Iso 9001 2015 internal audit checklist for manufacturing company pdf

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This checklist gives guidance to internal auditors in manufacturing companies that need to perform an ISO 9001 internal audit. It outlines the right questions to ask during the ISO 9001 internal audit process and provides useful links to other relevant free materials and details related to:

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Iso 9001 2015 Audit Checklist

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ISO 9001 2015 Internal Audit Checklist For Manufacturing Companies en

Original Title:

ISO 9001 2015 Internal Audit Checklist for Manufacturing Companies En

Audit your quality management system for compliance with iso 9001:2015. check your qms meets iso standards.

4 Context of the organization

Please complete all sections starting immediately below. This internal self-assessment will evaluate the compliance of your Quality Management System with ISO 9001:2015. Remember to attach evidence to items where required, and to sign off and complete this assessment in the final section.

Verify how the organization has determined external and internal issues relevant to its purpose and strategic direction.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization monitors and reviews information about these internal and external issues.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how these issues affect the ability to achieve the intended result of the QMS.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how organization determined relevant interested parties to QMS.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization has determined the impact or potential impact of the interested parties.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization has determined the relevant needs and expectations of interested parties.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization monitors and reviews information about interested parties and their relevant requirements.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the QMS scope considers the following:

Meets Requirement Non-Conformance Improvement Opportunity N/A

Reviewed documented information created to support the operation of its processes.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how the processes have been determined and how they interact.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how opportunities for improvement for the QMS and its processes are determined.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how resources are determined and allocated.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how responsibilities and authorities are determined.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how risks and opportunities are considered and what actions are taken to address them.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the processes for the QMS were determine. Verify the inputs and outputs to the processes.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the sequence and interaction of of the processes.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify what methods are used to monitor, measure and evaluate processes. Verify changes, if needed, are implemented to achieve intended results.

Meets Requirement Non-Conformance Improvement Opportunity N/A

5 Leadership

Top management is identified

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify top management demonstrates leadership and commitment by

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the quality policy ...

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify responsibilities and authorities for relevant roles are assigned and communicated within the organization

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify top management assigns responsibility and authority for..

Meets Requirement Non-Conformance Improvement Opportunity N/A

6 Planning

Verify how actions are integrated and implemented into the QMS processes.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how actions are planned to address risks and opportunities.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how actions are taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how risks and opportunities are determined and addressed so the QMS can achieve its intended results, prevent and reduce undesired effects and achieve continual improvement

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the internal and external issues and interested parties are considered when planning for the QMS?

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization evaluates the effectiveness of the actions.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify quality objectives are established at relevant functions, levels and processes.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the quality objectives are..

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how QMS changes are planned systematically.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how resources are made available.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how responsibility and authority is allocated and reallocated.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization considers the integrity of the QMS.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization demonstrates the purpose and potential consequences of changes.

Meets Requirement Non-Conformance Improvement Opportunity N/A

7 Support

Show me how measurement instruments are identified.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how measurement instruments are safeguarded from adjustments, damage and deterioration.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how measurement instruments are verified or calibrated at specific intervals against national or international standards. If no standards, show me documented information which is used as the basis for calibration or verification.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how needs from external providers are considered.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how the capabilities and constraints on internal resources are considered.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify documented information that shows evidence of fitness for purpose of monitoring and measurement resources.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how knowledge is maintained and made available to the extent necessary.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how resources are determined for the organization.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how resources are determined to ensure valid and reliable monitoring and measuring results.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization determines the necessary knowledge for the operation of processes and achieves conformity of products and services.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization determines the validity of previous measurements if you find an instrument to be defective during verification or calibration. Verify any actions taken.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization determines, provides and maintains the environment for the operation of processes to achieve products and service conformity.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization ensures that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken and that they are maintained to ensure continued fitness of purpose.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how you determine competence on the basis of appropriate education, training or experience.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how you determine the necessary competence of people doing work under your control that affects quality performance.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify documented information as evidence of competence where appropriate.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify people doing work under the organization's control are aware of

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify internal and external communication process (what, when, with whom and how to communicate).

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how the documented information is reviewed and approved for suitability and adequacy.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me that your documented information contains appropriate identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify documented information of external origin is identified, as appropriate, and controlled.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify documented information required by the ISO 9001:2015 standard.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify documented information that shows the effectiveness of the QMS.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.

Meets Requirement Non-Conformance Improvement Opportunity N/A

8 Operation

Determine how output from the planning process is suitable for operations.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how criteria for processes and acceptance for products and services are determined.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how outsourced processes are controlled.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how process control is implemented.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how requirements for products and services are determined.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how resources are determined.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization has planned, implemented and controlled processes needed to meet the requirements of products and services.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how product and service requirements including statutory and regulatory requirements are defined. Verify that the organization has the ability to meet the defined requirements and substantiate any claims for its products and services.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization reviews..

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify process to determine the requirements for products and services to be offered to potential customers and how the process is established, implemented and maintained.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify processes created for communicating with customers on information relating to products, services, enquiries, contracts, order handling, customer views, perceptions and complaints, handling or treatment of customer property and specific requirements for contingency actions.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the design and development process is established, implemented and maintained.

Meets Requirement Non-Conformance Improvement Opportunity N/A

In determining the stages and control for design and development, verify the organization considers..

Meets Requirement Non-Conformance Improvement Opportunity N/A

In determining requirements essential for the type of products and services being designed and developed, the organization shall consider..

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization applies controls to the design and development process to ensure that..

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization ensures the design and development outputs..

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify documented information on design and development changes, the result of reviews, the authorization of changes and the actions taken to prevent adverse impacts are retained.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization identifies, reviews and controls 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.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify controls applied to externally provided processes, products and services when products and services are intended for incorporation into the organization's own products and services, products and services are provided directly to the customer or a process, or part of a process, is provided by an external provider as a result of a decision by the organization.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify documented information of activities and actions arising from the evaluations.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization considers the potential impact of the external provided processes, products and services on its ability to meet customer and applicable statutory and regulatory requirements.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization determines controls applied to the external provision of processes, products and services and the resulting output.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization determines the verification, or other activities, necessary to ensure the externally provided processes, products and services meet requirements.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization ensures externally provided processes, products and services conform to specified requirements.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the effectiveness of the controls applied by the external provider.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization communicates to external providers its requirements for..

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the appointment of competent persons, including any required qualification.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the availability and use of suitable monitoring and measuring resources.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the implementation of actions to prevent human error (i.e. poke yoke, visual locations, checklist, emergency stops, templates, document control, ...)

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the implementation of monitoring and measuring activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the implementation of release, delivery and post-delivery activities.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization has documented information that defines the characteristics of the products to be produced, the services to be provided or the activities to be performed and the results to be achieved.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the use of suitable infrastructure and environment for the operation of processes.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify 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.

Meets Requirement Non-Conformance Improvement Opportunity N/A

How does the organization identify the status of process outputs.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how organization identifies outputs from the process to ensure conformity.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization controls the unique identification of process outputs when traceability is required. Verify documented information of traceability, where required.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization identifies, verifies, protects and safeguards customers' or external providers' property which is provided for use or incorporation into the organization's products or services.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify retained documented information for property that is damaged or otherwise found to be unsuitable for use.

Meets Requirement Non-Conformance Improvement Opportunity N/A

What care is provided to customers' or external providers' property?

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization ensures preservation of the process outputs to ensure conformity to requirements.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization considers the following to meet post-delivery activities.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization reviews and controls changes for production or service provision.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify retained documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify at appropriate stages product and service requirements have been met.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify products and services are not released to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by relevant authority and, as applicable, by the customer.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify retained documented information that shows evidence of conformity with acceptance criteria and traceability to person(s) authorizing the release.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify appropriate action is taken for nonconforming products and services (also include after delivery of product or during/after the provision of services).

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify that outputs that do not conform to requirements are identified and controlled.

Meets Requirement Non-Conformance Improvement Opportunity N/A

9 Performance evaluation

Review retained appropriate documented information

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization analyzes and evaluates:

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization evaluates the performance and effectiveness of its QMS.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization has determined what needs to be monitored and measured, the methods to be used, when it will be performed, analyzed and evaluated.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization monitors customers' perceptions of the degree to which their needs and expectations have been fulfilled.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Audit results reported to relevant management

Meets Requirement Non-Conformance Improvement Opportunity N/A

Auditors are objective and impartial

Meets Requirement Non-Conformance Improvement Opportunity N/A

Review retained documented information

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify appropriate correction and corrective actions are taken without delay

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify audit criteria and scope are created for each audit

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify audits are conducted at planned intervals

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify organization has established, implemented, and maintains an internal audit program

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the importance of the process, changes affecting the organization and the results of previous audits are considered

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify inputs to management review includes:

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify management reviews QMS at planned intervals

Meets Requirement Non-Conformance Improvement Opportunity N/A

10 Improvement

Verify the organization determines and selects opportunities for improvement to improve products and services, corrects, prevents or reduces undesired effects and improves the performance and effectiveness of the QMS.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify any changes made to the QMS, if necessary.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how organization evaluates the effectiveness of actions taken.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how organization implements necessary actions.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how organization reacts to nonconformity, including complaints, by evaluating how its takes action to control and correct it and how it deals with the consequences.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization evaluates the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify retained documented information that provides evidence of the nature of the nonconformity and any subsequent actions taken and the results of any corrective actions

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify the organization updates risks and opportunities determined during planning, if necessary.

Meets Requirement Non-Conformance Improvement Opportunity N/A

Verify how the organization continually improves. Does it 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?

Meets Requirement Non-Conformance Improvement Opportunity N/A

Sign Off

I, the undersigned, have completed this audit in an accurate manner. I have attached evidence as required and declare this assessment complete.

Full name and signature of auditor

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