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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 Management’s role has been
it was the first quality management standard of its kind.
Essentially, the main focus of the standard has been, and updated from old-fashioned
still is, to give confidence to customers that the company can
provide consistently-conforming products and services. management to the more modern
Since its creation, it has been revised every 6-8 years: in 1994,
2000, 2008 and now, most recently, in September 2015. The thought process of leadership.
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 term products. Strangely enough, a quality manual as its
time for the standard to undergo some major changes and own document is no longer required; it can be included in
modernization in the 2015 revision. It is important to note an electronic system. The old term quality management
that certified companies have a 3-year transition period, until system has now been replaced with the term context of the
September 2018, to update their quality systems to meet the organization, so instead of describing a separate quality
standard. system, it requires a description of the company’s organization.
This white paper explores the general changes of the 2015 While the old standard revision had some specific
revision and also discusses how the changes affect a company’s requirements for the test and measuring equipment, the new
calibration processes. 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
Main changes follow-up.
Let’s first take a look at the main changes in the 2015 revision. The new revision also has several smaller changes not
Before actually diving into the revised points in the mentioned here.
standard, a general level change is the High Level Structure In the next chapters, let’s look more deeply into the changes
(HLS) of the standard. This was updated into a new structure that have biggest impact on the calibration processes of test
that will also be common to other management standards, and measuring equipment.
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 Role of management
leadership. This is a pretty big and fundamental change, and As mentioned in the intro text, management’s role has
is a modernization of the obligations of the highest-level been updated from the old-fashioned management to the
management: its commitment, responsibility and resource more modern thought process of leadership. This puts new
allocation. responsibilities on the senior management, as they must
Another major change is the risk-based thinking approach demonstrate their commitment and take responsibility for the
that is found throughout the entire standard. Naturally, the effectiveness of the quality system, while enhancing customer
purpose of a quality management standard is to mitigate risks satisfaction. One could conclude that management’s role has
in order to achieve the outcome of compliant product delivery. changed from focusing on things to focusing on people, and
But now, this risk-based thinking has been included in many from doing things right to doing the right things. Also, instead
parts of the standard. This is also one of the changes that we of planning, organizing and directing, the role has moved
can see affecting calibration processes in the companies the to inspiring, influencing and motivating. So all in all, a big
most - more on that later on. transformation in the standard.
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, Risk-based thinking
resources, responsibilities, risks and opportunities. Risk-based thinking is one of the key elements in the new
The services have been highlighted as being part of the revision. This affects many elements throughout the standard.

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This is also what affects calibration processes the most. First, ISO Guide 73:2009, Risk management – Vocabulary.
let’s take a generic look at what risk-based thinking is then A GAMP guide is available on how to implement the risk-
discuss how it affects calibration processes. based approach for calibration management: The GAMP ®
Good Practice Guide: A Risk-Based Approach to Calibration
Management.
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 Risk-based thinking and calibration processes
the 2015 revision. Some companies may already be familiar When analyzing calibration processes, the same
with the risk-based approach from other standards, such as methodological approach as in the risk index example
the Good Manufacturing Practices (GMP) guidelines and mentioned earlier should be applied. It is important to analyze
Food and Drug Administration (FDA) regulations. It is all the measurement points and loops in the plant. Now, let’s
good to remember that although a risk is often considered a discuss an example of this approach.
negative thing, risk-based thinking also helps to reveal new
opportunities.
First, evaluate the consequences
Risk index
(impact/severity) – what will happen
When analyzing risks, it is often divided into two parts; the
impact (severity) of something happening, then the probability if this measurement fails, what would
(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 the consequences be? Secondly,
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 how likely is it that this measurement
example of a risk index often used in risk assessment. The
green area indicates low risk, yellow indicates medium and red will fail? With a multiplication of these
indicates a high risk area.
two, the risk index is calculated.
Risk Likehood
Index First, evaluate the consequences (impact/severity) –
1 2 3 4 5 what will happen if this measurement fails, what would
1 1 2 3 4 5 the consequences be? Secondly, how likely is it that this
measurement will fail? With a multiplication of these two,
2 2 4 6 8 10 the risk index is calculated. Naturally, keep in mind how the
Impact

3 3 6 9 12 15 risk can be diminished, or even eliminated. There are many


sources that the risk can come from; it can be human error, an
4 4 8 12 16 20 equipment failure, an accident, or a total surprise that cannot
be predicted in advance.
5 5 10 15 20 25 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
Risk management standard resources
measurements are provided with redundant independent
ISO does offer a dedicated standard for risk management: measurements, so if one measurement fails, the other(s) will
ISO/IEC 31010:2009, Risk management – Risk assessment continue working. This is most often the case in critical safety
techniques. measurements, which also typically have dedicated safety
There is also a vocabulary available for risk management: certified/approved measurement equipment. But in practice,

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it’s not always possible to add redundant measurements into this creates a big risk of human error. There can always be
all loops which are considered critical or important. typos or misunderstandings of unclear writing. Electronic
automatic documenting calibration equipment is therefore
recommended for calibration in order to reduce this risk. Of
How to handle the most important measurements course, automated documentation will also save time.
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 Perform automatic error calculation
those that are less critical. After the risk analysis, less important One essential aspect in any calibration is to analyze the
measurements can be calibrated less often, leaving more time calibration results and compare the found errors to the allowed
for the calibration and maintenance of the most important accuracy limits. Often this comparison is not an easy thing to
measurements. It is good to remember that the measurement do manually and there is a risk of calculation errors. To reduce
may fail any time between the periodical calibrations and the risk, electronic calibration equipment should be used that
that the longer the calibration period is, the longer time the automatically calculates the error, compares it to the allowed
measurement may have been faulty for. It is often easy to notice limit and makes the Pass/Fail decision automatically.
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 Analyze measurement drift over time
once it fails in calibration, perform an analysis on the impact As all measurements tend to drift over time, it is important to
of this measurement failure. For example, if there is a 1-year follow the history trend of the measurement. A history trend
calibration period and the measurement fails in calibration, it is a tool to analyze whether the instrument is likely to stay
means that in the worst-case scenario, this measurement could within the tolerance limit over the next calibration period,
have been bad for the whole year, assuming it failed right after or if the period should be adjusted. If the history shows that
the previous calibration. This can cause a variety of outcomes there is a risk, meaning the instrument is unstable and the
and, in serious cases, safety hazards, plant shutdowns, or measurement could fail during the next period, the calibration
product recalls. 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
Acceptance limit from process needs measurement is not so critical, the calibration period could be
Different measurement points in the process will have made longer and valuable resources could be released for more
different criticality and also different accuracy needs. These important measurements. History trend may be very labor-
acceptance/accuracy limits should be set by the process intensive to do manually, but some calibration management
specialists. Often, the same kind of transmitters are installed software can provide very easy ways to analyze the history
into locations with different accuracy needs. And too often, trend of measurements.
the acceptance limits in calibrations are set according to the
transmitter’s specifications, while they should be set by the
process requirements. This runs a risk that the more and less Calculate total uncertainty
critical measurement points will end up having the same An analysis of the total uncertainty is an essential aspect in any
acceptance limits in calibrations. 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
Best practices for calibration processes 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 Use automated procedures


the actual calibration results in your calibration process, The calibration procedures may be carried out differently

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


ABOUT THE AUTHOR
This will add uncertainty to the calibration results and
make it difficult to compare or trend the results. Automated
The author of this paper is Mr. Heikki Laurila, Product
calibration procedures with calibration management software
Marketing Manager at Beamex Oy Ab in Finland. Prior to
and automated documenting calibrators will ensure that the
his current role, he spent several years working as a quality
calibration procedures are always performed in the same
manager.
manner and are repeatable, reliable and comparable.
We received the ISO9001 certification for our company
(Beamex) back in 1992, during that time I was working as a
The bottom line quality manager. Back then, the ISO9001 standard was still
pretty new and the original 1987 revision of the standard
Overall, the 2015 revisions to the ISO9001 standard strive
was still valid. As I don’t work as a quality manager anymore,
for modernization and to keep up with continually-evolving I must admit that I have not followed the development of the
technology and proven best practices. Management has standard very closely. But now that the 2015 revision has
changed from organizing things the right way, to leadership, been released, I wanted to take a closer look and understand
organizing people doing the right things. Risk-based thinking the main changes. In particular, I wanted to understand how
may be considered the most prominent and important this latest update affects the calibration processes of our
theme as companies strive for excellence in all areas—plant customers, who mainly work in the process industry.
efficiency and safety, while maintaining product quality—to
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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