Internal Quality Management System Audit Checklist (ISO 9001:2015)

Internal Quality Management System Audit Checklist (ISO 9001:2015)
Q# ISO 9001:2015 Clause Audit Question Audit Evidence

4 Context of the Organization
4.1 Understanding the organization and its context
4.1q1 The organization shall determine external and How has the organization determined NISAS has prepared a comprehensive list of external and internal issues
internal issues that are relevant to its purpose and external and internal issues relevant to its that are relevant to its purpose and strategic direction at:
its strategic direction and that affect its ability to purpose and strategic direction?
achieve the intended result(s) of its quality How do these affect the ability to achieve
management system. the intended result of the QMS?
4.1q2 The organization shall monitor and review the How do you monitor and review information
information about these external and internal about these internal and external issues?
issues.
NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal,
technological, competitive, market, cultural, social, and economic environments, whether international,
national, regional or local.
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture
knowledge and performance of the organization.
4.2 Understanding the needs and expectations of interested parties
4.2q1 Due to their impact or potential impact on the How have you determined what interested
organization’s ability to consistently provide parties are relevant to the QMS?
products and services that meet customer and How have you determined what
applicable statutory and regulatory requirements, requirements those parties have that are
the organization shall determine: relevant to the QMS?
a) the interested parties that are relevant to the How has impact or potential impact been
quality management system; determined?
b) the requirements of these interested parties
that are relevant to the quality management
system.
4.2q2 The organization shall monitor and review the How do you monitor and review the
information about these interested parties and their information about interested parties and
relevant requirements. their relevant requirements?
4.3 Determining the scope of the quality management system
4.3q1 The organization shall determine the boundaries How have the boundaries and applicability
and applicability of the quality management system of the QMS been used to establish the
to establish its scope. scope of the organization?
4.3q2 When determining this scope, the organization How have:
shall consider: The external and internal issues;
a) the external and internal issues referred to in The requirements of relevant interested
4.1; parties and;
b) the requirements of relevant interested parties The products and services of the
referred to in 4.2; organization been considered when
c) the products and services of the organization. determining the scope of the organization?
4.3q3 Where a requirement of this International Standard How has the application of the International
within the determined scope can be applied, then it Standard within the scope been determined,
shall be applied by the organization. and how has it been applied by the
organization?
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
4.3q4 If any requirement(s) of this International Standard How have any requirements of the
cannot be applied, this shall not affect the International Standard been determined as
organization’s ability or responsibility to ensure not applicable? Show me how conformity of
conformity of products and services. products and services are not affected by
this.
4.3q5 The scope shall be available and be maintained as Where is the scope available? Where is it Scope required as documented information.
documented information stating the: maintained as documented information?
- products and services covered by the Does it state what products and services
quality management system; are covered by the QMS?
- justification for any instance where a Does it justify how instances of
requirement of this International Standard requirements of the QMS cannot be
cannot be applied. applied?
4.4 Quality management system and its processes
4.4q1 The organization shall establish, implement, How has the QMS been established? Show
maintain and continually improve a quality me how this is implemented. How is it
management system, including the processes maintained and continually improved? How
needed and their interactions, in accordance with have the processes been determined and
the requirements of this International Standard. how do they interact?
4.4q2 The organization shall determine the processes How have the processes been determined
needed for the quality management system and for the QMS?
their application throughout the organization and What are the inputs and outputs for those
shall determine: processes?
a) the inputs required and the outputs expected What is the sequence and interaction of the
from these processes; processes?
b) the sequence and interaction of these What are the criteria, methods,
processes; measurement and related performance
c) the criteria, methods, including measurements indicators needed to operate and control
and related performance indicators needed to those processes?
ensure the effective operation, and control of these What resources are needed and how are
processes; these made available?
d) the resources needed and ensure their How are responsibilities and authorities
availability; assigned for those processes?
e) the assignment of the responsibilities and How are risks and opportunities considered
authorities for these processes; and what plans are made to implement
f) the risks and opportunities in accordance with the actions to address them?
requirements of 6.1, and plan and implement the What methods are used to monitor,
appropriate actions to address them; measure and evaluate processes and, if
g) the methods for monitoring, measuring, as needed, what changes are made to achieve
appropriate, and evaluation of processes and, if intended results?
needed, the changes to processes to ensure that How are opportunities to improve the
they achieve intended results; processes and the QMS determined?
h) opportunities for improvement of the processes
and the quality management system.
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence

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