个人建议：组织环境（含内外部环境）归口部门应为公司高层（总经室）比较合适。
4.1条款是最高管理者的职责.具体这些事是谁去做,怎么做,然后怎么检查,不符合要求的怎么改善等等,那得看你自己公司的策划安排.需不需要形成文件,你可以自己去看标准的要求~,如果在审核时,没有相关证据的支持,仅仅靠自己的嘴巴说,你认为这样是否可行?
每个公司的产品.范围.企业所在地;顾客等等不一样,那么你的内外部背景因素也不一样。比方说,一家做电镀的企业和一家做软件开发的企业,它们所处的相关背景因素差的有多少,自己可以评估一下。:lol
对于组织环境，可以不做程序文件规定，外审时只要进行叙述就行，但必需要有环境的识别和评价，形成这样一个表单，进行内外部环境的识别、分析、评价包括采取的对应措施就可以了，以上是个人观点，谨供参考。
;P;P;P
谢谢分享
According to my comment from ISO consult, there is no need to generate any documented information, but the big boss should have the concept in mind, and build out the business plan, and company target and policy. Then each depts have their own goal for follow.
So, the each goal should meet the policy and plan big boss said.
dashtsai 发表于 2017-9-25 11:37
According to my comment from ISO consult, there is no need to generate any documented information, b ...
I'm very appreciated your explanation. I'm worried that if there is no documentation as the evidence to support this clause, just through the top management's statement, whether it's availabe or not. Meanwhile,
according to 6.1.1 clause, we need to consider 4.1& 4.2 requirements, and determine the risk and opportunity.
So, is available to us no documentation to support these clause?
:Q
for 6.1.1:
When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
Like I mentioned, the big boss will stated what he think, and then each dept should generate the target and way of working to fulfill what the big boss think. Then they become the evidence of the connection of clause 4 and 6.