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 Google Play
English
Safesite
General Industrygives a complete analysis of your organization's alignment with ISO 9001 standards. This portion co
This inspection
understanding, quality management and leadership.
None
11/13/2019
ISO 9001:2015 Mock Audit
Question
Understanding the organization and its context: Verify how the organization has determined external and internal is
relevant to its purpose
Understanding and strategic
the organization direction.
and its context: Verify how these issues affect the ability to achieve the intended re
the QMS.
Understanding the organization and its context: Verify how the organization monitors and reviews information abou
internal and external
Understanding issues.
the needs and expectations of interested parties: Verify how organization determined relevant intere
parties to QMS.
Understanding the needs and expectations of interested parties: Verify how the organization has determined the re
needs and expectations
Understanding the needsofand interested parties.
expectations of interested parties: Verify how the organization has determined the im
potential impact of the interested parties.
Understanding the needs and expectations of interested parties: Verify how the organization monitors and reviews
information about interested parties and their relevant requirements
Determining the scope of the quality management system: Verify the QMS scope considers the following:
Determining the scope of the quality management system: External and internal issues.
Determining the scope of the quality management system: The requirements of relevant interested parties.
Determining
Determining the the scope
scope of of the
the quality
quality management
management system:
system: The products
Verify how theand services of
organization thedetermined
has organization.
how the ISO
9001:2015 standard
Determining the scope is applied withinmanagement
of the quality the organization.
system: If the organization has determined any of the requiremen
ISO 9001:2015 standard not to be applicable, show me how conformity of products and services are not affected by
Determining
Determining the the scope
scope of of the
the quality
quality management
management system:
system: Verify
Verify QMS
scopescope
statesiswhat
documented.
products and services are cove
the QMS and how it justifies instances where requirements cannot be applied.
Quality
Quality management
management system system andand its
its processes:
processes: Show
Verify how
how the
the processes
processes have
for thebeen
QMS determined and howVerify
were determined. they inte
the
and outputs to the processes.
Quality
Quality management
management system system andand its
its processes:
processes: Verify
Verify the
the sequence and interaction
criteria, methods, of the processes.
measurement and related performance
indicators needed to operate and control the processes.
Quality management system and its processes: Verify how resources are determined and allocated.
Quality
Quality management
management system system andand its
its processes:
processes: Verify
Verify how
how responsibilities and authorities
risks and opportunities are determined.
are considered and what actions
taken to address them.
Quality management system and its processes: Verify what methods are used to monitor, measure and evaluate pr
Verify
Qualitychanges,
management if needed,
systemareand
implemented to achieve
its processes: intended
Verify how results. for improvement for the QMS and its proce
opportunities
determined.
Quality management system and its processes: Reviewed documented information created to support the operation
processes.
Leadership and commitment: Top management is identified.
Leadership and commitment: Verify top management demonstrates leadership and commitment by.
Leadership
Leadership and
and commitment:
commitment: Taking
Ensuring accountability
the QMS policyfor QMS effectiveness.
and objectives are established and are compatible with stra
direction and context of organization.
Leadership and commitment: Ensuring the QMS is integrated into organization's business processes.
Leadership and commitment: Promoting the use of the process approach and risk-based thinking.
Leadership and commitment: Ensuring resources are available.
Leadership and commitment: Communicating the importance of effective QMS and of conforming to its requiremen
Leadership and commitment: Ensuring intended outcomes.
Leadership and commitment: Engaging, directing and supporting persons to contribute to the effectiveness of the Q
Leadership
Leadership and
and commitment:
commitment: Promoting
Supportingcontinuous improvement.
other relevant management roles to demonstrate their leadership as it app
their areas of responsibility.
Leadership and commitment: Verify how top management demonstrates leadership and commitment with respect t
customer
Leadership focus
and by ensuring that
commitment: Customer and applicable statutory and regulatory requirements are determined, unde
and consistently
Leadership met.
and commitment: The risks and opportunities that affect product and service conformity and the ability t
enhance customer satisfaction are determined and addressed.
Leadership and
Policy: Verify thecommitment:
quality policyThe
... isfocus of enhancing
appropriate to the customer
purpose and satisfaction
context ofis the
maintained.
organization and supports its stra
direction.
Policy: Verify the quality policy ... provides a framework for setting quality objectives.
Policy: Verify the quality policy ... includes a commitment to satisfy applicable requirements.
Policy: Verify the quality policy ... includes a commitment to continual improvement of the QMS.
Policy: Verify QMS Policy is maintained as documented information.
Policy: Verify QMS Policy is communicated, understood and applied within the organization.
Policy: Verify QMS
Organizational Policy
roles, is availableand
responsibilities to relevant interested
authorities: parties.
Verify responsibilities and authorities for relevant roles are ass
and communicated within the organization.
Organizational roles, responsibilities and authorities: Verify top management assigns responsibility and authority for
Organizational roles, responsibilities and authorities: Ensuring the QMS conforms to the ISO 9001:2015 standard.
Organizational
Organizational roles,
roles, responsibilities
responsibilities and
and authorities:
authorities: Ensuring
Reportingthat processes
on the are delivering
performance of the QMStheirand
intended outputs.
on opportunitie
improvement, in particular to top management.
Organizational roles,
Organizational roles, responsibilities
responsibilities and
and authorities:
authorities: Ensuring
Ensuring the
the integrity
promotion of of
thecustomer focus throughout
QMS is maintained the orga
when changes
QMS aretoplanned
Actions addressand risksimplemented.
and opportunities: Verify how the internal and external issues and interested parties are co
when planning for the QMS?
Actions to address risks and opportunities: Verify how risks and opportunities are determined and addressed so the
can achieve its intended results, prevent and reduce undesired effects and achieve continual improvement.
Actions to address risks and opportunities: Verify how actions are planned to address risks and opportunities.
Actions to address risks and opportunities: Verify how actions are integrated and implemented into the QMS proces
Actions
Actions to
to address
address risks
risks and
and opportunities:
opportunities: Verify
Verify how
how the organization
actions are takenevaluates
to address therisks
effectiveness of the actions.
and opportunities determin
being appropriate to the potential impact on the conformity of products and services.
Quality objectives and planning to achieve them: Verify quality objectives are established at relevant functions, leve
processes.
Quality objectives and planning to achieve them: Verify the quality objectives are..
Quality objectives and planning to achieve them: Consistent with the quality policy.
Quality objectives and planning to achieve them: Measurable.
Quality
Quality objectives
objectives and
and planning
planning to
to achieve
achieve them:
them: Taking
Relevantinto
to account applicable
the conformity requirements.
of products and services and to the
enhancement of customer satisfaction.
Quality objectives and planning to achieve them: Monitored.
Quality objectives and planning to achieve them: Communicated.
Quality objectives and planning to achieve them: Updated as appropriate.
Quality
Quality objectives
objectives and
and planning
planning to to achieve
achieve them:
them: Verify
Verify objectives are documented.
how the organization determines what will be done, with wh
resources, when completed and how the results will be evaluated for quality objectives.
Planning of changes: Verify how QMS changes are planned systematically.
Planning of changes: Verify how the organization demonstrates the purpose and potential consequences of change
Planning of changes: Verify how the organization considers the integrity of the QMS.
Planning of changes: Verify how resources are made available.
Planning of changes: Verify how responsibility and authority is allocated and reallocated.
Resources: Verify how resources are determined for the organization.
Resources: Show me how the capabilities and constraints on internal resources are considered.
Resources: Verify
Resources: Show me howhow
the needs from external
organization providesproviders
persons are considered.
necessary to consistently meet customer, applicable statu
regulatory requirements
Resources: Verify how the fororganization
the QMS including the necessary
determines, provides andprocesses.
maintains the infrastructure for the operation of p
to achieve products and services conformity.
Resources: Verify how the organization determines, provides and maintains the environment for the operation of pr
to achieve products and service conformity.
Resources: Verify how resources are determined to ensure valid and reliable monitoring and measuring results.
Resources:
Competence: Verify
Show how
methe
how organization
you determineensures that the resources
the necessary competence provided are suitable
of people doing work for the speci
under your control tha
quality performance.
Competence:
Competence: Show Show meme how
how youyou determine
take actionscompetence on the basis
to acquire necessary of appropriate
competence where education,
applicable training
and howor experien
do you e
the effectiveness of those actions.
Competence: Verify documented information as evidence of competence where appropriate.
Awareness: Verify people doing work under the organization's control are aware of the quality policy.
Awareness:
Awareness: Verify
Verifypeople
peopledoing
doingwork
workunder
underthetheorganization's
organization'scontrol
controlare
areaware
awareof of the
theirrelevant quality
contribution to objectives.
the effective
the QMS, including the benefits of improved performance.
Awareness: Verify people doing work under the organization's control are aware of the implications of not conformi
the QMS requirements.
Communication: Verify internal and external communication process (what, when, with whom and how to commun
Documented information: Verify documented information required by the ISO 9001:2015 standard.
Documented information:
Documented information: Show
Verify me
documented
that your information
documentedthat shows the
information effectiveness
contains of theidentification,
appropriate QMS. format (la
software version, graphics, ...) and media (paper, electronic, ...).
Documented information: Show me how the documented information is reviewed and approved for suitability and
adequacy.
Documented information: Show me how you control documented information and make it available and suitable for
Tell me how you
Documented protect your
information: documented
Verify information.controls the distribution, access, retrieval, use, storage, pres
how the organization
legibility, control of changes, retention and disposition of documented information.
Documented information:
Operational planning Verify documented
and control: Verify how theinformation of external
organization origin is
has planned, identified, as
implemented appropriate,
and controlled and control
processes
to meet the requirements of products and services.
Operational
Operational planning
planning and
and control:
control: Verify
Verify how
how requirements for products
criteria for processes and servicesforare
and acceptance determined.
products and services are
determined.
Operational planning and control: Verify how resources are determined.
Operational
Operational planning
planning and
and control:
control: Verify
Show mehowdocumented
process control is implemented.
information that demonstrates processes have been carrie
planned and can demonstrate conformity of products and services.
Operational
Operational planning
planning and
and control:
control: Determine
Verify how how output
planned from the
changes areplanning process
controlled. Verifyishow
suitable for operations.
unintended changes are r
and what actions are taken to mitigate any adverse effects, as necessary.
Operational planningtoand
information relating control:services,
products, Verify how outsourced
enquiries, processes
contracts, orderare controlled.
handling, customer views, perceptions and com
handling or treatment of customer property and specific requirements for
Determination of requirements for products and services: Verify process to determine the contingency actions.
requirements for products
services to be offered to potential customers and how the process is established, implemented and maintained.
Determination of requirements for products and services: Customer requirements for delivery and post-delivery.
Determination
Determination of of requirements
requirements for for products
products and
and services:
services: Verify how the necessary
Requirements organization forreviews..
customer's specified or inten
where known.
Determination of requirements for products and services: Statutory and regulatory requirements applicable to the pr
and services
Determination
Determination of of requirements
requirements for for products
products and
and services:
services: Other
Show mecontract or order
that the review requirements.
is conducted prior to the organiz
commitment to supply products and services to the customer.
Determination of requirements for products and services: Verify how the organization resolves differences in the co
order requirements
Determination from those for
of requirements previously
products defined.
and services: Verify how the organization confirms customer requireme
where the customer doesn't provide a documented
Determination of requirements for products and services: statement.
Verify documented information of reviews describing new
changed requirements
Determination to products
of requirements and services.
for products and services: Verify documented information of amended reviews and h
relevantand
Design personnel are made
development aware ofand
of products those changes.
services: Verify how the design and development process is established,
implemented and maintained.
Design and development planning: In determining the stages and control for design and development, verify the
organization considers..
Design and development planning: the nature, duration and complexity of the activities.
Design and development planning: the requirements that specify particular process stages including applicable revi
Design and development planning: required verification and validation
Design and development planning: responsibilities and authorities.
Design and development planning: how interfaces are controlled between individuals and parties
Design
Design and
and development
development planning:
planning: the need
Verify for involvement
documented of customer
information and user
that confirms groups.
design and development requireme
been met.
Design and development inputs: In determining requirements essential for the type of products and services being d
and developed, the organization shall consider..
Design and development inputs: functional and performance requirements.
Design and development inputs: information derived from previous similar design and development activities.
Design and development inputs: statutory and regulatory requirements.
Design and development inputs: standard or codes of practice that the organization has committed to implement.
Design and development inputs: potential consequences of failure due to the nature of the products and services.
Design and development inputs: Verify that the inputs are complete and unambiguous.
Design
Design and
and development
development inputs:controls:Verify documented
Verify information
the organization appliesoncontrols
design toand
thedevelopment inputs are retained.
design and development process t
that..
Design
Design and
and development
development inputs:inputs: the results
reviews aretoconducted
be achieved are defined.
to evaluate the ability of the results of design and developm
meet requirements.
Design and development inputs: verification activities are conducted to ensure that the resulting products and servic
the requirements
Design for the specified
and development application
inputs: validation or intended
activities use.
are conducted to ensure that the resulting products and service
the requirements of the specified application or intended use.
Design and development inputs: any necessary actions are taken on problems determined during the reviews, or ve
and validation activities.
Design and development inputs: Verify documented information of these activities are retained.
Design and development outputs: Verify the organization ensures the design and development outputs..
Design and development outputs: meet the input requirements.
Design
Design and
and development
development outputs:
outputs: are adequate
include for the monitoring
or reference subsequentand processes
measuringfor requirements,
the provision ofasproducts and ,ser
appropriate an
acceptance criteria.
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.
Design
subsequentand development
to, the designoutputs: Verify documented
and development information
of products on design
and services, to theand
extentdevelopment
necessary outputs
to ensurearethatretained.
there
adverse impact on conformity to requirements.
Design and development changes: Verify documented information on design and development changes, the result
reviews,
Control ofthe authorization
externally of changes
provided processes,andproducts
the actions
andtaken to prevent
services: Verify adverse
how the impacts are retained.
organization ensures externally pro
processes, products and services conform to specified requirements.
services, products and services are provided directly to the customer or a process, or part of a process, is provided
external
Control ofprovider as aprovided
externally result ofprocesses,
a decision products
by the organization.
and services: Verify how the organization determines and applie
for the evaluation, selection, monitoring of performance
Control of externally provided processes, products and services: and re-evaluation of externalinformation
Verify documented providers. of activities and ac
arising
Controlfrom the evaluations.
of externally provided processes, products and services: Verify how the organization determines controls ap
the external provision
of the external provided of processes,
processes, products
products and
and services
services on
anditsthe resulting
ability output.
to meet customer and applicable statutory a
regulatory requirements
Control of externally provided processes, products and services: Verify the effectiveness of the controls applied by
external
Control ofprovider.
externally provided processes, products and services: Verify how the organization determines the verifica
other activities,
Control necessary
of externally providedto ensure the externally
processes, products provided processes,
and services: Verify theproducts and services
organization meet requirements.
communicates to external p
its requirements for.
Control
Control ofof externally
externally provided
provided processes,
processes, products
products and
and services:
services: the
the processes,
approval of products
product andandservices;
services methods,
to be providpro
and equipment; and the release of products and services.
Control of externally provided processes, products and services: competence, including any required qualification o
persons.
Control
Control ofof externally
externally provided
provided processes,
processes, products
products and
and services:
services: the external
control providers' interactions
and monitoring withproviders'
of the external the organiz
performance to be applied
Control of externally providedby the organization.
processes, products and services: verification or validation activities that the organiza
its customer, intends to perform at the external
characteristics of the products to be produced, the providers'
servicespremises.
to be provided or the activities to be performed and the
to be achieved.
Control
stages to ofverify
production and service
that criteria provision:
for control Verify the
of processes or availability
outputs, and and use of suitable
acceptance monitoring
criteria andand
for products measuring
services,resh
met.
Control of production and service provision: Verify the use of suitable infrastructure and environment for the operati
processes.
Control of production and service provision: Verify the appointment of competent persons, including any required
qualification.
results of the processes for production and service provision, where the resulting output cannot be verified by subse
monitoring or measurement.
Control of production and service provision: Verify the implementation of actions to prevent human error (i.e. poke y
visual locations, checklist, emergency stops, templates, document control, ...)
Control of production and service provision: Verify the implementation of release, delivery and post-delivery activitie
Identification and traceability: Verify how organization identifies outputs from the process to ensure conformity.
Identification
Identification and
and traceability:
traceability: How
Verifydoes
how the
the organization
organization identify
controlsthethestatus
unique of identification
process outputs.
of process outputs when
traceability is required. Verify documented information of traceability, where required.
Property
safeguards belonging to customers
customers' or externalorproviders'
external providers: Whatiscare
property which is provided
provided for usetoor
customers' or external
incorporation into theproviders'
organizatiopr
products or services.
Property belonging to customers or external providers: Verify retained documented information for property that is d
or otherwise found to be unsuitable for use.
Preservation: Verify how the organization ensures preservation of the process outputs to ensure conformity to requ
Post-delivery activities: Verify the organization considers the following to meet post-delivery activities.
Post-delivery activities: statutory and regulatory requirements
Post-delivery activities: potential undesired consequences associated with its products and services
Post-delivery activities: the nature, use and intended lifetime of its products and services
Post-delivery activities: customer requirements
Post-delivery activities: customer feedback
Control of changes: Verify how the organization reviews and controls changes for production or service provision.
Control of changes: Verify retained documented information describing the results of the review of changes, the per
authorizing the change and any necessary actions arising from the review.
Release of products
arrangements and services:
have been Verify
satisfactorily at appropriate
completed, unlessstages product
otherwise and service
approved requirements
by relevant have
authority and,been met.
as applicab
the customer.
Release of products and services: Verify retained documented information that shows evidence of conformity with
acceptance criteria and traceability to person(s) authorizing the release.
Control
Control of
of nonconforming
nonconforming outputs:
outputs: Verify
Verify that outputs action
appropriate that doisnot conform
taken to requirements
for nonconforming are identified
products and control
and services (also
after delivery of product or during/after the provision of services).
Control of nonconforming outputs: Correction
Control of nonconforming outputs: Segregation, containment, return or suspension of provision of products and serv
Control of nonconforming outputs: Informing the customer
Control of nonconforming outputs: Obtaining authorization for acceptance under concession
Control of nonconforming
actions taken, describes anyoutputs: Verify conformity
concessions obtained andto the requirements
identifies when nonconforming
the authority outputs
deciding the action are corrected
in respect of the
nonconformity.
Monitoring, measurement, analysis and evaluation: Verify the organization has determined what needs to be monito
measured, the
Monitoring, methods to analysis
measurement, be used, and
when it will be performed,
evaluation: analyzed and
Verify the organization evaluated.
evaluates the performance and effective
its QMS.
Monitoring,
Monitoring, measurement,
measurement, analysis
analysis and
and evaluation:
evaluation: Review retained
Verify the appropriate
organization documented
monitors customers'information
perceptions of the d
which their needs and expectations have been fulfilled.
Monitoring, measurement, analysis and evaluation: Verify the organization analyzes and evaluates:
Monitoring, measurement, analysis and evaluation: conformity of products and services.
Monitoring, measurement, analysis and evaluation: the degree of customer satisfaction.
Monitoring, measurement, analysis and evaluation: the performance and effectiveness of the QMS.
Monitoring, measurement, analysis and evaluation: if planning has been implemented effectively.
Monitoring, measurement, analysis and evaluation: the effectiveness of actions taken to address risks and opportun
Monitoring, measurement, analysis and evaluation: the performance of external providers.
Monitoring, measurement, analysis and evaluation: the need for improvements the QMS.
Internal audit: Verify audits are conducted at planned intervals
Internal audit:
Internal audit: Verify
Verify the
organization
importance hasofestablished,
the process,implemented, and maintains
changes affecting an internal
the organization andaudit program
the results of previous a
considered
Internal audit: Verify audit criteria and scope are created for each audit
Internal audit: Auditors are objective and impartial
Internal audit: Audit results reported to relevant management
Internal audit: Verify appropriate correction and corrective actions are taken without delay
Internal audit: Review retained documented information
Management review: Verify management reviews QMS at planned intervals
Management review: Verify inputs to management review includes:
Management review: status of actions from previous management reviews
Management review: changes in external and internal issues relevant to the QMS
Management review: customer satisfaction and feedback from relevant interested parties
Management review: the extent to which quality objectives have been met
Management review: process performance and conformity of products and services
Management review: nonconformities and corrective actions
Management review: monitoring and measurement results
Management review: audit results
Management review: the performance of external providers
Management review: adequacy of resources
Management review: effectiveness of actions taken to address risks and opportunities
Management review: opportunities for improvement
Management review: Verify outputs to management review includes:
Management review: opportunities for improvement
Management review: any need for changes to the QMS
Management review: resource needs
Management review:
General: Verify Verify retained
the organization documented
determines information
and selects opportunities for improvement to improve products and ser
corrects, prevents or reduces undesired effects and improves
Nonconformity and corrective action: Verify how organization reacts the performance and effectiveness
to nonconformity, of the QMS.
including complaints, by eval
how its takes action
Nonconformity to control action:
and corrective and correct
Verifyit how
and how it deals with evaluates
the organization the consequences.
the need for action to eliminate the caus
the nonconformity, in order that it does not recur or occur elsewhere.
Nonconformity and corrective action: Verify how organization implements necessary actions.
Nonconformity
Nonconformity and
and corrective
corrective action:
action: Verify
Verify how organizationupdates
the organization evaluates theand
risks effectiveness of actions
opportunities taken.
determined during plan
necessary.
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