GBT19002016质量管理体系新要求及条款标准要求文件的差距分析表

1、GBT19001-2016质量管理体系新要求及条款标准要求文件的差距分析表Part 1: New Co ncepts第一部分：新概念Tip: En sure that these new con cepts have bee n deployed in a manner that supports theProcess Approach and Risk Based Thinking提示：确保这些新概念已经以某种方式部署以支持过程方法和基于风险的思维New Con cepts新概念Phase阶段Clause(s) 条款Activity活动Evide nce of complia nce 符合性

2、证据Remark备注Busin ess Planning and Strategic Directio n经营策划和战略方 向Ide ntify 确定4.1, 4.2Have you ide ntified both in ter nal and exter nal issues and in terested parties that are releva nt to an d/or support the strategic directio n of your orga ni sati on?是否已经确定与组织有关的或者支持战略方向内、外部相关方和利益组织质量手册、经营计 划、方针目标A

3、ssess评估4.1,4.2,5.1.1,9.3.2,Is the strategic direct ion being assessed, reviewed and alig ned with the quality policy and objectives by top man ageme nt?高层管理是否已经评估、评审了战略方向和质量方针的一致性及证据质量手册、会议记 录、方针目标New requireme nt for the adopti on of a process approach (where before this was suggested) 采用过程方法的新 要求(

4、此前为建议)Ide ntify 确定4.4Has planning for the quality management system determined the processes of your orga ni sati on, their in puts and outputs and seque nee and in teracti on?是否已经策划确定组织的质量管理体系过程，输入、输出以及顺序 和相互作用？Is mon itori ng and measureme nt of the processes in place?过程的监视和测量是否已经确定？Are processes

5、docume nted to the exte nt n ecessary to support their operati on?过程是否已文件化以在一定程度上支持过程运行？Is docume nted in formati on available to provide con fide nce that the processes are being carried out as pla nn ed?是否有可获得的文件化信息以确信过程按策划进行？过程分析展开表 体系工程顺序相互 关系体系过程职责分配 表程序文件清单Action措施5.2.1Is the strategic directi

6、o n being utilised as an in put to the Quality Policy / Quality Objectives / Risk Man ageme nt / Man ageme nt Review processes?战略方向是否可以作为质量方针、质量目标、风险管理、管理评审过 程的输出？质量手册New Con cepts新概念Phase阶段Clause(s) 条款Activity活动Evide nce of complia nce 符合性证据Remark备注Process Risk 过程风险Ide ntify 确定6.1, 6.2Have risks to

7、 achiev ing process objectives bee n ide ntified-i.e.what problems or mistakes might occur?是否已识别获得过程证据的风险，如可能会发生什么问题或者错误？内外部重大风险清 单Assess评估4.4.1,6.3Have these risks bee n con sidered and addressed whe n establishi ng the QMS and whe n pla nning for cha nge to the QMS-i.e. what checks and balances ha

8、ve you incorporated into your activities to preve nt problems or mistakes?是否已考虑并解决在建立QMS和QMS变更的策划过程中遇到的风险，女口，在整合活动中米取了什么样的检查与制衡措施以预防问题或 者错误？质量手册SWOT分析报告YESAction措施6.3, 8.5.6Are process risks, (ie pote ntial problems or errors), con sidered dur ing pla nning for cha nge, and follow ing uninten ded ch

9、a nge, to en sure requireme nts continue to be met.进行变更策划以及伴随的非预期变更时，是否将过程风险(如潜在问题或错误)考虑进去，以确保持续地符合要求？质量手册SWOT分析报告YESAction措施10.2.1Following corrective actions, is there evidence that process risks have bee n reviewed, i.e. checks made to en sure the problem does not occur aga in, or new problems, (

10、risks) are not in troduced.进行纠正行动时，是否有过程风险的评审证据，如作出的检查以确保冋题不再发生，或者新的冋题(风险)不再出现。持续改进控制程序 纠正预防措施控制 程序Mo nitor 监视9.1.3,9.3.2Are you an alys ing the effective ness of actions take n to address process risks? How do you know your processes are effective and efficie nt?是否对应对过程风险采取的行动进行有效性分析？是如何知道过程 是有效的？检

11、验和试验控制程 序数据分析控制程序Product Risk 产品风险Ide ntify 确定5.1.2, 6.1,6.2, 8.3.2Have you identified the barriers or risks to achieving product or service complia nce? Has product complexity bee n con sidered duri ng desig n pla nning?是否识别获得符合要求的产品与服务会遇到的障碍或风险？是否在 涉及策划阶段就已经考虑产品复杂性？组织环境分析控制 程序法律法规清单Assess评估8.1Have

12、 these barriers/risks bee n con sidered as part of your pla nning of operati ons?运行策划中的障碍、风险是否已经考虑？组织环境识别表New Con cepts新概念Phase阶段Clause(s) 条款Activity活动Evide nce of complia nce 符合性证据Remark备注Assess评估8.2.2,8.2.3Have these product risks bee n con sidered whe n determ ining and review ing your customer r

13、equireme nts?确定和评审顾客要求时是否已经考虑产品风险？r品安全特性清Action措施834, 8.1Are the selected design and operational controls sensitive to the identified risks -i.e. appropriate for the likely consequences of failure?选定的设计和运行控制是否对识别的风险敏感，如对失败的可能后果的适当的感知产品安全控制程序Mo nitor 监视9.1.3,9.3.2Are you an alys ing the effective nes

14、s of the above actions, (take n to address product risks)?是否对上述行动的有效性进行分析(用来解决产品风险)？检验和试验控制程 序数据分析控制程序Risk to the provisi on of exter nally provided product (outsourci ng) 外部提供的产品(外 包)的风险Ide ntify 确定6.1Have risks associated with externally provided product and services, (outsourc in g), bee n ide nt

15、ified? For example, have you applied some form of criticality measure or rating, (formal or in formal), to your subc on tractors?外部提供的产品和服务(外包)的风险是否已经确定？例如：是否对 分包商进行某种形式的关键性测量或评级，(正式或非正式的)？供方控制程序 米购控制程序Assess评估8.4.1,8.4.2Do ide ntified risks or criticalitydeterm ine or in flue nce the type andexte n

16、t of con trols or oversight applied to the识别的风险或者关键性决定或者控制类型和程度的影响或监督是否适用于 selecti on of exter nal resources or suppliers外部资源或供应商的选择 con trols or oversightapplied to these exter nal resourcesor suppliers外部资源或供应商的控制或监督 degree of in formati on provided to these exter nal resources or suppliers?提供给外部资源

17、或供应商的信息的程度供方控制程序 米购控制程序Mo nitor 监视9.1.3,9.3.2Are you an alys ing the effective ness of actions take n to address risks aris ing from the use of exter nal resources - subc on tractors or suppliers?是否通过使用外部资源一一分包商或者供应商，对采取的行动进行有效性分析以应对风险？供方业绩监控记录 表GBT19001:2016 Gap An alysis Tool v1Part 2: ISO 9001:20

18、15 Requirements第二部分 ISO 9001:2015 的要求Tip: en sure that you can dem on strate that each requireme nt of ISO 9001:2015 has bee n addressed within the QMS.提示： 确保组织可以说明ISO 9001:2015的每一个要求已经应用在 QMS里面。ISO 9001:2015ISO 9001:2008 Cross Refere nee and the sig nifica nt cha nges from the 2008 vers ionISO 9001

19、:2008交叉引用和2008版的显著变化Evide nee of complia nee 符合性证据have Met the requireme nts of this clause?是否满足这些条 款的要求Remark备注YesNo4.1 Un dersta nding the orga ni sati on and its con text 理解组织及其环境New Requireme nt: addressed in part 1 above 新要求：上述第一部分已阐述组织环境分析控制程序4.2 Un dersta nding the n eeds and expectations of interested parties 理解相关方的需求和期望New Requireme nt: addressed in part 1 above 新要求：上述第一部分已阐述相关方需求与期望 表4.3 Determ ining the scope of the quality ma