{"id":1987,"date":"2025-12-15T16:18:20","date_gmt":"2025-12-15T16:18:20","guid":{"rendered":"https:\/\/ds-mold.com.tw\/?page_id=1987"},"modified":"2026-01-05T16:41:24","modified_gmt":"2026-01-05T16:41:24","slug":"quality-management-and-certifications","status":"publish","type":"page","link":"https:\/\/ds-mold.com.tw\/en\/about-us\/quality-management-and-certifications\/","title":{"rendered":"\u54c1\u8cea\u7ba1\u7406\u8207\u8a8d\u8b49"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1987\" class=\"elementor elementor-1987\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1b5827c e-flex e-con-boxed e-con e-parent\" data-id=\"1b5827c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ce8cafb e-con-full e-flex e-con e-child\" data-id=\"ce8cafb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f383ae1 elementor-widget elementor-widget-heading\" data-id=\"f383ae1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">\u95dc\u65bc\u9f0e\u9806<\/p>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7921240 elementor-widget elementor-widget-heading\" data-id=\"7921240\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u54c1\u8cea\u7ba1\u7406\u8207\u8a8d\u8b49<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2390c08 e-flex e-con-boxed e-con e-parent\" data-id=\"2390c08\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-c942938 e-con-full e-flex e-con e-child\" data-id=\"c942938\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dc0b6fd e-flex e-con-boxed e-con e-parent\" data-id=\"dc0b6fd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-146d967 e-con-full e-flex e-con e-child\" data-id=\"146d967\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49bf224 elementor-widget elementor-widget-text-editor\" data-id=\"49bf224\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 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fetchpriority=\"high\" decoding=\"async\" width=\"683\" height=\"1024\" src=\"https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-11-683x1024.jpg\" class=\"attachment-large size-large wp-image-2389\" alt=\"\" srcset=\"https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-11-683x1024.jpg 683w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-11-200x300.jpg 200w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-11-768x1152.jpg 768w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-11-1024x1536.jpg 1024w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-11-1365x2048.jpg 1365w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-11-8x12.jpg 8w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-11-scaled.jpg 1707w\" sizes=\"(max-width: 683px) 100vw, 683px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-60d5f22 e-con-full elementor-hidden-tablet elementor-hidden-mobile e-flex e-con e-child\" data-id=\"60d5f22\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8b20ffa e-con-full e-flex e-con e-child\" data-id=\"8b20ffa\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3758117 elementor-widget elementor-widget-text-editor\" data-id=\"3758117\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h2>\u4e00\u3001\u5df2\u53d6\u5f97\u4e4b\u54c1\u8cea\u7ba1\u7406\u8a8d\u8b49<\/h2>\n<br>\n<b>ISO 9001 \u570b\u969b\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71<\/b>\n<br><br>\n<b>\u5c0e\u5165\u5e74\u4efd\uff1a\u6c11\u570b 104 \u5e74\uff08\u897f\u5143 2015 \u5e74\uff09<\/b>\n<br><br>\n<span style=\"font-weight: 400;\">\u5c07\u300c\u63a5\u55ae \u2192 \u8a2d\u8a08\u958b\u767c \u2192 \u6a21\u5177\u88fd\u4f5c \u2192 \u5c04\u51fa\u6210\u578b \u2192 \u6aa2\u9a57 \u2192 \u5305\u88dd\u51fa\u8ca8\u300d\u5b8c\u6574\u7d0d\u5165\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u5efa\u7acb\u6a19\u6e96\u4f5c\u696d\u7a0b\u5e8f\uff08SOP\uff09\u8207\u8868\u55ae\u7d00\u9304\uff0c\u5305\u542b\uff1a\u8a02\u55ae\u5be9\u67e5\u3001\u5716\u9762\u8207\u898f\u683c\u78ba\u8a8d\u3001\u539f\u7269\u6599\u7ba1\u5236\u3001\u88fd\u7a0b\u7ba1\u5236\u3001\u6210\u54c1\u6aa2\u9a57\u8207\u7570\u5e38\u8655\u7406\u6d41\u7a0b\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u6bcf\u4e00\u6279\u7522\u54c1\u7686\u5177\u5099\u6599\u865f\u3001\u6279\u865f\u53ca\u751f\u7522\u7d00\u9304\uff0c\u9047\u5230\u5ba2\u6236\u8ffd\u6eaf\u9700\u6c42\u6216\u54c1\u8cea\u554f\u984c\u6642\uff0c\u80fd\u8fc5\u901f\u56de\u6eaf\u81f3\u539f\u7269\u6599\u8207\u751f\u7522\u689d\u4ef6\uff0c\u7e2e\u77ed\u554f\u984c\u91d0\u6e05\u6642\u9593\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u900f\u904e\u5b9a\u671f\u5167\u90e8\u7a3d\u6838\u8207\u7ba1\u7406\u5be9\u67e5\uff0c\u6301\u7e8c\u6aa2\u8a0e\u8207\u6539\u5584\u5404\u6d41\u7a0b\uff0c\u8b93\u54c1\u8cea\u7ba1\u7406\u4e0d\u53ea\u505c\u7559\u5728\u6587\u4ef6\uff0c\u800c\u662f\u5be6\u969b\u843d\u5be6\u5728\u73fe\u5834\u4f5c\u696d\u4e2d\u3002<\/span>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9292ace e-flex e-con-boxed e-con e-parent\" data-id=\"9292ace\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ef76785 e-con-full e-flex e-con e-child\" data-id=\"ef76785\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-315fd7f elementor-widget elementor-widget-text-editor\" data-id=\"315fd7f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h2>\u4e8c\u3001\u898f\u5283\u5c0e\u5165\u4e4b\u54c1\u8cea\u7ba1\u7406\u9ad4\u7cfb\uff08\u91ab\u7642\u76f8\u95dc\uff09<\/h2>\n<br>\n<b>ISO 13485 \u91ab\u7642\u5668\u6750\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\uff08\u898f\u5283\u5c0e\u5165\u4e2d\uff09<\/b>\n<br><br>\n<b>\u898f\u5283\u8d77\u59cb\uff1a\u6c11\u570b 114 \u5e74\uff08\u897f\u5143 2025 \u5e74\uff09\u4e4b\u5f8c\u5206\u968e\u6bb5\u5c0e\u5165<\/b>\n<br><br>\n<span style=\"font-weight: 400;\">\u56e0\u61c9\u91ab\u7642\u76f8\u95dc\u5851\u81a0\u88fd\u54c1\u5408\u4f5c\u6848\u9010\u5e74\u589e\u52a0\uff0c\u9f0e\u9806\u555f\u52d5 ISO 13485 \u5c0e\u5165\u898f\u5283\uff0c\u76ee\u6a19\u662f\u8b93\u91ab\u7642\u7528\u5851\u81a0\u96f6\u4ef6\u7684\u958b\u767c\u8207\u751f\u7522\uff0c\u5b8c\u5168\u7b26\u5408\u91ab\u7642\u5668\u6750\u7522\u696d\u5c0d\u54c1\u8cea\u8207\u6587\u4ef6\u7684\u8981\u6c42\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u5c0e\u5165\u91cd\u9ede\u65b9\u5411\u5305\u542b\uff1a<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u5f37\u5316<\/span><b>\u98a8\u96aa\u7ba1\u7406\uff08Risk Management\uff09<\/b><span style=\"font-weight: 400;\">\uff1a\u5f9e\u8a2d\u8a08\u3001\u6750\u6599\u3001\u88fd\u7a0b\u5230\u6700\u7d42\u4f7f\u7528\u60c5\u5883\uff0c\u7cfb\u7d71\u6027\u8a55\u4f30\u53ef\u80fd\u98a8\u96aa\u4e26\u63a1\u53d6\u9810\u9632\u63aa\u65bd\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u5b8c\u6574\u7684<\/span><b>\u8a2d\u8a08\u8207\u8b8a\u66f4\u7ba1\u5236<\/b><span style=\"font-weight: 400;\">\uff1a\u91dd\u5c0d\u91ab\u7642\u76f8\u95dc\u7522\u54c1\uff0c\u5efa\u7acb\u66f4\u56b4\u8b39\u7684\u8a2d\u8a08\u5be9\u67e5\u3001\u9a57\u8b49\u8207\u78ba\u8a8d\u7a0b\u5e8f\uff0c\u4ee5\u53ca\u8b8a\u66f4\u7ba1\u7406\u7d00\u9304\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u63d0\u5347<\/span><b>\u6279\u6b21\u8ffd\u6eaf<\/b><span style=\"font-weight: 400;\">\u80fd\u529b\uff1a\u4f7f\u91ab\u7642\u7522\u54c1\u80fd\u6e05\u695a\u5c0d\u61c9\u539f\u7269\u6599\u6279\u865f\u3001\u751f\u7522\u689d\u4ef6\u3001\u6aa2\u9a57\u7d00\u9304\u7b49\uff0c\u7b26\u5408\u91ab\u7642\u5668\u6750\u7b49\u7d1a\u7684\u8ffd\u6eaf\u9700\u6c42\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u5b8c\u6574\u7684<\/span><b>\u6587\u4ef6\u8207\u7d00\u9304\u7ba1\u7406<\/b><span style=\"font-weight: 400;\">\uff1a\u5305\u542b\u88fd\u9020\u7d00\u9304\u3001\u6aa2\u9a57\u7d00\u9304\u3001\u4e0d\u826f\u8655\u7f6e\u8207\u77ef\u6b63\u9810\u9632\u63aa\u65bd\uff08CAPA\uff09\u7b49\uff0c\u78ba\u4fdd\u6bcf\u500b\u74b0\u7bc0\u90fd\u6709\u5145\u5206\u7684\u66f8\u9762\u8b49\u64da\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u76ee\u524d\u70ba\u5206\u968e\u6bb5\u5c0e\u5165\u8207\u8abf\u6574\u6d41\u7a0b\u968e\u6bb5\uff0c\u672a\u4f86\u5b8c\u6210\u5c0e\u5165\u8207\u7a3d\u6838\u5f8c\uff0c\u5c07\u4ee5\u6b63\u5f0f\u53d6\u5f97 ISO 13485 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src=\"https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-14-683x1024.jpg\" class=\"attachment-large size-large wp-image-2392\" alt=\"\" srcset=\"https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-14-683x1024.jpg 683w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-14-200x300.jpg 200w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-14-768x1152.jpg 768w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-14-1024x1536.jpg 1024w, https:\/\/ds-mold.com.tw\/wp-content\/uploads\/2025\/12\/\u9f0e\u9806\u5851\u81a0\u6a21\u5177-\u5851\u81a0\u73fe\u5834\u5716-14-1365x2048.jpg 1365w, 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elementor-element-c00587b elementor-widget elementor-widget-text-editor\" data-id=\"c00587b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h2>\u4e09\u3001\u65e5\u5e38\u54c1\u8cea\u7ba1\u5236\u91cd\u9ede\uff08\u53ef\u8996\u9700\u8981\u64c7\u4e00\u6bb5\u653e\u5165\u578b\u9304\uff09<\/h2>\n<br>\n<span style=\"font-weight: 400;\">\u5c0d\u539f\u7269\u6599\u5be6\u65bd\u9032\u6599\u6aa2\u9a57\u8207\u7ba1\u7406\uff0c\u78ba\u4fdd\u6750\u6599\u7b26\u5408\u898f\u683c\u8981\u6c42\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u88fd\u7a0b\u4e2d\u9032\u884c\u9996\u4ef6\u3001\u5de1\u6aa2\u8207\u62bd\u9a57\uff0c\u53ca\u65e9\u767c\u73fe\u4e26\u6392\u9664\u7570\u5e38\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 400;\">\u91cd\u8981\u5c3a\u5bf8\u8207\u5916\u89c0\u9805\u76ee\u5236\u5b9a\u6aa2\u9a57\u6a19\u6e96\uff0c\u4e26\u4fdd\u7559\u6aa2\u9a57\u7d00\u9304\u3002<\/span>\n<br><br>\n<span style=\"font-weight: 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