Title Page

 Client / Site

 Conducted on (Date and Time)

Date
 Inspected by

 Location

Address
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
 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
 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
 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
 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
 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
 Is the provision of products and services carried out in controlled conditions
which include: <br>• the availability of documented information that defines the
characteristics of the products and services? <br>• the availability of
documented information that defines the activities to be performed and the
results to be achieved? <br>• 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? <br>•
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
 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
 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

 Inspector's Full Name and Signature

Sign