Quality Progress - December 2016 - 9


E RS

with subclauses 4.1 and 4.2. These identified
risks and opportunities must be addressed
to improve the QMS and ensure that it can
achieve intended results, enhance desired
effects and minimize undesired effects.
Similarly, opportunities associated with
subclauses 4.1 and 4.2 must be addressed.
These identified opportunities may include

It's essential for top management
to promote the use of risk-based
thinking and the process
approach during QMS planning.

increased market share via greater customer satisfaction, the development of new
products or services, improved resource and

actions to address risks and opportunities,

ISO 9001:2008 to ISO 9001:2015 or those

supply chain management that might lead

and determine how to integrate and imple-

planning to obtain their first ISO 9001:2015

to decreased costs of materials or services,

ment these planned activities into the QMS.

certification, I recommend taking online

and opportunities to develop personnel

The organization also must evaluate the

or classroom transition training. Additional

competencies and training.

effectiveness of actions taken. Subclause

guidance about risk assessments is available

6.1.2 (the organization shall plan) also refer-

in ISO 31000:2009.

Subclause 6.1.1 (subparts A through D)
requires an organization to determine pro-

ences subclause 4.4 and is the foundation

cess inputs and outputs, and the sequence

for several important events that must be

Based Thinking (CERM Academy, 2016) by

of QMS processes, process controls and

considered during QMS planning.

Greg Hutchins. The Juran Quality Handbook

criteria. It also must determine how it will

Subpart A of subclause 4.4.2 establishes

You should consider reading ISO: Risk

(McGraw-Hill Education, 2010) also contains

identify resource requirements, assign

requirements for documented information

responsibilities, implement changes as

(procedures) to be maintained that sup-

agement and should be a standard refer-

needed to ensure requirements are met,

port the processes, and subpart B identi-

ence for every quality professional.

and improve the effectiveness of the QMS

fies requirements for an organization to

and its processes.

retain documented information (records)

These data can be used to ensure requirements are met for subclause 6.1.1-such
as enhancing desired effects; preventing or

to provide confidence that processes were

a product, quality system and its processes.

portunities, and to integrate and implement

This is classic plan-do-check-act cycle.

them into the QMS. Although not specifically
stated in this subclause, planning actions to

9001:2015 requirements, such as developing:

be taken ensures:

*	 The QMS scope.

*	 Actions are evaluated prior to implemen-

*	 A quality policy.

tation to determine whether there will be

*	 Quality objectives and product-quality

adverse effects on a QMS, its processes,

*	 Product-acceptance criteria.
*	 Internal audits and control of nonconformances.
*	 Corrective action and management reviews to be included in the QMS planning
process.
Subclause 6.1.2 is important because of
its requirement for an organization to plan

Aston Technical Consulting Services LLC
Coldspring, TX

Subclause 6.1.2 requires an organization
to plan its actions to address risks and op-

objectives.

Bill Aston
Managing director

performed as planned.4

reducing undesired effects; and improving

These areas are further supported by ISO

a wealth of information about quality man-

products or interested parties.
*	 Implementation of planned actions are
communicated to appropriate parties and
responsibilities are assigned.
*	 Criteria are established to evaluate the
effectiveness of actions taken.
*	 Actions to be taken are appropriate to a
risk or opportunity that's being addressed.
For organizations transitioning from

REFERENCE AND NOTES
1.	For more information about risk-based thinking and the
process approach, read annex A.4, "Risk-based thinking in
ISO 9001:2015," in ISO 9001:2015-Quality management
systems-Requirements.
2.	International Organization for Standardization (ISO), ISO
9000:2015-Quality management systems-Fundamentals
and vocabulary, subclause 3.2.3-interested part.
3.	Read Bill Aston's "Standards Outlook: Leaders of Change"
(July 2016, pp. 54-55) for additional information about what
responsibilities top management should provide with regard
to leadership and the promotion of risk-based thinking.
4.	Additional information about documented information that
should be maintained versus retained is provided in ISO
9001:2015's annex A.6. For more information on annex
A.6, read QP's "Keep Calm and Prepare for ISO 9001:2015,"
(September 2015, pp. 18-28).

BIBLIOGRAPHY
ISO, ISO 31000:2009-Risk management-Principles and
Guidelines.
ISO, ISO 9000:2015-Quality management systems-
Fundamentals and vocabulary.
ISO, ISO 9001:2008-Quality management systems-
Requirements.
ISO, ISO 9001:2015-Quality management systems-
Requirements.

December 2016 * QP

9



Table of Contents for the Digital Edition of Quality Progress - December 2016

Quality Progress - December 2016 - cover1
Quality Progress - December 2016 - cover2
Quality Progress - December 2016 - 1
Quality Progress - December 2016 - 2
Quality Progress - December 2016 - 3
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Quality Progress - December 2016 - 5
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Quality Progress - December 2016 - cover3
Quality Progress - December 2016 - cover4
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