ISO 9001:2015 QMS Awareness - Scope of the quality management system
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What does
scope mean?
Scope =
Chance or opportunity to do something
Scope =
Variety of subjects that are being discussed, considered or looked into
Scope refers
to the combined objectives and requirements needed to complete a project. The
term is often used in project management, management systems and in consulting.
Properly defining the scope of a project allows managers to estimate costs and
the time required to finish the project. But in establishing the scope of a
management system, including the quality management system (QMS), the
organization needs to determine boundaries and applicability of the management
system.
Scope of the
quality management system of an organization = The boundaries or the areas of
the organization that are included and controlled within the quality management
system of the organization including the applicability of ISO 9001:2015 QMS
standard requirements within those boundaries or areas of the organization
Why an
organization needs to define the scope of its quality management system? An
organization needs to define the scope of its quality management system because
clear defining and understanding the scope of the organization’s quality
management system is vital to successfully implementing ISO 9001:2015 QMS
standard’s requirements in that organization
What is
required to do for determining the scope in case of the quality management
system? Following need to be done:
(1)
Consider - (i) Consider
determined external and internal issues (Please refer to clause 4.1 of the
standard), (ii) Consider determined needs and expectations of interested
parties (Please refer to clause 4.2 of the standard), and (iii) Organization's
product and services. And also think the standard's requirements not applicable
to your organization.
(2)
Determine - (i)
Determine boundaries and applicability of the QMS by considering the above, and
(ii) Determine if any requirements of ISO 9001:2015 QMS standard is not
applicable to the scope of the organization's QMS, then provide justification.
(3) Apply - Apply all requirements of ISO
9001:2015 QMS standard, if applicable within the scope of the organization.
(4)
Maintain - Maintain
documented information of organization's QMS scope, product and services
covered and justification if any ISO 9001:2015 QMS standard requirement(s) not
applicable to the scope. Making QMS scope statement of the organization's QMS
simple and easy to read can help to focus your QMS efforts.
(5) Make
available - Make
available the documented information that states the determined scope of the
organization's QMS.
Before
establishing the scope of the QMS, if all requirements of the standard are
applicable then well and good, but in case any requirements cannot be applied,
think about it and provide its justification. Here important point is that
conformity to ISO 9001:2015 QMS may only be claimed if determined requirements
as not being applicable do not affect the organization's ability /
responsibility to ensure the conformity of organization's products and services
and the enhancement of customer satisfaction.
Can you think
of a situation where any ISO 9001:2015 QMS standard’s requirements may not be
applicable to an organization? Yes, there may be such situations. There may be
many organizations (for example, organizations involved in only trading
activities, small organizations having very limited business activities), which
may not be involved in design and development processes as part of their
business activities, then the requirements of clause 8.3 of ISO 9001:2015 QMS
standard have no use for such organizations. However, important point here is
to provide the suitable justification for not applying the particular
requirements to the organization’s QMS.
Please
Note
ISO
9001:2015 QMS standard does not use the term 'exclusion' or refer to
'exclusions' in relation to the applicability of the standard's requirements to
the organization's QMS. It is for the organization to review the applicability
of ISO 9001:2015 QMS standard's requirements due to (i) the organization's
size, (ii) the organization's complexity, (iii) the management model adopted by
the organization, (iv) the range of organization's activities, and (v) the
nature of risks and opportunities the organization encounters. However, please
note that conformity to ISO 9001:2015 QMS may only be claimed if determined
requirements as not being applicable do not affect the organization's ability /
responsibility to ensure the conformity of organization's products / services
and the enhancement of customer satisfaction.
Both Clause
1 and Clause 4.3 of ISO 9001:2015 QMS standard speak about the scope. What the
difference between these two? Clause 1 provides the scope of the standard itself.
This clause is for informational purpose. Clause 1 does not include any
requirements to be met by an organization, while clause 4.3 deals with specific
requirements to be met for determining the scope of the organization’s QMS.
Clause 1 states – (i) ISO 9001:2015 QMS standard specifies requirements for a
quality management system, (ii) Requirements mentioned in this standard are
generic and applicable to any organization regardless of its type, size and
product / service. In fact, requirements of ISO 9001:2015 QMS standard are
mentioned in clause 4 to 10.
Think of
the following Questions
(i)
What
do you understand by QMS scope?
(ii)
What
do understand by the scope of the standard?\
(iii)
What
do you need to do for determining the QMS scope?
(iv)
What
will you do if any ISO 9001:2015 QMS requirements not applicable to your
organization?
(v)
Is
maintaining documented information of QMS scope necessary?
Best wishes,
- Keshav Ram
Singhal
Please have
your comments / reaction.
To train
your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING
HANDBOOK ON ISO 9001:2015 QMS AWARENESS” (ASIN: B093YFFY7Z), which is
available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country.
Thanks.
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