Clause 4: CONTEXT OF OUR ORGANIZATION
4.1 Understanding our organization and its context
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SI. |
Audit
Question |
Audit
Result |
Describe the Gap |
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1 |
Has our organization determined the external and internal issues that are relevant to its purpose and its strategic direction and that affect our ability to achieve the intended result(s) of our quality management system? (Are documents available like Business Plans, SWOT Analysis, Stakeholder Analysis, etc…) |
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2 |
Is our organization monitoring and reviewing information about these external and internal issues? How is it done? |
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4.2 Understanding the needs and expectations of interested parties
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SI. |
Audit Question |
Audit Result |
Describe the
Gap |
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b)
the requirements of these interested parties that are relevant to our quality
management system? (Any documentation available as evidence for
that?) |
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2 |
Whether and how our
organization monitors and reviews information about these interested parties and their relevant requirements? |
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4.3 Determining the scope of our quality management system
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Sl. # |
Audit Question |
Audit Result |
Describe the
Gap |
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1 |
Has our
organization determined the boundaries and applicability of our quality management system to establish its scope? (Scope
Statement available?) |
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2 |
When determining this
scope, did our organization consider: a)
the external and internal issues
referred to in 4.1? b) the requirements of relevant interested parties referred to in 4.2? c) the products and services of our organization. |
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3 |
Did our organization apply
all the requirements of the ISO
9001:2015 standard if they were applicable within the determined scope of our QMS? |
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4 |
Is the
scope of our
organization’s quality management system visually available and maintained as documented information somewhere? |
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5 |
Does the scope
state the types of our products and services covered, and provide justification for any requirement of the ISO 9001:2015 standard that our organization determines as not
applicable to the scope of our quality management system? |
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6 |
Are we aware
that conformity to the ISO 9001:2015 standard may only be claimed if the requirements determined as not
applicable do not affect our organization’s ability or responsibility to ensure
the conformity of our products and services and the enhancement of customer satisfaction? |
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4.4 Quality management system and its core processes
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Sl. # |
Audit Question |
Audit Result |
Describe the
Gap |
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1 |
(4.4.1) Has our organization determined the main QMS
related processes needed
for our quality
management system and their application throughout our organization? |
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2 |
(4.4.1) Has our organization ... a) determined the inputs required and the outputs
expected from these
processes? b) determined the sequence and interaction of these processes? (Flow charts?) c)
determined and applied the criteria and methods (including monitoring, measurements and related performance indicators)
needed to ensure the effective operation and
control of these processes? d) determined the resources needed
for these processes and ensured their
availability? e) assigned the responsibilities and
authorities for these
processes? f)
addressed the risks
and opportunities as determined in accordance with the requirements of 6.1 (planning)? g)
evaluated these processes and implemented any changes needed
to ensure that
these processes achieve their intended results? h)
tried to improve
these processes and also our entire quality
management system? |
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3 |
(4.4.2) To the extent
necessary, does our organization ... a)
maintain documented information to support the operation
of our QMS related processes? Please
cite some examples like Core Process Map, Quality Manual, etc... b)
retain documented information to have confidence that all QMS
related processes are being carried
out as planned? Records keeping? Please cite some examples. |
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