PDF《ISO 9001 新版标准及转》

5 Strategic Changes to Date Strategic Changes to Date Strategic Changes to Date Strategic Changes to Date 到目前为止的策略转变 15/03/2017 Copyright ?

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9 ? Exclusion 排除条款 (A5), 未明确限定条款. shall not affect the organization'

s ability or responsibility. ex: clause 7.1.5 (MM resources) and some clauses in the clause

8 operation, such as 8.3 design and development, 8.5.3 property of customers/providers. ? No Quality Manual clause 没有品质手册条款.(4.2.2) does not include a clause giving specific requirements for '

quality manual'

, but shall establish its QMS scope (4.3). ? No Management Representative clause 没有管理代表条款.(5.5.2) does not include a clause giving specific requirements for '

Management Representative'

appointment, but it is in its role/R&

A (5.3). ? No special process clause (752) replaced by 8.5.1.(f). 特殊制程 does not include a clause for special process, but incorporated into the clause Control of product and service provision clause 8.5.1.(f). ? No Preventive action clause 没有预防措施条款.(853) replaced by 6.1 risk. doesn'

t include a clause giving specific requirements for Preventive Action, but replaced by risk management in clauses (6.1) …etc. (风险取代之) 组织不需要 (Organizations do not need to) ? 废除 MR制度(Remove their management representatives). While there is no requirement in ISO 9001:2015 for a management representative, this does not prevent organizations from choosing to retain this role if they so wish. ? 丢掉 QM手册(Throw out their Quality). While ISO 9001:2015 sets out no requirement for organizations to hold either a Quality Manual or Documented Procedures, if this documentation is in place, needed and working well, there is no need for it to be withdrawn. ? 丢掉程序书/标准书及其他文件 (Throw out their Documented Procedures). While ISO 9001:2015 sets out no requirement for organizations to hold either a Quality Manual or Documented Procedures, if this documentation is in place, needed and working well, there is no need for it to be withdrawn ? 重编程序书文件号码: Renumber existing QMS documentation to correspond to the new clause references. 不需要改变的改变 Key changes you do not need to change 15/03/2017

6 可以改变的考量 Key changes you can change Key changes you can ch........