Quality Progress - March 2017 - 48


Standards-related developments and activities

Standard Issues
ISO 9001:2015

Check Your
Blind Spots

Pay attention to
often-overlooked new
ISO 9001 requirements

by John J. Guzik
The highly significant addition of risk-based thinking to ISO
9001:2015 has received a lot of attention. Many organizations focus so hard on this new requirement-some erroneously
wasting time and resources on a formal product-focused risk
management program, which is not what the standard really
requires-they can overlook the other new requirements.
In some cases, the other requirements can bring equally significant changes to a quality management system (QMS). These
new requirements include context of the organization, interested
parties, leadership, organizational knowledge, management of
change, the expansion of "monitoring and measuring equipment"
to "monitoring and measuring resources," and the ever-present
saturation of the standard with the concept of "engagement of
the people."
I was recently asked by a member of an organization's top
management to briefly describe the changes in ISO 9001:2015.
"Are you looking for an elevator speech?" I asked. The leaders
replied, "Yes."
I suggested their building wasn't tall enough. When organizations face the revision, they must be mindful of all the revisions
in ISO 9001:2015, not just the one getting the most attention:
risk-based thinking.

Vital context

Context of the organization requires that an organization take a
good look at itself to understand the internal and external issues
that can affect its business and QMS. This will allow it to build,
implement and improve a QMS so that the QMS contributes to the
organization's holistic business needs and doesn't just become a
set of tools that have no direct relationship to the organization's
real needs.
Add to this the consideration of interested parties' needs and
requirements that are relevant to the QMS. Also, an organization
must recognize the three pillars that must be considered when

48 QP

March 2017 ❘ qualityprogress.com

defining the scope of a QMS.
The three pillars are: internal and external issues, the
requirements of interested
parties that are relevant to the
QMS, and the products and
services of the organization.
This is critical to the up-front
QMS planning. If you disregard
or miss these requirements,
your organization is facing a
potential major nonconformity,
not to mention squandering
resources on a do-nothing
system.

Leading the way

Leadership is finally required
to take true ownership of an
organization's QMS. With
this addition to the standard,
authorization of the QMS now
truly comes from the top. By
removing the requirement for
a management representative (although organizations
may choose to keep one), the
crutch that top management
has been using-sometimes
too often-is now gone.
Even if an organization
chooses to keep the position of
management representative,
accountability now formally

rests with top management. It
is top management that will be
required to answer sensitive
questions about the effectiveness of the QMS. Driving the
controls of the QMS into the
regular business processes is
critical to this aspect.
Too often, organizations
have carried out regular business practices and conducted
the "other stuff" for ISO 9001.
These two aspects now must
have the same importance
in the organization for it to
achieve business sustainability
through quality management.

Managing change

Management of change is
mentioned in several places in
ISO 9001:2015. These mentions
include changes to product or
service requirements, changes
of documents or design
changes.
Perhaps the most significant mentions of change,
however, relate to changes
to the QMS: processes and to
operational processes. The
revised standard requires what
had been implied in all the
earlier versions-that changes


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Table of Contents for the Digital Edition of Quality Progress - March 2017

Seen and Heard
Expert Answers
Progress Report
Mr. Pareto Head
Field Notes
Innovation Imperative
Hard Wired
Propel Forward
Life After Disruption
Work Smarter, Not Harder
Statistics Spotlight
Standard Issues
Marketplace
Footnotes
Back to Basics
Quality Progress - March 2017 - cover1
Quality Progress - March 2017 - cover2
Quality Progress - March 2017 - 1
Quality Progress - March 2017 - 2
Quality Progress - March 2017 - 3
Quality Progress - March 2017 - 4
Quality Progress - March 2017 - 5
Quality Progress - March 2017 - Seen and Heard
Quality Progress - March 2017 - 7
Quality Progress - March 2017 - Expert Answers
Quality Progress - March 2017 - 9
Quality Progress - March 2017 - Progress Report
Quality Progress - March 2017 - 11
Quality Progress - March 2017 - 12
Quality Progress - March 2017 - Mr. Pareto Head
Quality Progress - March 2017 - Field Notes
Quality Progress - March 2017 - 15
Quality Progress - March 2017 - 16
Quality Progress - March 2017 - 17
Quality Progress - March 2017 - Innovation Imperative
Quality Progress - March 2017 - 19
Quality Progress - March 2017 - 20
Quality Progress - March 2017 - 21
Quality Progress - March 2017 - Hard Wired
Quality Progress - March 2017 - 23
Quality Progress - March 2017 - 24
Quality Progress - March 2017 - 25
Quality Progress - March 2017 - 26
Quality Progress - March 2017 - 27
Quality Progress - March 2017 - Propel Forward
Quality Progress - March 2017 - 29
Quality Progress - March 2017 - 30
Quality Progress - March 2017 - 31
Quality Progress - March 2017 - 32
Quality Progress - March 2017 - 33
Quality Progress - March 2017 - Life After Disruption
Quality Progress - March 2017 - 35
Quality Progress - March 2017 - 36
Quality Progress - March 2017 - 37
Quality Progress - March 2017 - 38
Quality Progress - March 2017 - 39
Quality Progress - March 2017 - Work Smarter, Not Harder
Quality Progress - March 2017 - 41
Quality Progress - March 2017 - 42
Quality Progress - March 2017 - 43
Quality Progress - March 2017 - Statistics Spotlight
Quality Progress - March 2017 - 45
Quality Progress - March 2017 - 46
Quality Progress - March 2017 - 47
Quality Progress - March 2017 - Standard Issues
Quality Progress - March 2017 - 49
Quality Progress - March 2017 - Marketplace
Quality Progress - March 2017 - 51
Quality Progress - March 2017 - Footnotes
Quality Progress - March 2017 - 53
Quality Progress - March 2017 - 54
Quality Progress - March 2017 - 55
Quality Progress - March 2017 - Back to Basics
Quality Progress - March 2017 - cover3
Quality Progress - March 2017 - cover4
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