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1、Q#ISO 9001:2015 Clause Audit Question Audit Evidence 4 Context of the Organization 4.1 Understanding the organization and its context 4.1q1 The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achiev
2、e the intended result(s)of its quality management system.How has the organization determined external and internal issues relevant to its purpose and strategic direction?How do these affect the ability to achieve the intended result of the QMS?4.1q2 The organization shall monitor and review the info
3、rmation about these external and internal issues.How do you monitor and review information about these internal and external issues?NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal,technological,competitive,market,cultural,social,and economic envi
4、ronments,whether international,national,regional or local.NOTE 2 Understanding the internal context can be facilitated by considering issues related to values,culture knowledge and performance of the organization.4.2 Understanding the needs and expectations of interested parties 4.2q1 Due to their i
5、mpact or potential impact on the organizations ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements,the organization shall determine:a)the interested parties that are relevant to the quality management system;b)the requirements
6、 of these interested parties that are relevant to the quality management system.How have you determined what interested parties are relevant to the QMS?How have you determined what requirements those parties have that are relevant to the QMS?How has impact or potential impact been determined?4.2q2 T
7、he organization shall monitor and review the information about these interested parties and their relevant requirements.How do you monitor and review the information about interested parties and their relevant requirements?4.3 Determining the scope of the quality management system 4.3q1 The organiza
8、tion shall determine the boundaries and applicability of the quality management system to establish its scope.How have the boundaries and applicability of the QMS been used to establish the scope of the organization?4.3q2 When determining this scope,the organization shall consider:a)the external and
9、 internal issues referred to in 4.1;b)the requirements of relevant interested parties referred to in 4.2;c)the products and services of the organization.How have:The external and internal issues;The requirements of relevant interested parties and;The products and services of the organization been co
10、nsidered when determining the scope of the organization?4.3q3 Where a requirement of this International Standard within the determined scope can be applied,then it shall be applied by the organization.How has the application of the International Standard within the scope been determined,and how has
11、it been applied by the organization?4.3q4 If any requirement(s)of this International Standard cannot be applied,this shall not affect the organizations ability or responsibility to ensure conformity of products and services.How have any requirements of the International Standard been determined as n
12、ot applicable?Show me how conformity of products and services are not affected by this.2/23 Q#ISO 9001:2015 Clause Audit Question Audit Evidence 4.3q5 The scope shall be available and be maintained as documented information stating the:-products and services covered by the quality management system;
13、-justification for any instance where a requirement of this International Standard cannot be applied.Where is the scope available?Where is it maintained as documented information?Does it state what products and services are covered by the QMS?Does it justify how instances of requirements of the QMS
14、cannot be applied?Scope required as documented information.4.4 Quality management system and its processes 4.4q1 The organization shall establish,implement,maintain and continually improve a quality management system,including the processes needed and their interactions,in accordance with the requir
15、ements of this International Standard.How has the QMS been established?Show me how this is implemented.How is it maintained and continually improved?How have the processes been determined and how do they interact?4.4q2 The organization shall determine the processes needed for the quality management
16、system and their application throughout the organization and shall determine:a)the inputs required and the outputs expected from these processes;b)the sequence and interaction of these processes;c)the criteria,methods,including measurements and related performance indicators needed to ensure the eff
17、ective operation,and control of these processes;d)the resources needed and ensure their availability;e)the assignment of the responsibilities and authorities for these processes;f)the risks and opportunities in accordance with the requirements of 6.1,and plan and implement the appropriate actions to
18、 address them;g)the methods for monitoring,measuring,as appropriate,and evaluation of processes and,if needed,the changes to processes to ensure that they achieve intended results;h)opportunities for improvement of the processes and the quality management system.How have the processes been determine
19、d for the QMS?What are the inputs and outputs for those processes?What is the sequence and interaction of the processes?What are the criteria,methods,measurement and related performance indicators needed to operate and control those processes?What resources are needed and how are these made availabl
20、e?How are responsibilities and authorities assigned for those processes?How are risks and opportunities considered and what plans are made to implement actions to address them?What methods are used to monitor,measure and evaluate processes and,if needed,what changes are made to achieve intended resu
21、lts?How are opportunities to improve the processes and the QMS determined?4.4q3 The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are bei
22、ng carried out as planned.What documented information exists to support the operation of processes?How is this documented information retained?How is confidence that the processes are being carried out as planned determined?Documented information to support the operation of processes.5 Leadership 5.
23、1 Leadership and commitment 5.1.1 Leadership and commitment for the quality management system 3/23 Q#ISO 9001:2015 Clause Audit Question Audit Evidence 5.1.1q1 Top management shall demonstrate leadership and commitment with respect to the quality management system by:a)taking accountability of the e
24、ffectiveness of the quality management system;b)ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and the context of the organization;c)ensuring that the quality policy is communicated,understood
25、and applied within the organization;d)ensuring the integration of the quality management system requirements into the organizations business processes;e)promoting awareness of the process approach;f)ensuring that the resources needed for the quality management system are available;g)communicating th
26、e importance of effective quality management and of conforming to the quality management system requirements;h)ensuring that the quality management system achieves its intended results;i)engaging,directing and supporting persons to contribute to the effectiveness of the quality management system;j)p
27、romoting continual improvement;k)supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.Show me how top management demonstrates leadership and commitment w.r.t.the QMS by taking accountability of the effectiveness of the QMS.How is t
28、he quality policy and objectives established for the QMS and how are they compatible with the strategic direction and the organizational context?How is the quality policy communicated within the organization?Show me how this is understood and applied.How are the requirements of the QMS integrated in
29、to the business processes?How do you promote awareness of the process approach?How do you ensure that resources needed for the QMS area available?How do you communicate the importance of effective quality management?How do you communicate the importance of conforming to the QMS requirements?How do y
30、ou ensure that the QMS achieves its intended results?How do you engage,direct and support people to contribute to the effectiveness of the QMS?How do you promote continual improvement?How do you support other relevant management roles to demonstrate leadership in their areas of responsibility?NOTE R
31、eference to“business”in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organizations existence;whether the organization is public,private,for profit or not for profit.5.1.2 Customer focus 4/23 Q#ISO 9001:2015 Clause Audit Question
32、 Audit Evidence 5.1.2q1 Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:a)customer requirements and applicable statutory and regulatory requirements are determined and met;b)the risks and opportunities that can affect conformity of products
33、and services and the ability to enhance customer satisfaction are determined and addressed;c)the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained;d)the focus on enhancing customer satisfaction is maintained.Sh
34、ow me how top management demonstrates leadership and commitment w.r.t.customer focus ensuring requirements and applicable statutory and regulatory requirements are determined and met.How are risks and opportunities that can affect conformity of products and services determined?How is the ability to
35、enhance customer satisfaction determined and addressed?How is the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements maintained?How is customer satisfaction maintained?5.2 Quality policy 5.2.1 5.2.1q1 Top management shall est
36、ablish,review and maintain a quality policy that:a)is appropriate to the purpose and context of the organization;b)provides a framework for setting and reviewing quality objectives;c)includes a commitment to satisfy applicable requirements;d)includes a commitment to continual improvement of the qual
37、ity management system.How does top management establish,review and maintain a quality policy?How is it determined to be appropriate to the purpose and context of the organization?Does it provide a framework for setting and reviewing quality objectives?Does it contain a commitment to satisfy applicab
38、le requirements?Does it include a commitment to continual improvement of the QMS?5.2.2 5.2.2q1 The quality policy shall:a)be available as documented information;b)be communicated,understood and applied within the organization;c)be available to relevant interested parties,as appropriate.Where is the
39、quality policy available as documented information?How is it communicated?Show me how it is understood and applied within the organization.How have you made it available to relevant interested parties?Quality Policy as document information 5.3 Organizational roles,responsibility and authorities 5.3q
40、1 Top management shall ensure that the responsibilities and authorities for relevant roles are assigned,communicated and understood within the organization.How does top management ensure that responsibilities and authorities for relevant roles are assigned,communicated and understood within the orga
41、nization?5/23 Q#ISO 9001:2015 Clause Audit Question Audit Evidence 5.3q2 Top management shall assign the responsibility and authority for:a)ensuring that the quality management system conforms to the requirements of this International Standard;b)ensuring that the processes are delivering their inten
42、ded outputs;c)reporting on the performance of the quality management system,on opportunities for improvement and on the need for change or innovation,and especially for reporting to top management;d)ensuring the promotion of customer focus throughout the organization;e)ensuring that the integrity of
43、 the quality management system is maintained when changes to the quality management system are planned and implemented.How does top management assign the responsibility and authority for:Ensuring that the QMS conforms to the International standard?Ensuring processes are delivering their intended out
44、puts?How is the performance of the QMS,opportunities for improvement and the need for change or innovation reported to top management?How is customer focus promoted within the organization?How is the integrity of the QMS maintained when changes to the QMS are planned and implemented?6 Planning for t
45、he quality management system 6.1 Actions to address risks and opportunities 6.1.1 6.1.1q1 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 ad
46、dressed to:a)give assurance that the quality management system can achieve its intended result(s);b)prevent,or reduce,undesired effects;c)achieve continual improvement.How are the internal and external issues and interested parties considered when planning for the QMS?How are risks and opportunities
47、 determined and addressed so that the QMS can:a)achieve its intended results;b)Prevent or reduce undesired effects;c)Achieve continual improvement?6.1.2 6.1.2q1 The organization shall plan:a)actions to address these risks and opportunities;b)how to:1)integrate and implement the actions into its qual
48、ity management system processes(see 4.4);2)evaluate the effectiveness of these actions.How are actions planned to address risks and opportunities?How are actions integrated and implemented into the QMS processes?How do you evaluate the effectiveness of the actions?6.1.2q2 Actions taken to address ri
49、sks and opportunities shall be proportionate to the potential impact on the conformity of products and services.How are actions taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services?6.2.2.1 Product design skills 6.
50、2.2.1q1 The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques.Applicable tools and techniques shall be identified by the organization.How do you determine that personnel with pro