Q# |
ISO 9001:2015 Clause |
Audit Question |
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4 Context of the Organization |
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4.1 Understanding the organization and its context |
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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 achieve 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? |
4.1q2 |
The organization shall monitor and review the information about these external and internal issues. |
How do you monitor and review information about these internal and external issues? |
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NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local. |
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4.2 Understanding the needs and expectations of interested parties |
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4.2q1 |
Due to their impact or potential impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
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How have you determined what interested parties are relevant to the QMS? |
4.2q2 |
The 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? |
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4.3 Determining the scope of the quality management system |
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4.3q1 |
The organization 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:
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How have: |
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 it been applied by the organization? |
4.3q4 |
If any requirement(s) of this International Standard cannot be applied, this shall not affect the organization’s ability or responsibility to ensure conformity of products and services. |
How have any requirements of the International Standard been determined as not applicable? Show me how conformity of products and services are not affected by this. |
4.3q5 |
The scope shall be available and be maintained as documented information stating the:
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Where is the scope available? Where is it maintained as documented information? |
4.4 Quality management system and its processes |
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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 requirements 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 system and their application throughout the organization and shall determine: |
How have the processes been determined for the QMS? |
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 being 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? |
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5 Leadership |
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5.1 Leadership and commitment |
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5.1.1 Leadership and commitment for the quality management system |
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5.1.1q1 |
Top management shall demonstrate leadership and commitment with respect to the quality management system by: |
Show me how top management demonstrates leadership and commitment w.r.t. the QMS by taking accountability of the effectiveness of the QMS. |
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NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence; whether the organization is public, private, for profit or not for profit.
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5.1.2 Customer focus |
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5.1.2q1 |
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: |
Show 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. |
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5.2 Quality policy |
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5.2.1 |
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5.2.1q1 |
Top management shall establish, review and maintain a quality policy that: |
How does top management establish, review and maintain a quality policy? |
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5.2.2 |
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5.2.2q1 |
The quality policy shall: |
Where is the quality policy available as documented information? |
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5.3 Organizational roles, responsibility and authorities |
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5.3q1 |
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 organization? |
5.3q2 |
Top management shall assign the responsibility and authority for: |
How does top management assign the responsibility and authority for: |
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6 Planning for the quality management system |
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6.1 Actions to address risks and opportunities |
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6.1.1 |
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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 |
How are the internal and external issues and interested parties considered when planning for the QMS?
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6.1.2 |
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6.1.2q1 |
The organization shall plan: |
How are actions planned to address risks and opportunities? |
6.1.2q2 |
Actions taken to address risks 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 |
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6.2.2.1q1 |
The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques. |
How do you determine that personnel with product design responsibility are competent to achieve design requirements? How do you determine skills required in applicable tools and techniques? How do you identify applicable tools and techniques? |
NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision. |
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6.2 Quality objectives and planning to achieve them |
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6.2.1 |
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6.2.1q1 |
The organization shall establish quality objectives at relevant functions, levels and processes. |
Where are the quality objectives and are these at all relevant functions, levels and processes? |
6.2.2 |
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6.2.2q1 |
When planning how to achieve its quality objectives, the organization shall determine: |
How does the organization determine what will be done, with what resources, when completed and how will results be evaluated for quality objectives? |
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6.3 Planning of changes |
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6.3q1 |
Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic manner.
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How are changes to the QMS planned systematically? |
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7 Support |
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7.1 Resources |
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7.1.1 General |
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7.1.1q1 |
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. |
Demonstrate how resources are determined for the establishment, implementation, maintenance and continual improvement of the QMS. |
7.1.2 People |
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7.1.2q1 |
To ensure that the organization can consistently meet customer and applicable statutory and regulatory requirements, the organization shall provide the persons necessary for the effective |
How do you provide persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes? |
7.1.3 Infrastructure |
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7.1.3q1 |
The organization shall determine, provide and maintain the infrastructure for the operation of its processes to achieve conformity of products and services. |
How do you determine, provide and maintain the infrastructure for the operation of processes to achieve products and service conformity? |
NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer. |
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7.1.4 Environment for the operation of processes |
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7.1.4q1 |
The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. |
How do you determine, provide and maintain the environment for the operation of processes to achieve products and service conformity? |
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NOTE Environment for the operation of processes can include physical, social, psychological, environmental and other factors (such as temperature, humidity, ergonomics and cleanliness). |
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7.1.5 Monitoring and measuring resources |
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7.1.5q1 |
Where monitoring or measuring is used for evidence of conformity of products and services to specified requirements the organization shall determine the resources needed to ensure valid and reliable monitoring and measuring results. |
How are the resources determined for ensuring valid and reliable monitoring and measuring results, where used? |
7.1.5q2 |
The organization shall ensure that the resources provided: |
How do you ensure that resources provided are suitable for the specific monitoring and measurement activities and are maintained to ensure continued fitness for purpose? |
7.1.5q3 |
The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measurement resources. |
Show me the documented information which is evidence of fitness for purpose of monitoring and measurement resources. |
7.1.5q4 |
Where measurement traceability is: a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by the organization to be an essential part of providing confidence in the validity of measurement results; measuring instruments shall be: |
Where applicable, show me how measurement instruments are: |
7.1.5q5 |
The organization shall determine if the validity of previous measurement results has been adversely affected when an instrument is found to be defective during its planned verification or calibration, or during its use, and take appropriate corrective action as necessary. |
How do you determine the validity of previous measurements if you find an instrument to be defective during verification or calibration? |
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7.1.6 Organizational knowledge |
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7.1.6q1 |
The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. |
How do you determine necessary knowledge for the operation of processes? How do you determine necessary knowledge to achieve conformity of products and services? |
7.1.6q2 |
This knowledge shall be maintained, and made available to the extent necessary. |
How do you maintain this knowledge and how do you make it available to the extent necessary? |
7.1.6q3 |
When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge. |
How do you consider current knowledge and how do you acquire additional knowledge when addressing changing needs and trends? |
NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned.
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7.2 Competence |
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7..2q1 |
The organization shall: |
Show me how: |
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-assignment of currently employed persons; or the hiring or contracting of competent persons. |
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7.3 Awareness |
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7.3q1 |
Persons doing work under the organization’s control shall be aware of: |
How are people aware of: |
7.4 Communication |
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7.4q1 |
The organization shall determine the internal and external communications relevant to the quality management system including: |
How do you determine internal and external communications relevant to the QMS? |
7.5 Documented information |
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7.5.1 General |
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7.5.1q1 |
The organization’s quality management system shall include: |
What documented information do you have as required by this standard? |
NOTE The extent of documented information for a quality management system can differ from one
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7.5.2 Creating and updating |
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7.5.2q1 |
When creating and updating documented information the organization shall ensure appropriate: |
Show me that your documented information contains: |
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7.5.3 Control of documented information |
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7.5.3.1 |
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7.5.3.1q1 |
Documented information required by the quality management system and by this International Standard shall be controlled to ensure: |
Show me how you control documented information. |
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7.5.3.2 |
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7.5.3.2q1 |
For the control of documented information, the organization shall address the following |
When controlling documented information, how do you address: |
7.5.3.2q2 |
Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and controlled. |
How do you identify as appropriate and control documented information of external origin which you have determined as necessary for the QMS |
NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.
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8 Operation |
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8.1 Operational planning and control |
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8.1q1 |
The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and to implement the actions determined in 6.1, by: |
How are processes needed to meet requirements for provision of products and services planned, implemented and controlled? |
8.1q2 |
The output of this planning shall be suitable for the organization's operations. |
How have you determined that the output from the planning process is suitable for your operations? |
8.1q3 |
The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. |
How do you control planned changes? How do you review the consequences of unintended changes? What action is taken to mitigate any adverse effects? |
8.1q4 |
The organization shall ensure that outsourced processes are controlled in accordance with 8.4. |
How do you control outsourced processes? |
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8.2 Determination of requirements for products and services |
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8.2.1 Customer communication |
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8.2.1q1 |
The organization shall establish the processes for communicating with customers in relation to:
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What are your processes for communicating with customers? How do you communicate information relating to:
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8.2.2 Determination of requirements related to products and services |
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8.2.2q1 |
The organization shall establish, implement and maintain a process to determine the requirements for the products and services to be offered to potential customers. |
What is your process to determine the requirements for products and services to be offered to potential customers? How do you establish, implement and maintain this process? |
8.2.2q2 |
The organization shall ensure that: |
How do you define product and service requirements including statutory and regulatory requirements? |
8.2.3 Review of requirements related to products and services |
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8.2.3q1 |
The organization shall review, as applicable: |
How do you review: |
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NOTE Requirements can also include those arising from relevant interested parties. |
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8.2.3q2 |
This review shall be conducted prior to the organization’s commitment to supply products and services to the customer and shall ensure contract or order requirements differing from those previously defined are resolved. |
Show me that the review is conducted prior to your commitment to supply products and services to your customers. How do you resolve contract or order requirements which differ from those previously defined? |
8.2.3q3 |
Where the customer does not provide a documented statement of their requirements, the customer requirements shall be confirmed by the organization before acceptance. |
How do you confirm customer requirements where the customer does not provide a documented statement? |
8.2.3q4 |
Documented information describing the results of the review, including any new or changed requirements for the products and services, shall be retained. |
Show me where you retain documented information which describes results of the review including any new or changed requirements. |
8.2.3q5 |
Where requirements for products and services are changed, the organization shall ensure that relevant documented information is amended and that relevant personnel are made aware of the changed requirements.
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Show me the documented information containing changes to products and services. How do you ensure that relevant personnel are made aware of those changes? |
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8.3 Design and development of products and services |
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8.3.1 General |
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8.3.1q1 |
Where the detailed requirements of the organization’s products and services are not already established or not defined by the customer or by other interested parties, such that they are adequate for subsequent production or service provision, the organization shall establish, implement and maintain a design and development process. |
How do you establish, implement and maintain a design and development process (where detailed requirements of your products and services are not already established or defined by the customer or other parties). |
NOTE 1 The organization can also apply the requirements given in 8.5 to the development of processes for production and services provision. |
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8.3.2 Design and development planning |
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8.3.2q1 |
In determining the stages and controls for design and development, the organization shall consider:
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When determining the stages and control for design and development, show me how you consider: |
8.3.3 Design and development inputs |
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8.3.3q1 |
The organization shall determine: |
Can you show me how you determine: |
8.3.3q2 |
Inputs shall be adequate for design and development purposes, complete, and unambiguous. Conflicts among inputs shall be resolved. |
How do you determine that inputs are adequate, complete and unambiguous for design and development? How do you resolve conflicts among inputs? |
8.3.4 Design and development controls |
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8.3.4q1 |
The controls applied to the design and development process shall ensure that: |
How do controls that are applied to the design and development process ensure: |
8.3.5 Design and development outputs |
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8.3.5q1 |
The organization shall ensure that design and development outputs: |
How do you ensure that design and development outputs: |
8.3.5q2 |
The organization shall retain the documented information resulting from the design and development process. |
Show me the documented information which results from the design and development process. |
8.3.6 Design and development changes |
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8.3.6q1 |
The organization shall review, control and identify changes made to design inputs and design outputs during the design and development of products and services or subsequently, to the extent that there is no adverse impact on conformity to requirements. |
How do you review, control and identify changes made to the design inputs and outputs during design and development of products and services ensuring no impact on conformity to requirements? |
8.3.6q2 |
Documented information on design and development changes shall be retained. |
Show me the documented information for design and development changes. |
8.4 Control of externally provided products and services |
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8.4.1 General |
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8.4.1q1 |
The organization shall ensure that externally provided processes, products, and services conform to specified requirements. |
How do you ensure externally provided processes, products and services conform to specified requirements? |
8.4.1q2 |
The organization shall apply the specified requirements for the control of externally provided products and services when: |
Show me how you apply specified requirements for the control of externally provided products and services when: |
8.4.1q3 |
The organization shall establish and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers based on their ability to provide processes or products and services in accordance with specified requirements. |
Show me how you establish and apply criteria for evaluation, selection, monitoring of performance and re-evaluation of external providers. How do you assess their ability to provide processes or products and services in accordance with specified requirements? |
8.4.1q4 |
The organization shall retain appropriate documented information of the results of the evaluations, monitoring of the performance and re-evaluations of the external providers.
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What documented information do you have of the results of evaluations, monitoring of performance and re-evaluations of external providers? |
8.4.2 Type and extent of control of external provision |
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8.4.2q1 |
In determining the type and extent of controls to be applied to the external provision of processes, products and services, the organization shall take into consideration: |
How do you determine the controls applied to the external provision of processes, products and services and take into consideration: |
8.4.2q2 |
The organization shall establish and implement verification or other activities necessary to ensure the externally provided processes, products and services do not adversely affect the organization's ability to consistently deliver conforming products and services to its customers. |
What verification or other activities do you have to ensure externally provided processes, products and services do not adversely affect your ability to consistently deliver conforming products and services to your customers? |
8.4.2q3 |
Processes or functions of the organization which have been outsourced to an external provider remain within the scope of the organization’s quality management system; accordingly, the organization shall consider a) and b) above and define both the controls it intends to apply to the external provider and those it intends to apply to the resulting process output. |
When processes or functions have been outsourced to external providers, how do you consider a) and b) in 8.4.1 and how do you define the controls intended to be applied to the external provider and to the resulting process output? |
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8.4.3 Information for external providers |
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8.4.3q1 |
The organization shall communicate to external providers applicable requirements for the following: |
Show me how you communicate to external providers, applicable requirements for: |
8.4.3q2 |
The organization shall ensure the adequacy of specified requirements prior to their communication to the external provider.
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Before you communicate with external providers, how do you ensure the adequacy of specified requirements? |
8.5 Production and service provision |
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8.5.1 Control of production and service provision |
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8.5.1q1 |
The organization shall implement controlled conditions for production and service provision, including delivery and post-delivery activities. |
What controlled conditions do you have for production and service provision, including delivery and post-delivery activities? |
8.5.1q2 |
Controlled conditions shall include, as applicable: |
Can you show me controlled conditions for: |
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8.5.2 Identification and traceability |
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8.5.2q1 |
Where necessary to ensure conformity of products and services, the organization shall use suitable means to identify process outputs. |
What means do you use to identify process outputs to ensure conformity of products and services? |
8.5.2q2 |
The organization shall identify the status of process outputs with respect to monitoring and measurement requirements throughout production and service provision. |
How do you identify the status of process outputs? |
8.5.2q3 |
Where traceability is a requirement, the organization shall control the unique identification of the process outputs, and retain any documented information necessary to maintain traceability. |
How do you control the unique identification of process outputs, where applicable? What documented information do you retain? |
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NOTE Process outputs are the results of any activities which are ready for delivery to the organization’s customer or to an internal customer (e.g. receiver of the inputs to the next process); they can include products, services, intermediate parts, components, etc.
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8.5.3 Property belonging to customers or external providers |
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8.5.3q1 |
The organization shall exercise care with property belonging to the customer or external providers while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard the customer’s or external provider’s property provided for use or incorporation into the products and services. |
What care do you provide for customer or external provider’s property while under your control?
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8.5.3q2 |
When property of the customer or external provider is incorrectly used, lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider. |
What means do you use to report to the customer or external provider if their property is incorrectly used, lost, damaged or found to be unsuitable for use? |
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NOTE Customer property can include material, components, tools and equipment, customer premises, intellectual property and personal data. |
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8.5.4 Preservation |
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8.5.4q1 |
The organization shall ensure preservation of process outputs during production and service provision, to the extent necessary to maintain conformity to requirements. |
How do you ensure preservation of process outputs during production and service provision to maintain conformity to product requirements? |
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NOTE Preservation can include identification, handling, packaging, storage, transmission or transportation, and protection. |
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8.5.5 Post-delivery activities |
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8.5.5q1 |
As applicable, the organization shall meet requirements for post-delivery activities associated with the products and services. |
How do you meet requirements for post-delivery activities associated with products and services? |
8.5.5q2 |
In determining the extent of post-delivery activities that are required, the organization shall consider: |
How do you determine: |
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NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal. |
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8.5.6 Control of changes |
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8.5.6q1 |
The organization shall review and control unplanned changes essential for production or service provision to the extent necessary to ensure continuing conformity with specified requirements. |
How do you review and control unplanned changes to ensure continuing conformity with specified requirements? |
8.5.6q2 |
The organization shall retain documented information describing the results of the review of changes, the personnel authorizing the change, and any necessary actions.
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What documented information can you show me which describes the results of reviews of changes, the personnel authorizing change and any necessary actions? |
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8.6 Release of products and services |
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8.6q1 |
The organization shall implement the planned arrangements at appropriate stages to verify that product and service requirements have been met. Evidence of conformity with the acceptance criteria shall be retained. |
Show me how planned arrangement have been implemented at appropriate stages to verify product and service requirements have been met. Show me what evidence you retain. |
8.6q2 |
The release of products and services to the customer shall not proceed until the planned arrangements for verification of conformity have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. Documented information shall provide traceability to the person(s) authorizing release of products and services for delivery to the customer. |
Show me how the release of products and services is held until planned arrangements for verification of conformity have been satisfactorily completed, unless approved by a relevant authority, or the customer if applicable. Show me documented information which shows traceability to the person authorizing release of products and services. |
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8.7 Control of non-conforming process outputs, products and services |
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8.7q1 |
The organization shall ensure process outputs, products and services that do not conform to requirements are identified and controlled to prevent their unintended use or delivery. |
How do you identify and control process outputs, products and services that do not conform to requirements and prevent their unintended use or delivery? |
8.7q2 |
The organization shall take appropriate corrective action based on the nature of the nonconformity and its impact on the conformity of products and services. This applies also to nonconforming products and services detected after delivery of the products or during the provision of the service. |
What appropriate corrective actions are taken based on the nature of the nonconformity and its impact on the conformity of products and services? How do you apply this to nonconformity detected after delivery? |
8.7q3 |
As applicable, the organization shall deal with nonconforming process outputs, products and services in one or more of the following ways: |
How you deal with nonconforming process outputs, products and services in terms of: |
8.7q4 |
Where nonconforming process outputs, products and services are corrected, conformity to the requirements shall be verified. |
How do you verify conformance where process outputs, products and services are corrected following nonconformance? |
8.7q5 |
The organization shall retain documented information of actions taken on nonconforming process outputs, products and services, including on any concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformity.
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What documented information do you keep following actions taken to address nonconformities, including any concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformance. |
9 Performance evaluation |
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9.1 Monitoring, measurement, analysis and evaluation |
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9.1.1 General |
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9.1.1q1 |
The organization shall determine: |
Show me how you determine: |
9.1.1q2 |
The organization shall ensure that monitoring and measurement activities are implemented in accordance with the determined requirements and shall retain appropriate documented information as |
What documented information can you show me that monitoring and measurement activities have been implemented in accordance with determined requirements? |
9.1.1q3 |
The organization shall evaluate the quality performance and the effectiveness of the quality management system. |
Show me how you evaluate the quality performance and the effectiveness of the QMS. |
9.1.2 Customer satisfaction |
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9.1.2q1 |
The organization shall monitor customer perceptions of the degree to which requirements have been met. |
How do you monitor customer perception of the degree to which requirements have been met? |
9.1.2q2 |
The organization shall obtain information relating to customer views and opinions of the organization and its products and services. |
How do you obtain information relating to customer views and opinions of your products and services? |
9.1.2q3 |
The methods for obtaining and using this information shall be determined. |
What methods for obtaining and using this information do you have? |
NOTE Information related to customer views can include customer satisfaction or opinion surveys, customer data on delivered products or services quality, market-share analysis, compliments, warranty claims and dealer reports. |
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9.1.3 Analysis and evaluation |
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9.1.3q1
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The organization shall analyse and evaluate appropriate data and information arising from monitoring, measurement and other sources. |
So me how you analyse and evaluate data and information arising from monitoring, measurement and other sources. |
9.1.3q2 |
The output of analysis and evaluation shall be used to: |
Show me how the output of analysis and evaluation is used to: |
9.1.3q3 |
The results of analysis and evaluation shall also be used to provide inputs to management review. |
Show me where the results of analysis and evaluation are used to provide inputs to management review. |
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9.2 Internal audit |
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9.2.1 |
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9.2.1q1 |
The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system; |
Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by Organization? (Review records to demonstrate conformance) |
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9.2.2 |
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9.2.2q1 |
The organization shall: |
Can you show me audit programme(s) that takes into consideration the quality objectives, importance of the processes, customer feedback, changes impacting the organization and the results of previous audits? |
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NOTE See ISO 19011 for guidance. |
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9.3 Management Review |
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9.3.1 |
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9.3.1q1 |
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness. |
What is the frequency that top management reviews the organization's QMS? How is the QMS deemed suitable, adequate and effective? |
9.3.1q2 |
The management review shall be planned and carried out taking into consideration: |
What kinds of information are reviewed in management reviews? These must include: |
9.3.2 |
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9.3.2q1 |
The outputs of the management review shall include decisions and actions related to: |
Show me that management reviews include decisions and actions relating to: |
9.3.2q2 |
The organization shall retain documented information as evidence of the results of management reviews. |
Show me what documented information you have as evidence of management reviews. |
10 Improvement |
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10.1 General |
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10.1q1 |
The organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction. |
How do you determine and select opportunities for improvement? What necessary actions have you implemented so that you have met customer requirements and enhanced customer satisfaction? |
10.1q2 |
This shall include, as appropriate: |
Show me how you have: |
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NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organization (e.g. transformation). |
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10.2 Nonconformity and corrective action |
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10.2.1 |
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10.2.1q1 |
When a nonconformity occurs, including those arising from complaints, the organization shall: |
When nonconformities occur, show me how; |
10.2.1q2 |
Corrective actions shall be appropriate to the effects of the nonconformities encountered. |
Show me how correction actions were appropriate to the effects of the nonconformities encountered. |
NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity. |
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10.2.2 |
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10.2.2q1 |
The organization shall retain documented information as evidence of: |
What documented information can you show me as evidence of: |
10.3 Continual improvement |
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10.3q1 |
The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system. |
Demonstrate that you continually improve the suitability, adequacy and effectiveness of the QMS. |
10.3q2 |
The organization shall consider the outputs of analysis and evaluation, and the outputs from management review, to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement. |
Demonstrate that outputs of analysis and evaluation and the outputs from management review are considered to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement. |
10.3q3 |
Where applicable, the organization shall select and utilise applicable tools and methodologies for investigation of the causes of underperformance and for supporting continual improvement. |
What applicable tools and methodologies for investigation of the causes of underperformance and to support continual improvement are selected? |
Source: https://newiso9001.files.wordpress.com/2014/09/audit-iso9001-2015-checklist.docx
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