Title Page
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Conducted on
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Auditor
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Company Name
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Address
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E-mail
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Telephone
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Contact or Management Representative
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Contact or MR email
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Contact or MR telephone
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Number of Employees
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Has the company noted on exclusions to the standard?
Summary Page
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Overall summary of company's QMS
ISO 9001:2015 Clauses
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Section 4 Context of the Organization
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4.1 Understanding the organization and its context
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Have internal and external issues been determined?
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When are these issues monitored and reviewed?
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ISO 9001 - 4.1 understanding the organization and its context
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4.2 Understanding the needs and expectations of interested parties
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Have interested parties and their requirements been determined?
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When are the interest parties and their requirements monitored and reviewed?
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4.3 Determining the scope
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Has the scope of the quality management system been defined?
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Does it match the current ISO certificate?
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Is the scope maintained as documented information?
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4.4 Quality management system and its processess
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Have processes been determined for the quality management system?
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Is there a documented Quality Manual?
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How is the Quality Manual maintained and reviewed?
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How does the company maintain its quality management system requirements?
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Do these processes include inputs and outputs that determine the sequence, interaction, criteria and methods for monitoring, measuring, KPIs?
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Have resources been determined for stated processes?
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Have authorities and responsibilities been assigned for the processes?
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Do the processes address risks and opportunities?
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How are the processes evaluated and changes implemented to determine if intended results are achieved?
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How are processes reviewed and improved?
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Section 4 assessment
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4.1 Understanding the organization and its context
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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4.2 Understanding the needs and expectations of interested parties
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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4.3 Determining the scope of the quality management system
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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4.4 Quality management system and its processes
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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Section 5 Leadership
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5.1 Leadership and commitment
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Has top management demonstrated leadership and commitment to their quality management system and to customer focus?
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5.2 Policy
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Does the company have a documented Quality Policy suitable to their QMS, with commitment to applicable requirements and continual improvement?
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How is the Quality Policy communicated within the organization and outside interested parties?
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Does the company have an organizational chart?
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5.3 Organization roles, responsibilities and authorities
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How are roles, responsibilities and authorities defined?
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Section 5 assessment
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5.1 Leadership and commitment
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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5.2 Policy
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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5.3 Organizational roles, responsibilities and authorities
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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Section 6 Planning
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6.1 Actions to address risks and opportunities
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Based on the company's determination of its interested parties and risks and opportunities as stated in Section 4, how did the organization ensure it can achieve its intended results, mitigate undesired effects, achieve improvement, plan actions to address issues, evaluate effectiveness of these actions?
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6.2 Quality Objectives and planning to achieve them
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Has the company established measurable Quality Objectives?
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Is the Quality Objectives information documented?
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Describe how they are monitored, communicated, evaluated, and updated?
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6.3 Planning of changes
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How does the company carry out planned changes?
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Section 6 assessment
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6.1 Actions to adderss risks and opportunities
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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6.2 Quality objectives an dplanning to achieve them
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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6.3 Planning of changes
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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Section 7 Support
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7.1 Resources
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7.1.2 People
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Did the company have sufficient persons available to ensure an effective implementation of its QMS, operations, and control processes?
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7.1.3 Infrastructure and 7.1.4 Environment
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Were the building and equipment maintained?
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Was the working environment suitable, such as good lightning, friendly and safe working conditions?
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7.1.5 Monitoring and measuring resources
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Has the company determined what is needed to be monitored and measured to verify products and services?
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Is equipment used in measurement traceability calibrated or verify?
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Is there a list of calibrated equipment?
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Is there any items that are currently out of calibration?
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Are these available to production?
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Check a selection of equipment on the shop floor and record the details.
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Are the items in the system?
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Are these in calibration?
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Are these identified as being calibrated?
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Check an externally calibrated item and record the details?
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Does this have a calibration certificate?
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Does the certificate show if the gauge was received in/out tolerance?
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Is there a plan in place to review items this gauge was used on if found out of tolerance?
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Is the certificate traceable to national standards?
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Have the calibration parameters been defined?
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Has the item passed the calibration requirements?
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Have the results been defined as acceptable?
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Is this documented?
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Have any items been calibrated internally?
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Is there a record of how it was calibrated?
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Are the calibration results available for review?
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Is the equipment that was used calibrated?
- Yes
- No
- N/A
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Provide explanation.
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7.1.6 Organizational know
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How does the company handle "tribal" knowledge that is needed for the operation of its processes and to achieve conforminity?
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7.2 Competence
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How does the company determine what is needed when hiring and training personnel?
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7.3 Awareness
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How does the company ensure it's employees are aware of the quality policy, quality objectives, their contribution to the QMS, and not conforming to QMS requirements?
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7.4 Communication
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What types of communication does the company use internally?
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What types of communication does the company use externally?
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7.5 Documented information
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Have necessary documents and forms been identified as needing controlled?
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Is access to the procedures available at the point of use?
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Are these protected form changes?
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Is there a change process in place?
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Is there evidence that the change process is being used?
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How are changes handled to ensure the latest revision is being used?
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Are document and record retention periods defined?
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Are these correct to the company's procedure and customer requirements?
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Are records controlled and easy to retrieve?
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Are electronically stored records backed up?
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Check a number of procedures, do these have correct revisions and revision history information?
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Section 7 assessment
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7.1 Resources
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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7.2 Competence
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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7.3 Awareness
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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7.4 Communication
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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7.5 Documented Information
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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Section 8 Operation
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8.1 Operational planning and control
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How are product/service requirements determined?
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How are product/service requirements controlled?
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How is data necessary to show conformity retained?
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8.2 Requirements for products and services
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What type of communication method is used between you and the customer?
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Does this communication allow the handling enquires, changes, providing information, ensuring the customer was satisfied with the product or service output?
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How does the company determine its requirements for products and services
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What type of process is used to review requirements prior to release?
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What and how is the review information retained?
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How are changes to customer requirements handled?
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8.3 Design and development of products and services
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What is the process for design and development planning?
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How does the company determine input requirments?
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What type of controls are applied to achieve intended results?
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Do these controls include a validation and verification process?
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Explain the validation process.
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Explain the verification process.
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What are the outputs from the design and development of products or services?
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How does the company handle changes to designs?
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How is information for design and development retained?
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8.4 Control of externally provided processes, products and services
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Has the company determined a criteria for its external providers?
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What determines the selection of an external provider?
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How are they evaluated
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How are external providers monitored?
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Is there a re-evaluation criteria or process?
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How are products or services received from an external provider controlled?
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How does the company ensure that requirements are communicated to the external provider?
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8.5 Productions and service procvision
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What type of output is used to ensure customer requirements are met once a project is released?
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How does the company handle identification of product and service outputs?
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How is traceability of outputs handled?
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How is documentation needed for traceability retained?
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If the company utilizes customer or external providers property, how is property identified, verified when applicable, and protected?
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How is preservation of outputs handled?
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What type of return or maintenance services to its products or services does the company have?
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When changes occurred during production of parts or services performed, how is the controlled or documentation showing results of changes retained?
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8.6 Release of products and services
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What evidence is retained showing finished product and services met requirements?
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Who has authority to release a finished product or service once completed?
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How is release of products and services documentation retained?
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8.7 Control of nonconforming outputs
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What is the process for nonconforming product?
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Is nonconforming product identified?
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Has nonconforming product been segregated from unintended use?
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If necessary has the customer been informed of nonconforming products or services?
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How is authorization obtained for acceptance of an "Use as is" product?
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When a product is repaired/reworked how is it verified to ensure it has been corrected?
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What documented information is retained that describes the nonconformity, actions taken, concessions obtained, identifying authority?
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Section 8 assessment
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8.1 Operation planning and control
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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8.2 Requirements for products and services
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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8.3 Design and development of products and services
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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8.4 Control of externally provided processes, products and services
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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8.5 Productions and service provision
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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8.6 Release of products and services
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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8.7 Control of nonconforming outputs
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Section 9 Performance evaluation
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9.1.1 General - Monitoring, measurement, analysis and evaluation
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Explain what the company monitors and measures, and when and how it is evaluated.
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9.1.2 Customer satisfaction
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How is customer satisfaction monitored?
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How is customer satisfaction measured?
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How often is customer perception reviewed?
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9.1.3 Analysis and evalution
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How does the company analyze and evaluate results from monitoring and measurement of date and information?
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9.2 Internal Audits
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Is there a documented internal audit process?
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Is there an audit plan defined?
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Does the plan cover all the processes and all areas of the standard?
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Have audits been conducted per the plan?
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Have any audits created nonconformances?
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Have the nonconformances been actioned and closed?
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Have the audits been conducted by trained auditors?
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Is objective evidence collected during the audit?
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Is documented information of the internal audit retained?
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9.3 Management Review
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How often are management reviews conducted?
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Did the management review include required inputs and outputs?
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Were there any changes or actions created from the management review?
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Have these changes or actions been implemented?
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Section 9 assessment
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9.1 Performance evaluation
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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9.2 Internal Audits
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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9.3 Management Review
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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Section 10 Improvement
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10.1 General
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Is there a process improvement plan defined?
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Have any process improvements been made?
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How are these logged or captured?
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10.2 Nonconformity and corrective action
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Is there a corrective action process?
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Explain process
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What format is used for corrective actions?
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Does this include a root cause analysis method?
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What time of root cause analysis is used?
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Are risk assessments' reviewed?
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Is the effectiveness of corrective actions recorded?
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10.3 Continual improvement
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How does the company handle continual improvement of its quality management system?
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Section 10 assessment
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10.1 General
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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10.2 Nonconformity and corrective actions
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
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10.3 Continual Improvement
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How many nonconformances were found?
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List nonconformance(s) description(s). Remember to place on the NC List .
