STANDARDS OUTLOOK

BY JOHN E. JACK WEST AND

CHARLES A. CIANFRANI

Innovation and ISO 9001:2015

Users debate inclusion of innovation in the upcoming revision
SHOULD INNOVATION be included in

purpose of innovation can be a manage-

create inventions that actually degrade per-

ISO 9001:2015? This question has become

ment system, process, product, service or

formance. Here is where a formal system

pertinent to quality professionals because

technology.

can be critical to ensuring the concepts are

the recently distributed International

A word that has a different meaning

properly used to achieve improvements.

Organization for Standardization Draft

but is frequently considered a synonym

It is also possible that improvement,

International Standard (ISO/DIS) 9001

for innovation is invention, which is idea

innovation and invention come together in

includes this word and concept as a quality

generation, the result being a device or

a single project (see Figure 1).

management system (QMS) requirement

process somebody has created after study

for the first time.

and experimentation. Invention does not

Reasons for the chatter

have an ISO/DIS 9000 definition.

Some of the concerns that have been

This inclusion has prompted considerable discussion and debate, especially in

It is also meaningful to distinguish

raised regarding the inclusion of require-

social media. The primary thrust of the

between innovation and improvement.

ments for innovation include:

chatter has been related to the appropri-

Improvement is defined in ISO/DIS 9000 as

Requirements in the DIS are vague and

ateness of inclusion of such a word and

activity to enhance performance.

When considering the inclusion of inno-

concept as a requirement.
On one side is the view that innova-

vation in ISO 9001:2015, we believe that it

cannot be clearly stated.

Innovation is a qualitative concept and
cannot be audited.

tion cannot and absolutely should not

is important to make a distinction between

be required. At the other extreme is the

innovation and invention, and equally im-

scope of a QMS.

position that innovation must uncondition-

portant to distinguish between innovation

Advocates of inclusion of requirements

ally be a component of any credible QMS

actions and the process of innovation.

because it is relevant to the sustainability

Innovation processes are beyond the

related to innovation have recognized current and anticipated trends organizations

Differing objectives

will need to address, including:

Before exploring this question and to

It is also important to understand the

Changing customer requirements.

ensure a common understanding, consider

difference between processes that are

Increased competition.

the ISO/DIS 9000 definition of innovation:

intended to achieve innovation and those

Continuing pressure to lower costs.

a process resulting in a new or substan-

directed at improvement because these

How new technology can impact prod-

tially changed object. The object for the

processes have different objectives.

of all organizations.

These ideas are

Innovation, invention and

improvement / FIGURE 1
Innovation
Process resulting in a new
or substantially changed
object.

Invention
A thing that somebody has
created, especially a device
or process, after study
and experimentation.

Improvement
Activity to enhance
performance.

often interrelated and

sometimes even con-

uct design and realization.

The impact of globalization on organizations.
The fact that innovation is embedded

flicted or confused.

in the content and intent of the quality

Ideally, a need drives

management principles such as leader-

invention and can

ship, involvement of people and con-

result in an innova-

tinual improvement, which are elements

tion that improves

of ISO 9001s foundation.

the product, process

The fact that innovation has always

and organizational

been an implicit ISO 9001 requirement

performance.

that is now being formally recognized.

Not all innovation

results in real im-

What should we do?

provement, however.

As of early 2015, it is not known whether

In fact, it is possible to

innovation requirements will be

May 2015 QP 55

explicitly included in ISO 9001:2015.

to successful innovation.

Although it is likely the word innovation,

In fact, the formal system

mentioned only once in the current DIS,

should be designed to foster

will be deleted, we believe any uncertainty

innovative improvements.

How a QMS can integrate

innovation / FIGURE 2

Furthermore, as was

is irrelevant.
This is because even if innovation is not
edition of ISO 9001:2015, it is an essential

opment,

process to incorporate into the QMS of all

professionals will fail to

organizations for many reasons, including:

dedicate effort to the

When considering the context of the

design and deployment

many

of processes to formally

ignore the role of innovation can be a

consider innovation for

significant deficiency.

products, services, processes,

technology

systems because doing so

9001:2015 requirements, but also will pro-

is perceived as difficult, or-

vide a foundation for achieving overall

ganizational resistance is

performance excellence (see Figure 4).

anticipated or they think

with the overall risk management

Mission
Vision
Strategies
Principles
Innovations
Action plans
Objectives

ion t
ovat
n
Inn roveme
p
Im

ing
n
r
a
Le it
d
Au and PA
CA

rce
orkfo
are w
Prep change
for

System development
Process management
Optimization

and

that will not only meet minimum ISO

Innovation processes must integrate

External scan
Self assessment
Internal scan

quality

organization (see Figures 2 and 3), to

It is vital to define and deploy a QMS

Ideas
Issues

ies
unit
ort

trol of design and devel-

Opp

an explicit requirement in the published

Strategic planning

Threats

true in the past for con-

Alignment
Objectives
People

Identify key processes

Do we have the
right processes
for the future?

Jack West and Charles

Cianfrani, 2015
CA = corrective action
PA = preventive action
QMS = quality management system

it will take too much time.

Innovation has become

processes of the organization (see DIS

an organizational imperative. A few years

customers constitutes real innovation

clauses 4 and 6).

ago, many of us did not understand what

and ensures the organizations continued

The major issue is that many quality

the word implied. Today, organizations

existence. Improving existing products

professionals do not recognize the impor-

need disciplined processes to facilitate the

and processes is critical, but improvement

tance of incorporating processes that for-

development of innovative products and

typically is focused only on advancing

mally require attention to innovation as an

services.

existing products or processes. Innovation

organizational imperative. All too often we

hear the formal system is an impediment

Invention is still important, but turning an idea into a product desired by

Innovation as an element
of the context of the
organization / FIGURE 3
Context
of the
organization

C
u r
e
s qu
t ri
e
om
e
mn
t
e s
r

Quality management system

Improvement
Leadership, planning and support
Innovation and resource
management

Performance
evaluation

Operational planning and control

Product (and service) realization

56 QP www.qualityprogress.com

C
s u
a
t s
i
s t
f
a
c o
t
i m
o
n e
r
Jack West and
Charles Cianfrani, 2015

processes focus on new or substantially

changed products and processes.

Innovation as a
component of the
quality hierarchy /

FIGURE 4

Six Sigma
and Baldrige
criteria

Worldclass
performance,
lower cost,
greater efficiency
and innovation

Beyond the
minimum

Beyond minimum
requirements

Foundation
Source: Concept developed by
Joe Tsiakals and used with permission

Prevent nonconforming service,

conform to customer requirements

Results

Keeping quality at the forefront

ogy and an overall QMS are essential to the

a QMS today and will continue to be, even

If the quality function desires to remain

sustainability of an organization.

if it is not an explicit requirement of ISO

Quality professionals should be asking

relevant in a changing business environment, it is not sufficient to continue to use

questions such as:

the same methods in the same way as in

Do formal innovation processes exist?

the pasteven the recent past. New or

Do those processes encourage appropriate innovation?

enhanced skills may be required, including

processes to manage innovation. Maintain-

Do results indicate the processes are

effective?

ing the status quo is not an option.

Even if innovation requirements do not

9001:2015. QP

Is there a process champion promoting

remain as an ISO 9001:2015 requirement,

the quest for innovative products and

processes to formally consider innovation

processes?

for products, services, processes, technol-

Innovation is an essential component of

THE ASQ STANDARDS CHANNEL

ASQ recently launched a video channel dedicated to the ISO 9001:2015 revision.
Thirty-plus video interviews with experts cover the basics of the revision, key
changes, industry effects and the concurrent ISO 14001 revision. Free access is
exclusive to ASQ members. Visit http://videos.asq.org/asq-standards-channel.

JOHN E. JACK WEST is a member of

Silver Fox Advisors in Houston. He is
past chair of the U.S. Technical Advisory Group to the International Organization for Standardization Technical
Committee 176 (ISO/TC 176) and lead
delegate of the committee responsible for the ISO 9000 family of quality
management system standards. He is an ASQ fellow and has
co-authored several ASQ Quality Press books.

CHARLES A. CIANFRANI is a principal

consultant for Green Lane Quality
Management Services in Green Lane,
PA. An ASQ fellow, Cianfrani is a
U.S. expert representative to ISO/
TC 176. He has an MBA from Drexel
University in Philadelphia and a
masters degree in applied statistics
from Villanova University in Pennsylvania.

videos.asq.org/asq-standards-channel

ASQ Standards
Channel: All You
Need to Know About
ISO 9001:2015
Find pertinent answers to your burning
ISO 9001:2015 questions on the new
ASQ Standards Channel.
30-plus informational video interviews
with top experts
Free for ASQ members

Sponsored by

ASQ-V0015 Filler HalfHz 6.875x4.875_MKG.indd 1

15-03-09 1:49 PM

May 2015 QP 57