10/1/22 13:13 Gap Analysis ISO 9001 Checklist - SafetyCulture
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Context of the Organization
Have all external and internal issues that are relevant to your organization’s purpose and
the achievement of customer satisfaction and the organization’s strategic direction been
determined?
Yes No N/A
Are these issues reviewed and monitored on a regular basis?
Yes No N/A
Have the needs and expectations of interested parties that are relevant to the QMS been
determined?
Yes No N/A
Was the scope of your QMS determined whilst taking into account all the external and
internal issues, the needs of interested parties and the scope your products and
services?
Yes No N/A
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10/1/22 13:13 Gap Analysis ISO 9001 Checklist - SafetyCulture
Is your QMS established, and does it include a description of the processes required and
their sequence and interaction?
Yes No N/A
Have the criteria for managing these processes and their interaction been established?
Yes No N/A
Have all responsibilities, methods, measurements and related performance indicators,
needed to ensure the effective operation and control, been established?
Yes No N/A
Leadership
Has top management taken accountability for the effectiveness of the QMS?
Yes No N/A
Have the policy and objectives for the QMS, which are compatible with the strategic
direction of the organization, been established and communicated?
Yes No N/A
Have the objectives been established at relevant departmental and individual levels with
the business?
Yes No N/A
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10/1/22 13:13 Gap Analysis ISO 9001 Checklist - SafetyCulture
Have the requirements for the QMS been integrated into the business processes and
have management promoted awareness of the process approach?
Yes No N/A
Have customer requirements and applicable statutory and regulatory requirements been
determined, met and communicated throughout the organization?
Yes No N/A
Have the risks and opportunities that are relevant to the QMS been established?
Yes No N/A
Has the organization established and communicated the responsibilities and authorities
for the effective operation of the QMS?
Yes No N/A
Planning
Have the risks and opportunities that need to be addressed to give assurance that the
QMS can achieve its intended result(s) been established?
Yes No N/A
Has the organization planned actions to address these risks and opportunities and
integrated them into the system processes?
Yes No N/A
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10/1/22 13:13 Gap Analysis ISO 9001 Checklist - SafetyCulture
Is there a defined process for the determining the need for changes to the QMS and
managing their implementation?
Yes No N/A
Support
Has the organization determined and provided the resources needed for the
establishment, implementation, maintenance and continual improvement of the QMS
(including people, environmental and infrastructure requirements)?
Yes No N/A
Is monitoring or measuring is used for evidence of conformity of products and services
to specified requirements?
Yes No N/A
Has the organization determined the resources needed to ensure valid and reliable
monitoring and measuring of results?
Yes No N/A
Has the organization determined the knowledge necessary for the operation of its
processes and the achievement of conformity of products and services and implemented
a lessons learned process?
Yes No N/A
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Has the organization ensured that those persons who can affect the performance of the
QMS are competent on the basis of appropriate education, training, or experience or
taken action to ensure that those persons can acquire the necessary competence?
Yes No N/A
Has the documented information required by the standard and necessary for the
effective implementation and operation of the QMS been established?
Yes No N/A
Operation
Is there a defined process for the provision of products and services that meet the
requirements defined by the customer?
Yes No N/A
Are there any changes planned?
Yes No N/A
Are they carried out in a controlled way and actions taken to mitigate any adverse
effects?
Yes No N/A
Are any outsourced processes managed and controlled?
Yes No N/A
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Is there a defined process for reviewing and communicating with customers in relation to
information relating to products and services, enquiries, contracts or order handling?
Yes No N/A
Is this review conducted prior to the organisation’s commitment to supply products and
services?
Yes No N/A
Do you design and develop products or services?
Yes No N/A
Are these processes established and implemented in line with the requirements of the
standard?
Yes No N/A
Do you ensure that externally provided processes, products, and services conform to
specified requirements?
Yes No N/A
Do you have criteria for the evaluation, selection, monitoring of performance and re-
evaluation of external providers?
Yes No N/A
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Is the provision of products and services carried out in controlled conditions which
include:
• the availability of documented information that defines the characteristics of the
products and services?
• the availability of documented information that defines the activities to be performed
and the results to be achieved?
• 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?
• the people carrying out the tasks are competent?
Yes No N/A
Do you have effective methods of ensuring traceability during the operation process?
Yes No N/A
Is property belonging to customers or external providers used in the provision of the
product or service?
Yes No N/A
Is this controlled effectively?
Yes No N/A
Is there a requirement for post-delivery activities associated with the products and
services such as warranty, maintenance services, recycling or final disposal?
Yes No N/A
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Are these defined and managed?
Yes No N/A
Are any nonconforming process outputs managed so as to prevent their unintended use?
Yes No N/A
Performance Evaluation
Has the organisation determined what needs to be monitored and measured and the
methods for monitoring, measurement, analysis and evaluation, to ensure valid results?
Yes No N/A
Has it established when the results from monitoring and measurement shall be analyzed
and evaluated?
Yes No N/A
Have methods of monitoring customer perceptions of the provision of products and
services been established?
Yes No N/A
Has it determined the need or opportunities for improvements within the QMS and how
these will be fed into management reviews?
Yes No N/A
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Has the organisation established a process for an internal audit of the QMS?
Yes No N/A
Has an approach to perform management reviews been established and implemented?
Yes No N/A
Improvement
Has the organisation determined and selected opportunities for improvement and
implemented the necessary actions to meet customer requirements and enhance
customer satisfaction?
Yes No N/A
Does the organisation operate appropriate processes for managing nonconformities and
the related corrective actions?
Yes No N/A
Has the organisation decided on how it will address the requirement to continually
improve the suitability, adequacy, and effectiveness of the QMS?
Yes No N/A
Completion
Recommendations
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10/1/22 13:13 Gap Analysis ISO 9001 Checklist - SafetyCulture
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