{"id":11509,"date":"2022-06-30T11:49:24","date_gmt":"2022-06-30T03:49:24","guid":{"rendered":"https:\/\/www.chienfu.com\/?p=11509"},"modified":"2023-11-01T09:26:36","modified_gmt":"2023-11-01T01:26:36","slug":"iso13485","status":"publish","type":"post","link":"https:\/\/www.chienfu.us\/zh-hant\/iso13485\/","title":{"rendered":"\u91ab\u7642\u96f6\u4ef6\u52a0\u5de5\u627e\u5343\u5bcc\uff1f\uff01\u6709 ISO 13485 \u8a8d\u8b49\u5b89\u5566\uff01"},"content":{"rendered":"<h3><strong>\u91ab\u7642\u96f6\u4ef6 \u5e02\u5834<\/strong><\/h3>\n<p>\u4e0d\u53ea\u662f\u53f0\u7063\uff0c\u53ef\u4ee5\u8aaa\u6574\u500b\u4e16\u754c\u90fd\u5728\u6162\u6162\u8b8a\u8001\uff01\u9ad8\u9f61\u5316\u662f\u5168\u7403\u7684\u8da8\u52e2\uff0c\u70ba\u63d0\u9ad8\u4eba\u985e\u751f\u6d3b\u54c1\u8cea\uff0c\u91ab\u7642\u7522\u696d\u7684\u5feb\u901f\u767c\u5c55\u662f\u6211\u5011\u80fd\u60f3\u898b\u7684\u672a\u4f86\uff0c\u6839\u64da<a href=\"https:\/\/ieknet.iek.org.tw\/\" target=\"_blank\" rel=\"noopener\">\u5de5\u7814\u9662IEK Consulting\u5831\u544a<\/a>\uff0c\u5168\u7403\u91ab\u7642\u5668\u6750\u5e02\u5834\u898f\u6a21\u57282020\u5e74\u90544,273\u5104\u7f8e\u5143\uff0c\u9810\u4f302021\u5e74\u53ef\u90544,377\u5104\u7f8e\u5143\uff1b\u9810\u671f\u5c07\u4ee5\u5e74\u8907\u5408\u6210\u9577\u73874.8%\u7684\u901f\u5ea6\uff0c\u81f32023\u5e74\u9054\u52304,914\u5104\u7f8e\u5143\u3002\u91ab\u7642\u96f6\u4ef6 \u52a0\u5de5\u5c31\u662f\u6211\u5011CNC\u52a0\u5de5\u5ee0\u672a\u4f86\u7684\u8da8\u52e2\uff01<\/p>\n<p><img decoding=\"async\" class=\"post-content-img aligncenter\" title=\"\u91ab\u7642\u96f6\u4ef6\u52a0\u5de5\u627e\u5343\u5bcc\uff1f\uff01\u6709 ISO 13485 \u8a8d\u8b49\u5b89\u5566\uff01\" src=\"https:\/\/www.chienfu.us\/wp-content\/uploads\/2022\/06\/2120-scaled.jpg\" alt=\"\u91ab\u7642\u96f6\u4ef6\" width=\"671\" height=\"299\" \/><\/p>\n<h3><strong>\u91ab\u7642\u8a8d\u8b49 ISO 13485<\/strong><\/h3>\n<p>\u696d\u754c\u7684\u4eba\u90fd\u77e5\u9053\u91ab\u7642\u96f6\u4ef6\u662f\u8da8\u52e2\u800c\u4e14\u5229\u6f64\u9ad8\uff0c\u4f46\u662f\u4e0d\u662f\u6bcf\u500b\u91d1\u5c6c\u52a0\u5de5\u5ee0\u90fd\u80fd\u505a\u7684\u3002\u539f\u56e0\u5f88\u7c21\u55ae\u91ab\u7642\u96f6\u4ef6\u88fd\u4f5c\u689d\u4ef6\u76f8\u5c0d\u56b4\u683c\uff0c\u7562\u7adf\u9019\u4e9b\u96f6\u4ef6\u548c\u6211\u5011\u7684\u5065\u5eb7\u606f\u606f\u76f8\u95dc\uff01\u76ee\u524d\u4e3b\u6d41\u7684\u91ab\u7642\u4f01\u696d\u5546\u90fd\u4f86\u81ea\u6b50\u3001\u7f8e\u3001\u52a0\u9019\u4e9b\u570b\u5bb6\u5728\u7522\u696d\u93c8\u7684\u5be9\u6838\u4e0a\u90fd\u7279\u5225\u56b4\u683c\u901a\u5e38\u4ee5 ISO 9001\u3001EN 46001 \u6216 ISO 13485 \u4f5c\u70ba\u54c1\u4fdd\u7684\u8981\u6c42\uff01<br \/>\n\u800c\u5343\u5bcc\u6191\u85c9\u8457\u826f\u597d\u7684\u52a0\u5de5\u54c1\u8cea\u548c\u53cb\u5584\u7684\u52a0\u5de5\u74b0\u7bc0\u5728 2018\u5e74\u5c31\u53d6\u5f97\u4e86ISO13485\uff01\u610f\u5473\u8457\u6211\u5011\u6709\u80fd\u529b\u9032\u884c\u91ab\u7642\u5668\u6750\u95dc\u9375\u96f6\u4ef6\u7684\u88fd\u9020\u3002<\/p>\n<p><a href=\"https:\/\/www.chienfu.us\/wp-content\/uploads\/2022\/06\/Chienfu-ISO13485.pdf\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"post-content-img aligncenter\" title=\"\u91ab\u7642\u96f6\u4ef6\u52a0\u5de5\u627e\u5343\u5bcc\uff1f\uff01\u6709 ISO 13485 \u8a8d\u8b49\u5b89\u5566\uff01\" src=\"https:\/\/www.chienfu.us\/wp-content\/uploads\/2022\/06\/\u622a\u5716-2022-06-29-\u4e0b\u53485.49.14.png\" alt=\"\u91ab\u7642\u96f6\u4ef6\" width=\"474\" height=\"415\" \/><\/a><\/p>\n<h3><strong>\u5343\u5bcc\u7684\u52a0\u5de5\u80fd\u529b<\/strong><\/h3>\n<p>\u6211\u5011\u5834\u5167\u64c1\u6709\u8fd1150\u53f0\u7684CNC\u8a2d\u5099\u5305\u542bSHIMADA\u76846\u8ef8\u6a5f\u4ee5\u53caDMG NTX1000\uff0c\u591a\u6a23\u7684\u8a2d\u5099\u80fd\u5343\u5bcc\u7684\u52a0\u5de5\u80fd\u529b\u53ef\u4ee5\u505a\u5230\uff1a<\/p>\n<p><b>\u52a0\u5de5\u5916\u5f91 <\/b><b>Diameter:<\/b>\u222e1 mm~\u222e300 mm<\/p>\n<p><b>\u52a0\u5de5\u9577\u5ea6 <\/b><b>Length:\u00a0 <\/b>0.5 mm~1000 mm<\/p>\n<p><b>\u4e3b\u8981\u8eca\u524a\u6750\u6599 <\/b><b>Material: <\/b>\u4e0d\u92b9\u92fc\u3001\u78b3\u92fc\u3001\u92c1\u3001\u5feb\u524a\u92fc\u3001\u9285\u3001\u9226\u3001\u5851\u81a0<\/p>\n<p><b>\u516c\u5dee <\/b><b>Tolerance <\/b>: 0.01 mm<\/p>\n<p>\u53d6\u5f97ISO\u8a8d\u8b49\u53ea\u662f\u958b\u59cb\uff0c\u91ab\u7642\u96f6\u4ef6\u90fd\u6703\u6709\u66f4\u52a0\u56b4\u82db\u7684\u898f\u5b9a\uff0c\u5343\u5bcc\u548c\u745e\u58eb\u91ab\u7642\u5927\u5ee0\u6709\u6301\u7e8c\u5408\u4f5c\uff0c\u4f46\u662f\u6b50\u76df\u570b\u5bb6\u5c0d\u65bc\u91ab\u7642\u96f6\u4ef6\u7684\u8981\u6c42\u66f4\u70ba\u56b4\u683c\uff0c\u70ba\u4e86\u63d0\u4f9b\u66f4\u597d\u7684\u7522\u54c1\u54c1\u8cea\u4ee5\u53ca\u670d\u52d9\u5343\u5bcc\u7279\u5225\u8cfc\u7f6e\u4e86\u8521\u53f8\u8a2d\u5099\u78ba\u4fdd\u54c1\u8cea\u9032\u4e00\u6b65\u7684\u63d0\u5347\uff01<br \/>\n<a href=\"https:\/\/www.chienfu.us\/wp-content\/uploads\/2022\/06\/Chienfu-ISO13485.pdf\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"post-content-img aligncenter\" title=\"\u91ab\u7642\u96f6\u4ef6\u52a0\u5de5\u627e\u5343\u5bcc\uff1f\uff01\u6709 ISO 13485 \u8a8d\u8b49\u5b89\u5566\uff01\" src=\"https:\/\/www.chienfu.us\/wp-content\/uploads\/2023\/10\/\u622a\u5716-2023-10-31-\u4e0a\u53488.37.18-1.png\" alt=\"\u91ab\u7642\u96f6\u4ef6\" width=\"474\" height=\"415\" \/><\/a><\/p>\n<h4><span style=\"color: #3366ff;\">\u66f4\u591a\u76f8\u95dc\u63a1\u8a2a\u6587\u7ae0<\/span><\/h4>\n<p class=\"post-title entry-title \"><a title=\"Permanent Link: \u806f\u5408\u665a\u5831 \u9322\u7dda\u4eba\u7269\uff0f\u75db\u9ede\u8b8a\u751f\u610f\" href=\"https:\/\/www.chienfu.us\/zh-hant\/ceo-of-chienfu-sloky-jeff-chuang-on-union-evening-news\/\" target=\"_blank\" rel=\"bookmark noopener\">\u806f\u5408\u665a\u5831 \u9322\u7dda\u4eba\u7269\uff0f\u75db\u9ede\u8b8a\u751f\u610f<\/a><\/p>\n<p class=\"post-title entry-title \"><a title=\"Permanent Link: \u4e09\u7acb\u65b0\u805e\u64ad\u51fa\u2502\u3010\u85aa\u52d5\u5927\u672a\u4f86\u3011\" href=\"https:\/\/www.chienfu.us\/zh-hant\/chienfu-sloky-on-set-inews\/\" target=\"_blank\" rel=\"bookmark noopener\">\u4e09\u7acb\u65b0\u805e\u64ad\u51fa\u2502\u3010\u85aa\u52d5\u5927\u672a\u4f86\u3011<\/a><\/p>\n<p class=\"post-title entry-title \"><a title=\"Permanent Link: \u5343\u5bcc\u4f01\u696d\u7522\u5b78\u5408\u4f5c\u6210\u679c\" href=\"https:\/\/www.chienfu.us\/zh-hant\/%e5%8d%83%e5%af%8c%e4%bc%81%e6%a5%ad%e7%94%a2%e5%ad%b8%e5%90%88%e4%bd%9c%e6%88%90%e6%9e%9c\/\" target=\"_blank\" rel=\"bookmark noopener\">\u5343\u5bcc\u4f01\u696d\u7522\u5b78\u5408\u4f5c\u6210\u679c<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u91ab\u7642\u96f6\u4ef6 \u5e02\u5834 \u4e0d\u53ea\u662f\u53f0\u7063\uff0c\u53ef\u4ee5\u8aaa\u6574\u500b\u4e16\u754c\u90fd\u5728\u6162\u6162\u8b8a\u8001\uff01\u9ad8\u9f61\u5316\u662f\u5168\u7403\u7684\u8da8\u52e2\uff0c\u70ba\u63d0\u9ad8\u4eba\u985e\u751f\u6d3b\u54c1\u8cea\uff0c\u91ab\u7642\u7522\u696d\u7684\u5feb\u901f\u767c\u5c55\u662f\u6211\u5011\u80fd\u60f3\u898b\u7684\u672a\u4f86\uff0c\u6839\u64da\u5de5\u7814\u9662IEK Consulting\u5831\u544a\uff0c\u5168\u7403\u91ab\u7642\u5668\u6750\u5e02\u5834\u898f\u6a21\u57282020\u5e74\u90544,273\u5104\u7f8e\u5143\uff0c\u9810\u4f302021\u5e74\u53ef\u90544,377\u5104\u7f8e\u5143\uff1b\u9810\u671f\u5c07\u4ee5\u5e74\u8907\u5408\u6210\u9577\u73874.8%\u7684\u901f\u5ea6\uff0c\u81f32023\u5e74\u9054\u52304,914\u5104\u7f8e\u5143\u3002\u91ab\u7642\u96f6\u4ef6 \u52a0\u5de5\u5c31\u662f\u6211\u5011CNC\u52a0\u5de5\u5ee0\u672a\u4f86\u7684\u8da8\u52e2\uff01 \u91ab\u7642\u8a8d\u8b49 ISO 13485 \u696d\u754c\u7684\u4eba\u90fd\u77e5\u9053\u91ab\u7642\u96f6\u4ef6\u662f\u8da8\u52e2\u800c\u4e14\u5229\u6f64\u9ad8\uff0c\u4f46\u662f\u4e0d\u662f\u6bcf\u500b\u91d1\u5c6c\u52a0\u5de5\u5ee0\u90fd\u80fd\u505a\u7684\u3002\u539f\u56e0\u5f88\u7c21\u55ae\u91ab\u7642\u96f6\u4ef6\u88fd\u4f5c\u689d\u4ef6\u76f8\u5c0d\u56b4\u683c\uff0c\u7562\u7adf\u9019\u4e9b\u96f6\u4ef6\u548c\u6211\u5011\u7684\u5065\u5eb7\u606f\u606f\u76f8\u95dc\uff01\u76ee\u524d\u4e3b\u6d41\u7684\u91ab\u7642\u4f01\u696d\u5546\u90fd\u4f86\u81ea\u6b50\u3001\u7f8e\u3001\u52a0\u9019\u4e9b\u570b\u5bb6\u5728\u7522\u696d\u93c8\u7684\u5be9\u6838\u4e0a\u90fd\u7279\u5225\u56b4\u683c\u901a\u5e38\u4ee5 ISO 9001\u3001EN 46001 \u6216 ISO 13485 \u4f5c\u70ba\u54c1\u4fdd\u7684\u8981\u6c42\uff01 \u800c\u5343\u5bcc\u6191\u85c9\u8457\u826f\u597d\u7684\u52a0\u5de5\u54c1\u8cea\u548c\u53cb\u5584\u7684\u52a0\u5de5\u74b0\u7bc0\u5728 2018\u5e74\u5c31\u53d6\u5f97\u4e86ISO13485\uff01\u610f\u5473\u8457\u6211\u5011\u6709\u80fd\u529b\u9032\u884c\u91ab\u7642\u5668\u6750\u95dc\u9375\u96f6\u4ef6\u7684\u88fd\u9020\u3002 \u5343\u5bcc\u7684\u52a0\u5de5\u80fd\u529b \u6211\u5011\u5834\u5167\u64c1\u6709\u8fd1150\u53f0\u7684CNC\u8a2d\u5099\u5305\u542bSHIMADA\u76846\u8ef8\u6a5f\u4ee5\u53caDMG NTX1000\uff0c\u591a\u6a23\u7684\u8a2d\u5099\u80fd\u5343\u5bcc\u7684\u52a0\u5de5\u80fd\u529b\u53ef\u4ee5\u505a\u5230\uff1a \u52a0\u5de5\u5916\u5f91 Diameter:\u222e1 mm~\u222e300 mm \u52a0\u5de5\u9577\u5ea6 Length:\u00a0 0.5 mm~1000 mm \u4e3b\u8981\u8eca\u524a\u6750\u6599 Material: \u4e0d\u92b9\u92fc\u3001\u78b3\u92fc\u3001\u92c1\u3001\u5feb\u524a\u92fc\u3001\u9285\u3001\u9226\u3001\u5851\u81a0 \u516c\u5dee Tolerance : 0.01 mm \u53d6\u5f97ISO\u8a8d\u8b49\u53ea\u662f\u958b\u59cb\uff0c\u91ab\u7642\u96f6\u4ef6\u90fd\u6703\u6709\u66f4\u52a0\u56b4\u82db\u7684\u898f\u5b9a\uff0c\u5343\u5bcc\u548c\u745e\u58eb\u91ab\u7642\u5927\u5ee0\u6709\u6301\u7e8c\u5408\u4f5c\uff0c\u4f46\u662f\u6b50\u76df\u570b\u5bb6\u5c0d\u65bc\u91ab\u7642\u96f6\u4ef6\u7684\u8981\u6c42\u66f4\u70ba\u56b4\u683c\uff0c\u70ba\u4e86\u63d0\u4f9b\u66f4\u597d\u7684\u7522\u54c1\u54c1\u8cea\u4ee5\u53ca\u670d\u52d9\u5343\u5bcc\u7279\u5225\u8cfc\u7f6e\u4e86\u8521\u53f8\u8a2d\u5099\u78ba\u4fdd\u54c1\u8cea\u9032\u4e00\u6b65\u7684\u63d0\u5347\uff01 \u66f4\u591a\u76f8\u95dc\u63a1\u8a2a\u6587\u7ae0 \u806f\u5408\u665a\u5831 \u9322\u7dda\u4eba\u7269\uff0f\u75db\u9ede\u8b8a\u751f\u610f \u4e09\u7acb\u65b0\u805e\u64ad\u51fa\u2502\u3010\u85aa\u52d5\u5927\u672a\u4f86\u3011 \u5343\u5bcc\u4f01\u696d\u7522\u5b78\u5408\u4f5c\u6210\u679c<\/p>\n","protected":false},"author":2,"featured_media":11535,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50,6],"tags":[],"class_list":["post-11509","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-cn","category-6"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u91ab\u7642\u96f6\u4ef6 \u52a0\u5de5\u627e\u5343\u5bcc\uff1f\uff01\u6709 ISO 13485 \u8a8d\u8b49\u5b89\u5566\uff01<\/title>\n<meta name=\"description\" content=\"\u91ab\u7642\u96f6\u4ef6 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