316\u5730\u518d\u73b0\u4e3a\uff1a<\/p>\n<ul>\n<li><strong>\u8ba1\u5212 (Plan):<\/strong> \u5728\u7cfb\u7edf\u5185\u9884\u5148\u8bbe\u5b9a\u6240\u6709\u4e0e\u8d28\u91cf\u76f8\u5173\u7684\u6807\u51c6\u548c\u8ba1\u5212\u3002\u8fd9\u5305\u62ec\u5b9a\u4e49\u539f\u6750\u6599\u7684\u68c0\u9a8c\u6807\u51c6\uff08AQL\uff09\u3001\u8bbe\u5b9a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u5173\u952e\u63a7\u5236\u70b9\uff08SPC\uff09\u53c2\u6570\u3001\u7f16\u5236\u8bbe\u5907\u7ef4\u62a4\u8ba1\u5212\u3001\u4ee5\u53ca\u5236\u5b9a\u5185\u90e8\u548c\u5916\u90e8\u7684\u5ba1\u6838\u65e5\u7a0b\u3002\u6240\u6709\u6807\u51c6\u90fd\u4ee5\u7ed3\u6784\u5316\u6570\u636e\u7684\u5f62\u5f0f\u5b58\u50a8\uff0c\u7248\u672c\u6e05\u6670\uff0c\u67e5\u9605\u65b9\u4fbf\u3002<\/li>\n<li><strong>\u6267\u884c (Do):<\/strong> \u5728\u65e5\u5e38\u5de5\u4f5c\u4e2d\uff0c\u5458\u5de5\u4f9d\u7167\u7cfb\u7edf\u8bbe\u5b9a\u7684\u6d41\u7a0b\u6267\u884c\u4efb\u52a1\u3002\u68c0\u9a8c\u5458\u901a\u8fc7\u79fb\u52a8\u7aef\u6216PC\u7aef\u8bb0\u5f55\u6765\u6599\u68c0\u9a8c\uff08IQC\uff09\u6570\u636e\uff0c\u64cd\u4f5c\u5de5\u626b\u63cf\u6761\u7801\u8bb0\u5f55\u751f\u4ea7\u6279\u6b21\u4fe1\u606f\uff0c\u7cfb\u7edf\u81ea\u52a8\u91c7\u96c6\u8bbe\u5907\u8fd0\u884c\u53c2\u6570\u3002\u6240\u6709\u6267\u884c\u5c42\u7684\u6570\u636e\u88ab\u5b9e\u65f6\u3001\u51c6\u786e\u5730\u8bb0\u5f55\u5230\u7edf\u4e00\u7684\u6570\u636e\u5e93\u4e2d\uff0c\u53d6\u4ee3\u4e86\u6613\u51fa\u9519\u3001\u96be\u8ffd\u6eaf\u7684\u624b\u5de5\u7eb8\u8d28\u8868\u683c\u3002<\/li>\n<li><strong>\u68c0\u67e5 (Check):<\/strong> \u7cfb\u7edf\u57fa\u4e8e\u6536\u96c6\u5230\u7684\u6570\u636e\u8fdb\u884c\u81ea\u52a8\u5316\u7684\u5206\u6790\u4e0e\u76d1\u63a7\u3002\u4f8b\u5982\uff0c\u7cfb\u7edf\u53ef\u4ee5\u5b9e\u65f6\u751f\u6210\u4ea7\u54c1\u76f4\u901a\u7387\uff08FPY\uff09\u62a5\u8868\u3001\u67cf\u62c9\u56fe\uff0c\u81ea\u52a8\u5224\u65adSPC\u63a7\u5236\u56fe\u662f\u5426\u51fa\u73b0\u5f02\u5e38\u70b9\u3002\u4e00\u65e6\u53d1\u751f\u4e0d\u5408\u683c\u54c1\u6216\u6d41\u7a0b\u504f\u79bb\uff0c\u7cfb\u7edf\u4f1a\u7acb\u5373\u89e6\u53d1\u8b66\u62a5\uff0c\u5e76\u751f\u6210\u4e0d\u5408\u683c\u54c1\u62a5\u544a\uff0c\u901a\u77e5\u76f8\u5173\u8d1f\u8d23\u4eba\u3002<\/li>\n<li><strong>\u5904\u7406 (Act):<\/strong> \u8fd9\u662f\u5b9e\u73b0\u6301\u7eed\u6539\u8fdb\u7684\u5173\u952e\u95ed\u73af\u3002\u5f53\u7cfb\u7edf\u68c0\u67e5\u5230\u95ee\u9898\u540e\uff0c\u4f1a\u81ea\u52a8\u542f\u52a8\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\uff08CAPA\uff09\u6d41\u7a0b\u3002\u76f8\u5173\u56e2\u961f\u88ab\u6307\u6d3e\u8fdb\u884c\u6839\u672c\u539f\u56e0\u5206\u6790\uff08RCA\uff09\uff0c\u5236\u5b9a\u5e76\u6267\u884c\u7ea0\u6b63\u63aa\u65bd\u3002\u63aa\u65bd\u5b8c\u6210\u540e\uff0c\u7cfb\u7edf\u4f1a\u6301\u7eed\u8ffd\u8e2a\u5176\u6548\u679c\uff0c\u5e76\u5c06\u6210\u529f\u7684\u89e3\u51b3\u65b9\u6848\u66f4\u65b0\u5230\u201c\u8ba1\u5212\u201d\u73af\u8282\u7684\u6807\u51c6\u6587\u4ef6\u4e2d\uff0c\u4ece\u800c\u5f62\u6210\u4e00\u4e2a\u87ba\u65cb\u5f0f\u4e0a\u5347\u7684\u8d28\u91cf\u6539\u8fdb\u95ed\u73af\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"2_%E5%85%B3%E9%94%AE%E6%A8%A1%E5%9D%97%E6%9E%84%E6%88%90%EF%BC%9A%E6%94%AF%E6%92%91%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%E7%9A%84%E5%85%A8%E6%99%AF%E8%A7%86%E5%9B%BE\"><\/span>2. \u5173\u952e\u6a21\u5757\u6784\u6210\uff1a\u652f\u6491\u8d28\u91cf\u7ba1\u7406\u7684\u5168\u666f\u89c6\u56fe<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4e00\u4e2a\u5168\u9762\u7684QMS\u7cfb\u7edf\u901a\u5e38\u7531\u591a\u4e2a\u76f8\u4e92\u5173\u8054\u7684\u529f\u80fd\u6a21\u5757\u6784\u6210\uff0c\u5b83\u4eec\u5171\u540c\u652f\u6491\u8d77\u4f01\u4e1a\u8d28\u91cf\u7ba1\u7406\u7684\u5168\u666f\u89c6\u56fe\u3002\u5bf9\u4e8e\u51b3\u7b56\u8005\u800c\u8a00\uff0c\u7406\u89e3\u8fd9\u4e9b\u6a21\u5757\u7684\u529f\u80fd\u53ca\u5176\u5e26\u6765\u7684\u4ef7\u503c\uff0c\u6709\u52a9\u4e8e\u660e\u786e\u4f01\u4e1a\u5728\u4e0d\u540c\u9636\u6bb5\u7684\u5b9e\u65bd\u91cd\u70b9\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th align=\"left\">\u6838\u5fc3\u6a21\u5757<\/th>\n<th align=\"left\">\u6838\u5fc3\u529f\u80fd<\/th>\n<th align=\"left\">\u4e3a\u4f01\u4e1a\u5e26\u6765\u7684\u4e1a\u52a1\u4ef7\u503c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td align=\"left\"><strong>\u6587\u4ef6\u63a7\u5236 (Document Control)<\/strong><\/td>\n<td align=\"left\">\u96c6\u4e2d\u7ba1\u7406\u6240\u6709\u8d28\u91cf\u6587\u4ef6\uff08\u5982SOP\u3001\u68c0\u9a8c\u6807\u51c6\u3001\u56fe\u7eb8\uff09\uff0c\u63a7\u5236\u6587\u4ef6\u7684\u521b\u5efa\u3001\u5ba1\u6279\u3001\u5206\u53d1\u3001\u4fee\u8ba2\u548c\u5e9f\u6b62\u5168\u8fc7\u7a0b\u3002\u786e\u4fdd\u6240\u6709\u5c97\u4f4d\u4f7f\u7528\u7684\u90fd\u662f\u6700\u65b0\u6709\u6548\u7248\u672c\u3002<\/td>\n<td align=\"left\"><strong>\u5408\u89c4\u6027\u4e0e\u4e00\u81f4\u6027\uff1a<\/strong> \u8f7b\u677e\u6ee1\u8db3ISO9001\u7b49\u4f53\u7cfb\u5bf9\u6587\u4ef6\u63a7\u5236\u7684\u8981\u6c42\uff0c\u907f\u514d\u56e0\u4f7f\u7528\u8fc7\u65f6\u6587\u4ef6\u5bfc\u81f4\u7684\u751f\u4ea7\u9519\u8bef\u548c\u8d28\u91cf\u4e8b\u6545\u3002<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u4e0d\u5408\u683c\u54c1\u7ba1\u7406 (Non-conformance Management)<\/strong><\/td>\n<td align=\"left\">\u4ece\u53d1\u73b0\u4e0d\u5408\u683c\u54c1\uff08\u6765\u6599\u3001\u5728\u5236\u54c1\u3001\u6210\u54c1\uff09\u5f00\u59cb\uff0c\u542f\u52a8\u6807\u51c6\u5316\u7684\u5728\u7ebf\u5904\u7406\u6d41\u7a0b\uff0c\u5305\u62ec\u9694\u79bb\u3001\u8bc4\u5ba1\u3001\u8fd4\u5de5\u3001\u62a5\u5e9f\u7b49\u3002\u5168\u7a0b\u8bb0\u5f55\uff0c\u8d23\u4efb\u5230\u4eba\u3002<\/td>\n<td align=\"left\"><strong>\u98ce\u9669\u63a7\u5236\u4e0e\u6210\u672c\u964d\u4f4e\uff1a<\/strong> \u5feb\u901f\u54cd\u5e94\u8d28\u91cf\u5f02\u5e38\uff0c\u9632\u6b62\u4e0d\u5408\u683c\u54c1\u6d41\u5165\u4e0b\u4e00\u5de5\u5e8f\u6216\u5ba2\u6237\u7aef\uff0c\u901a\u8fc7\u6570\u636e\u5206\u6790\u627e\u5230\u4e0d\u5408\u683c\u54c1\u4ea7\u751f\u7684\u539f\u56e0\uff0c\u964d\u4f4e\u5e9f\u54c1\u7387\u3002<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd (CAPA)<\/strong><\/td>\n<td align=\"left\">\u5f53\u53d1\u751f\u91cd\u5927\u6216\u91cd\u590d\u6027\u8d28\u91cf\u95ee\u9898\u65f6\uff0c\u542f\u52a8\u7ed3\u6784\u5316\u7684\u6839\u672c\u539f\u56e0\u5206\u6790\u3001\u7ea0\u6b63\u63aa\u65bd\u5236\u5b9a\u3001\u5b9e\u65bd\u9a8c\u8bc1\u4e0e\u6548\u679c\u8bc4\u4f30\u6d41\u7a0b\uff0c\u5e76\u5c06\u7ecf\u9a8c\u56fa\u5316\u4e3a\u9884\u9632\u63aa\u65bd\u3002<\/td>\n<td align=\"left\"><strong>\u6839\u672c\u6027\u6539\u8fdb\uff1a<\/strong> \u5c06\u8d28\u91cf\u7ba1\u7406\u4ece\u201c\u88ab\u52a8\u6551\u706b\u201d\u5347\u7ea7\u4e3a\u201c\u4e3b\u52a8\u9632\u706b\u201d\uff0c\u7cfb\u7edf\u6027\u5730\u6d88\u9664\u95ee\u9898\u6839\u6e90\uff0c\u9632\u6b62\u540c\u7c7b\u95ee\u9898\u518d\u6b21\u53d1\u751f\uff0c\u5b9e\u73b0\u6301\u7eed\u6539\u8fdb\u3002<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u4f9b\u5e94\u5546\u8d28\u91cf\u7ba1\u7406 (SQM)<\/strong><\/td>\n<td align=\"left\">\u7ba1\u7406\u4f9b\u5e94\u5546\u6863\u6848\u3001\u51c6\u5165\u5ba1\u6838\u3001\u7ee9\u6548\u8bc4\u4f30\uff08\u5982\u6765\u6599\u5408\u683c\u7387\u3001\u4ea4\u4ed8\u53ca\u65f6\u6027\uff09\uff0c\u5e76\u5728\u7ebf\u5904\u7406\u4f9b\u5e94\u5546\u76f8\u5173\u7684\u8d28\u91cf\u95ee\u9898\uff08SCAR\uff09\uff0c\u5b9e\u73b0\u534f\u540c\u6539\u8fdb\u3002<\/td>\n<td align=\"left\"><strong>\u4f9b\u5e94\u94fe\u7a33\u5b9a\u4e0e\u8d28\u91cf\u63d0\u5347\uff1a<\/strong> \u5efa\u7acb\u4ee5\u6570\u636e\u4e3a\u4f9d\u636e\u7684\u4f9b\u5e94\u5546\u9009\u62e9\u4e0e\u6dd8\u6c70\u673a\u5236\uff0c\u5c06\u8d28\u91cf\u7ba1\u7406\u5411\u4e0a\u6e38\u5ef6\u4f38\uff0c\u4ece\u6e90\u5934\u4fdd\u8bc1\u539f\u6750\u6599\u8d28\u91cf\uff0c\u964d\u4f4e\u91c7\u8d2d\u98ce\u9669\u3002<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u5ba1\u6838\u7ba1\u7406 (Audit Management)<\/strong><\/td>\n<td align=\"left\">\u8ba1\u5212\u3001\u6267\u884c\u548c\u8ddf\u8e2a\u5185\u5916\u90e8\u8d28\u91cf\u5ba1\u6838\uff08\u5982\u4f53\u7cfb\u5ba1\u6838\u3001\u8fc7\u7a0b\u5ba1\u6838\u3001\u4ea7\u54c1\u5ba1\u6838\uff09\u3002\u5728\u7ebf\u7ba1\u7406\u5ba1\u6838\u8ba1\u5212\u3001\u68c0\u67e5\u8868\u3001\u4e0d\u7b26\u5408\u9879\u62a5\u544a\u53ca\u6574\u6539\u9a8c\u8bc1\u3002<\/td>\n<td align=\"left\"><strong>\u4f53\u7cfb\u5065\u5eb7\u5ea6\u76d1\u63a7\uff1a<\/strong> \u786e\u4fdd\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5f97\u5230\u6709\u6548\u6267\u884c\u548c\u6301\u7eed\u76d1\u7763\uff0c\u9ad8\u6548\u5e94\u5bf9\u5ba2\u6237\u5ba1\u6838\u548c\u7b2c\u4e09\u65b9\u8ba4\u8bc1\uff0c\u63d0\u5347\u5ba2\u6237\u4fe1\u4efb\u5ea6\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"%E4%BA%8C%E3%80%81%E8%B6%85%E8%B6%8A%E7%90%86%E8%AE%BA%EF%BC%9A%E4%B8%AD%E5%B0%8F%E4%BC%81%E4%B8%9A%E5%A6%82%E4%BD%95%E5%BA%94%E7%94%A8QMS%E7%B3%BB%E7%BB%9F%E6%8F%90%E5%8D%87%E8%B4%A8%E9%87%8F%E7%AE%A1%E7%90%86%EF%BC%9F\"><\/span>\u4e8c\u3001\u8d85\u8d8a\u7406\u8bba\uff1a\u4e2d\u5c0f\u4f01\u4e1a\u5982\u4f55\u5e94\u7528QMS\u7cfb\u7edf\u63d0\u5347\u8d28\u91cf\u7ba1\u7406\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u7406\u89e3\u4e86QMS\u7cfb\u7edf\u7684\u6784\u6210\uff0c\u66f4\u5173\u952e\u7684\u95ee\u9898\u5728\u4e8e\u5982\u4f55\u5c06\u5176\u5e94\u7528\u5230\u4f01\u4e1a\u7684\u5b9e\u9645\u8fd0\u8425\u4e2d\uff0c\u4f7f\u5176\u771f\u6b63\u6210\u4e3a\u63d0\u5347\u8d28\u91cf\u7ba1\u7406\u7684\u5229\u5668\u3002\u4ee5\u4e0b\u5c06\u901a\u8fc7\u4e09\u4e2a\u5173\u952e\u6b65\u9aa4\uff0c\u4e3a\u60a8\u63cf\u7ed8\u4e00\u5e45\u4ece\u57fa\u7840\u8ffd\u6eaf\u5230\u667a\u80fd\u51b3\u7b56\u7684\u5b9e\u8df5\u8def\u7ebf\u56fe\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"1_%E6%AD%A5%E9%AA%A4%E4%B8%80%EF%BC%9A%E4%BB%8E%E6%9D%A5%E6%96%99%E6%A3%80%E9%AA%8C%EF%BC%88IQC%EF%BC%89%E5%88%B0%E8%BF%87%E7%A8%8B%E6%8E%A7%E5%88%B6%EF%BC%88IPQC%EF%BC%89%E7%9A%84%E5%85%A8%E7%A8%8B%E8%BF%BD%E6%BA%AF\"><\/span>1. \u6b65\u9aa4\u4e00\uff1a\u4ece\u6765\u6599\u68c0\u9a8c\uff08IQC\uff09\u5230\u8fc7\u7a0b\u63a7\u5236\uff08IPQC\uff09\u7684\u5168\u7a0b\u8ffd\u6eaf<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u8d28\u91cf\u8ffd\u6eaf\u662f\u73b0\u4ee3\u8d28\u91cf\u7ba1\u7406\u7684\u57fa\u77f3\u3002\u5f53\u8d28\u91cf\u95ee\u9898\u53d1\u751f\u65f6\uff0c\u5982\u679c\u65e0\u6cd5\u5feb\u901f\u3001\u7cbe\u51c6\u5730\u5b9a\u4f4d\u95ee\u9898\u6839\u6e90\uff0c\u4f01\u4e1a\u5c06\u9762\u4e34\u5de8\u5927\u7684\u53ec\u56de\u6210\u672c\u3001\u54c1\u724c\u58f0\u8a89\u635f\u5931\u751a\u81f3\u6cd5\u5f8b\u98ce\u9669\u3002QMS\u7cfb\u7edf\u901a\u8fc7\u4e3a\u6bcf\u4e00\u4e2a\u7269\u6599\u548c\u4ea7\u54c1\u8d4b\u4e88\u552f\u4e00\u7684\u201c\u6570\u5b57\u8eab\u4efd\u8bc1\u201d\uff0c\u6784\u5efa\u4e86\u4e00\u4e2a\u4ece\u4f9b\u5e94\u5546\u5230\u5ba2\u6237\u7684\u5168\u6d41\u7a0b\u8d28\u91cf\u8ffd\u6eaf\u4f53\u7cfb\u3002<\/p>\n<p>\u5177\u4f53\u64cd\u4f5c\u4e0a\uff0c\u4f01\u4e1a\u53ef\u4ee5\u8fd9\u6837\u90e8\u7f72\uff1a<\/p>\n<ul>\n<li><strong>\u6765\u6599\u68c0\u9a8c (IQC)\uff1a<\/strong> \u5f53\u4f9b\u5e94\u5546\u7684\u539f\u6750\u6599\u9001\u8fbe\u65f6\uff0c\u4ed3\u7ba1\u5458\u626b\u63cf\u6765\u6599\u5305\u88c5\u4e0a\u7684\u6761\u7801\uff0cQMS\u7cfb\u7edf\u81ea\u52a8\u8c03\u51fa\u8be5\u7269\u6599\u7684\u68c0\u9a8c\u6807\u51c6\u548c\u62bd\u6837\u65b9\u6848\u3002\u68c0\u9a8c\u5458\u4f7f\u7528\u5e73\u677f\u7535\u8111\u6216\u626b\u7801\u67aa\uff0c\u5728\u7cfb\u7edf\u754c\u9762\u4e0a\u8bb0\u5f55\u68c0\u9a8c\u7ed3\u679c\uff08\u5c3a\u5bf8\u3001\u6027\u80fd\u3001\u5916\u89c2\u7b49\uff09\uff0c\u5e76\u4e0a\u4f20\u73b0\u573a\u7167\u7247\u3002\u5408\u683c\u54c1\u81ea\u52a8\u5165\u5e93\u5e76\u751f\u6210\u552f\u4e00\u7684\u5165\u5e93\u6279\u6b21\u53f7\uff1b\u4e0d\u5408\u683c\u54c1\u5219\u81ea\u52a8\u89e6\u53d1\u4e0d\u5408\u683c\u54c1\u5904\u7406\u6d41\u7a0b\uff0c\u5e76\u8bb0\u5f55\u5230\u4f9b\u5e94\u5546\u7684\u7ee9\u6548\u6863\u6848\u4e2d\u3002<\/li>\n<li><strong>\u751f\u4ea7\u8fc7\u7a0b\u63a7\u5236 (IPQC)\uff1a<\/strong> \u5728\u751f\u4ea7\u9886\u6599\u65f6\uff0c\u5de5\u4eba\u626b\u63cf\u539f\u6750\u6599\u7684\u6279\u6b21\u6761\u7801\uff0c\u7cfb\u7edf\u81ea\u52a8\u8bb0\u5f55\u8be5\u6279\u6b21\u4ea7\u54c1\u4f7f\u7528\u4e86\u54ea\u4e9b\u6279\u6b21\u7684\u539f\u6750\u6599\u3002\u5728\u6bcf\u4e2a\u5173\u952e\u5de5\u5e8f\uff0c\u7cfb\u7edf\u8bb0\u5f55\u4e0b\u751f\u4ea7\u65f6\u95f4\u3001\u64cd\u4f5c\u5458\u3001\u8bbe\u5907\u7f16\u53f7\u3001\u8bbe\u5907\u8fd0\u884c\u53c2\u6570\uff08\u5982\u6e29\u5ea6\u3001\u538b\u529b\uff09\u7b49\u5173\u952e\u4fe1\u606f\u3002\u901a\u8fc7\u4e0eMES\uff08\u5236\u9020\u6267\u884c\u7cfb\u7edf\uff09\u96c6\u6210\uff0c\u8fd9\u4e9b\u6570\u636e\u751a\u81f3\u53ef\u4ee5\u81ea\u52a8\u91c7\u96c6\u3002\u534a\u6210\u54c1\u6216\u6210\u54c1\u540c\u6837\u4f1a\u751f\u6210\u65b0\u7684\u6279\u6b21\u53f7\u6216\u552f\u4e00\u7684\u5e8f\u5217\u53f7\uff0c\u4e0e\u4e4b\u524d\u7684\u5de5\u5e8f\u4fe1\u606f\u5b8c\u5168\u5173\u8054\u3002<\/li>\n<li><strong>\u6210\u54c1\u51fa\u5e93 (OQC)\uff1a<\/strong> \u5728\u4ea7\u54c1\u53d1\u8d27\u524d\uff0c\u7cfb\u7edf\u4f1a\u8fdb\u884c\u6700\u7ec8\u68c0\u9a8c\uff0c\u5e76\u5c06\u51fa\u5e93\u4fe1\u606f\uff08\u5982\u5ba2\u6237\u3001\u8ba2\u5355\u53f7\u3001\u53d1\u8d27\u65e5\u671f\uff09\u4e0e\u4ea7\u54c1\u6279\u6b21\/\u5e8f\u5217\u53f7\u7ed1\u5b9a\u3002<\/li>\n<\/ul>\n<p>\u901a\u8fc7\u8fd9\u6837\u4e00\u5957\u5b8c\u6574\u7684\u8ffd\u6eaf\u94fe\u6761\uff0c\u4e00\u65e6\u7ec8\u7aef\u5ba2\u6237\u62a5\u544a\u67d0\u4e2a\u4ea7\u54c1\u5b58\u5728\u7f3a\u9677\uff0c\u4f01\u4e1a\u53ea\u9700\u5728QMS\u7cfb\u7edf\u4e2d\u8f93\u5165\u8be5\u4ea7\u54c1\u7684\u5e8f\u5217\u53f7\uff0c\u5373\u53ef\u5728\u6570\u79d2\u5185\u53cd\u5411\u8ffd\u6eaf\u5230\u5176\u5b8c\u6574\u7684\u201c\u751f\u547d\u5c65\u5386\u201d\uff1a\u5b83\u662f\u4f55\u65f6\u51fa\u5e93\u7684\u3001\u7ecf\u8fc7\u4e86\u54ea\u4e9b\u751f\u4ea7\u5de5\u5e8f\u3001\u7531\u8c01\u64cd\u4f5c\u3001\u4f7f\u7528\u4e86\u54ea\u53f0\u8bbe\u5907\u3001\u7528\u4e86\u54ea\u4e2a\u6279\u6b21\u7684\u539f\u6750\u6599\u3001\u8be5\u539f\u6750\u6599\u7684\u4f9b\u5e94\u5546\u662f\u8c01\u3001\u5f53\u65f6\u7684\u6765\u6599\u68c0\u9a8c\u62a5\u544a\u662f\u600e\u6837\u7684\u3002\u8fd9\u79cd\u7cbe\u51c6\u5b9a\u4f4d\u80fd\u529b\uff0c\u4f7f\u5f97\u4f01\u4e1a\u53ef\u4ee5\u5c06\u53ec\u56de\u8303\u56f4\u7f29\u5c0f\u5230\u6700\u5c0f\u5355\u5143\uff0c\u5feb\u901f\u9501\u5b9a\u95ee\u9898\u73af\u8282\u5e76\u8fdb\u884c\u6574\u6539\uff0c\u5c06\u6f5c\u5728\u635f\u5931\u964d\u81f3\u6700\u4f4e\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_%E6%AD%A5%E9%AA%A4%E4%BA%8C%EF%BC%9A%E4%BB%8E%E8%A2%AB%E5%8A%A8%E5%93%8D%E5%BA%94%E5%88%B0%E4%B8%BB%E5%8A%A8%E9%A2%84%E9%98%B2%EF%BC%88CAPA%EF%BC%89%E7%9A%84%E6%9C%BA%E5%88%B6%E5%BB%BA%E7%AB%8B\"><\/span>2. \u6b65\u9aa4\u4e8c\uff1a\u4ece\u88ab\u52a8\u54cd\u5e94\u5230\u4e3b\u52a8\u9884\u9632\uff08CAPA\uff09\u7684\u673a\u5236\u5efa\u7acb<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u8bb8\u591a\u4e2d\u5c0f\u4f01\u4e1a\u7684\u8d28\u91cf\u7ba1\u7406\u4ecd\u505c\u7559\u5728\u201c\u5934\u75db\u533b\u5934\u3001\u811a\u75db\u533b\u811a\u201d\u7684\u88ab\u52a8\u54cd\u5e94\u9636\u6bb5\u3002\u4eca\u5929\u89e3\u51b3\u4e86A\u95ee\u9898\uff0c\u660e\u5929B\u95ee\u9898\u53c8\u5192\u51fa\u6765\uff0c\u56e2\u961f\u7ec8\u65e5\u5fd9\u4e8e\u201c\u6551\u706b\u201d\uff0c\u5374\u65e0\u6cd5\u6839\u9664\u95ee\u9898\u3002QMS\u7cfb\u7edf\u7684\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\uff08CAPA\uff09\u6a21\u5757\uff0c\u6b63\u662f\u4e3a\u4e86\u6253\u7834\u8fd9\u4e00\u56f0\u5c40\uff0c\u5efa\u7acb\u4e00\u5957\u4ece\u88ab\u52a8\u54cd\u5e94\u5230\u4e3b\u52a8\u9884\u9632\u7684\u7cfb\u7edf\u6027\u6539\u8fdb\u673a\u5236\u3002<\/p>\n<p>\u8ba9\u6211\u4eec\u901a\u8fc7\u4e00\u4e2a\u6848\u4f8b\u6765\u8bf4\u660e\u5176\u8fd0\u4f5c\u65b9\u5f0f\uff1a\u5047\u8bbe\u67d0\u7535\u5b50\u4ea7\u54c1\u5728\u6210\u54c1\u6d4b\u8bd5\u4e2d\uff0c\u8fde\u7eed\u51fa\u73b0\u4e09\u6279\u6b21\u201c\u5c4f\u5e55\u95ea\u70c1\u201d\u7684\u4e0d\u5408\u683c\u62a5\u544a\u3002<\/p>\n<ol>\n<li><strong>\u89e6\u53d1\u4e0e\u62a5\u544a\uff1a<\/strong> \u5728QMS\u7cfb\u7edf\u4e2d\uff0c\u5f53\u201c\u5c4f\u5e55\u95ea\u70c1\u201d\u8fd9\u4e00\u7f3a\u9677\u7684\u53d1\u751f\u9891\u7387\u8d85\u8fc7\u9884\u8bbe\u9608\u503c\u65f6\uff0c\u7cfb\u7edf\u4f1a\u81ea\u52a8\u521b\u5efa\u4e00\u4e2aCAPA\u8bf7\u6c42\uff0c\u5e76\u6307\u6d3e\u7ed9\u8d28\u91cf\u90e8\u95e8\u8d1f\u8d23\u4eba\u3002\u8fd9\u53d6\u4ee3\u4e86\u8fc7\u53bb\u4f9d\u8d56\u90ae\u4ef6\u6216\u53e3\u5934\u6c47\u62a5\u7684\u6ede\u540e\u548c\u9057\u6f0f\u3002<\/li>\n<li><strong>\u539f\u56e0\u5206\u6790\uff1a<\/strong> \u8d28\u91cf\u8d1f\u8d23\u4eba\u53ec\u96c6\u76f8\u5173\u4eba\u5458\uff08\u751f\u4ea7\u3001\u5de5\u7a0b\u3001\u91c7\u8d2d\uff09\u7ec4\u6210\u4e34\u65f6\u5c0f\u7ec4\u3002\u4ed6\u4eec\u5728CAPA\u6d41\u7a0b\u7684\u6307\u5f15\u4e0b\uff0c\u4f7f\u7528\u201c\u9c7c\u9aa8\u56fe\u201d\u3001\u201c5Why\u5206\u6790\u6cd5\u201d\u7b49\u5de5\u5177\u8fdb\u884c\u6839\u672c\u539f\u56e0\u5206\u6790\uff08RCA\uff09\u3002\u6240\u6709\u5206\u6790\u8fc7\u7a0b\u3001\u4f1a\u8bae\u7eaa\u8981\u548c\u8d23\u4efb\u4eba\u90fd\u88ab\u8bb0\u5f55\u5728\u7cfb\u7edf\u4e2d\u3002\u6700\u7ec8\uff0c\u4ed6\u4eec\u53d1\u73b0\u95ee\u9898\u6839\u6e90\u5e76\u975e\u5c4f\u5e55\u672c\u8eab\uff0c\u800c\u662f\u67d0\u6279\u6b21\u7684\u8fde\u63a5\u5668\u5c3a\u5bf8\u504f\u5c0f\uff0c\u5bfc\u81f4\u63a5\u89e6\u4e0d\u826f\u3002<\/li>\n<li><strong>\u5236\u5b9a\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\uff1a<\/strong>\n<ul>\n<li><strong>\u7ea0\u6b63\u63aa\u65bd\uff08\u6cbb\u6807\uff09\uff1a<\/strong> \u7acb\u5373\u9694\u79bb\u5e76\u66f4\u6362\u6240\u6709\u5df2\u4f7f\u7528\u8be5\u6279\u6b21\u8fde\u63a5\u5668\u7684\u5728\u5236\u54c1\u548c\u5e93\u5b58\u54c1\u3002<\/li>\n<li><strong>\u9884\u9632\u63aa\u65bd\uff08\u6cbb\u672c\uff09\uff1a<\/strong> \u2460 \u66f4\u65b0\u6765\u6599\u68c0\u9a8c\u6807\u51c6\uff0c\u589e\u52a0\u5bf9\u8fde\u63a5\u5668\u5173\u952e\u5c3a\u5bf8\u7684\u6d4b\u91cf\u9879\uff1b\u2461 \u4e0e\u91c7\u8d2d\u90e8\u95e8\u534f\u540c\uff0c\u8981\u6c42\u4f9b\u5e94\u5546\u63d0\u4f9b\u8be5\u5c3a\u5bf8\u7684\u8fc7\u7a0b\u80fd\u529b\u6307\u6570\uff08Cpk\uff09\u62a5\u544a\uff1b\u2462 \u5728\u88c5\u914d\u5de5\u5e8f\u589e\u52a0\u4e00\u4e2a\u7b80\u5355\u7684\u7535\u6027\u80fd\u6d4b\u8bd5\uff0c\u4ee5\u4fbf\u53ca\u65e9\u53d1\u73b0\u95ee\u9898\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u5b9e\u65bd\u4e0e\u9a8c\u8bc1\uff1a<\/strong> \u6240\u6709\u63aa\u65bd\u88ab\u5206\u914d\u7ed9\u5177\u4f53\u8d1f\u8d23\u4eba\u548c\u5b8c\u6210\u671f\u9650\uff0c\u5e76\u5728\u7cfb\u7edf\u4e2d\u8ddf\u8e2a\u8fdb\u5ea6\u3002\u63aa\u65bd\u5b8c\u6210\u540e\uff0c\u8d28\u91cf\u90e8\u95e8\u9700\u8981\u6301\u7eed\u76d1\u63a7\u4e00\u6bb5\u65f6\u95f4\uff08\u5982\u4e00\u4e2a\u6708\uff09\u7684\u4ea7\u54c1\u5408\u683c\u7387\uff0c\u7528\u6570\u636e\u9a8c\u8bc1\u63aa\u65bd\u7684\u6709\u6548\u6027\u3002<\/li>\n<li><strong>\u77e5\u8bc6\u56fa\u5316\uff1a<\/strong> \u9a8c\u8bc1\u6709\u6548\u7684\u9884\u9632\u63aa\u65bd\uff0c\u5c06\u88ab\u7cfb\u7edf\u5316\u5730\u66f4\u65b0\u5230\u5bf9\u5e94\u7684\u6587\u4ef6\uff08\u5982\u68c0\u9a8c\u6807\u51c6SOP\u3001\u4f5c\u4e1a\u6307\u5bfc\u4e66\uff09\u4e2d\uff0c\u6210\u4e3a\u7ec4\u7ec7\u65b0\u7684\u6807\u51c6\u4f5c\u4e1a\u6d41\u7a0b\u3002<\/li>\n<\/ol>\n<p>\u901a\u8fc7CAPA\u6a21\u5757\uff0c\u4f01\u4e1a\u5c06\u6bcf\u4e00\u6b21\u8d28\u91cf\u5f02\u5e38\u90fd\u8f6c\u5316\u4e3a\u4e00\u6b21\u5b9d\u8d35\u7684\u5b66\u4e60\u548c\u6539\u8fdb\u673a\u4f1a\uff0c\u9010\u6b65\u51cf\u5c11\u95ee\u9898\u7684\u91cd\u590d\u53d1\u751f\uff0c\u5b9e\u73b0\u8d28\u91cf\u6c34\u5e73\u7684\u87ba\u65cb\u5f0f\u4e0a\u5347\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_%E6%AD%A5%E9%AA%A4%E4%B8%89%EF%BC%9A%E4%BB%8E%E6%95%B0%E6%8D%AE%E5%AD%A4%E5%B2%9B%E5%88%B0%E6%99%BA%E8%83%BD%E5%86%B3%E7%AD%96%E7%9A%84%E6%8A%A5%E8%A1%A8%E5%88%86%E6%9E%90\"><\/span>3. \u6b65\u9aa4\u4e09\uff1a\u4ece\u6570\u636e\u5b64\u5c9b\u5230\u667a\u80fd\u51b3\u7b56\u7684\u62a5\u8868\u5206\u6790<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5982\u679c\u8bf4\u8ffd\u6eaf\u548cCAPA\u662fQMS\u7684\u6267\u884c\u9aa8\u67b6\uff0c\u90a3\u4e48\u6570\u636e\u5206\u6790\u5c31\u662f\u5176\u51b3\u7b56\u5927\u8111\u3002\u4f20\u7edf\u7684\u8d28\u91cf\u7ba1\u7406\u4f9d\u8d56\u4e8e\u6708\u5e95\u6216\u5b63\u672b\u7531\u6587\u5458\u624b\u5de5\u6c47\u603b\u7684Excel\u62a5\u8868\uff0c\u8fd9\u4e9b\u62a5\u8868\u4e0d\u4ec5\u8017\u65f6\u8017\u529b\u3001\u5bb9\u6613\u51fa\u9519\uff0c\u66f4\u4e25\u91cd\u7684\u662f\u4fe1\u606f\u6ede\u540e\uff0c\u65e0\u6cd5\u4e3a\u7ba1\u7406\u5c42\u7684\u5373\u65f6\u51b3\u7b56\u63d0\u4f9b\u652f\u6301\u3002QMS\u7cfb\u7edf\u901a\u8fc7\u5176\u5f3a\u5927\u7684\u62a5\u8868\u5f15\u64ce\uff0c\u5c06\u6563\u843d\u5728\u5404\u4e2a\u6d41\u7a0b\u4e2d\u7684\u6570\u636e\u5b64\u5c9b\u8fde\u63a5\u8d77\u6765\uff0c\u8f6c\u5316\u4e3a\u7ba1\u7406\u8005\u89e6\u624b\u53ef\u53ca\u7684\u667a\u80fd\u51b3\u7b56\u770b\u677f\u3002<\/p>\n<p>\u4f01\u4e1a\u7ba1\u7406\u8005\u53ef\u4ee5\u8fd9\u6837\u5229\u7528QMS\u7684\u62a5\u8868\u529f\u80fd\uff1a<\/p>\n<ul>\n<li><strong>\u914d\u7f6e\u5173\u952e\u8d28\u91cf\u6307\u6807\uff08KPIs\uff09\u770b\u677f\uff1a<\/strong> \u5728\u7cfb\u7edf\u4e2d\uff0c\u7ba1\u7406\u8005\u53ef\u4ee5\u50cf\u642d\u79ef\u6728\u4e00\u6837\uff0c\u62d6\u62fd\u751f\u6210\u81ea\u5df1\u5173\u5fc3\u7684\u53ef\u89c6\u5316\u62a5\u8868\u3002\u4f8b\u5982\uff0cCEO\u53ef\u4ee5\u5b9a\u5236\u4e00\u4e2a\u5305\u542b\u4ee5\u4e0b\u56fe\u8868\u7684\u201c\u8d28\u91cf\u9a7e\u9a76\u8231\u201d\uff1a\n<ul>\n<li><strong>\u4ea7\u54c1\u76f4\u901a\u7387\uff08FPY\uff09\u8d8b\u52bf\u56fe\uff1a<\/strong> \u5b9e\u65f6\u76d1\u63a7\u4ea7\u7ebf\u4e00\u6b21\u6027\u901a\u8fc7\u7387\uff0c\u76f4\u89c2\u53cd\u6620\u6574\u4f53\u751f\u4ea7\u7a33\u5b9a\u6027\u3002<\/li>\n<li><strong>\u767e\u4e07\u5206\u4e4b\u7f3a\u9677\u6570\uff08PPM\uff09\u5206\u6790\uff1a<\/strong> \u6309\u4ea7\u54c1\u3001\u4ea7\u7ebf\u3001\u65f6\u95f4\u7ef4\u5ea6\u5206\u6790PPM\u53d8\u5316\uff0c\u5feb\u901f\u5b9a\u4f4d\u8d28\u91cf\u74f6\u9888\u3002<\/li>\n<li><strong>\u5ba2\u6237\u6295\u8bc9\u7387\u4e0e\u7f3a\u9677\u7c7b\u578b\u67cf\u62c9\u56fe\uff1a<\/strong> \u8bc6\u522b\u5bfc\u81f4\u5ba2\u6237\u6295\u8bc9\u7684\u4e3b\u8981\u7f3a\u9677\u7c7b\u578b\uff0c\u4e3a\u8d28\u91cf\u6539\u8fdb\u786e\u5b9a\u4f18\u5148\u6b21\u5e8f\uff08\u4e8c\u516b\u539f\u5219\uff09\u3002<\/li>\n<li><strong>\u4f9b\u5e94\u5546\u6765\u6599\u5408\u683c\u7387\u6392\u540d\uff1a<\/strong> \u6e05\u6670\u5c55\u793a\u5404\u4f9b\u5e94\u5546\u7684\u8d28\u91cf\u8868\u73b0\uff0c\u4e3a\u91c7\u8d2d\u51b3\u7b56\u63d0\u4f9b\u6570\u636e\u652f\u6301\u3002<\/li>\n<li><strong>CAPA\u5b8c\u6210\u7387\u4e0e\u6709\u6548\u6027\u4eea\u8868\u76d8\uff1a<\/strong> \u76d1\u63a7\u8d28\u91cf\u6539\u8fdb\u9879\u76ee\u7684\u6267\u884c\u6548\u7387\u548c\u5b9e\u9645\u6548\u679c\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u5b9e\u73b0\u6570\u636e\u9a71\u52a8\u7684\u51b3\u7b56\uff1a<\/strong> \u5f53CEO\u5728\u770b\u677f\u4e0a\u53d1\u73b0\u67d0\u6761\u4ea7\u7ebf\u7684FPY\u7a81\u7136\u4e0b\u964d\u65f6\uff0c\u4ed6\u53ef\u4ee5\u7acb\u5373\u70b9\u51fb\u56fe\u8868\uff0c\u4e0b\u94bb\uff08Drill-down\uff09\u67e5\u770b\u8be5\u4ea7\u7ebf\u5177\u4f53\u7684\u7f3a\u9677\u7c7b\u578b\u3001\u53d1\u751f\u65f6\u95f4\u3001\u6d89\u53ca\u6279\u6b21\u7b49\u8be6\u7ec6\u4fe1\u606f\u3002\u4ed6\u751a\u81f3\u53ef\u4ee5\u76f4\u63a5\u5728\u7cfb\u7edf\u91cc\u5c06\u8be5\u5f02\u5e38\u60c5\u51b5\u6307\u6d3e\u7ed9\u751f\u4ea7\u603b\u76d1\uff0c\u5e76\u8981\u6c42\u5176\u542f\u52a8CAPA\u6d41\u7a0b\u3002\u6574\u4e2a\u51b3\u7b56\u8fc7\u7a0b\u4ece\u53d1\u73b0\u95ee\u9898\u5230\u91c7\u53d6\u884c\u52a8\uff0c\u53ef\u80fd\u53ea\u9700\u8981\u51e0\u5206\u949f\uff0c\u800c\u975e\u51e0\u5929\u751a\u81f3\u51e0\u5468\u3002\u8fd9\u79cd\u5b9e\u65f6\u3001\u900f\u660e\u3001\u53ef\u8ffd\u6eaf\u7684\u6570\u636e\u6d1e\u5bdf\u529b\uff0c\u4f7f\u5f97\u7ba1\u7406\u5c42\u80fd\u591f\u771f\u6b63\u57fa\u4e8e\u4e8b\u5b9e\u8fdb\u884c\u51b3\u7b56\uff0c\u654f\u9510\u5730\u6355\u6349\u8d28\u91cf\u8d8b\u52bf\uff0c\u9884\u89c1\u6f5c\u5728\u98ce\u9669\uff0c\u4ece\u800c\u5c06\u7ba1\u7406\u8d44\u6e90\u6295\u5165\u5230\u6700\u9700\u8981\u7684\u5730\u65b9\u3002<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%89%E3%80%81%E9%80%89%E5%9E%8B%E5%9D%90%E6%A0%87%E7%B3%BB%EF%BC%9A%E4%BC%A0%E7%BB%9FQMS%E4%B8%8E%E6%96%B0%E4%B8%80%E4%BB%A3%E6%97%A0%E4%BB%A3%E7%A0%81%E5%B9%B3%E5%8F%B0%E7%9A%84%E5%AF%B9%E6%AF%94\"><\/span>\u4e09\u3001\u9009\u578b\u5750\u6807\u7cfb\uff1a\u4f20\u7edfQMS\u4e0e\u65b0\u4e00\u4ee3<span class=\"xintheme_keyword_link\"><a href=\"https:\/\/www.zdsztech.com\/engine\" target=\"_blank\" title=\"\u65e0\u4ee3\u7801\u5e73\u53f0\">\u65e0\u4ee3\u7801\u5e73\u53f0<\/a><\/span>\u7684\u5bf9\u6bd4<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5f53\u4f01\u4e1a\u51b3\u7b56\u8005\u8ba4\u8bc6\u5230QMS\u7cfb\u7edf\u7684\u91cd\u8981\u6027\u540e\uff0c\u4e0b\u4e00\u4e2a\u6311\u6218\u4fbf\u662f\u5982\u4f55\u9009\u62e9\u5408\u9002\u7684\u7cfb\u7edf\u3002\u5e02\u573a\u4e0a\u7684QMS\u89e3\u51b3\u65b9\u6848\u7433\u7405\u6ee1\u76ee\uff0c\u4f46\u4e3b\u8981\u53ef\u4ee5\u5206\u4e3a\u4e24\u5927\u9635\u8425\uff1a\u4f20\u7edf\u7684\u6210\u54c1QMS\u8f6f\u4ef6\u548c\u57fa\u4e8e\u65b0\u4e00\u4ee3\u65e0\u4ee3\u7801\/\u4f4e\u4ee3\u7801\u5e73\u53f0\u6784\u5efa\u7684QMS\u5e94\u7528\u3002\u7406\u89e3\u4e8c\u8005\u7684\u5dee\u5f02\uff0c\u662f\u4e3a\u4f01\u4e1a\u9009\u62e9\u6b63\u786e\u8def\u5f84\u7684\u5173\u952e\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"1_%E4%BC%A0%E7%BB%9FQMS%E7%B3%BB%E7%BB%9F%E7%9A%84%E4%BC%98%E5%8A%BF%E4%B8%8E%E5%B1%80%E9%99%90\"><\/span>1. \u4f20\u7edfQMS\u7cfb\u7edf\u7684\u4f18\u52bf\u4e0e\u5c40\u9650<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4f20\u7edf\u7684QMS\u8f6f\u4ef6\u901a\u5e38\u7531\u8d44\u6df1\u8f6f\u4ef6\u5382\u5546\u5f00\u53d1\uff0c\u5b83\u4eec\u5728\u5e02\u573a\u4e0a\u5b58\u5728\u5df2\u4e45\uff0c\u5f62\u6210\u4e86\u4e00\u5957\u76f8\u5bf9\u6210\u719f\u7684\u6a21\u5f0f\u3002<\/p>\n<p><strong>\u4f18\u52bf\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u529f\u80fd\u6df1\u5ea6\u4e0e\u884c\u4e1a\u6a21\u677f\uff1a<\/strong> \u4f20\u7edfQMS\u7cfb\u7edf\u7ecf\u8fc7\u591a\u5e74\u53d1\u5c55\uff0c\u5f80\u5f80\u5185\u7f6e\u4e86\u9488\u5bf9\u7279\u5b9a\u884c\u4e1a\uff08\u5982\u6c7d\u8f66\u3001\u533b\u7597\u5668\u68b0\u3001\u7535\u5b50\uff09\u7684\u6df1\u5ea6\u529f\u80fd\u6a21\u5757\u548c\u7b26\u5408\u6cd5\u89c4\uff08\u5982IATF16949, FDA 21 CFR Part 11\uff09\u7684\u6807\u51c6\u6d41\u7a0b\u6a21\u677f\u3002\u5bf9\u4e8e\u8eab\u5904\u5f3a\u76d1\u7ba1\u884c\u4e1a\u3001\u9700\u8981\u5feb\u901f\u6ee1\u8db3\u5408\u89c4\u6027\u8981\u6c42\u7684\u4f01\u4e1a\u6765\u8bf4\uff0c\u8fd9\u63d0\u4f9b\u4e86\u4e00\u4e2a\u5f00\u7bb1\u5373\u7528\u7684\u89e3\u51b3\u65b9\u6848\u3002<\/li>\n<li><strong>\u6210\u719f\u7a33\u5b9a\uff1a<\/strong> \u4f5c\u4e3a\u6807\u51c6\u5316\u4ea7\u54c1\uff0c\u5176\u6838\u5fc3\u529f\u80fd\u7ecf\u8fc7\u4e86\u5927\u91cf\u5ba2\u6237\u7684\u9a8c\u8bc1\uff0c\u7cfb\u7edf\u7a33\u5b9a\u6027\u548c\u53ef\u9760\u6027\u901a\u5e38\u8f83\u9ad8\u3002<\/li>\n<\/ul>\n<p><strong>\u5c40\u9650\uff1a<\/strong><\/p>\n<p>\u7136\u800c\uff0c\u5bf9\u4e8e\u8ffd\u6c42\u7075\u6d3b\u6027\u548c\u5feb\u901f\u53d1\u5c55\u7684\u4e2d\u5c0f\u4f01\u4e1a\u800c\u8a00\uff0c\u4f20\u7edfQMS\u7684\u5c40\u9650\u6027\u4e5f\u65e5\u76ca\u51f8\u663e\uff1a<\/p>\n<ul>\n<li><strong>\u5b9e\u65bd\u5468\u671f\u957f\uff0c\u6210\u672c\u9ad8\u6602\uff1a<\/strong> \u4f20\u7edf\u8f6f\u4ef6\u7684\u5b9e\u65bd\u901a\u5e38\u662f\u4e00\u4e2a\u5e9e\u5927\u7684IT\u9879\u76ee\uff0c\u6d89\u53ca\u9700\u6c42\u8c03\u7814\u3001\u84dd\u56fe\u8bbe\u8ba1\u3001\u4e8c\u6b21\u5f00\u53d1\u3001\u6d4b\u8bd5\u4e0a\u7ebf\u7b49\u591a\u4e2a\u9636\u6bb5\uff0c\u5468\u671f\u5f80\u5f80\u957f\u8fbe6-12\u4e2a\u6708\u3002\u9ad8\u6602\u7684\u8f6f\u4ef6\u8bb8\u53ef\u8d39\u3001\u5b9e\u65bd\u670d\u52a1\u8d39\u548c\u5b9a\u5236\u5f00\u53d1\u8d39\uff0c\u5bf9\u9884\u7b97\u6709\u9650\u7684\u4e2d\u5c0f\u4f01\u4e1a\u6784\u6210\u4e86\u5de8\u5927\u538b\u529b\u3002<\/li>\n<li><strong>\u6d41\u7a0b\u50f5\u5316\uff0c\u96be\u4ee5\u9002\u5e94\u53d8\u5316\uff1a<\/strong> \u4f20\u7edfQMS\u7684\u4e1a\u52a1\u6d41\u7a0b\u662f\u56fa\u5316\u5728\u4ee3\u7801\u91cc\u7684\u3002\u5f53\u4e2d\u5c0f\u4f01\u4e1a\u7684\u4e1a\u52a1\u6d41\u7a0b\u9700\u8981\u8c03\u6574\u6216\u4f18\u5316\u65f6\uff08\u4f8b\u5982\u589e\u52a0\u4e00\u4e2a\u65b0\u7684\u68c0\u9a8c\u73af\u8282\u3001\u4fee\u6539\u4e00\u4e2a\u5ba1\u6279\u6d41\u7a0b\uff09\uff0c\u5f80\u5f80\u9700\u8981\u539f\u5382\u8fdb\u884c\u6602\u8d35\u4e14\u8017\u65f6\u7684\u4e8c\u6b21\u5f00\u53d1\u3002\u8fd9\u79cd\u50f5\u5316\u6027\u4f7f\u5176\u96be\u4ee5\u8ddf\u4e0a\u4f01\u4e1a\u5feb\u901f\u53d8\u5316\u7684\u4e1a\u52a1\u9700\u6c42\u3002<\/li>\n<li><strong>\u201c\u6c34\u571f\u4e0d\u670d\u201d\uff0c\u4f7f\u7528\u7387\u4f4e\uff1a<\/strong> \u7531\u4e8e\u7cfb\u7edf\u6d41\u7a0b\u4e0e\u4f01\u4e1a\u73b0\u6709\u64cd\u4f5c\u4e60\u60ef\u53ef\u80fd\u5b58\u5728\u8f83\u5927\u5dee\u5f02\uff0c\u52a0\u4e0a\u754c\u9762\u901a\u5e38\u8f83\u4e3a\u590d\u6742\uff0c\u5458\u5de5\u5b66\u4e60\u6210\u672c\u9ad8\uff0c\u62b5\u89e6\u60c5\u7eea\u5927\u3002\u8fd9\u5e38\u5e38\u5bfc\u81f4\u7cfb\u7edf\u4e0a\u7ebf\u540e\uff0c\u5b9e\u9645\u4f7f\u7528\u7387\u4f4e\uff0c\u6700\u7ec8\u6ca6\u4e3a\u201c\u6446\u8bbe\u201d\uff0c\u65e0\u6cd5\u771f\u6b63\u843d\u5730\uff0c\u6295\u8d44\u56de\u62a5\u7387\u6781\u4f4e\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"2_%E6%96%B0%E8%B6%8B%E5%8A%BF%EF%BC%9A%E4%B8%BA%E4%BB%80%E4%B9%88%E6%97%A0%E4%BB%A3%E7%A0%81%E5%B9%B3%E5%8F%B0%E6%88%90%E4%B8%BAQMS%E5%AE%9E%E6%96%BD%E7%9A%84%E6%96%B0%E9%80%89%E6%8B%A9%EF%BC%9F\"><\/span>2. \u65b0\u8d8b\u52bf\uff1a\u4e3a\u4ec0\u4e48\u65e0\u4ee3\u7801\u5e73\u53f0\u6210\u4e3aQMS\u5b9e\u65bd\u7684\u65b0\u9009\u62e9\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u8fd1\u5e74\u6765\uff0c\u4ee5<strong>\u652f\u9053\u5e73\u53f0<\/strong>\u4e3a\u4ee3\u8868\u7684\u65e0\u4ee3\u7801\/\u4f4e\u4ee3\u7801\u5f00\u53d1\u5e73\u53f0\uff0c\u4e3a\u4e2d\u5c0f\u4f01\u4e1a\u5b9e\u65bdQMS\u7cfb\u7edf\u63d0\u4f9b\u4e86\u4e00\u79cd\u5168\u65b0\u7684\u3001\u66f4\u5177\u5438\u5f15\u529b\u7684\u8303\u5f0f\u3002\u8fd9\u7c7b\u5e73\u53f0\u5e76\u975e\u63d0\u4f9b\u4e00\u4e2a\u56fa\u5316\u7684QMS\u4ea7\u54c1\uff0c\u800c\u662f\u63d0\u4f9b\u4e00\u5957\u53ef\u89c6\u5316\u7684\u201c\u5f00\u53d1\u5de5\u5177\u201d\uff0c\u8ba9\u4f01\u4e1a\u80fd\u591f\u50cf\u642d\u79ef\u6728\u4e00\u6837\uff0c\u5feb\u901f\u3001\u7075\u6d3b\u5730\u6784\u5efa\u5b8c\u5168\u7b26\u5408\u81ea\u8eab\u9700\u6c42\u7684\u7ba1\u7406\u5e94\u7528\uff0c\u5305\u62ecQMS\u7cfb\u7edf\u3002<\/p>\n<p>\u8fd9\u79cd\u65b0\u8303\u5f0f\u7684\u6838\u5fc3\u4ef7\u503c\u5728\u4e8e\u5176\u9ad8\u5ea6\u7684\u7075\u6d3b\u6027\u548c\u5f3a\u5927\u7684\u6269\u5c55\u6027\uff0c\u5b83\u5b8c\u7f8e\u5730\u89e3\u51b3\u4e86\u4f20\u7edfQMS\u7684\u8bf8\u591a\u75db\u70b9\u3002<\/p>\n<ul>\n<li><strong>\u5458\u5de5\u53c2\u4e0e\u8bbe\u8ba1\uff0c\u7cfb\u7edf\u968f\u4e1a\u52a1\u53d1\u5c55\uff1a<\/strong> 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