Quality Progress - March 2017 - 49


to overall QMS processes and
to operational processes must
be carried out in a controlled
manner.
Organizations that don't
consider the impact of changes
to other processes as well as
to their products or services
through risk-based thinking are
destined to fail. I had an experience and-I'm sure it wasn't
unique-in which I was involved
in resurrecting an organization that had gone from high
profitability to near-ruin within
one year.
This happened because
when the organization was
implementing its QMS for its
initial ISO 9001 certification,
it started making rampant
changes to its processes without considering the potential
effects on other processes.
The result was devastating,
and the organization was on
the verge of bankruptcy.

In operational control

Control of changes to operational processes is even more
specific. There is a requirement
for the review and control of
the changes to ensure a product or service will continue to
meet requirements. Records
of these changes also are
required to include the results
of the review of changes,
actions resulting from the
review and the identification of
persons authoring the change.
Many have asked why this
requirement is so specific. It's
because these kinds of processes have a direct impact on
customers through products

and services, not to mention
the potential for negative
impacts to other internal
operational processes-which,
in turn, can also directly affect
the customer in the same way.

Organizational
knowledge

While organizational knowledge is a new requirement
of ISO 9001:2015, it's really
not new to many organizations. Most organizations
already have some sort of
information-transfer activities
in place-whether they are
defined processes or simply
informal practices.
These could include
cross-functional awareness
sessions, departmental meetings where issues relevant
to the QMS are discussed,
on-the-job training, lessons
learned programs or operator
notes. All of these relate to the
new organizational knowledge
requirement. The concept
here is to secure information
that is critical to continuing
the effective operation of the
organization's processes.

Monitor and measure

The expansion of "monitoring
and measuring equipment" to
"monitoring and measuring
resources" is more than a mere
verbiage change, as we saw
in the 2000 version of ISO
9001. With the 2000 change,
many organizations wondered
whether there was a significant
difference between "equipment" and "devices," when
there was not.

The 2008 version of the
standard reverted the language
back to "equipment" to end
the consternation. This change,
however, actually expands the
scope of application of calibration to include things such
as visual comparisons, go-no
go gauges, and software and
software-driven tools.
In the past, organizations
have been able to sidestep
the issue of preserving the
integrity of some of these tools
because they were technically
not "equipment," yet they have
a direct impact on the conformity of a product or service.

Understanding
engagement

Perhaps the best kept secret
related to changes in ISO
9001:2015 is the saturation
of the standard with the
concept of "engagement of
the people." While no single
clause specifies it, the notion is

mentioned at least 10 times.
As an underlying concept,
people engagement carries
ownership of the processes
beyond simple involvement
of the people. By engaging
people, an organization will
implement an effective QMS,
and conversely, an effectively implemented QMS
will promote and enhance
engagement of the people.
The application of people
engagement is a never-ending
cycle-much like continual
improvement.
Bypassing these lesspublicized new requirements
of ISO 9001:2015 can result in
a major nonconformity. Even
if their absence is somehow
missed by an auditor, however, I can't imagine how the
resulting impact on the effectiveness of the QMS will prove
devastating.
Remember to keep your eye
on the ball.

John J. Guzik is principal of Impact
Management in Hanover, PA. He is
a participating member of the U.S.
Technical Advisory Group to ISO Technical
Committee 176 and the ASQ ASC Z1-Q
subcommittee on quality management.

qualityprogress.com ❘ March 2017

QP 49


http://www.qualityprogress.com

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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