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ISO 9001 2015 Audit Checklist
Section 1: 4.1 Understanding The Organization And Its Context
1. 1. Has the organization determined 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?
Yes
No
N/A
2. 2. Does the organization monitor and review information about these external and internal issues?
Yes
No
N/A
Section 2: 4.2 Understanding The Needs And Expectations Of Interested Parties
1. 1. Has the organization determined the interested parties that are relevant to the quality management system?
Yes
No
N/A
2. 2. Has the organization determined the requirements of these interested parties that are relevant to the quality management system?
Yes
No
N/A
3. 3. Does the organization monitor and review information about these interested parties and their relevant requirements?
Yes
No
N/A
Section 3: 4.3 Determining The Scope Of The Quality Management System
1. 1. Has the organization determined the boundaries and applicability of the quality management system to establish its scope?
Yes
No
N/A
2. 2. Has the organization considered the external and internal issues?
Yes
No
N/A
3. 3. Has the organization considered the requirements of relevant interested parties?
Yes
No
N/A
4. 4. Has the organization considered the products and services of the organization?
Yes
No
N/A
5. 5. Has the organization applied all the requirements of ISO 9001 if they are applicable within the determined scope of its quality management system?
Yes
No
N/A
6. 6. Is the scope of the organization’s quality management system available and maintained as documented information?
Yes
No
N/A
7. 7. Does the scope state the types of products and services covered and provide justification for any requirement of ISO 9001 that the organization determines is not applicable to the scope of its quality management system?
Yes
No
N/A
8. 8. Do any requirements determined by the organization as not being applicable not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction?
Yes
No
N/A
Section 4: 4.4 Quality Management System And Its Processes
1. 1. Has the organization established, implemented, maintained, and continually improved a quality management system, including the processes needed and their interactions, in accordance with the requirements of ISO 9001?
Yes
No
N/A
2. 2. Has the organization determined the processes needed for the quality management system and their application throughout the organization?
Yes
No
N/A
3. 3. Has the organization determined the inputs required and the outputs expected from these processes?
Yes
No
N/A
4. 4. Has the organization determined the sequence and interaction of these processes?
Yes
No
N/A
5. 5. Has the organization determined and applied the criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes?
Yes
No
N/A
6. 6. Has the organization determined the resources needed for these processes and ensured their availability?
Yes
No
N/A
7. 7. Has the organization assigned the responsibilities and authorities for these processes?
Yes
No
N/A
8. 8. Has the organization addressed the risks and opportunities as determined in accordance with the requirements of?
Yes
No
N/A
9. 9. Has the organization evaluated these processes and implemented any changes needed to ensure that these processes achieve their intended results?
Yes
No
N/A
10. 10. Has the organization improved the processes and the quality management system?
Yes
No
N/A
11. 11. To the extent necessary, does the organization: • maintain documented information to support the operation of its processes? • retain documented information to have confidence that the processes are being carried out as planned?
Yes
No
N/A
Section 5: 5.1 Leadership And Commitment - 5.1.1 General
1. 1. Has top management taken accountability for the effectiveness of the quality management system?
Yes
No
N/A
2. 2. Has top management ensured that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization?
Yes
No
N/A
3. 3. Has top management ensured the integration of the quality management system requirements into the organization’s business processes?
Yes
No
N/A
4. 4. Has top management promoted the use of the process approach and risk-based thinking?
Yes
No
N/A
5. 5. Has top management ensured that the resources needed for the quality management system are available?
Yes
No
N/A
6. 6. Has top management communicated the importance of effective quality management and conformed to the quality management system requirements?
Yes
No
N/A
7. 7. Has top management ensured that the quality management system achieves its intended results?
Yes
No
N/A
8. 8. Has top management engaged, directed, and supported persons to contribute to the effectiveness of the quality management system?
Yes
No
N/A
9. 9. Has top management ensured in promoting improvement?
Yes
No
N/A
10. 10. Has top management ensured in supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?
Yes
No
N/A
Section 6: 5.1 Leadership And Commitment - 5.1.2 Customer Focus
1. 1. Has top management ensured customer and applicable statutory and regulatory requirements are determined, understood, and consistently met?
Yes
No
N/A
2. 2. Has top management assessed the risks and opportunities that can affect the conformity of products and services and the ability to enhance customer satisfaction are determined and addressed?
Yes
No
N/A
3. 3. Has top management ensured the focus on enhancing customer satisfaction is maintained?
Yes
No
N/A
Section 7: 5.2 Policy - 5.2.1 Developing The Quality Policy
1. 1. Has top management developed a quality policy that is appropriate to the purpose and context of the organization and supports its strategic direction?
Yes
No
N/A
2. 2. Has top management developed a quality policy that provides a framework for setting quality objectives?
Yes
No
N/A
3. 3. Has top management developed a quality policy that includes a commitment to satisfy applicable requirements?
Yes
No
N/A
4. 4. Has top management developed a quality policy that includes a commitment to continual improvement of the quality management system?
Yes
No
N/A
Section 8: 5.2 Policy - 5.2.2 Communicating The Quality Policy
1. 1. Is the quality policy available and maintained as documented information?
Yes
No
N/A
2. 2. Is the quality policy communicated, understood, and applied within the organization?
Yes
No
N/A
3. 3. Is the quality policy available to relevant interested parties, as appropriate?
Yes
No
N/A
Section 9: 6.1 Actions To Address Risks And Opportunities - 6.1.1 Considering Issues
1. 1. Has the organization given assurance that the quality management system can achieve its intended result(s)?
Yes
No
N/A
2. 2. Has the organization enhanced desirable effects?
Yes
No
N/A
3. 3. Has the organization prevented, or reduced, undesired effects?
Yes
No
N/A
4. 4. Has the organization achieved improvement?
Yes
No
N/A
Section 10: 6.1 Actions To Address Risks And Opportunities - 6.1.2 Organization Planning
1. 1. Has the organization planned actions to address risks and opportunities?
Yes
No
N/A
2. 2. Has the organization planned to integrate and implement the actions into its quality management system processes?
Yes
No
N/A
3. 3. Has the organization evaluated the effectiveness of these actions?
Yes
No
N/A
4. 4. Are actions taken to address risks and opportunities proportionate to the potential impact on the conformity of products and services?
Yes
No
N/A
Section 11: 6.2 Quality Objectives And Planning To Achieve Them - 6.2.1 Establishing Quality Objectives
1. 1. Has the organization established quality objectives at relevant functions, levels, and processes needed for the quality management system?
Yes
No
N/A
2. 2. Are the quality objectives consistent with the quality policy?
Yes
No
N/A
3. 3. Are the quality objectives measurable?
Yes
No
N/A
4. 4. Are the quality objectives taking into account applicable requirements?
Yes
No
N/A
5. 5. Are the quality objectives relevant to the conformity of products and services and to the enhancement of customer satisfaction?
Yes
No
N/A
6. 6. Are the quality objectives monitored?
Yes
No
N/A
7. 7. Are the quality objectives communicated?
Yes
No
N/A
8. 8. Are the quality objectives updated as appropriate?
Yes
No
N/A
9. 9. Does the organization maintain documented information on the quality objectives?
Yes
No
N/A
10. 10. When planning how to achieve its quality objectives, has the organization determined: • what will be done? • what resources will be required? • who will be responsible? • when it will be completed? • how the results will be evaluated?
Yes
No
N/A
Section 12: 6.3 Planning Of Changes
1. 1. When the organization determines the need for change to the quality management system are changes carried out in a planned and systematic manner?
Yes
No
N/A
2. 2. Does the organization consider the purpose of the change and any of its potential consequences?
Yes
No
N/A
3. 3. Does the organization consider the integrity of the quality management system?
Yes
No
N/A
4. 4. Does the organization consider the availability of resources?
Yes
No
N/A
5. 5. Does the organization consider the allocation or reallocation of responsibilities and authorities?
Yes
No
N/A
Section 13: 7.1 Resources - 7.1.1 General
1. 1. Has the organization determined and provided the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system?
Yes
No
N/A
2. 2. Has the organization considered the capabilities of, and constraints on, existing internal resources?
Yes
No
N/A
3. 3. Has the organization considered what needs to be obtained from external providers?
Yes
No
N/A
Section 14: 7.1 Resources - 7.1.2 People
1. 1. Has the organization determined and provided the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes?
Yes
No
N/A
Section 15: 7.1 Resources - 7.1.3 Infrastructure
1. 1. Has the organization determined, provided, and maintained the infrastructure necessary for the operation of its processes to achieve the conformity of products and services?
Yes
No
N/A
Section 16: 7.1 Resources - 7.1.4 Environment For The Operation Of Processes
1. 1. Has the organization determined, provided, and maintained the environment necessary for the operation of its processes and to achieve the conformity of products and services?
Yes
No
N/A
Section 17: 7.1 Resources - 7.1.5 Monitoring And Measurement Resources - 7.1.5.1 General
1. 1. When monitoring or measuring is used to verify the conformity of products and services to specified, has the organization determined and provided the resources needed to ensure valid and reliable results?
Yes
No
N/A
2. 2. Does the organization ensure that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken?
Yes
No
N/A
3. 3. Does the organization ensure that the resources provided are maintained to ensure their continued fitness for their purpose?
Yes
No
N/A
4. 4. Does the organization retain appropriate documented information as evidence of fitness for the purpose of monitoring and measurement resources?
Yes
No
N/A
Section 18: 7.1 Resources - 7.1.5 Monitoring And Measurement Resources - 7.1.5.2 Measurement Traceability
1. 1. Is measuring equipment calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards?
Yes
No
N/A
2. 2. When no such standards exist, is the basis used for calibration or verification retained as documented information? • identified in order to determine its status? • safeguarded from adjustments, damage, or deterioration that would invalidate the calibration status and subsequent measurement results?
Yes
No
N/A
3. 3. Does the organization determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary?
Yes
No
N/A
Section 19: 7.1 Resources - 7.1.6 Organizational Knowledge
1. 1. Does the organization determine the knowledge necessary for the operation of its processes and to achieve the conformity of products and services?
Yes
No
N/A
2. 2. Is this knowledge maintained and made available to the extent necessary?
Yes
No
N/A
3. 3. When addressing changing needs and trends, does the organization consider its current knowledge and determine how to acquire or access the necessary additional knowledge and required updates?
Yes
No
N/A
Section 20: 7.2 Competence
1. 1. Has the organization determined the necessary competence of the person(s) doing work under its control that affects the performance and effectiveness of the quality management system?
Yes
No
N/A
2. 2. Has the organization ensured that these persons are competent on the basis of appropriate education, training, or experience?
Yes
No
N/A
3. 3. Has the organization taken actions, where applicable, to acquire the necessary competence and evaluated the effectiveness of the actions taken?
Yes
No
N/A
4. 4. Has the organization retained appropriate documented information as evidence of competence?
Yes
No
N/A
Section 21: 7.3 Awareness
1. 1. Are staff aware of the quality policy?
Yes
No
N/A
2. 2. Are staff aware of the relevant quality objectives?
Yes
No
N/A
3. 3. Are staff aware of their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance?
Yes
No
N/A
4. 4. Are staff aware of the implications of not conforming with the quality management system requirements?
Yes
No
N/A
Section 22: 7.4 Communication
1. 1. Has the organization determined what it will communicate?
Yes
No
N/A
2. 2. Has the organization determined when to communicate?
Yes
No
N/A
3. 3. Has the organization determined with whom to communicate?
Yes
No
N/A
4. 4. Has the organization determined on how to communicate?
Yes
No
N/A
5. 5. Has the organization determined who communicates?
Yes
No
N/A
Section 23: 7.5 Documented Information - 7.5.1 General
1. 1. Does the organization’s quality management system include documented information required by ISO 9001?
Yes
No
N/A
2. 2. Does the organization’s quality management system document information determined by the organization as being necessary for the effectiveness of the quality management system?
Yes
No
N/A
Section 24: 7.5 Documented Information -7.5.2 Creating And Updating
1. 1. Does the organization ensure appropriate identification and description (e.g., a title, date, author, or reference number)?
Yes
No
N/A
2. 2. Does the organization ensure appropriate format (e.g., language, software version, graphics) and media (e.g., paper, electronic)?
Yes
No
N/A
3. 3. Does the organization ensure appropriate review and approval for suitability and adequacy?
Yes
No
N/A
Section 25: 7.5 Documented Information -7.5.3 Control Of Documented Information - 7.5.3.1 Availability Of Documented Information
1. 1. Is the documented information available and suitable for use, where and when it is needed?
Yes
No
N/A
2. 2. Is the documented information adequately protected (e.g., from loss of confidentiality, improper use, or loss of integrity)?
Yes
No
N/A
Section 26: 7.5 Documented Information -7.5.3 Control Of Documented Information - 7.5.3.2 Organizational Activities
1. 1. Has the organization addressed distribution, access, retrieval, and use?
Yes
No
N/A
2. 1. Has the organization addressed distribution, access, retrieval, and use?
Yes
No
N/A
3. 2. Has the organization addressed storage and preservation, including preservation of legibility?
Yes
No
N/A
4. 2. Has the organization addressed storage and preservation, including preservation of legibility?
Yes
No
N/A
5. 3. Has the organization addressed control of changes (e.g., version control)?
Yes
No
N/A
6. 3. Has the organization addressed control of changes (e.g., version control)?
Yes
No
N/A
7. 4. Has the organization addressed retention and disposition?
Yes
No
N/A
8. 4. Has the organization addressed retention and disposition?
Yes
No
N/A
9. 5. Is documented information of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, identified as appropriate and controlled?
Yes
No
N/A
10. 5. Is documented information of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, identified as appropriate and controlled?
Yes
No
N/A
11. 6. Is documented information retained as evidence of conformity protected from unintended alterations?
Yes
No
N/A
12. 6. Is documented information retained as evidence of conformity protected from unintended alterations?
Yes
No
N/A
Section 27: 8.1 Operational Planning And Control
1. 1. Has the organization determined requirements for the product and services?
Yes
No
N/A
2. 1. Has the organization determined requirements for the product and services?
Yes
No
N/A
3. 2. Has the organization established criteria for the processes and the acceptance of products and services?
Yes
No
N/A
4. 2. Has the organization established criteria for the processes and the acceptance of products and services?
Yes
No
N/A
5. 3. Has the organization determined the resources needed to achieve conformity to product and service requirements?
Yes
No
N/A
6. 3. Has the organization determined the resources needed to achieve conformity to product and service requirements?
Yes
No
N/A
7. 4. Has the organization implemented control of the processes in accordance with the criteria?
Yes
No
N/A
8. 4. Has the organization implemented control of the processes in accordance with the criteria?
Yes
No
N/A
9. 5. Has the organization determined, maintained, and retained documented information to the extent necessary: • to have confidence that the processes have been carried out as planned? • to demonstrate the conformity of products and services to their requirements?
Yes
No
N/A
10. 5. Has the organization determined, maintained, and retained documented information to the extent necessary: • to have confidence that the processes have been carried out as planned? • to demonstrate the conformity of products and services to their requirements?
Yes
No
N/A
11. 6. Is the output of this planning suitable for the organization's operations?
Yes
No
N/A
12. 6. Is the output of this planning suitable for the organization's operations?
Yes
No
N/A
13. 7. Does the organization control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary?
Yes
No
N/A
14. 7. Does the organization control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary?
Yes
No
N/A
15. 8. Does the organization ensure that outsourced processes are controlled in accordance with 8.4?
Yes
No
N/A
16. 8. Does the organization ensure that outsourced processes are controlled in accordance with 8.4?
Yes
No
N/A
Section 28: 8.2 Requirements For Products And Services - 8.2.1 Customer Communication
1. 1. Has customer communication provided information relating to products and services?
Yes
No
N/A
2. 1. Has customer communication provided information relating to products and services?
Yes
No
N/A
3. 2. Has customer communication handled inquiries, contracts, or order handling, including changes?
Yes
No
N/A
4. 2. Has customer communication handled inquiries, contracts, or order handling, including changes?
Yes
No
N/A
5. 3. Has customer communication obtained customer feedback relating to products and services, including customer complaints?
Yes
No
N/A
6. 3. Has customer communication obtained customer feedback relating to products and services, including customer complaints?
Yes
No
N/A
7. 4. Has customer communication handled or controlled customer property?
Yes
No
N/A
8. 4. Has customer communication handled or controlled customer property?
Yes
No
N/A
9. 5. Has customer communication established specific requirements for contingency actions, when relevant?
Yes
No
N/A
10. 5. Has customer communication established specific requirements for contingency actions, when relevant?
Yes
No
N/A
Section 29: 8.2 Requirements For Products And Services -8.2.2 Determination Of Requirements Related To Products And Services
1. 1. Does the organization ensure that the requirements for products and services are defined?
Yes
No
N/A
2. 1. Does the organization ensure that the requirements for products and services are defined?
Yes
No
N/A
3. 2. Does the organization ensure that any applicable statutory and regulatory requirements are met?
Yes
No
N/A
4. 2. Does the organization ensure that any applicable statutory and regulatory requirements are met?
Yes
No
N/A
5. 3. Does the organization ensure those requirements considered necessary by the organization are met?
Yes
No
N/A
6. 3. Does the organization ensure those requirements considered necessary by the organization are met?
Yes
No
N/A
7. 4. Does the organization meet the claims for the products and services it offers?
Yes
No
N/A
8. 4. Does the organization meet the claims for the products and services it offers?
Yes
No
N/A
Section 30: 8.2 Requirements For Products And Services -8.2.3 Review Of Requirements Related To Products And Services - 8.2.3.1 Ability To Meet Requirements
1. 1. Does the organization ensure that it has the ability to meet the requirements for products and services to be offered to customers?
Yes
No
N/A
2. 1. Does the organization ensure that it has the ability to meet the requirements for products and services to be offered to customers?
Yes
No
N/A
3. 2. Has the organization conducted a review to meet the requirements specified by the customer, including the requirements for delivery and post-delivery activities?
Yes
No
N/A
4. 2. Has the organization conducted a review to meet the requirements specified by the customer, including the requirements for delivery and post-delivery activities?
Yes
No
N/A
5. 3. Has the organization conducted a review for the requirements not stated by the customer, but necessary for the specified or intended use, when known?
Yes
No
N/A
6. 3. Has the organization conducted a review for the requirements not stated by the customer, but necessary for the specified or intended use, when known?
Yes
No
N/A
7. 4. Has the organization conducted a review for requirements as specified by the organization?
Yes
No
N/A
8. 4. Has the organization conducted a review for requirements as specified by the organization?
Yes
No
N/A
9. 5. Has the organization conducted a review for statutory and regulatory requirements applicable to the products and services?
Yes
No
N/A
10. 5. Has the organization conducted a review for statutory and regulatory requirements applicable to the products and services?
Yes
No
N/A
11. 6. Has the organization conducted a review for contract or order requirements differing from those previously expressed?
Yes
No
N/A
12. 6. Has the organization conducted a review for contract or order requirements differing from those previously expressed?
Yes
No
N/A
13. 7. Does the organization ensure that contract or order requirements differing from those previously defined are resolved?
Yes
No
N/A
14. 7. Does the organization ensure that contract or order requirements differing from those previously defined are resolved?
Yes
No
N/A
15. 8. When the customer does not provide a documented statement of their requirements, are the customer requirements confirmed by the organization before acceptance?
Yes
No
N/A
16. 8. When the customer does not provide a documented statement of their requirements, are the customer requirements confirmed by the organization before acceptance?
Yes
No
N/A
Section 31: 8.2 Requirements For Products And Services -8.2.3 Review Of Requirements Related To Products And Services - 8.2.3.2 Retained Information
1. 1. Does the organization retain documented information, as applicable: • on the results of the review? • on any new requirements for the products and services?
Yes
No
N/A
2. 1. Does the organization retain documented information, as applicable: • on the results of the review? • on any new requirements for the products and services?
Yes
No
N/A
Section 32: 8.2 Requirements For Products And Services - 8.2.4 Changes To Requirements For Products And Services
1. 1. Does the organization ensure that relevant documented information is amended and that relevant persons are made aware of the changed requirements when the requirements for products and services are changed.
Yes
No
N/A
2. 1. Does the organization ensure that relevant documented information is amended and that relevant persons are made aware of the changed requirements when the requirements for products and services are changed.
Yes
No
N/A
Section 33: 8.3 Design And Development Of Products And Services - 8.3.1 General
1. 1. Has the organization established, implemented, and maintained a design and development process that is appropriate to ensure the subsequent provision of products and services?
Yes
No
N/A
2. 1. Has the organization established, implemented, and maintained a design and development process that is appropriate to ensure the subsequent provision of products and services?
Yes
No
N/A
Section 34: 8.3 Design And Development Of Products And Services - 8.3.2 Design And Development Planning
1. 1. Does the organization consider the nature, duration, and complexity of the design and development activities?
Yes
No
N/A
2. 1. Does the organization consider the nature, duration, and complexity of the design and development activities?
Yes
No
N/A
3. 2. Does the organization consider the required process stages, including applicable design and development reviews?
Yes
No
N/A
4. 2. Does the organization consider the required process stages, including applicable design and development reviews?
Yes
No
N/A
5. 3. Does the organization consider the required design and development verification and validation activities?
Yes
No
N/A
6. 3. Does the organization consider the required design and development verification and validation activities?
Yes
No
N/A
7. 4. Does the organization consider the responsibilities and authorities involved in the design and development process?
Yes
No
N/A
8. 4. Does the organization consider the responsibilities and authorities involved in the design and development process?
Yes
No
N/A
9. 5. Does the organization consider the internal and external resource needs for the design and development of products and services?
Yes
No
N/A
10. 5. Does the organization consider the internal and external resource needs for the design and development of products and services?
Yes
No
N/A
11. 6. Does the organization consider the need to control interfaces between persons involved in the design and development process?
Yes
No
N/A
12. 6. Does the organization consider the need to control interfaces between persons involved in the design and development process?
Yes
No
N/A
13. 7. Does the organization consider the need for involvement of customers and users in the design and development process?
Yes
No
N/A
14. 7. Does the organization consider the need for involvement of customers and users in the design and development process?
Yes
No
N/A
15. 8. Does the organization consider the requirements for subsequent provision of products and services?
Yes
No
N/A
16. 8. Does the organization consider the requirements for subsequent provision of products and services?
Yes
No
N/A
17. 9. Does the organization consider the level of control expected for the design and development process by customers and other relevant interested parties?
Yes
No
N/A
18. 9. Does the organization consider the level of control expected for the design and development process by customers and other relevant interested parties?
Yes
No
N/A
19. 10. Does the organization consider the documented information needed to demonstrate that design and development requirements have been met?
Yes
No
N/A
20. 10. Does the organization consider the documented information needed to demonstrate that design and development requirements have been met?
Yes
No
N/A
Section 35: 8.3 Design And Development Of Products And Services - 8.3.3 Design And Development Inputs
1. 1. Does the organization determine the requirements essential for the specific types of products and services to be designed and developed?
Yes
No
N/A
2. 1. Does the organization determine the requirements essential for the specific types of products and services to be designed and developed?
Yes
No
N/A
3. 2. Does the organization consider functional and performance requirements?
Yes
No
N/A
4. 2. Does the organization consider functional and performance requirements?
Yes
No
N/A
5. 3. Does the organization consider the information derived from previous similar design and development activities?
Yes
No
N/A
6. 3. Does the organization consider the information derived from previous similar design and development activities?
Yes
No
N/A
7. 4. Does the organization consider statutory and regulatory requirements?
Yes
No
N/A
8. 4. Does the organization consider statutory and regulatory requirements?
Yes
No
N/A
9. 5. Does the organization consider standards or codes of practice that the organization has committed to implementing?
Yes
No
N/A
10. 5. Does the organization consider standards or codes of practice that the organization has committed to implementing?
Yes
No
N/A
11. 6. Does the organization consider the potential consequences of failure due to the nature of the products and services?
Yes
No
N/A
12. 6. Does the organization consider the potential consequences of failure due to the nature of the products and services?
Yes
No
N/A
13. 7. Are inputs adequate for design and development purposes, complete and unambiguous?
Yes
No
N/A
14. 7. Are inputs adequate for design and development purposes, complete and unambiguous?
Yes
No
N/A
15. 8. Are conflicting design and development inputs resolved?
Yes
No
N/A
16. 8. Are conflicting design and development inputs resolved?
Yes
No
N/A
17. 9. Does the organization retain documented information on design and development inputs
Yes
No
N/A
18. 9. Does the organization retain documented information on design and development inputs
Yes
No
N/A
Section 36: 8.3 Design And Development Of Products And Services - 8.3.4 Design And Development Controls
1. 1. Does the organization ensure that the results to be achieved are defined?
Yes
No
N/A
2. 1. Does the organization ensure that the results to be achieved are defined?
Yes
No
N/A
3. 2. Does the organization ensure that the reviews are conducted to evaluate the ability of the results of design and development to meet requirements?
Yes
No
N/A
4. 2. Does the organization ensure that the reviews are conducted to evaluate the ability of the results of design and development to meet requirements?
Yes
No
N/A
5. 3. Does the organization ensure that the verification activities are conducted to ensure that the design and development outputs meet the input requirements?
Yes
No
N/A
6. 3. Does the organization ensure that the verification activities are conducted to ensure that the design and development outputs meet the input requirements?
Yes
No
N/A
7. 4. Does the organization ensure that the validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use?
Yes
No
N/A
8. 4. Does the organization ensure that the validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use?
Yes
No
N/A
9. 5. Does the organization ensure that any necessary actions are taken on problems determined during the reviews, or verification and validation activities?
Yes
No
N/A
10. 5. Does the organization ensure that any necessary actions are taken on problems determined during the reviews, or verification and validation activities?
Yes
No
N/A
11. 6. Does the organization ensure that the documented information of these activities is retained?
Yes
No
N/A
12. 6. Does the organization ensure that the documented information of these activities is retained?
Yes
No
N/A
Section 37: 8.3 Design And Development Of Products And Services - 8.3.5 Design And Development Outputs
1. 1. Do the design and development outputs meet the input requirements?
Yes
No
N/A
2. 1. Do the design and development outputs meet the input requirements?
Yes
No
N/A
3. 2. Are the design and development outputs adequate for the subsequent processes for the provision of products and services?
Yes
No
N/A
4. 2. Are the design and development outputs adequate for the subsequent processes for the provision of products and services?
Yes
No
N/A
5. 3. Do the design and development outputs include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria?
Yes
No
N/A
6. 3. Do the design and development outputs include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria?
Yes
No
N/A
7. 4. Do the design and development outputs specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision?
Yes
No
N/A
8. 4. Do the design and development outputs specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision?
Yes
No
N/A
9. 5. Does the organization retain documented information on the design and development process?
Yes
No
N/A
10. 5. Does the organization retain documented information on the design and development process?
Yes
No
N/A
Section 38: 8.3 Design And Development Of Products And Services - 8.3.6 Design And Development Changes
1. 1. Does the organization identify, review, and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements?
Yes
No
N/A
2. 1. Does the organization identify, review, and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements?
Yes
No
N/A
3. 2. Is documented information retained on design and development changes?
Yes
No
N/A
4. 2. Is documented information retained on design and development changes?
Yes
No
N/A
5. 3. Is documented information retained on the results of reviews?
Yes
No
N/A
6. 3. Is documented information retained on the results of reviews?
Yes
No
N/A
7. 4. Is documented information retained on the authorization of the changes?
Yes
No
N/A
8. 4. Is documented information retained on the authorization of the changes?
Yes
No
N/A
9. 5. Is documented information retained on the actions taken to prevent adverse impacts?
Yes
No
N/A
10. 5. Is documented information retained on the actions taken to prevent adverse impacts?
Yes
No
N/A
Section 39: 8.4 Control Of Externally Provided Products And Services - 8.4.1 General
1. 1. Does the organization ensure that externally provided processes, products, and services conform to requirements?
Yes
No
N/A
2. 1. Does the organization ensure that externally provided processes, products, and services conform to requirements?
Yes
No
N/A
3. 2. Are products and services from external providers intended for incorporation into the organization’s own products and services?
Yes
No
N/A
4. 2. Are products and services from external providers intended for incorporation into the organization’s own products and services?
Yes
No
N/A
5. 3. Are products and services provided directly to the customer(s) by external providers on behalf of the organization?
Yes
No
N/A
6. 3. Are products and services provided directly to the customer(s) by external providers on behalf of the organization?
Yes
No
N/A
7. 4. Is a process, or part of a process, provided by an external provider as a result of a decision by the organization?
Yes
No
N/A
8. 4. Is a process, or part of a process, provided by an external provider as a result of a decision by the organization?
Yes
No
N/A
9. 5. Has the organization determined and applied 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 requirements?
Yes
No
N/A
10. 5. Has the organization determined and applied 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 requirements?
Yes
No
N/A
11. 6. Does the organization retain documented information on these activities and any necessary actions arising from the evaluations?
Yes
No
N/A
12. 6. Does the organization retain documented information on these activities and any necessary actions arising from the evaluations?
Yes
No
N/A
Section 40: 8.4 Control Of Externally Provided Products And Services - 8.4.2 Type And Extent Of Control
1. 1. Does the organization ensure that externally provided processes, products, and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers?
Yes
No
N/A
2. 1. Does the organization ensure that externally provided processes, products, and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers?
Yes
No
N/A
3. 2. Does the organization ensure that externally provided processes remain within the control of its quality management system?
Yes
No
N/A
4. 2. Does the organization ensure that externally provided processes remain within the control of its quality management system?
Yes
No
N/A
5. 3. Does the organization define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output?
Yes
No
N/A
6. 3. Does the organization define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output?
Yes
No
N/A
7. 4. Does the organization take into consideration the potential impact of the externally provided processes, products, and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements?
Yes
No
N/A
8. 4. Does the organization take into consideration the potential impact of the externally provided processes, products, and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements?
Yes
No
N/A
9. 5. Does the organization take into consideration the effectiveness of the controls applied by the external provider
Yes
No
N/A
10. 5. Does the organization take into consideration the effectiveness of the controls applied by the external provider
Yes
No
N/A
11. 6. Does the organization determine the verification or other activities necessary to ensure that the externally provided processes, products, and services meet requirements?
Yes
No
N/A
12. 6. Does the organization determine the verification or other activities necessary to ensure that the externally provided processes, products, and services meet requirements?
Yes
No
N/A
Section 41: 8.4 Control Of Externally Provided Products And Services - 8.4.3 Information For External Providers
1. 1. Does the organization ensure the adequacy of requirements prior to their communication to the external provider?
Yes
No
N/A
2. 1. Does the organization ensure the adequacy of requirements prior to their communication to the external provider?
Yes
No
N/A
3. 2. Does the organization communicate ensure the processes, products, and services are provided?
Yes
No
N/A
4. 2. Does the organization communicate ensure the processes, products, and services are provided?
Yes
No
N/A
5. 3. Does the organization ensure the approval of: • products and services? • methods, processes, and equipment? • the release of products and services?
Yes
No
N/A
6. 3. Does the organization ensure the approval of: • products and services? • methods, processes, and equipment? • the release of products and services?
Yes
No
N/A
7. 4. Does the organization ensure competence, including any required qualification of persons?
Yes
No
N/A
8. 4. Does the organization ensure competence, including any required qualification of persons?
Yes
No
N/A
9. 5. Does the organization ensure the external providers’ interactions with the organization?
Yes
No
N/A
10. 5. Does the organization ensure the external providers’ interactions with the organization?
Yes
No
N/A
11. 6. Does the organization ensure control and monitoring of the external provider’s performance to be applied by the organization?
Yes
No
N/A
12. 6. Does the organization ensure control and monitoring of the external provider’s performance to be applied by the organization?
Yes
No
N/A
13. 7. Does the organization ensure verification or validation activities that the organization, or its customer, intends to perform at the external provider’s premises?
Yes
No
N/A
14. 7. Does the organization ensure verification or validation activities that the organization, or its customer, intends to perform at the external provider’s premises?
Yes
No
N/A
Section 42: 8.5 Production And Service Provision - 8.5.1 Control Of Production And Service Provision
1. 1. Has the organization implemented production and service provision under controlled conditions?
Yes
No
N/A
2. 1. Has the organization implemented production and service provision under controlled conditions?
Yes
No
N/A
3. 2. Do the controlled conditions include the availability of documented information that define • the characteristics of the products to be produced, the services to be provided, or the activities to be performed? • the results to be achieved?
Yes
No
N/A
4. 2. Do the controlled conditions include the availability of documented information that define • the characteristics of the products to be produced, the services to be provided, or the activities to be performed? • the results to be achieved?
Yes
No
N/A
5. 3. Do the controlled conditions include the availability and use of suitable monitoring and measuring resources?
Yes
No
N/A
6. 3. Do the controlled conditions include the availability and use of suitable monitoring and measuring resources?
Yes
No
N/A
7. 4. Do the controlled conditions include the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met?
Yes
No
N/A
8. 4. Do the controlled conditions include the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met?
Yes
No
N/A
9. 5. Do the controlled conditions include the use of suitable infrastructure and environment for the operation of processes?
Yes
No
N/A
10. 5. Do the controlled conditions include the use of suitable infrastructure and environment for the operation of processes?
Yes
No
N/A
11. 6. Do the controlled conditions include the appointment of competent persons, including any required qualification?
Yes
No
N/A
12. 6. Do the controlled conditions include the appointment of competent persons, including any required qualification?
Yes
No
N/A
13. 7. Do the controlled conditions include the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement?
Yes
No
N/A
14. 7. Do the controlled conditions include the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement?
Yes
No
N/A
15. 8. Do the controlled conditions include the implementations of actions to prevent human error?
Yes
No
N/A
16. 8. Do the controlled conditions include the implementations of actions to prevent human error?
Yes
No
N/A
17. 9. Do the controlled conditions include the implementation of release, delivery, and post-delivery activities?
Yes
No
N/A
18. 9. Do the controlled conditions include the implementation of release, delivery, and post-delivery activities?
Yes
No
N/A
Section 43: 8.5 Production And Service Provision - 8.5.2 Identification And Traceability
1. 1. Does the organization use suitable means to identify outputs when it is necessary to ensure the conformity of products and services?
Yes
No
N/A
2. 1. Does the organization use suitable means to identify outputs when it is necessary to ensure the conformity of products and services?
Yes
No
N/A
3. 2. Does the organization identify the status of process outputs with respect to monitoring and measurement requirements throughout production and service provision?
Yes
No
N/A
4. 2. Does the organization identify the status of process outputs with respect to monitoring and measurement requirements throughout production and service provision?
Yes
No
N/A
5. 3. When traceability is a requirement, does the organization control the unique identification of the outputs and retain any documented information necessary to enable traceability?
Yes
No
N/A
6. 3. When traceability is a requirement, does the organization control the unique identification of the outputs and retain any documented information necessary to enable traceability?
Yes
No
N/A
Section 44: 8.5 Production And Service Provision - 8.5.3 Property Belonging To Customers Or External Providers
1. 1. Does the organization 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?
Yes
No
N/A
2. 1. Does the organization 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?
Yes
No
N/A
3. 2. Does the organization identify, verify, protect, and safeguard the customer’s or external provider’s property provided for use or incorporation into the products and services?
Yes
No
N/A
4. 2. Does the organization identify, verify, protect, and safeguard the customer’s or external provider’s property provided for use or incorporation into the products and services?
Yes
No
N/A
Section 45: 8.5 Production And Service Provision - 8.5.4 Preservation
1. 1. Does the organization preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements?
Yes
No
N/A
2. 1. Does the organization preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements?
Yes
No
N/A
Section 46: 8.5 Production And Service Provision - 8.5.5 Post-delivery Activities
1. 1. Does the organization meet requirements for post-delivery activities associated with the products and services?
Yes
No
N/A
2. 1. Does the organization meet requirements for post-delivery activities associated with the products and services?
Yes
No
N/A
3. 2. Does the organization consider the statutory and regulatory requirements?
Yes
No
N/A
4. 2. Does the organization consider the statutory and regulatory requirements?
Yes
No
N/A
5. 3. Does the organization consider the potential undesired consequences associated with its products and services?
Yes
No
N/A
6. 3. Does the organization consider the potential undesired consequences associated with its products and services?
Yes
No
N/A
7. 4. Does the organization consider the nature, use, and intended lifetime of the products and services?
Yes
No
N/A
8. 4. Does the organization consider the nature, use, and intended lifetime of the products and services?
Yes
No
N/A
9. 5. Does the organization consider customer requirements?
Yes
No
N/A
10. 5. Does the organization consider customer requirements?
Yes
No
N/A
11. 6. Does the organization consider customer feedback?
Yes
No
N/A
12. 6. Does the organization consider customer feedback?
Yes
No
N/A
Section 47: 8.5 Production And Service Provision - 8.5.6 Control Of Changes
1. 1. Does the organization review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements?
Yes
No
N/A
2. 1. Does the organization review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements?
Yes
No
N/A
3. 2. Does the organization retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review?
Yes
No
N/A
4. 2. Does the organization retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review?
Yes
No
N/A
Section 48: 8.6 Release Of Products And Services
1. 1. Does the organization implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met?
Yes
No
N/A
2. 1. Does the organization implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met?
Yes
No
N/A
3. 2. Does the release of products and services to the customer not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer?
Yes
No
N/A
4. 2. Does the release of products and services to the customer not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer?
Yes
No
N/A
5. 3. Does the organization retain documented information on the release of products and services?
Yes
No
N/A
6. 3. Does the organization retain documented information on the release of products and services?
Yes
No
N/A
7. 4. Does this documented information include evidence of conformity with the acceptance criteria?
Yes
No
N/A
8. 4. Does this documented information include evidence of conformity with the acceptance criteria?
Yes
No
N/A
9. 5. Does this documented information include traceability to the person(s) authorizing the release?
Yes
No
N/A
10. 5. Does this documented information include traceability to the person(s) authorizing the release?
Yes
No
N/A
Section 49: 8.7 Control Of Nonconforming Process Outputs, Products And Services - 8.7.1 Nonconforming Outputs
1. 1. Does the organization ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery?
Yes
No
N/A
2. 1. Does the organization ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery?
Yes
No
N/A
3. 2. Does the organization take appropriate corrective action based on the nature of the nonconformity and its effect on the conformity of products and services?
Yes
No
N/A
4. 2. Does the organization take appropriate corrective action based on the nature of the nonconformity and its effect on the conformity of products and services?
Yes
No
N/A
5. 3. Does this also apply to nonconforming products and services detected after delivery of the products, during or after the provision of services?
Yes
No
N/A
6. 3. Does this also apply to nonconforming products and services detected after delivery of the products, during or after the provision of services?
Yes
No
N/A
7. 4. Does the organization deal with nonconforming outputs in one or more of the following ways: • correction? • segregation, containment, return, or suspension of provision of products and services? • informing the customer? • obtaining authorization for acceptance under concession?
Yes
No
N/A
8. 4. Does the organization deal with nonconforming outputs in one or more of the following ways: • correction? • segregation, containment, return, or suspension of provision of products and services? • informing the customer? • obtaining authorization for acceptance under concession?
Yes
No
N/A
9. 5. When nonconforming outputs are corrected, is conformity to the requirements verified?
Yes
No
N/A
10. 5. When nonconforming outputs are corrected, is conformity to the requirements verified?
Yes
No
N/A
11. 6. Does the organization retain documented information on 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?
Yes
No
N/A
12. 6. Does the organization retain documented information on 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?
Yes
No
N/A
13. 7. Does the organization retain documented information that: • describes the nonconformity? • describes the action taken? • describes any concessions obtained? • identifies the authority deciding the action in respect of the nonconformity?
Yes
No
N/A
14. 7. Does the organization retain documented information that: • describes the nonconformity? • describes the action taken? • describes any concessions obtained? • identifies the authority deciding the action in respect of the nonconformity?
Yes
No
N/A
Section 50: 9.1 Monitoring, Measurement, Analysis, And Evaluation - 9.1.1 General
1. 1. Has the organization determined what needs to be monitored and measured?
Yes
No
N/A
2. 1. Has the organization determined what needs to be monitored and measured?
Yes
No
N/A
3. 2. Has the organization determined the methods for monitoring, measurement, analysis, and evaluation, as applicable, to ensure valid results?
Yes
No
N/A
4. 2. Has the organization determined the methods for monitoring, measurement, analysis, and evaluation, as applicable, to ensure valid results?
Yes
No
N/A
5. 3. Has the organization determined when the monitoring and measuring shall be performed?
Yes
No
N/A
6. 3. Has the organization determined when the monitoring and measuring shall be performed?
Yes
No
N/A
7. 4. Has the organization determined when the results from monitoring and measurement shall be analyzed and evaluated?
Yes
No
N/A
8. 4. Has the organization determined when the results from monitoring and measurement shall be analyzed and evaluated?
Yes
No
N/A
9. 5. Does the organization evaluate the performance and the effectiveness of the quality management system?
Yes
No
N/A
10. 5. Does the organization evaluate the performance and the effectiveness of the quality management system?
Yes
No
N/A
11. 6. Does the organization retain appropriate documented information as evidence of the results?
Yes
No
N/A
12. 6. Does the organization retain appropriate documented information as evidence of the results?
Yes
No
N/A
Section 51: 9.1 Monitoring, Measurement, Analysis, And Evaluation - 9.1.2 Customer Satisfaction
1. 1. Does the organization monitor customer perceptions of the degree to which their needs and expectations have been fulfilled?
Yes
No
N/A
2. 1. Does the organization monitor customer perceptions of the degree to which their needs and expectations have been fulfilled?
Yes
No
N/A
3. 2. Has the organization determined the methods for obtaining, monitoring, and reviewing this information?
Yes
No
N/A
4. 2. Has the organization determined the methods for obtaining, monitoring, and reviewing this information?
Yes
No
N/A
Section 52: 9.1 Monitoring, Measurement, Analysis, And Evaluation - 9.1.3 Analysis And Evaluation
1. 1. Does the organization analyze and evaluate appropriate data and information arising from monitoring and measurement?
Yes
No
N/A
2. 1. Does the organization analyze and evaluate appropriate data and information arising from monitoring and measurement?
Yes
No
N/A
3. 2. Are the results of the analysis used to evaluate the conformity of products and services?
Yes
No
N/A
4. 2. Are the results of the analysis used to evaluate the conformity of products and services?
Yes
No
N/A
5. 3. Are the results of the analysis used to evaluate the degree of customer satisfaction?
Yes
No
N/A
6. 3. Are the results of the analysis used to evaluate the degree of customer satisfaction?
Yes
No
N/A
7. 4. Are the results of the analysis used to evaluate the performance and effectiveness of the quality management system?
Yes
No
N/A
8. 4. Are the results of the analysis used to evaluate the performance and effectiveness of the quality management system?
Yes
No
N/A
9. 5. Are the results of the analysis used to evaluate ff planning has been implemented effectively?
Yes
No
N/A
10. 5. Are the results of the analysis used to evaluate ff planning has been implemented effectively?
Yes
No
N/A
11. 6. Are the results of the analysis used to evaluate the effectiveness of actions taken to address risks and opportunities?
Yes
No
N/A
12. 6. Are the results of the analysis used to evaluate the effectiveness of actions taken to address risks and opportunities?
Yes
No
N/A
13. 7. Are the results of the analysis used to evaluate the performance of external providers?
Yes
No
N/A
14. 7. Are the results of the analysis used to evaluate the performance of external providers?
Yes
No
N/A
15. 8. Are the results of the analysis used to evaluate the need for improvements within the quality management system?
Yes
No
N/A
16. 8. Are the results of the analysis used to evaluate the need for improvements within the quality management system?
Yes
No
N/A
Section 53: 9.2 Internal Audit
1. 1. Does the organization conform to the organization’s own requirements for its quality management system?
Yes
No
N/A
2. 1. Does the organization conform to the organization’s own requirements for its quality management system?
Yes
No
N/A
3. 2. Does the organization conform to the requirements of ISO 9001 being effectively implemented and maintained?
Yes
No
N/A
4. 2. Does the organization conform to the requirements of ISO 9001 being effectively implemented and maintained?
Yes
No
N/A
5. 3. Does the organization plan, establish, implement, and maintain an audit program(s) including the frequency, methods, responsibilities, planning requirements, and reporting, which take into consideration the importance of the processes concerned, customer feedback, changes affecting the organization, and the results of previous audits?
Yes
No
N/A
6. 3. Does the organization plan, establish, implement, and maintain an audit program(s) including the frequency, methods, responsibilities, planning requirements, and reporting, which take into consideration the importance of the processes concerned, customer feedback, changes affecting the organization, and the results of previous audits?
Yes
No
N/A
7. 4. Does the organization define the audit criteria and scope for each audit?
Yes
No
N/A
8. 4. Does the organization define the audit criteria and scope for each audit?
Yes
No
N/A
9. 5. Does the organization select auditors and conduct audits to ensure objectivity and the impartiality of the audit process?
Yes
No
N/A
10. 5. Does the organization select auditors and conduct audits to ensure objectivity and the impartiality of the audit process?
Yes
No
N/A
11. 6. Does the organization ensure that the results of the audits are reported to relevant management?
Yes
No
N/A
12. 6. Does the organization ensure that the results of the audits are reported to relevant management?
Yes
No
N/A
13. 7. Does the organization take appropriate corrections and corrective actions without undue delay?
Yes
No
N/A
14. 7. Does the organization take appropriate corrections and corrective actions without undue delay?
Yes
No
N/A
15. 8. Does the organization retain documented information as evidence of the implementation of the audit program and the audit results?
Yes
No
N/A
16. 8. Does the organization retain documented information as evidence of the implementation of the audit program and the audit results?
Yes
No
N/A
Section 54: 9.3 Management Review - 9.3.1 General
1. 1. Does top management review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization?
Yes
No
N/A
2. 1. Does top management review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization?
Yes
No
N/A
Section 55: 9.3 Management Review - 9.3.2 Management Review Inputs
1. 1. Has the management reviewed the status of actions from previous management reviews?
Yes
No
N/A
2. 1. Has the management reviewed the status of actions from previous management reviews?
Yes
No
N/A
3. 2. Has the management reviewed changes in external and internal issues that are relevant to the quality management system?
Yes
No
N/A
4. 2. Has the management reviewed changes in external and internal issues that are relevant to the quality management system?
Yes
No
N/A
5. 3. Has the management reviewed information on the performance and effectiveness of the quality management system?
Yes
No
N/A
6. 3. Has the management reviewed information on the performance and effectiveness of the quality management system?
Yes
No
N/A
7. 4. Has the management reviewed customer satisfaction and feedback from relevant interested parties?
Yes
No
N/A
8. 4. Has the management reviewed customer satisfaction and feedback from relevant interested parties?
Yes
No
N/A
9. 5. Has the management reviewed the extent to which quality objectives have been met?
Yes
No
N/A
10. 5. Has the management reviewed the extent to which quality objectives have been met?
Yes
No
N/A
11. 6. Has the management reviewed process performance and the conformity of products and services?
Yes
No
N/A
12. 6. Has the management reviewed process performance and the conformity of products and services?
Yes
No
N/A
13. 7. Has the management reviewed nonconformities and corrective actions?
Yes
No
N/A
14. 7. Has the management reviewed nonconformities and corrective actions?
Yes
No
N/A
15. 8. Has the management reviewed monitoring and measurement results?
Yes
No
N/A
16. 8. Has the management reviewed monitoring and measurement results?
Yes
No
N/A
17. 9. Has the management reviewed audit results?
Yes
No
N/A
18. 9. Has the management reviewed audit results?
Yes
No
N/A
19. 10. Has the management reviewed the performance of external providers?
Yes
No
N/A
20. 10. Has the management reviewed the performance of external providers?
Yes
No
N/A
21. 11. Has the management reviewed the adequacy of resources?
Yes
No
N/A
22. 11. Has the management reviewed the adequacy of resources?
Yes
No
N/A
23. 12. Has the management reviewed the effectiveness of actions taken to address risks and opportunities?
Yes
No
N/A
24. 12. Has the management reviewed the effectiveness of actions taken to address risks and opportunities?
Yes
No
N/A
25. 13. Has the management reviewed opportunities for improvement?
Yes
No
N/A
26. 13. Has the management reviewed opportunities for improvement?
Yes
No
N/A
Section 56: 9.3 Management Review - 9.3.3 Management Review Outputs
1. 1. Has the management reviewed opportunities for improvement?
Yes
No
N/A
2. 1. Has the management reviewed opportunities for improvement?
Yes
No
N/A
3. 2. Has the management reviewed any need for changes to the quality management system?
Yes
No
N/A
4. 2. Has the management reviewed any need for changes to the quality management system?
Yes
No
N/A
5. 3. Has the management reviewed resource needs?
Yes
No
N/A
6. 3. Has the management reviewed resource needs?
Yes
No
N/A
7. 4. Does the organization retain documented information as evidence of the results of management reviews?
Yes
No
N/A
8. 4. Does the organization retain documented information as evidence of the results of management reviews?
Yes
No
N/A
Section 57: 10.1 General
1. 1. Does the organization determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction?
Yes
No
N/A
2. 1. Does the organization determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction?
Yes
No
N/A
3. 2. Are improving products and services to meet requirements as well as to address future needs and expectations done?
Yes
No
N/A
4. 2. Are improving products and services to meet requirements as well as to address future needs and expectations done?
Yes
No
N/A
5. 3. Is correcting, preventing, or reducing undesired effects done?
Yes
No
N/A
6. 3. Is correcting, preventing, or reducing undesired effects done?
Yes
No
N/A
7. 4. Is improving the performance and effectiveness of the quality management system done?
Yes
No
N/A
8. 4. Is improving the performance and effectiveness of the quality management system done?
Yes
No
N/A
Section 58: 10.2 Nonconformity And Corrective Action
1. 1. Does the organization react to the nonconformity and, as applicable: • take action to control and correct it? • deal with the consequences?
Yes
No
N/A
2. 1. Does the organization react to the nonconformity and, as applicable: • take action to control and correct it? • deal with the consequences?
Yes
No
N/A
3. 2. Does the organization review and analyze the nonconformity?
Yes
No
N/A
4. 2. Does the organization review and analyze the nonconformity?
Yes
No
N/A
5. 3. Does the organization determine the causes of the nonconformity?
Yes
No
N/A
6. 3. Does the organization determine the causes of the nonconformity?
Yes
No
N/A
7. 4. Does the organization determine if similar nonconformities exist or could potentially occur?
Yes
No
N/A
8. 4. Does the organization determine if similar nonconformities exist or could potentially occur?
Yes
No
N/A
9. 5. Does the organization implement any action needed?
Yes
No
N/A
10. 5. Does the organization implement any action needed?
Yes
No
N/A
11. 6. Does the organization review the effectiveness of any corrective action taken?
Yes
No
N/A
12. 6. Does the organization review the effectiveness of any corrective action taken?
Yes
No
N/A
13. 7. Does the organization update risks and opportunities determined during planning if necessary?
Yes
No
N/A
14. 7. Does the organization update risks and opportunities determined during planning if necessary?
Yes
No
N/A
15. 8. Does the organization make changes to the quality management system if necessary?
Yes
No
N/A
16. 8. Does the organization make changes to the quality management system if necessary?
Yes
No
N/A
17. 9. Are the corrective actions appropriate to the effects of the nonconformities encountered?
Yes
No
N/A
18. 9. Are the corrective actions appropriate to the effects of the nonconformities encountered?
Yes
No
N/A
19. 10. Does the organization retain documented information as evidence of: • the nature of the nonconformities and any subsequent actions taken? • the results of any corrective action?
Yes
No
N/A
20. 10. Does the organization retain documented information as evidence of: • the nature of the nonconformities and any subsequent actions taken? • the results of any corrective action?
Yes
No
N/A
Section 59: 10.3 Continual Improvement
1. 1. Does the organization continually improve the suitability, adequacy, and effectiveness of the quality management system?
Yes
No
N/A
2. 1. Does the organization continually improve the suitability, adequacy, and effectiveness of the quality management system?
Yes
No
N/A
3. 2. Does the organization consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement?
Yes
No
N/A
4. 2. Does the organization consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement?
Yes
No
N/A