ISO 9001 2015 Audit Checklist

Use the ISO 9001-2015 Audit Checklist for a systematic review of your quality management processes, in preparation for the ISO 9001 certification.

ISO 9001 2015 Audit Checklist



4.1 Understanding The Organization And Its Context

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?


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2. Does the organization monitor and review information about these external and internal issues?


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4.2 Understanding The Needs And Expectations Of Interested Parties

1. Has the organization determined the interested parties that are relevant to the quality management system?


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2. Has the organization determined the requirements of these interested parties that are relevant to the quality management system?


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3. Does the organization monitor and review information about these interested parties and their relevant requirements?


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4.3 Determining The Scope Of The Quality Management System

1. Has the organization determined the boundaries and applicability of the quality management system to establish its scope?


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2. Has the organization considered the external and internal issues?


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3. Has the organization considered the requirements of relevant interested parties?


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4. Has the organization considered the products and services of the organization?


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5. Has the organization applied all the requirements of ISO 9001 if they are applicable within the determined scope of its quality management system?


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6. Is the scope of the organization’s quality management system available and maintained as documented information?


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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?


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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?


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4.4 Quality Management System And Its Processes

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?


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2. Has the organization determined the processes needed for the quality management system and their application throughout the organization?


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3. Has the organization determined the inputs required and the outputs expected from these processes?


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4. Has the organization determined the sequence and interaction of these processes?


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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?


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6. Has the organization determined the resources needed for these processes and ensured their availability?


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7. Has the organization assigned the responsibilities and authorities for these processes?


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8. Has the organization addressed the risks and opportunities as determined in accordance with the requirements of?


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9. Has the organization evaluated these processes and implemented any changes needed to ensure that these processes achieve their intended results?


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10. Has the organization improved the processes and the quality management system?


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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?


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5.1 Leadership And Commitment - 5.1.1 General

1. Has top management taken accountability for the effectiveness of the quality management system?


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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?


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3. Has top management ensured the integration of the quality management system requirements into the organization’s business processes?


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4. Has top management promoted the use of the process approach and risk-based thinking?


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5. Has top management ensured that the resources needed for the quality management system are available?


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6. Has top management communicated the importance of effective quality management and conformed to the quality management system requirements?


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7. Has top management ensured that the quality management system achieves its intended results?


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8. Has top management engaged, directed, and supported persons to contribute to the effectiveness of the quality management system?


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9. Has top management ensured in promoting improvement?


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10. Has top management ensured in supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?


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5.1 Leadership And Commitment - 5.1.2 Customer Focus

1. Has top management ensured customer and applicable statutory and regulatory requirements are determined, understood, and consistently met?


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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?


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3. Has top management ensured the focus on enhancing customer satisfaction is maintained?


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5.2 Policy - 5.2.1 Developing The Quality Polic

1. Has top management developed a quality policy that is appropriate to the purpose and context of the organization and supports its strategic direction?


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2. Has top management developed a quality policy that provides a framework for setting quality objectives?


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3. Has top management developed a quality policy that includes a commitment to satisfy applicable requirements?


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4. Has top management developed a quality policy that includes a commitment to continual improvement of the quality management system?


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5.2 Policy - 5.2.2 Communicating The Quality Policy

1. Is the quality policy available and maintained as documented information?


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2. Is the quality policy communicated, understood, and applied within the organization?


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3. Is the quality policy available to relevant interested parties, as appropriate?


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6.1 Actions To Address Risks And Opportunities - 6.1.1 Considering Issues

1. Has the organization given assurance that the quality management system can achieve its intended result(s)?


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2. Has the organization enhanced desirable effects?


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3. Has the organization prevented, or reduced, undesired effects?


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4. Has the organization achieved improvement?


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6.1 Actions To Address Risks And Opportunities - 6.1.2 Organization Planning

1. Has the organization planned actions to address risks and opportunities?


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2. Has the organization planned to integrate and implement the actions into its quality management system processes?


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3. Has the organization evaluated the effectiveness of these actions?


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4. Are actions taken to address risks and opportunities proportionate to the potential impact on the conformity of products and services?


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6.2 Quality Objectives And Planning To Achieve Them - 6.2.1 Establishing Quality Objectives

1. Has the organization established quality objectives at relevant functions, levels, and processes needed for the quality management system?


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2. Are the quality objectives consistent with the quality policy?


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3. Are the quality objectives measurable?


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4. Are the quality objectives taking into account applicable requirements?


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5. Are the quality objectives relevant to the conformity of products and services and to the enhancement of customer satisfaction?


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6. Are the quality objectives monitored?


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7. Are the quality objectives communicated?


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8. Are the quality objectives updated as appropriate?


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9. Does the organization maintain documented information on the quality objectives?


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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?


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6.3 Planning Of Changes

1. When the organization determines the need for change to the quality management system are changes carried out in a planned and systematic manner?


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2. Does the organization consider the purpose of the change and any of its potential consequences?


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3. Does the organization consider the integrity of the quality management system?


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4. Does the organization consider the availability of resources?


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5. Does the organization consider the allocation or reallocation of responsibilities and authorities?


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7.1 Resources - 7.1.1 General

1. Has the organization determined and provided the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system?


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2. Has the organization considered the capabilities of, and constraints on, existing internal resources?


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3. Has the organization considered what needs to be obtained from external providers?


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7.1 Resources - 7.1.2 People

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?


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7.1 Resources - 7.1.3 Infrastructure

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?


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7.1 Resources - 7.1.4 Environment For The Operation Of Processes

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?


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7.1 Resources - 7.1.5 Monitoring And Measurement Resources - 7.1.5.1 General

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?


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2. Does the organization ensure that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken?


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3. Does the organization ensure that the resources provided are maintained to ensure their continued fitness for their purpose?


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4. Does the organization retain appropriate documented information as evidence of fitness for the purpose of monitoring and measurement resources?


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7.1 Resources - 7.1.5 Monitoring And Measurement Resources - 7.1.5.2 Measurement Traceability

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?


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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?


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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?


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7.1 Resources - 7.1.6 Organizational Knowledge

1. Does the organization determine the knowledge necessary for the operation of its processes and to achieve the conformity of products and services?


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2. Is this knowledge maintained and made available to the extent necessary?


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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?


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7.2 Competence

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?


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2. Has the organization ensured that these persons are competent on the basis of appropriate education, training, or experience?


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3. Has the organization taken actions, where applicable, to acquire the necessary competence and evaluated the effectiveness of the actions taken?


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4. Has the organization retained appropriate documented information as evidence of competence?


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7.3 Awareness

1. Are staff aware of the quality policy?


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2. Are staff aware of the relevant quality objectives?


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3. Are staff aware of their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance?


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4. Are staff aware of the implications of not conforming with the quality management system requirements?


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7.4 Communication

1. Has the organization determined what it will communicate?


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2. Has the organization determined when to communicate?


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3. Has the organization determined with whom to communicate?


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4. Has the organization determined on how to communicate?


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5. Has the organization determined who communicates?


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7.5 Documented Information - 7.5.1 General

1. Does the organization’s quality management system include documented information required by ISO 9001?


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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?


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7.5 Documented Information -7.5.2 Creating And Updating

1. Does the organization ensure appropriate identification and description (e.g., a title, date, author, or reference number)?


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2. Does the organization ensure appropriate format (e.g., language, software version, graphics) and media (e.g., paper, electronic)?


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3. Does the organization ensure appropriate review and approval for suitability and adequacy?


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7.5 Documented Information -7.5.3 Control Of Documented Information - 7.5.3.1 Availability Of Documented Information

1. Is the documented information available and suitable for use, where and when it is needed?


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2. Is the documented information adequately protected (e.g., from loss of confidentiality, improper use, or loss of integrity)?


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7.5 Documented Information -7.5.3 Control Of Documented Information - 7.5.3.2 Organizational Activities

1. Has the organization addressed distribution, access, retrieval, and use?


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2. Has the organization addressed storage and preservation, including preservation of legibility?


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3. Has the organization addressed control of changes (e.g., version control)?


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4. Has the organization addressed retention and disposition?


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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?


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6. Is documented information retained as evidence of conformity protected from unintended alterations?


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8.1 Operational Planning And Control

1. Has the organization determined requirements for the product and services?


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2. Has the organization established criteria for the processes and the acceptance of products and services?


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3. Has the organization determined the resources needed to achieve conformity to product and service requirements?


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4. Has the organization implemented control of the processes in accordance with the criteria?


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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?


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6. Is the output of this planning suitable for the organization's operations?


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7. Does the organization control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary?


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8. Does the organization ensure that outsourced processes are controlled in accordance with 8.4?


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8.2 Requirements For Products And Services - 8.2.1 Customer Communication

1. Has customer communication provided information relating to products and services?


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2. Has customer communication handled inquiries, contracts, or order handling, including changes?


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3. Has customer communication obtained customer feedback relating to products and services, including customer complaints?


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4. Has customer communication handled or controlled customer property?


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5. Has customer communication established specific requirements for contingency actions, when relevant?


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8.2 Requirements For Products And Services -8.2.2 Determination Of Requirements Related To Products And Services

1. Does the organization ensure that the requirements for products and services are defined?


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2. Does the organization ensure that any applicable statutory and regulatory requirements are met?


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3. Does the organization ensure those requirements considered necessary by the organization are met?


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4. Does the organization meet the claims for the products and services it offers?


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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. Does the organization ensure that it has the ability to meet the requirements for products and services to be offered to customers?


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2. Has the organization conducted a review to meet the requirements specified by the customer, including the requirements for delivery and post-delivery activities?


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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?


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4. Has the organization conducted a review for requirements as specified by the organization?


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5. Has the organization conducted a review for statutory and regulatory requirements applicable to the products and services?


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6. Has the organization conducted a review for contract or order requirements differing from those previously expressed?


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7. Does the organization ensure that contract or order requirements differing from those previously defined are resolved?


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8. When the customer does not provide a documented statement of their requirements, are the customer requirements confirmed by the organization before acceptance?


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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. Does the organization retain documented information, as applicable: • on the results of the review? • on any new requirements for the products and services?


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8.2 Requirements For Products And Services - 8.2.4 Changes To Requirements For Products And Services

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.


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8.3 Design And Development Of Products And Services - 8.3.1 General

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?


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8.3 Design And Development Of Products And Services - 8.3.2 Design And Development Planning

1. Does the organization consider the nature, duration, and complexity of the design and development activities?


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2. Does the organization consider the required process stages, including applicable design and development reviews?


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3. Does the organization consider the required design and development verification and validation activities?


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4. Does the organization consider the responsibilities and authorities involved in the design and development process?


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5. Does the organization consider the internal and external resource needs for the design and development of products and services?


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6. Does the organization consider the need to control interfaces between persons involved in the design and development process?


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7. Does the organization consider the need for involvement of customers and users in the design and development process?


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8. Does the organization consider the requirements for subsequent provision of products and services?


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9. Does the organization consider the level of control expected for the design and development process by customers and other relevant interested parties?


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10. Does the organization consider the documented information needed to demonstrate that design and development requirements have been met?


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8.3 Design And Development Of Products And Services - 8.3.3 Design And Development Inputs

1. Does the organization determine the requirements essential for the specific types of products and services to be designed and developed?


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2. Does the organization consider functional and performance requirements?


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3. Does the organization consider the information derived from previous similar design and development activities?


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4. Does the organization consider statutory and regulatory requirements?


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5. Does the organization consider standards or codes of practice that the organization has committed to implementing?


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6. Does the organization consider the potential consequences of failure due to the nature of the products and services?


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7. Are inputs adequate for design and development purposes, complete and unambiguous?


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8. Are conflicting design and development inputs resolved?


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9. Does the organization retain documented information on design and development inputs


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8.3 Design And Development Of Products And Services - 8.3.4 Design And Development Controls

1. Does the organization ensure that the results to be achieved are defined?


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2. Does the organization ensure that the reviews are conducted to evaluate the ability of the results of design and development to meet requirements?


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3. Does the organization ensure that the verification activities are conducted to ensure that the design and development outputs meet the input requirements?


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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?


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5. Does the organization ensure that any necessary actions are taken on problems determined during the reviews, or verification and validation activities?


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6. Does the organization ensure that the documented information of these activities is retained?


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8.3 Design And Development Of Products And Services - 8.3.5 Design And Development Outputs

1. Do the design and development outputs meet the input requirements?


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2. Are the design and development outputs adequate for the subsequent processes for the provision of products and services?


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3. Do the design and development outputs include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria?


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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?


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5. Does the organization retain documented information on the design and development process?


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8.3 Design And Development Of Products And Services - 8.3.6 Design And Development Changes

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?


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2. Is documented information retained on design and development changes?


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3. Is documented information retained on the results of reviews?


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4. Is documented information retained on the authorization of the changes?


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5. Is documented information retained on the actions taken to prevent adverse impacts?


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8.4 Control Of Externally Provided Products And Services - 8.4.1 General

1. Does the organization ensure that externally provided processes, products, and services conform to requirements?


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2. Are products and services from external providers intended for incorporation into the organization’s own products and services?


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3. Are products and services provided directly to the customer(s) by external providers on behalf of the organization?


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4. Is a process, or part of a process, provided by an external provider as a result of a decision by the organization?


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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?


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6. Does the organization retain documented information on these activities and any necessary actions arising from the evaluations?


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8.4 Control Of Externally Provided Products And Services - 8.4.2 Type And Extent Of Control

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?


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2. Does the organization ensure that externally provided processes remain within the control of its quality management system?


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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?


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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?


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5. Does the organization take into consideration the effectiveness of the controls applied by the external provider


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6. Does the organization determine the verification or other activities necessary to ensure that the externally provided processes, products, and services meet requirements?


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8.4 Control Of Externally Provided Products And Services - 8.4.3 Information For External Providers

1. Does the organization ensure the adequacy of requirements prior to their communication to the external provider?


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2. Does the organization communicate ensure the processes, products, and services are provided?


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3. Does the organization ensure the approval of: • products and services? • methods, processes, and equipment? • the release of products and services?


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4. Does the organization ensure competence, including any required qualification of persons?


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5. Does the organization ensure the external providers’ interactions with the organization?


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6. Does the organization ensure control and monitoring of the external provider’s performance to be applied by the organization?


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7. Does the organization ensure verification or validation activities that the organization, or its customer, intends to perform at the external provider’s premises?


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8.5 Production And Service Provision - 8.5.1 Control Of Production And Service Provision

1. Has the organization implemented production and service provision under controlled conditions?


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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?


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3. Do the controlled conditions include the availability and use of suitable monitoring and measuring resources?


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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?


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5. Do the controlled conditions include the use of suitable infrastructure and environment for the operation of processes?


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6. Do the controlled conditions include the appointment of competent persons, including any required qualification?


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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?


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8. Do the controlled conditions include the implementations of actions to prevent human error?


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9. Do the controlled conditions include the implementation of release, delivery, and post-delivery activities?


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8.5 Production And Service Provision - 8.5.2 Identification And Traceability

1. Does the organization use suitable means to identify outputs when it is necessary to ensure the conformity of products and services?


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2. Does the organization identify the status of process outputs with respect to monitoring and measurement requirements throughout production and service provision?


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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?


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8.5 Production And Service Provision - 8.5.3 Property Belonging To Customers Or External Providers

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?


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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?


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8.5 Production And Service Provision - 8.5.4 Preservation

1. Does the organization preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements?


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8.5 Production And Service Provision - 8.5.5 Post-delivery Activities

1. Does the organization meet requirements for post-delivery activities associated with the products and services?


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2. Does the organization consider the statutory and regulatory requirements?


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3. Does the organization consider the potential undesired consequences associated with its products and services?


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4. Does the organization consider the nature, use, and intended lifetime of the products and services?


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5. Does the organization consider customer requirements?


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6. Does the organization consider customer feedback?


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8.5 Production And Service Provision - 8.5.6 Control Of Changes

1. Does the organization review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements?


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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?


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8.6 Release Of Products And Services

1. Does the organization implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met?


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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?


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3. Does the organization retain documented information on the release of products and services?


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4. Does this documented information include evidence of conformity with the acceptance criteria?


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5. Does this documented information include traceability to the person(s) authorizing the release?


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8.7 Control Of Nonconforming Process Outputs, Products And Services - 8.7.1 Nonconforming Outputs

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?


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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?


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3. Does this also apply to nonconforming products and services detected after delivery of the products, during or after the provision of services?


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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?


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5. When nonconforming outputs are corrected, is conformity to the requirements verified?


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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?


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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?


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9.1 Monitoring, Measurement, Analysis, And Evaluation - 9.1.1 General

1. Has the organization determined what needs to be monitored and measured?


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2. Has the organization determined the methods for monitoring, measurement, analysis, and evaluation, as applicable, to ensure valid results?


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3. Has the organization determined when the monitoring and measuring shall be performed?


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4. Has the organization determined when the results from monitoring and measurement shall be analyzed and evaluated?


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5. Does the organization evaluate the performance and the effectiveness of the quality management system?


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6. Does the organization retain appropriate documented information as evidence of the results?


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9.1 Monitoring, Measurement, Analysis, And Evaluation - 9.1.2 Customer Satisfaction

1. Does the organization monitor customer perceptions of the degree to which their needs and expectations have been fulfilled?


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2. Has the organization determined the methods for obtaining, monitoring, and reviewing this information?


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9.1 Monitoring, Measurement, Analysis, And Evaluation - 9.1.3 Analysis And Evaluation

1. Does the organization analyze and evaluate appropriate data and information arising from monitoring and measurement?


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2. Are the results of the analysis used to evaluate the conformity of products and services?


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3. Are the results of the analysis used to evaluate the degree of customer satisfaction?


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4. Are the results of the analysis used to evaluate the performance and effectiveness of the quality management system?


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5. Are the results of the analysis used to evaluate ff planning has been implemented effectively?


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6. Are the results of the analysis used to evaluate the effectiveness of actions taken to address risks and opportunities?


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7. Are the results of the analysis used to evaluate the performance of external providers?


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8. Are the results of the analysis used to evaluate the need for improvements within the quality management system?


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9.2 Internal Audit

1. Does the organization conform to the organization’s own requirements for its quality management system?


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2. Does the organization conform to the requirements of ISO 9001 being effectively implemented and maintained?


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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?


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4. Does the organization define the audit criteria and scope for each audit?


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5. Does the organization select auditors and conduct audits to ensure objectivity and the impartiality of the audit process?


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6. Does the organization ensure that the results of the audits are reported to relevant management?


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7. Does the organization take appropriate corrections and corrective actions without undue delay?


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8. Does the organization retain documented information as evidence of the implementation of the audit program and the audit results?


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9.3 Management Review - 9.3.1 General

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?


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9.3 Management Review - 9.3.2 Management Review Inputs

1. Has the management reviewed the status of actions from previous management reviews?


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2. Has the management reviewed changes in external and internal issues that are relevant to the quality management system?


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3. Has the management reviewed information on the performance and effectiveness of the quality management system?


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4. Has the management reviewed customer satisfaction and feedback from relevant interested parties?


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5. Has the management reviewed the extent to which quality objectives have been met?


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6. Has the management reviewed process performance and the conformity of products and services?


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7. Has the management reviewed nonconformities and corrective actions?


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8. Has the management reviewed monitoring and measurement results?


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9. Has the management reviewed audit results?


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10. Has the management reviewed the performance of external providers?


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11. Has the management reviewed the adequacy of resources?


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12. Has the management reviewed the effectiveness of actions taken to address risks and opportunities?


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13. Has the management reviewed opportunities for improvement?


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9.3 Management Review - 9.3.3 Management Review Outputs

1. Has the management reviewed opportunities for improvement?


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2. Has the management reviewed any need for changes to the quality management system?


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3. Has the management reviewed resource needs?


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4. Does the organization retain documented information as evidence of the results of management reviews?


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10.1 General

1. Does the organization determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction?


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2. Are improving products and services to meet requirements as well as to address future needs and expectations done?


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3. Is correcting, preventing, or reducing undesired effects done?


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4. Is improving the performance and effectiveness of the quality management system done?


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10.2 Nonconformity And Corrective Action

1. Does the organization react to the nonconformity and, as applicable: • take action to control and correct it? • deal with the consequences?


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2. Does the organization review and analyze the nonconformity?


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3. Does the organization determine the causes of the nonconformity?


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4. Does the organization determine if similar nonconformities exist or could potentially occur?


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5. Does the organization implement any action needed?


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6. Does the organization review the effectiveness of any corrective action taken?


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7. Does the organization update risks and opportunities determined during planning if necessary?


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8. Does the organization make changes to the quality management system if necessary?


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9. Are the corrective actions appropriate to the effects of the nonconformities encountered?


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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?


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10.3 Continual Improvement

1. Does the organization continually improve the suitability, adequacy, and effectiveness of the quality management system?


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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?


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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