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Calibration White Paper

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2015 revision of ISO9001

- what are the changes
and how do they affect
calibration processes?

BEAMEX Calibration White Paper

2015 revision of ISO9001 - what are the changes

and how do they affect calibration processes?
Background
The ISO9001 standard was initially published in 1987 and
it was the first quality management standard of its kind.
Essentially, the main focus of the standard has been, and
still is, to give confidence to customers that the company can
provide consistently-conforming products and services.
Since its creation, it has been revised every 6-8 years: in 1994,
2000, 2008 and now, most recently, in September 2015. The
2008 revision can be considered a minor revision, meaning
the main contents of the standard remained from the late 90s.
The world has changed quite a bit since the 90s, so it was
time for the standard to undergo some major changes and
modernization in the 2015 revision. It is important to note
that certified companies have a 3-year transition period, until
September 2018, to update their quality systems to meet the
standard.
This white paper explores the general changes of the 2015
revision and also discusses how the changes affect a companys
calibration processes.
Main changes
Lets first take a look at the main changes in the 2015 revision.
Before actually diving into the revised points in the
standard, a general level change is the High Level Structure
(HLS) of the standard. This was updated into a new structure
that will also be common to other management standards,
such as the ISO14000 environmental management standard.
An important management-level change in the revision
is that the older term management has been replaced with
leadership. This is a pretty big and fundamental change, and
is a modernization of the obligations of the highest-level
management: its commitment, responsibility and resource
allocation.
Another major change is the risk-based thinking approach
that is found throughout the entire standard. Naturally, the
purpose of a quality management standard is to mitigate risks
in order to achieve the outcome of compliant product delivery.
But now, this risk-based thinking has been included in many
parts of the standard. This is also one of the changes that we
can see affecting calibration processes in the companies the
most - more on that later on.
Other changes, like the process-based approach, which was
always included in the standard, require more details about
the processes, such as determination of the input and output,
resources, responsibilities, risks and opportunities.
The services have been highlighted as being part of the
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Managements role has been

updated from old-fashioned
management to the more modern
thought process of leadership.
term products. Strangely enough, a quality manual as its
own document is no longer required; it can be included in
an electronic system. The old term quality management
system has now been replaced with the term context of the
organization, so instead of describing a separate quality
system, it requires a description of the companys organization.
While the old standard revision had some specific
requirements for the test and measuring equipment, the new
revision takes a higher-level approach and sets requirements
for all the required resources (human and equipment) to be
made available and adequate for the use in measurements and
follow-up.
The new revision also has several smaller changes not
mentioned here.
In the next chapters, lets look more deeply into the changes
that have biggest impact on the calibration processes of test
and measuring equipment.
Role of management
As mentioned in the intro text, managements role has
been updated from the old-fashioned management to the
more modern thought process of leadership. This puts new
responsibilities on the senior management, as they must
demonstrate their commitment and take responsibility for the
effectiveness of the quality system, while enhancing customer
satisfaction. One could conclude that managements role has
changed from focusing on things to focusing on people, and
from doing things right to doing the right things. Also, instead
of planning, organizing and directing, the role has moved
to inspiring, influencing and motivating. So all in all, a big
transformation in the standard.
Risk-based thinking
Risk-based thinking is one of the key elements in the new
revision. This affects many elements throughout the standard.

2015 revision of ISO9001 - what are the changes and how do they affect calibration processes?

BEAMEX Calibration White Paper

This is also what affects calibration processes the most. First,

lets take a generic look at what risk-based thinking is then
discuss how it affects calibration processes.
General on risk-based approach
Although risk-based thinking has been already included in the
earlier revisions of the standard, it is very much highlighted in
the 2015 revision. Some companies may already be familiar
with the risk-based approach from other standards, such as
the Good Manufacturing Practices (GMP) guidelines and
Food and Drug Administration (FDA) regulations. It is
good to remember that although a risk is often considered a
negative thing, risk-based thinking also helps to reveal new
opportunities.
Risk index
When analyzing risks, it is often divided into two parts; the
impact (severity) of something happening, then the probability
(likelihood) of it to happen. Often, both of these are rated
on a scale of 1 to 5. When you multiply the impact with the
likelihood, a 1 to 25 rating of the risk index is formed. The
bigger the index, the bigger the risk. The chart below is an
example of a risk index often used in risk assessment. The
green area indicates low risk, yellow indicates medium and red
indicates a high risk area.

Impact

Risk
Index

Risk-based thinking and calibration processes

When analyzing calibration processes, the same
methodological approach as in the risk index example
mentioned earlier should be applied. It is important to analyze
all the measurement points and loops in the plant. Now, lets
discuss an example of this approach.

First, evaluate the consequences

(impact/severity) what will happen
if this measurement fails, what would
the consequences be? Secondly,
how likely is it that this measurement
will fail? With a multiplication of these
two, the risk index is calculated.

Likehood
1

10

12

15

12

16

20

10

15

20

25

Risk management standard resources

ISO does offer a dedicated standard for risk management:
ISO/IEC 31010:2009, Risk management Risk assessment
techniques.
There is also a vocabulary available for risk management:
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ISO Guide 73:2009, Risk management Vocabulary.

A GAMP guide is available on how to implement the riskbased approach for calibration management: The GAMP
Good Practice Guide: A Risk-Based Approach to Calibration
Management.

First, evaluate the consequences (impact/severity)

what will happen if this measurement fails, what would
the consequences be? Secondly, how likely is it that this
measurement will fail? With a multiplication of these two,
the risk index is calculated. Naturally, keep in mind how the
risk can be diminished, or even eliminated. There are many
sources that the risk can come from; it can be human error, an
equipment failure, an accident, or a total surprise that cannot
be predicted in advance.
There can be some measurements in a process plant that
will have very severe consequences if they fail, so these will
be the most critical to consider. Sometimes the most critical
measurements are provided with redundant independent
measurements, so if one measurement fails, the other(s) will
continue working. This is most often the case in critical safety
measurements, which also typically have dedicated safety
certified/approved measurement equipment. But in practice,

2015 revision of ISO9001 - what are the changes and how do they affect calibration processes?

BEAMEX Calibration White Paper

its not always possible to add redundant measurements into

all loops which are considered critical or important.
How to handle the most important measurements
For an important measurement, start by installing measuring
equipment known/found to be the most reliable. Next,
calibrate the most important measurements more often than
those that are less critical. After the risk analysis, less important
measurements can be calibrated less often, leaving more time
for the calibration and maintenance of the most important
measurements. It is good to remember that the measurement
may fail any time between the periodical calibrations and
that the longer the calibration period is, the longer time the
measurement may have been faulty for. It is often easy to notice
if an instrument totally fails, but if the instrument only starts
to slowly measure wrong, although outside allowed tolerances,
it is often difficult to realize until the next calibration. And
once it fails in calibration, perform an analysis on the impact
of this measurement failure. For example, if there is a 1-year
calibration period and the measurement fails in calibration, it
means that in the worst-case scenario, this measurement could
have been bad for the whole year, assuming it failed right after
the previous calibration. This can cause a variety of outcomes
and, in serious cases, safety hazards, plant shutdowns, or
product recalls.
Acceptance limit from process needs
Different measurement points in the process will have
different criticality and also different accuracy needs. These
acceptance/accuracy limits should be set by the process
specialists. Often, the same kind of transmitters are installed
into locations with different accuracy needs. And too often,
the acceptance limits in calibrations are set according to the
transmitters specifications, while they should be set by the
process requirements. This runs a risk that the more and less
critical measurement points will end up having the same
acceptance limits in calibrations.
Best practices for calibration processes

this creates a big risk of human error. There can always be

typos or misunderstandings of unclear writing. Electronic
automatic documenting calibration equipment is therefore
recommended for calibration in order to reduce this risk. Of
course, automated documentation will also save time.
Perform automatic error calculation
One essential aspect in any calibration is to analyze the
calibration results and compare the found errors to the allowed
accuracy limits. Often this comparison is not an easy thing to
do manually and there is a risk of calculation errors. To reduce
the risk, electronic calibration equipment should be used that
automatically calculates the error, compares it to the allowed
limit and makes the Pass/Fail decision automatically.
Analyze measurement drift over time
As all measurements tend to drift over time, it is important to
follow the history trend of the measurement. A history trend
is a tool to analyze whether the instrument is likely to stay
within the tolerance limit over the next calibration period,
or if the period should be adjusted. If the history shows that
there is a risk, meaning the instrument is unstable and the
measurement could fail during the next period, the calibration
period should be made shorter. Otherwise an OOT (Out Of
Tolerance) situation could happen with all of its consequences.
On the other hand, if the instrument is very stable and the
measurement is not so critical, the calibration period could be
made longer and valuable resources could be released for more
important measurements. History trend may be very laborintensive to do manually, but some calibration management
software can provide very easy ways to analyze the history
trend of measurements.
Calculate total uncertainty
An analysis of the total uncertainty is an essential aspect in any
calibration. The whole idea of calibration is lost if reference
equipment is not traceable and is not accurate enough for the
calibration work. Always be aware of the total uncertainty
of your whole calibration process, including the calibration
equipment used and also all of the other aspects in the process.

Eliminate manual entry

If you are manually handwriting the documentation of
the actual calibration results in your calibration process,
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Use automated procedures

The calibration procedures may be carried out differently

2015 revision of ISO9001 - what are the changes and how do they affect calibration processes?

BEAMEX Calibration White Paper

due to being done by different people, or at different times.

This will add uncertainty to the calibration results and
make it difficult to compare or trend the results. Automated
calibration procedures with calibration management software
and automated documenting calibrators will ensure that the
calibration procedures are always performed in the same
manner and are repeatable, reliable and comparable.
The bottom line
Overall, the 2015 revisions to the ISO9001 standard strive
for modernization and to keep up with continually-evolving
technology and proven best practices. Management has
changed from organizing things the right way, to leadership,
organizing people doing the right things. Risk-based thinking
may be considered the most prominent and important
theme as companies strive for excellence in all areasplant
efficiency and safety, while maintaining product qualityto
stay competitive and profitable in a global market; and the
most advanced calibration processes, comprised of calibration
software and documenting calibrators to create an automated
process, play a vital role in satisfying the risk-based thinking
approach.

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ABOUT THE AUTHOR

The author of this paper is Mr. Heikki Laurila, Product
Marketing Manager at Beamex Oy Ab in Finland. Prior to
his current role, he spent several years working as a quality
manager.
We received the ISO9001 certification for our company
(Beamex) back in 1992, during that time I was working as a
quality manager. Back then, the ISO9001 standard was still
pretty new and the original 1987 revision of the standard
was still valid. As I dont work as a quality manager anymore,
I must admit that I have not followed the development of the
standard very closely. But now that the 2015 revision has
been released, I wanted to take a closer look and understand
the main changes. In particular, I wanted to understand how
this latest update affects the calibration processes of our
customers, who mainly work in the process industry.

2015 revision of ISO9001 - what are the changes and how do they affect calibration processes?