DIY ISO 9001 Checklist

C– Compliant, no actions are needed for compliance

OFI – Opportunities for improvement. Minor improvement actions are needed for compliance
NC – Non-conformance. Major corrective actions are needed for compliance
 Context of the organisation
Improvements Needed Corrective Actions
Gap Analysis Question C OFI NC Evidence, documentation and notes
[OFI] Needed [NC]

Have you identified all internal and external

issues impacting your organisation’s purpose, ✔
strategies and customer satisfaction levels?

Have you implemented a regular reviewing

and monitoring process to continually assess
the above issues?

Have you established the relevant

expectations and requirements of
stakeholders and interested parties pertinent
to your Quality Management System (QMS)?

Have you established the scope of your QMS

taking into consideration all internal and
external issues, interested parties and your
organisation’s product and service offerings?

Have you set up your QMS to contain

all necessary processes, their interactions
and sequences?

Have you ensured effective control

and operation by establishing criteria for
managing your QMS’s processes, interactions,
sequences, methods, responsibilities,
measurements and relevant indicators
of performance?

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 Leadership
Improvements Needed Corrective Actions
Gap Analysis Question C OFI NC Evidence, documentation and notes
[OFI] Needed [NC]

Has your organisation’s management

team taken responsibility for ensuring
the QMS’s effectiveness?

Have QMS policies and objectives

compatible with your organisation’s
strategic direction been established
and communicated to your team?

Have you established QMS objectives at all

relevant departmental and individual levels?

Have your processes been updated

to integrate the QMS’s requirements and
has your management team communicated
the new processes to the business?

Have you established and met statutory,

client, and regulatory requirements and
communicated them to your employees?

Have the relevant QMS risks and

opportunities been identified?

Have you identified and assigned the

authority and responsibilities required
for efficient QMS operation?

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 Planning
Improvements Needed Corrective Actions
Gap Analysis Question C OFI NC Evidence, documentation and notes
[OFI] Needed [NC]

Have you established which

opportunities and risks must be addressed
to provide assurance that the QMS can
fulfill its intended purpose(s)?

Have you established which actions must

be taken to address the above risks and
opportunities and established processes
to achieve those actions?
Have you established a process to
determine and implement any changes
needed to the QMS to ensure the above
processes are implemented?

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 Support
Improvements Needed Corrective Actions
Gap Analysis Question C OFI NC Evidence, documentation and notes
[OFI] Needed [NC]
Have you established and given the
necessary resources required for the
setup, maintenance and ongoing
improvement of the QMS’s environmental,
infrastructure and personnel requirements?
If necessary, have you established which
resources are required for accurate and
reliable measuring and monitoring of
product or service conformity?
Have you established the required
knowledge for process operation and
product or service conformity and
enforced a process for lessons learnt?

Have the individuals responsible for QMS

performance received adequate training,
education or experience?

Have you determined what documentation

is needed by the standard for the
implementation and operation of your QMS?

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 Operations
Improvements Needed Corrective Actions
Gap Analysis Question C OFI NC Evidence, documentation and notes
[OFI] Needed [NC]

Have you established a clear process for

providing products or services which meet
our customers’ defined requirements?

Are planned changes conducted in a

controlled manner with actions taken
to minimise any negative impacts?

Have you taken steps to control and manage

all outsourced processes?

Have you established a clear process

for evaluating and communicating with
customers in terms of contracts, enquiries,
products and services and order handling?
Is the above evaluation undertaken before
your business commits to supplying a
product or service? If your business
developed or designs products or services
do you implement these processes in line
with the standard’s requirements?

Are all outsourced/external products,

processes and services meeting all
specified standards and requirements?

Have you put in place criteria for external

provider selection, evaluation, monitoring
and performance?

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 Operations
Improvements Needed Corrective Actions
Gap Analysis Question C OFI NC Evidence, documentation and notes
[OFI] Needed [NC]
Does your organisation provide products
and services under controlled conditions
including:

• Documented information availability

related to defining your product and
service characteristics
• Documented information availability
related to providing definitions for the
activities being performed and any
results that are achieved
• Measurement and monitoring of
processes and activities at required
stages to ensure product and service
acceptance, control and verification
processes have been met
• Monitoring and measurement activities
at appropriate stages to verify that
criteria for control of processes and
process outputs, and acceptance criteria
for products and services, have been met?
• Ensuring all individuals performing tasks
are qualified and competent.
• Operation process traceability assurance
methods are in place.

Have you established effective processes

to ensure operations traceability?

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 Operations
Improvements Needed Corrective Actions
Gap Analysis Question C OFI NC Evidence, documentation and notes
[OFI] Needed [NC]

Are you effectively controlling the provision

of products or services when customer or
external provider property is involved?

Have you defined and provided ongoing

management for post-service or product
delivery activities such as maintenance,
warranties, disposal or recycling?

Have you put in place processes to manage

any nonconforming outputs and prevent
their unintentional use?

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 Performance evaluation
Improvements Needed Corrective Actions
Gap Analysis Question C OFI NC Evidence, documentation and notes
[OFI] Needed [NC]
Have you established what needs to be
measured and monitored and how ongoing
monitoring, analysis, measurement and
evaluation will be carried out to ensure
accurate results?

Have you determined when and how often

monitoring and measurement results will be
analysed and evaluated?

Have you determined how customer

perceptions of product and service provisions
will be monitored?

Have you established QMS improvement

opportunities and how they’ll impact
management reviews?

Have you created an internal QMS audit

process?

Have you created and enforced a

management review process?

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 Improvement
Improvements Needed Corrective Actions
Gap Analysis Question C OFI NC Evidence, documentation and notes
[OFI] Needed [NC]

Have you established and implemented

the required improvement opportunities
required to meet customer needs and
improve satisfaction levels?

Have you established processes for

the management of nonconformities
and any required corrective actions?

Have you determined how you will

continually improve your QMS’s suitability,
performance and effectiveness?

Are you managing any nonconforming

process outputs and preventing
unintended use?

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