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What’s new in ISO 9001?

Overview:

• ISO 9001 received a significant

revision for 2015

• The most significant changes have to

do with how the system is

implemented rather than specific

requirements

ISO 9001 is the most popular ISO

standard utilized worldwide, with about

1.14M certifications each year. This

represents over 70% of all ISO

certifications, so when ISO makes a

change to 9001, the effect is felt

worldwide.

In its latest revision, the most significant

changes are directed to how ISO expects

companies to implement ISO 9001 and

integrate it into their other systems.

The 3 changes that matter most

1. Move to Risk Based Thinking

Identifying and assessing risk is nothing

new to ISO 9001, or most other

management systems for that matter.

They all require you to identify the risks

that can impact quality (for instance), and

put in place controls to mitigate that risk.

The key difference now is that ISO is

seeking to move organizations to a more

systematic way of thinking about risk.

This means that risk is incorporated into

how every control is developed, and not

all risks are controlled in the same way.

This has deep implications into everything

from the design of the controls to how

they system is governed, and can lead to

significant cost reduction if correctly

applied.

Figure 1: Moving from reactive risk ID to

proactive, systematic risk ID

2. Emphasis on Leadership

ISO is not alone in this trend. Lack of

leadership commitment often tops the

list of reasons why initiatives like ISO fail,

so it is no surprise to see ISO and other

organizations integrate it into their

requirements.

Unfortunately, many will misinterpret this

as leadership support. Support can only

go so far, and further emphasizes the

mentality that the management system

applies to all except “management”.

Leadership commitment to the system is

ultimately shown in the culture that they

establish through their actions and what

actions they reward or discourage.

The solution is to take a proactive

approach to managing culture, and

integrating the desired culture with the

management system in a cohesive way.

Figure 2: WP&C 7-Element OEMS

3. Encourage using a single integrated

management system

One of the most significant changes to

ISO 9001 is the elimination of a

requirement to have a quality manual.

This change is part of a broader shift from

having multiple, discrete systems for each

desired result to a realization that a more

effective approach is to have a single

integrated system. ISO now encourages a

“Process Approach”, which further

supports utilizing a single integrated

system of processes.

The WP&C 7-Element OEMS is designed

in anticipation of this shift and can meet

the requirements for all ISO standards

under one single system.

Figure 3: Utilizing a single integrated

management system to comply with multiple

external systems

We can help… and it’s easier than

you think

We saw these changes coming long ago

and have the appropriate tools and

services to help you prepare for not only

this change, but future changes to other

ISO standards all at once. Give us a call

today to schedule an assessment of your

current system and get started.

Are you ready? Preparing for ISO 9001:2015

Spotlight