Professional Documents
Culture Documents
GO DIGITAL TODAY
Information
Client / Site
Conducted on
Prepared by
Location
Personnel
Summary
Verify how the organization has determined external and internal issues relevant to its
purpose and strategic direction.
N/A
Verify how these issues affect the ability to achieve the intended result of the QMS.
N/A
Verify how the organization monitors and reviews information about these internal and
external issues.
N/A
N/A
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Verify how the organization has determined the relevant needs and expectations of
interested parties.
N/A
Verify how the organization has determined the impact or potential impact of the
interested parties.
N/A
Verify how the organization monitors and reviews information about interested parties
and their relevant requirements.
N/A
N/A
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Verify how the organization has determined how the ISO 9001:2015 standard is applied
within the organization.
N/A
If the organization has determined any of the requirements of the ISO 9001:2015
standard not to be applicable, show me how conformity of products and services are not
affected by this.
N/A
N/A
Verify scope states what products and services are covered by the QMS and how it
justifies instances where requirements cannot be applied.
N/A
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Show me how the processes have been determined and how they interact.
N/A
Verify how the processes for the QMS were determine. Verify the inputs and outputs to
the processes.
N/A
N/A
Verify the criteria, methods, measurement and related performance indicators needed to
operate and control the processes.
N/A
N/A
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N/A
Verify how risks and opportunities are considered and what actions are taken to address
them.
N/A
Verify what methods are used to monitor, measure and evaluate processes. Verify
changes, if needed, are implemented to achieve intended results.
N/A
Verify how opportunities for improvement for the QMS and its processes are determined.
N/A
N/A
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N/A
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5 Leadership
N/A
N/A
Ensuring the QMS policy and objectives are established and are
compatible with strategic direction and context of organization
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Verify how top management demonstrates leadership and commitment with respect to
customer focus by ensuring that
N/A
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5.2 Policy
N/A
N/A
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Verify QMS Policy is communicated, understood and applied within the organization.
N/A
N/A
Verify responsibilities and authorities for relevant roles are assigned and communicated
within the organization
N/A
N/A
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Verify top management has identified a management representative and has access to
top management to resolve quality management issues
N/A
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6 Planning
Verify how the internal and external issues and interested parties are considered when
planning for the QMS?
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
N/A
N/A
Verify how actions are integrated and implemented into the QMS processes.
N/A
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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.
N/A
Verify quality objectives are established at relevant functions, levels and processes.
N/A
N/A
measurable.
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moinitored.
communicated.
updated as appropriate.
N/A
Verify how the organization determines what will be done, with what resources, when
completed and how the results will be evaluated for quality objectives.
N/A
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N/A
Verify how the organization demonstrates the purpose and potential consequences of
changes.
N/A
N/A
N/A
N/A
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7 Support
7.1 Resources
N/A
Show me how the capabilities and constraints on internal resources are considered.
N/A
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.
N/A
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Verify how the organization determines, provides and maintains the infrastructure for the
operation of processes to achieve products and services conformity.
N/A
Verify how the organization determines, provides and maintains the environment for the
operation of processes to achieve products and service conformity.
N/A
Verify how resources are determined to ensure valid and reliable monitoring and
measuring results.
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.
N/A
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Verify documented information that shows evidence of fitness for purpose of monitoring
and measurement resources.
N/A
N/A
N/A
N/A
Verify process for recall of monitoring and measuring equipment requiring calibration or
verification.
N/A
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N/A
equipment type
unique identification
location
calibration/verification method
frequency
acceptance criteria
N/A
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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.
N/A
Verify how the organization determines the necessary knowledge for the operation of
processes and achieves conformity of products and services.
N/A
Verify how knowledge is maintained and made available to the extent necessary.
N/A
Verify how the organization determines current knowledge and how its acquires
additional knowledge when addressing changing needs and trends.
N/A
7.2 Competence
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Show me how you determine the necessary competence of people doing work under
your control that affects quality performance.
N/A
Show me how you determine competence on the basis of appropriate education, training
or experience.
N/A
Show me how you take actions to acquire necessary competence where applicable and
how do you evaluate the effectiveness of those actions.
N/A
N/A
7.3 Awareness
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Verify people doing work under the organization's control are aware of
N/A
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7.4 Communication
Verify internal and external communication process (what, when, with whom and how to
communicate).
N/A
N/A
N/A
N/A
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Show me how the documented information is reviewed and approved for suitability and
adequacy.
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.
N/A
Verify how the organization controls the distribution, access, retrieval, use, storage,
preservation, legibility, control of changes, retention and disposition of documented
information.
N/A
Verify how the organization prevents the unintended use of obsolete documented
information by removal or by application of suitable identification or controls if kept for
any purposes
N/A
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N/A
N/A
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8 Operation
Verify how the organization has planned, implemented and controlled processes needed
to meet the requirements of products and services.
N/A
N/A
1. personal/product safety
6. product obsolescence
Verify how criteria for processes and acceptance for products and services are
determined.
N/A
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1. design verification
2. process control
- SPC
- DOE
3. verification
4. FMEA
Verify how resources are determined to achieve product/service conformity and meet on-
time delivery
N/A
N/A
Show me documented information that demonstrates processes have been carried out
as planned and can demonstrate conformity of products and services.
N/A
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Verify processes and controls to manage critical items, including production process
controls when key characteristics have been identified, are determined.
N/A
N/A
Verify processes and resources to support the use and maintenance of the
product/service have been determined.
N/A
N/A
N/A
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Verify the organization plans and manages the product/service provision in a structure
and controlled manner (i.e. project planning, project management or program
management).
N/A
Determine how output from the planning process is suitable for operations.
N/A
Quality plan can be the documented information showing the QMS processes and the
resources to be applied.
Verify how planned changes are controlled. Verify how unintended changes are reviewed
and what actions are taken to mitigate any adverse effects, as necessary.
N/A
N/A
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N/A
N/A
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N/A
N/A
Verify process is planned, implemented and controlled to assure product safety during
the entire product life cycle, as appropriate.
N/A
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N/A
N/A
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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.
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.
N/A
N/A
Verify organizational risks (i.e. new technology, ability and capacity to provide, short
delivery time frame) have been identified
N/A
N/A
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N/A
Verify mutual agreement was negotiated with the customer if some customer
requirements cannot be met or can only partially be met.
N/A
Show me that the review is conducted prior to the organization's commitment to supply
products and services to the customer.
N/A
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Verify how the organization resolves differences in the contract or order requirements
from those previously defined.
N/A
Verify how the organization confirms customer requirements where the customer doesn't
provide a documented statement.
N/A
N/A
Verify documented information of amended reviews and how relevant personnel are
made aware of those changes.
N/A
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Verify how the design and development process is established, implemented and
maintained.
N/A
In determining the stages and control for design and development, verify the organization
considers..
N/A
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Verify documented information that confirms design and development requirements have
been met.
N/A
Verify the design and development effort is divided into distinct activities and that for
each activity, the tasks, necessary resources, responsibilities, design content and
inputs/outputs are defined (when appropriate)
N/A
Verify planning considers the ability to provide, verify, test and maintain products and
services (reference output of 8.1.a)
N/A
In determining requirements essential for the type of products and services being
designed and developed, the organization shall consider..
N/A
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N/A
N/A
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Verify the organization applies controls to the design and development process to ensure
that..
N/A
N/A
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N/A
Verify verification and validation tests are planned, controlled, reviewed, and documented
to ensure and prove the following:
N/A
test plans or specifications identify the test item being tested and
the resources being used, define test objectives and conditions,
parameters to be recorded and relevant acceptance criteria.
the correct configuration of the test item is submitted for the test.
the requirements of the test plan and the test procedures are
observed.
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Verify monitoring and measuring used for testing are controlled per section 7.1.5
N/A
N/A
N/A
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Verify data required to allow the product to be identified, manufactured, verified, used
and maintained is defined.
N/A
1. drawings, part lists and specifications necessary to define the configuration and the
design features of the product.
3. technical data and repair schemes for operating and maintaining the product.
N/A
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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.
N/A
Verify process to notify customer prior to its implementation about changes that affect
customer requirements.
N/A
N/A
8.4.1 General
Verify how the organization ensures externally provided processes, products and
services conform to specified requirements.
N/A
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Verify that the organization is responsible for the conformity of all externally provided
processes, products and services, including those from sources defined be the customer.
N/A
N/A
Verify risks associated with the external provision of processes, products and services as
well as the selection and use of external providers are identified and managed.
N/A
Verify external providers apply appropriate controls to their direct and sub-tier external
providers to ensure requirements are met.
N/A
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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.
N/A
Verify how the organization determines and applies criteria for the evaluation, selection,
monitoring of performance and re-evaluation of external providers.
N/A
Verify documented information of activities and actions arising from the evaluations.
N/A
Verify the process, responsibilities and authority for the approval status decision,
changes of the approval status and conditions for a controlled use of external providers
depending on their approval status.
N/A
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Verify external provider register that includes, approval status and scope of approval.
N/A
N/A
Verify actions required when external providers do not meet requirements are defined.
N/A
N/A
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Verify how the organization determines controls applied to the external provision of
processes, products and services and the resulting output.
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.
N/A
N/A
Verify the results of the periodic review of external provider performance (see 8.4.1.1.c)
N/A
Verify how the organization determines the verification, or other activities, necessary to
ensure the externally provided processes, products and services meet requirements.
N/A
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Verify that verification activities (inspection or periodic testing when there is a high risk of
NC including counterfeit parts) are based on risks identified by the organization.
N/A
N/A
Verify scope and requirements are defined and a register is maintained when verification
activities are delegated to the external provider. This process shall be periodically
monitored.
N/A
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Verify process to validate the accuracy of test reports used to confirm that the product
meets requirements.
N/A
N/A
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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.
N/A
Verify the availability and use of suitable monitoring and measuring resources.
N/A
N/A
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Verify documented information for monitoring and measuring activity for product
acceptance includes:
N/A
Verify sampling plan is justified on the basis of recognized statistical principles and
appropriate for use if sampling is used for product acceptance.
N/A
Verify the use of suitable infrastructure (i.e. jigs, fixtures, molds) and environment for the
operation of processes.
N/A
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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. (these processes could be referred
to as special processes)
N/A
Verify the implementation of actions to prevent human error (i.e. poke yoke, visual
locations, checklist, emergency stops, templates, document control, ...)
N/A
N/A
Verify the establishment of criteria for workmanship (i.e. written standards, representative
samples, illustrations)
N/A
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Verify all products (i.e. parts quantities, split orders, nonconforming product) during
production are accounted for
N/A
Verify identified critical items, including key characteristics, are controlled and monitored.
N/A
Verify methods are determined to measure variable data (i.e. tooling, on-machine
probing, inspection equipment)
N/A
N/A
Verify the availability of evidence that all production and inspection/verification operations
have been completed as planned, or as otherwise documented and authorized.
N/A
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Verify the provision for the prevention, detection and removal of foreign objects.
N/A
Verify the control and monitoring of utilities and supplies (i.e. water, compressed air,
electricity, chemical products) to the extent they affect conformity to product
requirements.
N/A
Verify products are identified and recorded before being released for subsequent
production use pending the completion of all required measuring and monitoring activities
(allow for recall and replacement)
N/A
Verify equipment, tools and software programs used to automate, control, monitor or
measure production processes are validated prior to final release for production and are
maintained.
N/A
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Verify storage requirements for production equipment or tooling (include any periodic
preservation or condition checks) are defined.
N/A
N/A
qualification of persons.
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Verify production process verification activities that ensure the production process is able
to produce products that meet requirements are implemented.
N/A
These activities can include risk assessments, capacity studies, capability studies and
control plans.
N/A
N/A
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Verify how organization identifies outputs from the process to ensure conformity.
N/A
Verify that the organization maintains the identification of the configuration of the
products and services in order to identify any differences between the actual
configuration and the required configuration.
N/A
N/A
Verify how the organization controls the unique identification of process outputs when
traceability is required. Verify documented information of traceability, where required.
N/A
N/A
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2. Ability to trace products manufactured from the same batch of raw materials or
manufacturing batch to delivery
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.
N/A
Verify retained documented information for property that is damaged or otherwise found
to be unsuitable for use.
N/A
8.5.4 Preservation
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Verify how the organization ensures preservation of the process outputs to ensure
conformity to requirements.
N/A
Verify that preservation of outputs, when applicable in accordance with specifications and
applicable statutory and regulatory requirements, provisions for:
N/A
cleaning
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N/A
the nature, use and intended lifetime of its products and services
customer requirements
customer feedback
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Verify organization takes appropriate action when problems are detected after delivery.
N/A
Verify how the organization reviews and controls changes for production or service
provision.
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.
N/A
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N/A
Verify at appropriate stages product and service requirements have been met.
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.
N/A
N/A
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Verify retained documented information shows evidence that the products and services
meet defined requirements when required to demonstrate product qualification.
N/A
Verify the organization provides all documented information required to accompany the
products and services are present at delivery.
N/A
Verify that outputs that do not conform to requirements are identified and controlled.
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).
N/A
Correction.
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Verify documented information for the nonconformity control process includes provisions
for:
N/A
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N/A
N/A
Verify counterfeit, or suspect counterfeit, parts are controlled to prevent reentry into the
supply chain.
N/A
N/A
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N/A
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9 Performance evaluation
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.
N/A
Verify the organization evaluates the performance and effectiveness of its QMS.
N/A
N/A
Verify the organization monitors customers' perceptions of the degree to which their
needs and expectations have been fulfilled.
N/A
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N/A
on-time delivery.
customer complaints.
Verify plans have been developed and implemented to addresses identified deficiencies
and evaluate their effectiveness.
N/A
Verify the organization analyzes and evaluates (can include information from external
sources (i.e. government/industry alerts, advisories):
N/A
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N/A
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N/A
Verify the importance of the process, changes affecting the organization and the results
of previous audits are considered
N/A
Verify audit criteria and scope are created for each audit
N/A
N/A
N/A
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Verify appropriate correction and corrective actions are taken without delay
N/A
N/A
N/A
N/A
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audit results
adequacy of resources
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N/A
resource needs
risks identified
N/A
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10 Improvement
10.1 General
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.
N/A
N/A
Verify how the organization evaluates the need for action to eliminate the cause(s)
(including, as applicable, those related to human factors) of the nonconformity, in order
that it does not recur or occur elsewhere.
N/A
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N/A
N/A
Verify the organization updates risks and opportunities determined during planning, if
necessary.
N/A
N/A
Verify corrective action requirements are flowed down to external providers when it is
determined that the external provider is responsible for the nonconformity.
N/A
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Verify specific actions are taken when timely and effective corrective actions are not
achieved.
N/A
Verify the organization maintains documented information that defines the nonconformity
and corrective action management process.
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
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?
N/A
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Verify how the organization monitors the implementation of improvement activities and
evaluates the effectiveness of the results.
N/A
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