Quality Progress - December 2016 - 8


EXPERTANSWE R
Addressing risks in
ISO 9001:2015

process. Who, when and how will identified

ested parties' expectations also is essential

external and internal issues be monitored

for establishing requirements for resources

Q: I'm struggling with the implementation

and reviewed? According to subclause

such as materials, external support services,

of subclause 6.1 in ISO 9001:2015-actions

9.3.2b, reviewing external and internal

process controls, equipment and personnel

to address risks and opportunities. I've read

issues is a required input item for manage-

competencies.

and re-read the 2015 revision, and plotted

ment reviews, but ISO 9001:2015 doesn't

different ways to implement this concept,

prescribe a frequency for conducting man-

leadership is indispensable because it's

but I can't see the forest for the trees. Do

agement reviews.

responsible for determining an organiza-

you have any advice about how to imple-

tion's risk appetite and identifying the level

reviews occur annually. For monitoring and

of risk it's willing to accept. ISO 9001:2015's

reviewing external and internal issues, it

subclause 5.1.1, requires top management

A: ISO 9001:2015's clause 6 is particular to

may be acceptable to establish frequencies

to be responsible for providing resources

quality management system (QMS) plan-

that coincide with scheduled management

and leadership, and maintaining account-

ning. For effective QMS planning, there are

review dates. This timing, however, is prob-

ability for the QMS's effectiveness. Unlike

several essential components and activities,

ably best developed based on the level of

ISO 9001:2008, the 2015 revision does not

such as identifying risks and opportunities,

risk associated with the issues identified.

require the organization to appoint a man-

using risk-based thinking (RBT) and applying

Remember, ISO 9001:2015 does not

agement representative. These duties and

require a defined frequency for monitoring

responsibilities rightfully remain with top

Note that subclause 6.1.1 refers to sub-

and reviewing these external and internal is-

management.

clause 4.1, which requires an organization

sues. These are actions an organization may

and its context to be understood. Under-

choose to conduct to improve the effec-

organization to conduct formal risk assess-

standing the organization, its context, stra-

tiveness of its QMS, or monitor and control

ments, it's the organization's responsibility

tegic direction or method used to achieve its

identified risks.

to determine which RBT method to use that

ment this part of the standard?

the process approach.1

goals is not only necessary to identify risks

Subclause 4.2 requires an organization

While ISO 9001:2015 doesn't require an

best matches with operational and product

and opportunities, but it's also required to

to understand needs and expectations of

needs. There are many different strategies

develop a robust QMS that includes a quality

interested parties, and monitor and review

that can be used to assess risk-such as a

policy and objectives mandated by sub-

information about these relevant parties. So,

turtle diagram; strength, weaknesses, oppor-

clauses 5.2.1 and 6.2.1, respectively. Some

who are "interested parties?"

tunities and threats chart; heat map; barrier

organizations might maintain documented

Interested parties could include: custom-

chart; or failure mode and effects analysis.

mission and value statements to commu-

ers; suppliers; employees; registrars; the

The selected risk-assessment strategy

nicate their goals and strategies, but this is

organization's financial stakeholders; insur-

should be appropriate to the complexity or

not an ISO 9001:2015 requirement.

ance providers; or government agencies

criticalness of the product, related process-

such as state, local or federal regulators. ISO

es and the organization's risk appetite. It's

tion to identify relevant external and internal

9000:2015's subclause 3.2.3 defines an inter-

essential for top management to promote

issues that affect its ability to achieve its

ested party as "a person or organization that

the use of RBT and the process approach

goals or QMS's intended results. Examples

can impact, be impacted by, or perceive itself

during QMS planning.3

of relevant external and internal issues you

to be impacted by a decision or activity."

Subclause 4.1 also requires an organiza-

should consider are provided in subclause

2

Identifying relevant interested parties,

While ISO 9001:2015 doesn't have a defined frequency for monitoring and review-

4.1's notes two and three. While this sub-

including their needs and expectations,

ing information about interested parties, it

clause requires relevant external and inter-

is critical to a QMS planning process. By

may be beneficial to do so. This is because

nal issues to be monitored and reviewed, it

understanding these areas, an organization

it can identify changes that represent an

does not prescribe a frequency at which you

can effectively use RBT to identify risks and

unacceptable level of risk to the organiza-

should monitor and review them.

opportunities associated with meeting ex-

tion or QMS.

This is why it's important to consider
these activities during the QMS planning

8

Most organizations' management

Top management involvement and

QP * www.qualityprogress.com

pectations and requirements. Having a firm
understanding of requirements and inter-

Generally, subclause 6.1.1 requires an
organization to determine risks associated


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