STANDARDS OUTLOOK

BY R. DAN REID

Putting Things In Context

Implementing new requirements in ISO 9001:2015
IT CAN BE argued that ISO 9001:2015

quality objectives.3

and objectives as indicated within the or-

enhances the role quality management

The 2008 version of ISO 9001 men-

ganizations vision statement. The mission

systems (QMS) play in the success of

tioned the purpose of the organization

statement will indicate how [the organiza-

an organization and its business pro-

only in the context of ensuring that a qual-

tion] plan[s] on reaching those goals and

cesses. Evidence of this, in part, is in a

ity policy is appropriate to that purpose.

objectives.4

new requirement in subclause 4.1 titled,

It did not mention the strategic direction

Understanding the organization and its

of an organization, perhaps because the

to serve and satisfy its customers.5 This

context.

QMS was not previously thought to be a

follows the logic that businesses exist to

boardroom topic necessarily.

serve customers, so customers are more

This subclause requires an organization to determine external and internal

The new concept of context in sub-

The purpose has also been defined as

important than stockholders, workers or

issues that are relevant to its purpose and

clause 4.1 also requires that the issues that

management. Without customers, there

its strategic direction and that affect its

can affect the intended results of the QMS

is no business. ISO 9001:2015 deals with

ability to achieve the intended result(s) of

be determined. This means these intended

customers in a broader fashion by describ-

its quality management system.1

results or outcomes of the QMS must

ing them as interested parties, but more

be determined up front. Figure 1 shows

on that later.

ISO 9000 adds that the creation of

unity of purpose and the direction and

intended outcomes as an output of the

engagement of people enable an orga-

scoping of the QMS.

Others could argue that the purpose of

a for-profit organization is to make money,
and that for not-for-profit organizations,

nization to align its strategies, policies,

processes and resources to achieve its

Finding purpose

it is to serve some segment of society in

objectives (see Figure 1, p. 68). It also

The purpose and strategic direction of an

some prescribed way. Curiously, in ISO

asserts: Leaders at all levels establish

organization are traditionally boardroom

9001:2015, purpose and strategic direction

unity of purpose and direction and

topics. There are differing views on what

are not defined, but both terms are used in

create conditions in which people are

the purpose of an organization is. It has

the new context requirement in subclause

engaged in achieving the organizations

been defined as: to accomplish the goals

4.1.

The word mission is defined as an

organizations purpose for existing as
expressed by top management.6 Because
mission is defined as the purpose, mission
is shown as an input for determining the
context in Figure 1 and is a good starting
point for engineering or reengineering a
QMS.

Defining context
In ISO 9001, context is defined as the
combination of internal and external
issues that can have an effect on an organizations (subclause 3.2.1) approach to
developing and achieving its objectives.7
ISO 9000 offers more guidance. Understanding the context of the organization
is a process. This process determines

December 2015 QP 67

STANDARDS OUTLOOK
factors which influence the organizations
purpose, objectives and sustainability. It
considers internal factors, such as values,
culture, knowledge and performance of

Planning the quality management

systemISO 9001:2015-related
clauses / FIGURE 1

the organization. It also considers external

factors, such as legal, technological,

Mission

competitive, market, cultural, social and

economic environments. Examples of the
ways in which an organizations purpose
can be expressed include its vision, mis-

Strategic
direction

Interested party
expectations
(4.2)

Understanding
context (4.1)

sion, policies and objectives.8 The issues

to be determined are those that:

Relevant?
(4.1, 4.2)

Are relevant to the organizations purpose.

Are relevant to the organizations strategic direction.
Can affect its ability to achieve the
intended results of its QMS.

External issues

(Re)scope of
management
system (4.3)

Intended
outcomes

Policy
development
(5.2.1)

Quality policy

External issue examples include:

Resources (7.1)

Technology. New technology has

the potential to make current products
or services obsolete. Business leaders
should keep their organizational strategies

Identification
of risks
Identify risks
and
andopportunities
opportunities
(6.1)

Process
controls (8.1)

updated in the face of continually evolving

technologies, ensure that their organizations continue to look ahead and use tech-

Processes (4.4)

Documented
information (7.5)

Objectives
setting and
planning (6.2)

Plans

nologies to improve internal performance.

Objectives
Documented
information (7.5)

Disruptive technologies can change the

check

game for businesses, creating entirely new

products and services, as well as shifting
Data (9.1.3)

pools of value between producers or from

Metrics (9.1.1)

producers to consumers.

Yes

Technologys impact on a QMS involves

On target?

organizational knowledge. When addressing changing needs and trends, the

No

organization shall consider its current

Corrective
action (10.2.1)

knowledge and determine how to acquire

or access any necessary additional knowledge and required updates.10
Competition. A privately owned

process effectiveness and efficiency, and

provides? Due to the nature of their busi-

stamping organization has a much differ-

can affect the amount of documented

nesses, pharmaceutical organizations,

ent competitive landscape from that of a

information needed and the amount of

hospitals and utility companies must act

turbocharger manufacturer. Competition

resources that are available.

on the risk in their QMSs much differ-

typically drives prices down and quality

Litigation profile of the organi-

and service up. These issues emphasize

zation. How much risk is involved in

manufacturer of cloth gloves. Problems

the critical need for good benchmarking,

the product or service the organization

with their product or service can result in

68 QP www.qualityprogress.com

ently and more diligently than does a

Technologys impact on a quality management

system involves organizational knowledge.
lawsuits, which can be costly regardless

Geographical. Delivery can be more

and efficiency of a QMS and its intended

of outcome. Legal costs just to mount a

complex to manage depending on where

defense are significant. This requires bet-

the organization is located and with what

Organizational structure. Is your

ter planning and risk mitigation through

customers it chooses to contract. Export-

organization a more traditional, pyramid

improved design, process controls and

ing of products, as well as added regula-

structure or a matrix organization where

error-proofing.

tory issues increases inventory to the

a worker has more than one supervisor?

supply pipeline and carries more risk for

This structure can affect various elements

design changes.

of the QMS, including subclauses:

Regulatory environment. Product

and service sectors may be required to
comply with regulatory and statutory

Some locations are prone to natural

outcomes.

5.3 on organizational roles, responsi-

requirements that can be ambiguous and

disasterssuch as being in a flood plain

complex. Often, organizations need a

or earthquake zonewhich places a

7.4 on communication.

regulatory consultant to help identify and

premium on business continuity planning

7.1.6 on organizational knowledge.

deal with the applicable requirements.

and supply chain risk mitigation, which is

This affects the new requirement for orga-

costly at best.

Customer-specific requirements.
aerospace, require third-party certifica-

Are the authorities for work adequately

and effectively specified and aligned
with the responsibilities assigned? ISO

nizational knowledge.
Some sectors, such as automotive and

bilities and authorities.

Internal issues

9001:2015 requirements for communica-

Examples of internal issues include:

tion include determining the who, what,

Resources. About the time of the

when and how for internal and external

communications and the target audience.

tion to ISO 9001-based QMS standards.

economic turmoil in 2008, many organiza-

Suppliers also are obligated to comply

tions elected to downsize by reducing

with additional customer-specific require-

headcount. No doubt, many people who

specific to the organization gained by ex-

ments, which add significant complexity

were left working in these organizations

perience that is used and shared. Quality

as organizations operate at lower levels of

were required to do what had been the

guru Philip B. Crosby indicated commu-

the supply chain.

work of several others, in addition to their

nication is hard work. If you dont plan

own work.

for it and work at it, it does not happen.11

Organizations at the top require their

suppliers to flow down their requirements

Without reengineering the processes in-

Knowledge is described as knowledge

Complexity in organization structure and

to their suppliers. These suppliers typi-

volved, this dramatic cut in resources can

cally add their own requirements and pass

significantly affect an organizations QMS

them all down to their suppliers. Add to

and, arguably, its ability to achieve its

product and service offerings the organi-

that the need for second-party, on-site as-

purpose. Technical human resourcesen-

zation chooses will affect a QMS. Product

sessments to determine conformance, and

gineers and quality practitionerscan be

complexity, volume, target markets and in-

organizations are forced to deal with a lot

hard to replace. This emphasizes the need

tended application are all issues that must

of work for little added value. This affects

for capturing organizational knowledge,

be decided, planned for and effectively ad-

resources, supplier management (control

another new requirement in the ISO 9001

dressed. Clearly, this can affect resources,

of externally provided processes, products

revision.

organizational knowledge, infrastructure,

and services), data and documented

information.

Other assets, such as infrastructure,

also must be considered. Information

related issues can affect a QMS.

Products and services. Even the

competency and other QMS elements.

Interested party needs and ex-

Union or nonunion. This also could

systems are now at the forefront of key

pectations. In ISO 9001:2008, the term

be argued as an internal issue. Regardless,

processes that support a QMS through

interested party was not used. It was

this can affect a quality system in several

control of documented information, such

addressed in ISO 9004:2008: ISO 9004

areas, such as communication, awareness,

as procedures and records. Outdated or

provides a wider focus on quality man-

competency and policy.

insufficient IT can harm the effectiveness

agement than ISO 9001; it addresses the

December 2015 QP 69

STANDARDS OUTLOOK
needs and expectations of all interested
parties and their satisfaction, by the
systematic and continual improvement of
the organizations performance.12

from Figure 1 are:

Linkages. A link to the mission and
strategic direction of the organization.
The scope or rescoping of a QMS.

Objectives should be measureable and time based. They should be

reset after they are achieved to drive
improvement. Metrics must be monitored

The scope of a QMS may change. The

and acted on as necessary to achieve

clause 4.2) to include the requirements

scope defines what is included in a QMS.

planned results. Good metrics drive good

of relevant interested parties within the

The definition of management system

behavior; just as bad ones drive wrong

QMS. ISO 9000 adds guidance: Relevant

now provides for a narrow scope of one

behavior. Be sure to choose wisely. QP

interested parties are those that provide

or more functions or disciplines inside

significant risk to organizational sustain-

an organization, as well as the entire

ability if their needs and expectations are

organization.

There is now a requirement (sub-

not met.13
Interested parties can affect the level

While there is no longer an explicit

provision for exclusions in the standard,

of control expected for the design and de-

minimalists could argue that the appli-

velopment process.14 Feedback from rel-

cable requirements from the standard

evant interested parties must be included

that must be included in the management

in the management review process.15

system can be those applicable to only

The quality policy must be available

to relevant interested parties, as appro-

one or more functions rather than the

whole organization.

priate.16 Examples of interested parties

Organizations that choose to do this

include providers, partners, customers,

will make life difficult for customers that

investors, employees or society as a

require third-party certification unless the

whole.17 Determining interested party

customers address this issue in customer-

needs and expectations is now an input to

specific requirements. The addition of

the scoping of a QMS (see Figure 1).

interested party needs and the context

Note that the intent of the standard is

that the organization determine which
interested parties are relevant. An organi-

requirement could, on the other hand,

require a scope expansion.
QMS outcomes. The standard refers

zation could take a minimalist approach

to the QMS outcomes, creating a need for

to this and exclude some parties or re-

determining them.

quirements that may, in fact, be relevant.

Identification of risks and oppor-

Certainly, auditors of a system will need

tunities. Standards writers point out

to audit the criteria used and determine

that the concept of risk has always been

the effectiveness of an organizations

inherent to ISO 9001, but it is now an

conclusions.

explicit requirement. Full risk management is not required, but risks must

Revising your QMS

be determined and addressed. Risks

Context and interested party expecta-

pertaining to products, processes and

tions are not the only clauses that must

suppliers should be included. Identified

now be considered in planning. Figure 1

risks will need efforts to mitigate them

depicts one way to look at the planning

through design and process controls and

and implementation of major elements

verification activities.

of the revised standard. It could be

Objectives. The continued use of

argued that processes such as objectives

enterprise-level objectives that are to be

setting, resource allocation and QMS

deployed and aligned with more specific

processes are not actually sequential or

objectives at relevant levels and functions

in the order shown in Figure 1, which is

inside an organization is key and is main-

true enough. The important takeaways

tained from past versions of the standard.

70 QP www.qualityprogress.com

REFERENCES
1. International Organization for Standardization (ISO), Final
Draft International Standard ISO 9001:2015Quality
management systemsRequirements, Subclause 4.1
Understanding the organization and its context.
2. ISO, Final Draft International Standard ISO 9000:2015
Quality management systemsFundamentals and
vocabulary, Subclause 2.3.2.2Rationale.
3. Ibid, Subclause 2.3.2.1Statement.
4. Answers.com, What is the Purpose of an Organization?
Oct. 4, 2015, http://tinyurl.com/purposeoforg.
5. Angelfire.com, The Purpose of Business Organization,
Oct. 4, 2015, http://tinyurl.com/q53hgtp.
6. ISO, Final Draft International Standard ISO 9000:2015
Quality management systemsFundamentals and
vocabulary, Subclause 3.5.11Mission.
7. Ibid, Subclause 3.2.2Context of the organization
(terms).
8. Ibid, Subclause 2.2.3Context of an organization.
9. James Manyika, Michael Chui, Jacques Bughin, Richard
Dobbs, Peter Bisson and Alex Marrs, Disruptive Technologies: Advances That Will Transform Life, Business and
the Global Economy, McKinsey & Co., Oct. 4, 2015, http://
tinyurl.com/nmbecug.
10. ISO, Final Draft International Standard ISO 9001:2015
Quality management systemsRequirements, Subclause
7.1.6Organizational knowledge.
11. Philip B. Crosby, Quality is Free: The Art of Making Quality Certain, McGraw-Hill, 1979.
12. ISO, ISO 9001:2008Quality management systemsRequirements, Subclause 0.3Relationship with ISO 9004.
13. ISO, Final Draft International Standard ISO 9000:2015
Quality management systemsFundamentals and
vocabulary, Subclause 2.2.4Interested parties.
14. ISO, Final Draft International Standard ISO 9001:2015
Quality management systemsRequirements, Subclause
8.3.2Design and development planning.
15. Ibid, Subclause 9.3.2Management review inputs.
16. Ibid, Subclause 5.2.2Communicating the quality policy.
17. ISO, Final Draft International Standard ISO 9000:2015
Quality management systemsFundamentals and
vocabulary, Subclause 2.3.7.4 Possible actions (relationship management).

R. DAN REID is the director of

standards and consulting at Omnex
Engineering and Management in
Ann Arbor, MI. He is an author of
ISO Technical Specification 16949,
QS-9000/QSA, ISO 9001:2000, the
first International Organization
for Standardization international
workshop agreement, the Chrysler, Ford, GM Advanced
Product Quality Planning With Control Plan, Production Part
Approval Process and Potential Failure Modes and Effects
Analysis manuals and the AIAG Business Operating Systems
for Healthcare Organizations. Reid was the first delegation
leader of the International Automotive Task Force. He is an
ASQ fellow and an ASQ-certified quality engineer.