{"id":81,"date":"2026-05-30T07:37:20","date_gmt":"2026-05-30T07:37:20","guid":{"rendered":"https:\/\/blog.joezhou.top\/iso-9001-8-5-quot-quot\/"},"modified":"2026-05-30T07:37:20","modified_gmt":"2026-05-30T07:37:20","slug":"iso-9001-8-5-quot-quot","status":"publish","type":"post","link":"https:\/\/www.joezhou.top\/?p=81","title":{"rendered":"ISO 9001 \u7b2c8.5\u6761\u6df1\u5ea6\u62c6\u89e3\uff1a\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u2014\u2014\u8d28\u91cf\u7ba1\u7406\u7684&quot;\u4e3b\u6218\u573a&quot;"},"content":{"rendered":"<h1 id=\"iso-9001-85\">ISO 9001 \u7b2c8.5\u6761\u6df1\u5ea6\u62c6\u89e3\uff1a\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u2014\u2014\u8d28\u91cf\u7ba1\u7406\u7684&#8221;\u4e3b\u6218\u573a&#8221;<\/h1>\n<p>ISO 9001 \u7684\u7b2c8\u7ae0&#8221;\u8fd0\u884c&#8221;\u662f\u6574\u4e2a\u6807\u51c6\u4e2d\u6761\u76ee\u6700\u591a\u7684\u4e00\u7ae0\uff0c\u800c <strong>8.5 \u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u7684\u63a7\u5236<\/strong> \u53c8\u662f\u5176\u4e2d\u6700\u539a\u5b9e\u7684\u4e00\u6761\u3002\u5982\u679c\u8bf4\u7b2c6\u7ae0&#8221;\u7b56\u5212&#8221;\u662f\u753b\u84dd\u56fe\uff0c\u7b2c7\u7ae0&#8221;\u8d44\u6e90&#8221;\u662f\u5907\u5f39\u836f\uff0c\u90a3 8.5 \u5c31\u662f\u771f\u6b63\u5f00\u6253\u7684\u5730\u65b9\u2014\u2014\u4ea7\u54c1\/\u670d\u52a1\u5728\u8fd9\u91cc\u88ab\u5236\u9020\u51fa\u6765\u3001\u4ea4\u4ed8\u51fa\u53bb\u3002<\/p>\n<p>\u672c\u6587\u9010\u6761\u62c6\u89e3 8.5 \u7684\u56db\u4e2a\u5b50\u6761\u6b3e\uff0c\u7ed3\u5408\u5ba1\u6838\u5b9e\u8df5\u7ed9\u51fa\u53ef\u843d\u5730\u7684\u7406\u89e3\u3002<\/p>\n<hr \/>\n<h2 id=\"85\">\u4e00\u30018.5 \u603b\u89c8\uff1a\u56db\u4e2a\u5b50\u6761\u6b3e\u7684\u903b\u8f91<\/h2>\n<table>\n<thead>\n<tr>\n<th>\u5b50\u6761\u6b3e<\/th>\n<th>\u6807\u9898<\/th>\n<th>\u6838\u5fc3\u95ee\u9898<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>8.5.1<\/strong><\/td>\n<td>\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u7684\u63a7\u5236<\/td>\n<td>\u4f60\u600e\u4e48\u786e\u4fdd\u8fc7\u7a0b\u53d7\u63a7\uff1f<\/td>\n<\/tr>\n<tr>\n<td><strong>8.5.2<\/strong><\/td>\n<td>\u6807\u8bc6\u548c\u53ef\u8ffd\u6eaf\u6027<\/td>\n<td>\u51fa\u4e86\u95ee\u9898\u80fd\u8ffd\u56de\u53bb\u5417\uff1f<\/td>\n<\/tr>\n<tr>\n<td><strong>8.5.3<\/strong><\/td>\n<td>\u987e\u5ba2\u6216\u5916\u90e8\u4f9b\u65b9\u7684\u8d22\u4ea7<\/td>\n<td>\u522b\u4eba\u7684\u4e1c\u897f\u4f60\u7ba1\u597d\u4e86\u5417\uff1f<\/td>\n<\/tr>\n<tr>\n<td><strong>8.5.4<\/strong><\/td>\n<td>\u9632\u62a4<\/td>\n<td>\u4ea7\u54c1\/\u670d\u52a1\u4ea4\u4ed8\u524d\u4fdd\u62a4\u597d\u6ca1\u6709\uff1f<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u8fd9\u56db\u6761\u5f62\u6210\u4e00\u6761\u63a7\u5236\u94fe\uff1a<\/p>\n<pre class=\"codehilite\"><code>\u8fc7\u7a0b\u53d7\u63a7(8.5.1) \u2192 \u8fc7\u7a0b\u4e2d\u53ef\u8ffd\u6eaf(8.5.2) \u2192 \u4ed6\u4eba\u7269\u54c1\u53d7\u7ba1(8.5.3) \u2192 \u4ea4\u4ed8\u524d\u9632\u62a4(8.5.4)\n<\/code><\/pre>\n<hr \/>\n<h2 id=\"851\">\u4e8c\u30018.5.1 \u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u7684\u63a7\u5236<\/h2>\n<h3 id=\"_1\">\u6807\u51c6\u8981\u6c42<\/h3>\n<p>\u6807\u51c6\u5217\u51fa\u4e86\u516d\u4e2a&#8221;\u53d7\u63a7\u6761\u4ef6&#8221;\uff0c\u7ec4\u7ec7\u5e94\u5728<strong>\u9002\u7528\u65f6<\/strong>\u4e88\u4ee5\u6ee1\u8db3\uff1a<\/p>\n<ol>\n<li>\u83b7\u5f97\u6210\u6587\u4fe1\u606f\uff0c\u89c4\u5b9a\u6240\u751f\u4ea7\u7684\u4ea7\u54c1\u3001\u63d0\u4f9b\u7684\u670d\u52a1\u6216\u8fdb\u884c\u7684\u6d3b\u52a8\u7684\u7279\u6027<\/li>\n<li>\u83b7\u5f97\u6210\u6587\u4fe1\u606f\uff0c\u89c4\u5b9a\u62df\u83b7\u5f97\u7684\u7ed3\u679c<\/li>\n<li>\u5728\u9002\u5f53\u9636\u6bb5\u5b9e\u65bd\u76d1\u89c6\u548c\u6d4b\u91cf\u6d3b\u52a8\uff0c\u4ee5\u9a8c\u8bc1\u662f\u5426\u7b26\u5408\u8fc7\u7a0b\u6216\u8f93\u51fa\u7684\u63a7\u5236\u51c6\u5219<\/li>\n<li>\u4e3a\u8fc7\u7a0b\u7684\u8fd0\u884c\u63d0\u4f9b\u9002\u5b9c\u7684\u57fa\u7840\u8bbe\u65bd\u548c\u73af\u5883<\/li>\n<li>\u914d\u5907\u80dc\u4efb\u7684\u4eba\u5458\uff0c\u5305\u62ec\u6240\u8981\u6c42\u7684\u8d44\u683c<\/li>\n<li>\u82e5\u8f93\u51fa\u7ed3\u679c\u4e0d\u80fd\u7531\u540e\u7eed\u7684\u76d1\u89c6\u6216\u6d4b\u91cf\u52a0\u4ee5\u9a8c\u8bc1\uff0c\u5e94\u5bf9\u8fd9\u4e9b\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u8fc7\u7a0b\u5b9e\u73b0\u7b56\u5212\u3001\u786e\u8ba4\u3001\u518d\u786e\u8ba4<\/li>\n<\/ol>\n<h3 id=\"_2\">\u5173\u952e\u7406\u89e3<\/h3>\n<p><strong>&#8220;\u9002\u7528\u65f6&#8221;\u4e0d\u7b49\u4e8e&#8221;\u53ef\u9009\u9879&#8221;\u3002<\/strong> \u6807\u51c6\u7528\u7684\u662f&#8221;\u5728\u9002\u7528\u65f6&#8221;\uff08as applicable\uff09\uff0c\u610f\u601d\u662f\uff1a\u5982\u679c\u4f60\u786e\u8ba4\u67d0\u4e00\u6761\u5bf9\u4f60\u7684\u8fc7\u7a0b\u4e0d\u9002\u7528\uff0c\u4f60\u9700\u8981\u6709\u5408\u7406\u7684\u7406\u7531\uff0c\u800c\u4e0d\u662f\u76f4\u63a5\u8df3\u8fc7\u3002\u5ba1\u6838\u65f6\u8fd9\u516d\u6761\u9010\u6761\u8fc7\uff0c\u4f60\u8df3\u8fc7\u7684\u6bcf\u4e00\u6761\u90fd\u8981\u89e3\u91ca\u4e3a\u4ec0\u4e48\u3002<\/p>\n<h3 id=\"_3\">\u516d\u4e2a\u53d7\u63a7\u6761\u4ef6\u7684\u5ba1\u6838\u5b9e\u8bc1<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u53d7\u63a7\u6761\u4ef6<\/th>\n<th>\u5ba1\u6838\u5458\u4f1a\u95ee<\/th>\n<th>\u5e38\u89c1\u4e0d\u5408\u683c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u2460 \u4ea7\u54c1\/\u670d\u52a1\u7279\u6027\u6587\u4ef6<\/td>\n<td>&#8220;\u4f60\u4eec\u6709\u6ca1\u6709\u5199\u6e05\u695a\u4ea7\u54c1\u8be5\u662f\u4ec0\u4e48\u6837\uff1f&#8221;<\/td>\n<td>\u53ea\u6709\u53e3\u5934\u8981\u6c42\uff0c\u6ca1\u6709\u6210\u6587\u89c4\u8303<\/td>\n<\/tr>\n<tr>\n<td>\u2461 \u9884\u671f\u7ed3\u679c\u6587\u4ef6<\/td>\n<td>&#8220;\u5458\u5de5\u600e\u4e48\u77e5\u9053\u505a&#8217;\u5bf9&#8217;\u4e86\uff1f&#8221;<\/td>\n<td>\u68c0\u9a8c\u6807\u51c6\u7f3a\u5931\u6216\u8fc7\u4e8e\u7b3c\u7edf<\/td>\n<\/tr>\n<tr>\n<td>\u2462 \u76d1\u89c6\u548c\u6d4b\u91cf<\/td>\n<td>&#8220;\u4f60\u4eec\u5728\u8fc7\u7a0b\u4e2d\u54ea\u4e2a\u8282\u70b9\u505a\u68c0\u67e5\uff1f&#8221;<\/td>\n<td>\u53ea\u505a\u6700\u7ec8\u68c0\u9a8c\uff0c\u8fc7\u7a0b\u65e0\u76d1\u63a7<\/td>\n<\/tr>\n<tr>\n<td>\u2463 \u57fa\u7840\u8bbe\u65bd\u548c\u73af\u5883<\/td>\n<td>&#8220;\u8bbe\u5907\u6821\u51c6\u4e86\u5417\uff1f\u6e29\u6e7f\u5ea6\u8fbe\u6807\u5417\uff1f&#8221;<\/td>\n<td>\u8bbe\u5907\u8d85\u671f\u672a\u6821\u51c6\uff0c\u65e0\u73af\u5883\u8bb0\u5f55<\/td>\n<\/tr>\n<tr>\n<td>\u2464 \u4eba\u5458\u8d44\u683c<\/td>\n<td>&#8220;\u505a\u8fd9\u4e2a\u5de5\u5e8f\u7684\u4eba\u6709\u8d44\u8d28\u5417\uff1f&#8221;<\/td>\n<td>\u7279\u79cd\u4f5c\u4e1a\u65e0\u8bc1\u4e0a\u5c97<\/td>\n<\/tr>\n<tr>\n<td>\u2465 \u7279\u6b8a\u8fc7\u7a0b\u786e\u8ba4<\/td>\n<td>&#8220;\u8fd9\u4e2a\u710a\u63a5\/\u70ed\u5904\u7406\u8fc7\u7a0b\uff0c\u4f60\u4eec\u600e\u4e48\u786e\u8ba4\u53c2\u6570\u6709\u6548\uff1f&#8221;<\/td>\n<td>\u4ece\u672a\u505a\u8fc7\u8fc7\u7a0b\u786e\u8ba4\uff0c\u6216\u786e\u8ba4\u8bb0\u5f55\u7f3a\u5931<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3 id=\"6\">\u5173\u4e8e\u7b2c\u2465\u70b9\u2014\u2014&#8221;\u7279\u6b8a\u8fc7\u7a0b&#8221;\u7684\u6df1\u5165\u7406\u89e3<\/h3>\n<p>\u8fd9\u662f 8.5.1 \u4e2d\u6700\u5bb9\u6613\u51fa\u95ee\u9898\u7684\u70b9\u3002<strong>\u7279\u6b8a\u8fc7\u7a0b<\/strong>\uff08Special Process\uff09\u7684\u5b9a\u4e49\u662f\uff1a<\/p>\n<blockquote>\n<p>\u8fc7\u7a0b\u7684\u8f93\u51fa\u4e0d\u80fd\u7531\u540e\u7eed\u7684\u76d1\u89c6\u6216\u6d4b\u91cf\u52a0\u4ee5\u9a8c\u8bc1\uff0c\u81f4\u4f7f\u4ea7\u54c1\u6295\u5165\u4f7f\u7528\u540e\u95ee\u9898\u624d\u663e\u73b0\u3002<\/p>\n<\/blockquote>\n<p>\u5178\u578b\u7684\u7279\u6b8a\u8fc7\u7a0b\u5305\u62ec\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u884c\u4e1a<\/th>\n<th>\u5178\u578b\u7279\u6b8a\u8fc7\u7a0b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5236\u9020\u4e1a<\/td>\n<td>\u710a\u63a5\u3001\u70ed\u5904\u7406\u3001\u8868\u9762\u5904\u7406\u3001\u94f8\u9020<\/td>\n<\/tr>\n<tr>\n<td>\u5efa\u7b51\u4e1a<\/td>\n<td>\u6df7\u51dd\u571f\u6d47\u7b51\u3001\u9632\u6c34\u65bd\u5de5<\/td>\n<\/tr>\n<tr>\n<td>\u533b\u7597<\/td>\n<td>\u706d\u83cc\u3001\u65e0\u83cc\u704c\u88c5<\/td>\n<\/tr>\n<tr>\n<td>\u8f6f\u4ef6<\/td>\n<td>\u7f16\u8bd1\u6784\u5efa\uff08\u8f93\u51fa\u662f\u5426\u6b63\u786e\u65e0\u6cd5\u4ec5\u9760\u6d4b\u8bd5\u7a77\u5c3d\u9a8c\u8bc1\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u5bf9\u7279\u6b8a\u8fc7\u7a0b\u7684\u786e\u8ba4\u5e94\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u8fc7\u7a0b\u53c2\u6570\u7684\u8bc4\u5ba1\u548c\u6279\u51c6<\/strong>\uff1a\u5982\u710a\u63a5\u7684\u7535\u6d41\u3001\u7535\u538b\u3001\u901f\u5ea6<\/li>\n<li><strong>\u8bbe\u5907\u8ba4\u53ef<\/strong>\uff1a\u8bbe\u5907\u80fd\u529b\u662f\u5426\u6ee1\u8db3\u8981\u6c42<\/li>\n<li><strong>\u4eba\u5458\u8d44\u683c\u9274\u5b9a<\/strong>\uff1a\u710a\u5de5\u8bc1\u3001\u70ed\u5904\u7406\u64cd\u4f5c\u8bc1\u7b49<\/li>\n<li><strong>\u7279\u5b9a\u7684\u65b9\u6cd5\u548c\u7a0b\u5e8f<\/strong>\uff1a\u5de5\u827a\u89c4\u7a0b\u3001\u4f5c\u4e1a\u6307\u5bfc\u4e66<\/li>\n<li><strong>\u518d\u786e\u8ba4\u8981\u6c42<\/strong>\uff1a\u4f55\u65f6\u9700\u8981\u91cd\u65b0\u786e\u8ba4\uff08\u5982\u6362\u8bbe\u5907\u3001\u6362\u6750\u6599\u3001\u505c\u7ebf\u540e\u91cd\u542f\uff09<\/li>\n<\/ul>\n<hr \/>\n<h2 id=\"852\">\u4e09\u30018.5.2 \u6807\u8bc6\u548c\u53ef\u8ffd\u6eaf\u6027<\/h2>\n<h3 id=\"_4\">\u6807\u51c6\u8981\u6c42<\/h3>\n<blockquote>\n<p>\u7ec4\u7ec7\u5e94\u5728\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u7684\u5168\u8fc7\u7a0b\u4e2d\uff0c\u6839\u636e\u76d1\u89c6\u548c\u6d4b\u91cf\u8981\u6c42\u8bc6\u522b\u8f93\u51fa\u72b6\u6001\u3002<br \/>\n\u7ec4\u7ec7\u5e94\u5728\u6709\u53ef\u8ffd\u6eaf\u6027\u8981\u6c42\u7684\u573a\u5408\uff0c\u63a7\u5236\u8f93\u51fa\u7684\u552f\u4e00\u6027\u6807\u8bc6\uff0c\u5e76\u4fdd\u7559\u6240\u9700\u7684\u6210\u6587\u4fe1\u606f\u4ee5\u5b9e\u73b0\u53ef\u8ffd\u6eaf\u3002<\/p>\n<\/blockquote>\n<h3 id=\"_5\">\u4e24\u4e2a\u6982\u5ff5\u8981\u5206\u6e05<\/h3>\n<p><strong>\u6807\u8bc6\uff08Identification\uff09<\/strong> \u2260 <strong>\u53ef\u8ffd\u6eaf\u6027\uff08Traceability\uff09<\/strong><\/p>\n<table>\n<thead>\n<tr>\n<th>\u7ef4\u5ea6<\/th>\n<th>\u6807\u8bc6<\/th>\n<th>\u53ef\u8ffd\u6eaf\u6027<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u76ee\u7684<\/td>\n<td>\u533a\u5206&#8221;\u8fd9\u662f\u4ec0\u4e48&#8221;\u548c&#8221;\u4ec0\u4e48\u72b6\u6001&#8221;<\/td>\n<td>\u56de\u6eaf&#8221;\u4ece\u54ea\u6765\u3001\u5230\u54ea\u53bb&#8221;<\/td>\n<\/tr>\n<tr>\n<td>\u8303\u56f4<\/td>\n<td>\u5168\u8fc7\u7a0b\u5fc5\u987b\u505a<\/td>\n<td>\u53ea\u5728\u6709\u8981\u6c42\u65f6\u505a<\/td>\n<\/tr>\n<tr>\n<td>\u793a\u4f8b<\/td>\n<td>\u5408\u683c\/\u4e0d\u5408\u683c\u6807\u7b7e\u3001\u72b6\u6001\u724c<\/td>\n<td>\u6279\u53f7\u8ffd\u6eaf\u3001\u5e8f\u5217\u53f7\u8ffd\u6eaf<\/td>\n<\/tr>\n<tr>\n<td>\u6210\u672c<\/td>\n<td>\u4f4e<\/td>\n<td>\u9ad8\uff08\u9700\u8981\u5168\u94fe\u8def\u8bb0\u5f55\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3 id=\"_6\">\u4ec0\u4e48\u65f6\u5019\u9700\u8981\u53ef\u8ffd\u6eaf\u6027\uff1f<\/h3>\n<ul>\n<li>\u6cd5\u89c4\u8981\u6c42\uff1a\u533b\u7597\u5668\u68b0\uff08UDI\uff09\u3001\u98df\u54c1\uff08\u6279\u6b21\u8ffd\u6eaf\uff09\u3001\u6c7d\u8f66\uff08IATF 16949 \u5168\u91cf\u8ffd\u6eaf\uff09<\/li>\n<li>\u5408\u540c\u8981\u6c42\uff1a\u5ba2\u6237\u5728\u5408\u540c\u4e2d\u660e\u786e\u8ffd\u6eaf\u8981\u6c42<\/li>\n<li>\u7ec4\u7ec7\u81ea\u8eab\u98ce\u9669\uff1a\u9ad8\u4ef7\u503c\u4ea7\u54c1\u3001\u5b89\u5168\u5173\u952e\u4ea7\u54c1<\/li>\n<\/ul>\n<h3 id=\"_7\">\u5ba1\u6838\u5b9e\u4f8b<\/h3>\n<blockquote>\n<p>\u5ba1\u6838\u5458\u6307\u7740\u4ed3\u5e93\u91cc\u4e00\u7bb1\u96f6\u4ef6\u95ee\uff1a&#8221;\u8fd9\u7bb1\u96f6\u4ef6\u7684\u6765\u6599\u68c0\u9a8c\u8bb0\u5f55\u5728\u54ea\uff1f\u7528\u7684\u662f\u54ea\u4e2a\u4f9b\u5e94\u5546\u7684\u54ea\u6279\u6750\u6599\uff1f&#8221;<\/p>\n<\/blockquote>\n<p>\u5982\u679c\u4f60\u7ffb\u904d\u7cfb\u7edf\u90fd\u627e\u4e0d\u5230 \u2192 8.5.2 \u4e0d\u5408\u683c\u3002<\/p>\n<hr \/>\n<h2 id=\"853\">\u56db\u30018.5.3 \u987e\u5ba2\u6216\u5916\u90e8\u4f9b\u65b9\u7684\u8d22\u4ea7<\/h2>\n<h3 id=\"_8\">\u6807\u51c6\u8981\u6c42<\/h3>\n<blockquote>\n<p>\u7ec4\u7ec7\u5728\u63a7\u5236\u6216\u4f7f\u7528\u987e\u5ba2\u6216\u5916\u90e8\u4f9b\u65b9\u7684\u8d22\u4ea7\u65f6\uff0c\u5e94\u59a5\u5584\u4fdd\u62a4\u3002<\/p>\n<\/blockquote>\n<h3 id=\"_9\">\u4ec0\u4e48\u7b97&#8221;\u987e\u5ba2\/\u5916\u90e8\u4f9b\u65b9\u8d22\u4ea7&#8221;\uff1f<\/h3>\n<p>\u8fdc\u4e0d\u6b62&#8221;\u5ba2\u6237\u5bc4\u6765\u7684\u6837\u54c1&#8221;\u8fd9\u4e48\u7b80\u5355\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u7c7b\u578b<\/th>\n<th>\u793a\u4f8b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5b9e\u7269<\/td>\n<td>\u5ba2\u6237\u63d0\u4f9b\u7684\u539f\u6750\u6599\u3001\u6a21\u5177\u3001\u5de5\u88c5\u5939\u5177<\/td>\n<\/tr>\n<tr>\n<td>\u77e5\u8bc6\u4ea7\u6743<\/td>\n<td>\u5ba2\u6237\u63d0\u4f9b\u7684\u56fe\u7eb8\u3001\u914d\u65b9\u3001\u8f6f\u4ef6\u4ee3\u7801<\/td>\n<\/tr>\n<tr>\n<td>\u6570\u636e<\/td>\n<td>\u5ba2\u6237\u59d4\u6258\u5904\u7406\u7684\u4e2a\u4eba\u6570\u636e\u3001\u4e1a\u52a1\u6570\u636e<\/td>\n<\/tr>\n<tr>\n<td>\u573a\u6240<\/td>\n<td>\u5728\u5ba2\u6237\u73b0\u573a\u4f5c\u4e1a\u65f6\u7684\u573a\u5730\u548c\u8bbe\u65bd<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3 id=\"_10\">\u7ba1\u63a7\u8981\u6c42<\/h3>\n<ol>\n<li><strong>\u8bc6\u522b<\/strong>\uff1a\u6536\u5230\u65f6\u767b\u8bb0\u3001\u6807\u8bc6<\/li>\n<li><strong>\u4fdd\u62a4<\/strong>\uff1a\u59a5\u5584\u5b58\u50a8\u3001\u9632\u6b62\u635f\u574f<\/li>\n<li><strong>\u62a5\u544a<\/strong>\uff1a\u53d1\u73b0\u4e22\u5931\/\u635f\u574f\u65f6\u901a\u77e5\u5bf9\u65b9<\/li>\n<li><strong>\u8bb0\u5f55<\/strong>\uff1a\u4fdd\u7559\u76f8\u5173\u6210\u6587\u4fe1\u606f<\/li>\n<\/ol>\n<h3 id=\"_11\">\u5e38\u89c1\u7ffb\u8f66\u573a\u666f<\/h3>\n<ul>\n<li>\u5ba2\u6237\u6a21\u5177\u5728\u8f66\u95f4\u65e0\u4eba\u7ba1\u7406\uff0c\u6df7\u5165\u62a5\u5e9f\u533a<\/li>\n<li>\u5ba2\u6237\u63d0\u4f9b\u7684\u56fe\u7eb8\u88ab\u968f\u610f\u590d\u5370\u5206\u53d1\u7ed9\u65e0\u5173\u4eba\u5458<\/li>\n<li>SaaS \u670d\u52a1\u5546\u5904\u7406\u5ba2\u6237\u6570\u636e\u65f6\u672a\u533a\u5206\u6240\u6709\u6743\uff0c\u6570\u636e\u51fa\u5883\u8fdd\u89c4<\/li>\n<\/ul>\n<hr \/>\n<h2 id=\"854\">\u4e94\u30018.5.4 \u9632\u62a4<\/h2>\n<h3 id=\"_12\">\u6807\u51c6\u8981\u6c42<\/h3>\n<blockquote>\n<p>\u7ec4\u7ec7\u5728\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u671f\u95f4\uff0c\u5e94\u5bf9\u8f93\u51fa\u8fdb\u884c\u9632\u62a4\uff0c\u4ee5\u786e\u4fdd\u7b26\u5408\u8981\u6c42\u3002<br \/>\n\u9632\u62a4\u53ef\u5305\u62ec\u6807\u8bc6\u3001\u5904\u7f6e\u3001\u5305\u88c5\u3001\u50a8\u5b58\u3001\u4f20\u8f93\u6216\u8fd0\u8f93\u4ee5\u53ca\u4fdd\u62a4\u3002<\/p>\n<\/blockquote>\n<h3 id=\"_13\">&#8220;\u9632\u62a4&#8221;\u4e0d\u53ea\u662f\u5305\u88c5<\/h3>\n<p>\u6807\u51c6\u660e\u786e\u5217\u4e3e\u4e86\u516d\u4e2a\u7ef4\u5ea6\uff1a<\/p>\n<pre class=\"codehilite\"><code>\u6807\u8bc6 \u2192 \u5904\u7f6e \u2192 \u5305\u88c5 \u2192 \u50a8\u5b58 \u2192 \u4f20\u8f93 \u2192 \u4fdd\u62a4\n<\/code><\/pre>\n<table>\n<thead>\n<tr>\n<th>\u7ef4\u5ea6<\/th>\n<th>\u5178\u578b\u573a\u666f<\/th>\n<th>\u5e38\u89c1\u95ee\u9898<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u6807\u8bc6<\/strong><\/td>\n<td>\u6613\u788e\u54c1\u3001\u9632\u6f6e\u6807\u8bc6<\/td>\n<td>\u65e0\u6807\u8bc6\u6216\u6807\u8bc6\u8131\u843d<\/td>\n<\/tr>\n<tr>\n<td><strong>\u5904\u7f6e<\/strong><\/td>\n<td>\u642c\u8fd0\u65b9\u5f0f\uff08\u8f7b\u62ff\u8f7b\u653e\uff09<\/td>\n<td>\u7c97\u66b4\u642c\u8fd0\u5bfc\u81f4\u635f\u574f<\/td>\n<\/tr>\n<tr>\n<td><strong>\u5305\u88c5<\/strong><\/td>\n<td>\u7f13\u51b2\u6750\u6599\u3001\u5bc6\u5c01\u5305\u88c5<\/td>\n<td>\u5305\u88c5\u6750\u6599\u4e0d\u5339\u914d\u4ea7\u54c1\u7279\u6027<\/td>\n<\/tr>\n<tr>\n<td><strong>\u50a8\u5b58<\/strong><\/td>\n<td>\u4ed3\u5e93\u6e29\u6e7f\u5ea6\u3001\u5148\u8fdb\u5148\u51fa<\/td>\n<td>\u65e0\u73af\u5883\u63a7\u5236\u3001\u65e0FIFO<\/td>\n<\/tr>\n<tr>\n<td><strong>\u4f20\u8f93<\/strong><\/td>\n<td>\u52a0\u5bc6\u4f20\u8f93\u3001\u9632\u7be1\u6539<\/td>\n<td>\u654f\u611f\u6570\u636e\u660e\u6587\u4f20\u8f93<\/td>\n<\/tr>\n<tr>\n<td><strong>\u4fdd\u62a4<\/strong><\/td>\n<td>\u9632\u9759\u7535\u3001\u9632\u5c18\u3001\u9632\u9759\u7535\u624b\u73af<\/td>\n<td>\u65e0\u9759\u7535\u9632\u62a4\u63aa\u65bd<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3 id=\"_14\">\u670d\u52a1\u7c7b\u4ea7\u54c1\u7684\u9632\u62a4<\/h3>\n<p>\u5f88\u591a\u4eba\u4ee5\u4e3a 8.5.4 \u53ea\u9002\u7528\u4e8e\u5236\u9020\u4e1a\uff0c\u5176\u5b9e<strong>\u670d\u52a1\u4e5f\u9700\u8981\u9632\u62a4<\/strong>\uff1a<\/p>\n<ul>\n<li>\u8f6f\u4ef6\u4ea4\u4ed8\u524d\uff1a\u4ee3\u7801\u51bb\u7ed3\u3001\u7248\u672c\u63a7\u5236\u3001\u9632\u8bef\u53d1\u5e03<\/li>\n<li>\u54a8\u8be2\u670d\u52a1\uff1a\u4ea4\u4ed8\u524d\u6587\u6863\u7684\u7248\u672c\u63a7\u5236\u548c\u5ba1\u6279<\/li>\n<li>\u91d1\u878d\u670d\u52a1\uff1a\u5ba2\u6237\u6570\u636e\u5728\u4f20\u8f93\u548c\u5b58\u50a8\u4e2d\u7684\u52a0\u5bc6\u4fdd\u62a4<\/li>\n<\/ul>\n<hr \/>\n<h2 id=\"85_1\">\u516d\u3001\u5ba1\u6838\u5458\u89c6\u89d2\uff1a8.5 \u7684\u6838\u5fc3\u5ba1\u67e5\u8def\u5f84<\/h2>\n<p>\u5ba1\u6838\u5458\u5728\u73b0\u573a\u5ba1\u6838\u65f6\uff0c\u901a\u5e38\u6309\u4ee5\u4e0b\u8def\u5f84\u8d70\uff1a<\/p>\n<pre class=\"codehilite\"><code>\u7b56\u5212\u6587\u4ef6(8.1) \u2192 8.5.1\u8fc7\u7a0b\u63a7\u5236 \u2192 \u73b0\u573a\u5de1\u76d8 \u2192 8.5.2\u6807\u8bc6 \u2192 8.5.3\u5ba2\u8d22 \u2192 8.5.4\u9632\u62a4\n<\/code><\/pre>\n<p><strong>\u6700\u5e38\u5f00\u51fa\u4e0d\u7b26\u5408\u9879\u7684\u4e09\u4e2a\u70b9<\/strong>\uff1a<\/p>\n<ol>\n<li><strong>8.5.1 \u7279\u6b8a\u8fc7\u7a0b\u672a\u786e\u8ba4<\/strong>\uff1a\u6ca1\u6709\u786e\u8ba4\u8bb0\u5f55\uff0c\u6216\u786e\u8ba4\u8fc7\u671f\u672a\u518d\u786e\u8ba4<\/li>\n<li><strong>8.5.2 \u72b6\u6001\u6807\u8bc6\u7f3a\u5931<\/strong>\uff1a\u8f66\u95f4\u91cc\u5206\u4e0d\u6e05\u54ea\u4e2a\u662f\u5408\u683c\u54c1\u3001\u54ea\u4e2a\u662f\u5f85\u68c0\u54c1<\/li>\n<li><strong>8.5.4 \u9632\u62a4\u4e0d\u5230\u4f4d<\/strong>\uff1a\u4ed3\u5e93\u73af\u5883\u5931\u63a7\u3001\u5305\u88c5\u4e0d\u5f53\u3001\u6570\u636e\u4f20\u8f93\u65e0\u52a0\u5bc6<\/li>\n<\/ol>\n<h3 id=\"_15\">\u73b0\u573a\u5ba1\u6838\u5feb\u901f\u81ea\u68c0<\/h3>\n<p>\u8d70\u5230\u751f\u4ea7\/\u670d\u52a1\u73b0\u573a\uff0c\u95ee\u81ea\u5df1\u4e09\u4e2a\u95ee\u9898\uff1a<\/p>\n<ol>\n<li><strong>\u64cd\u4f5c\u4eba\u5458\u6709\u6ca1\u6709&#8221;\u89c4\u77e9&#8221;\u53ef\u5faa\uff1f<\/strong>\uff088.5.1 \u2460\u2461\uff09<\/li>\n<li><strong>\u6211\u80fd\u5206\u6e05\u54ea\u4e2a\u662f\u5408\u683c\u7684\u3001\u54ea\u4e2a\u662f\u4e0d\u5408\u683c\u7684\u5417\uff1f<\/strong>\uff088.5.2\uff09<\/li>\n<li><strong>\u4ea7\u54c1\/\u670d\u52a1\u5728\u4ea4\u4ed8\u7ed9\u6211\u4e4b\u524d\uff0c\u4fdd\u62a4\u5f97\u597d\u4e0d\u597d\uff1f<\/strong>\uff088.5.4\uff09<\/li>\n<\/ol>\n<p>\u5982\u679c\u4e09\u4e2a\u95ee\u9898\u7684\u7b54\u6848\u90fd\u662f&#8221;\u80fd&#8221;\uff0c8.5 \u7684\u98ce\u9669\u57fa\u672c\u53ef\u63a7\u3002<\/p>\n<hr \/>\n<h2 id=\"iso-90012026\">\u4e03\u3001\u5c55\u671b\uff1aISO 9001:2026 \u7248\u53ef\u80fd\u7684\u53d8\u5316<\/h2>\n<p>\u5f53\u524d CD\uff08\u59d4\u5458\u4f1a\u8349\u6848\uff09\u9636\u6bb5\uff0c8.5 \u6761\u6b3e\u5728\u7ed3\u6784\u4e0a\u9884\u8ba1\u4e0d\u4f1a\u5927\u6539\uff0c\u4f46\u6709\u51e0\u4e2a\u8d8b\u52bf\u503c\u5f97\u5173\u6ce8\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53d8\u5316\u65b9\u5411<\/th>\n<th>\u5f71\u54cd<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5f3a\u5316<strong>\u6570\u5b57\u5316\u8f6c\u578b<\/strong>\u4e2d\u7684\u8fc7\u7a0b\u63a7\u5236<\/td>\n<td>\u8f6f\u4ef6\u5f00\u53d1\u3001AI \u8f85\u52a9\u51b3\u7b56\u7b49\u573a\u666f\u7eb3\u5165 8.5.1<\/td>\n<\/tr>\n<tr>\n<td><strong>\u6c14\u5019\u53d8\u5316<\/strong>\u76f8\u5173\u8981\u6c42\u4e0b\u6c89\u5230\u8fd0\u884c\u5c42<\/td>\n<td>8.5.4 \u9632\u62a4\u53ef\u80fd\u589e\u52a0\u73af\u5883\u9002\u5e94\u6027\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u5f3a\u5316<strong>\u670d\u52a1\u884c\u4e1a<\/strong>\u9002\u7528\u6027<\/td>\n<td>&#8220;\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b&#8221;\u53ef\u80fd\u8fdb\u4e00\u6b65\u62c6\u5206\u670d\u52a1\u573a\u666f<\/td>\n<\/tr>\n<tr>\n<td>\u4f9b\u5e94\u94fe\u97e7\u6027<\/td>\n<td>8.5.3 \u53ef\u80fd\u6269\u5c55\u5bf9\u5916\u90e8\u4f9b\u65b9\u8d22\u4ea7\u7684\u7ba1\u63a7\u8303\u56f4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr \/>\n<h2 id=\"_16\">\u603b\u7ed3<\/h2>\n<p>8.5 \u662f ISO 9001 \u8fd0\u884c\u63a7\u5236\u7684&#8221;\u4e3b\u6218\u573a&#8221;\uff0c\u5b83\u7684\u903b\u8f91\u53ef\u4ee5\u7528\u4e00\u53e5\u8bdd\u6982\u62ec\uff1a<\/p>\n<blockquote>\n<p><strong>\u8fc7\u7a0b\u8981\u6709\u89c4\u77e9\uff088.5.1\uff09\uff0c\u8fc7\u7a0b\u53ef\u8ffd\u6eaf\uff088.5.2\uff09\uff0c\u522b\u4eba\u7684\u4e1c\u897f\u8981\u7ba1\u597d\uff088.5.3\uff09\uff0c\u4ea4\u4ed8\u524d\u8981\u4fdd\u62a4\u597d\uff088.5.4\uff09\u3002<\/strong><\/p>\n<\/blockquote>\n<p>\u5ba1\u6838\u65f6\uff0c\u8fd9\u56db\u6761\u4e0d\u662f\u5b64\u7acb\u5ba1\u67e5\u7684\uff0c\u800c\u662f\u4e00\u6761\u94fe\u6761\u2014\u2014\u4ece\u8fc7\u7a0b\u63a7\u5236\u5230\u8fc7\u7a0b\u8f93\u51fa\u4fdd\u62a4\uff0c\u4efb\u4f55\u4e00\u4e2a\u73af\u8282\u65ad\u88c2\u90fd\u53ef\u80fd\u4ea7\u751f\u4e0d\u5408\u683c\u54c1\u3002<\/p>\n<hr \/>\n<h2 id=\"_17\">\u53c2\u8003\u8d44\u6e90<\/h2>\n<ul>\n<li>ISO 9001:2015 \u7b2c8.5\u6761\u539f\u6587<\/li>\n<li>ISO 9000:2015 \u672f\u8bed\u5b9a\u4e49\uff083.5.2 \u7279\u6b8a\u8fc7\u7a0b\uff09<\/li>\n<li>IATF 16949:2016 \u7b2c8.5 \u6761\uff08\u6c7d\u8f66\u884c\u4e1a\u7684\u5f3a\u5316\u8981\u6c42\uff09<\/li>\n<li>ISO 13485:2016 \u7b2c7.5 \u6761\uff08\u533b\u7597\u5668\u68b0\u7684\u8ffd\u6eaf\u548c\u8fc7\u7a0b\u786e\u8ba4\u8981\u6c42\uff09<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>ISO 9001 \u7b2c8.5\u6761\u6df1\u5ea6\u62c6\u89e3\uff1a\u751f\u4ea7\u548c\u670d\u52a1\u63d0\u4f9b\u2014\u2014\u8d28\u91cf\u7ba1\u7406\u7684&#8221;\u4e3b\u6218\u573a&#8221; ISO  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