4 STEPS TO IMPLEMENT THE ISO 17025 IMPARTIALITY PROCEDURE

https://calibrationawareness.com/4-steps-to-implement-iso-17025-impartality-procedure

Since the transition from version 2005 to version 2017 began, I have received several
comments regarding the ISO 17025 impartiality procedure.

There is also a question: "Is it mandatory to have an impartiality procedure?"

Like many others, before I begin to understand and create my own procedure, I find it difficult
to understand the requirements of the standard.

Even though this topic about impartiality is not new (yes, it is), it is already in the old version,
still, once it was introduced in the new version with a separate clause, it was like it was the
first time that I expose myself to it. .

Even more so when I read the term “Risk Assessment” for the Risk to Impartiality Identified.
When I started creating my process or procedure, I was stuck on what to do next. One more
thing that overwhelms me is the statement, "in progress."

When I was reading the standard, it seems that fairness is easy to understand and implement,
but once it needs to be documented for a procedure, the challenge now arises.

The challenges are:

1. How can I identify risks to impartiality?

2. Once identified, how can I perform an evaluation or analysis?

3. How can I run Impartiality Risk Identification on an ongoing basis?

4. How can I manage fairness implementation risk?

But fortunately, after a good conversation with my advisor (who I am very grateful for the way
he delivers his evaluation), I finally understood what is missing in my own way of
understanding this process.

And in this post, I will present to you the following:

 Impartiality requirements according to ISO 17025: 2017

 Understanding impartiality (terms and definitions)
 The risk to the clause and requirements related to impartiality
 Commitment to impartiality
 Fairness implementation procedure (in 4 steps)
 Identification and monitoring of risk to impartiality.
 Impartiality Risk Analysis and Assessment: Risk Assessment
 Address risk: eliminate and mitigate risk to impartiality
 Identification on a continuous basis
 Monitoring impartiality risk: maintaining impartiality
 Impartiality Process Flowchart

Understand impartiality requirements and ISO 17025:2017 impartiality

One reason to have honesty and integrity in laboratory results is to have unbiased and, of
course, accurate results. This can be achieved through the implementation of Impartiality,
integrated into our laboratory activities and as part of our work ethic.

To be impartial to laboratory activities is to be free to exercise your professional judgment and

competence based on the actual data results you have gathered using established procedures.

After the publication of the new revision of ISO 17025, impartiality has become one of the
main requirements to be implemented or even integrated into all laboratory activities. This
means that it is a mandatory process that must be implemented.

It is not a new requirement, but this time, it now has a new clause with a clear and direct
requirement for its implementation (see clause below).

But being impartial to laboratory activities requires awareness to be understood and

implemented smoothly. This is not the responsibility of a single person.

But like any other activity, following a certain procedure or system makes it more interesting
and easier to implement (as it applies to me according to the system I will share below. Keep
reading)

To begin to understand fairness, I have included their definition of the standard. According to
ISO 17025, clause 3.1 Impartiality means:

"The presence of objectivity."

Note that 3.1 says that "objectivity is understood to mean that no conflicts of interest exist or
are resolved so as not to negatively influence laboratory activities" are free from conflicts of
interest, Freedom from bias, free from bias, neutrality , Justice, Open mind, impartiality,
detachment and balance.

According to clause 4 of ISO 17025:2017, below are the General Requirements for Impartiality.

 Laboratory activities will be undertaken impartially, structured and managed to

safeguard impartiality.
 Management must be committed to impartiality.
 The laboratory must ensure impartiality in all its activities and not allow commercial,
financial or other pressures to compromise impartiality.
 The laboratory must identify the risk to impartiality on an ongoing basis;
 Once a bias risk is identified, the laboratory must demonstrate how to minimize or
eliminate that risk.

Below are some examples of fairness in laboratory activities to understand it better.

 you are not auditing your own work during the scheduled internal audit
 The technicians are not involved in the marketing where they perform the calibration.
 is not in favor of any request that involves falsification of results
 the company does not pressure you financially
Commitment to impartiality

So how can we demonstrate that the administration is committed to implementing

impartiality?

It is difficult to implement fairness or take action to resolve identified fairness risk without
support from senior management.

Management must be committed to strengthening implementation support

Ways to show commitment are:

 Including a statement on impartiality in the quality policy signed by management.

 Included in discussions at management review meeting
 Included in the training program and review of staff performance during contract
renewal.

Impartiality procedure implementation requirements for ISO 17025:2017

The procedure for maintaining impartiality of laboratory activities can be divided into different
steps or stages to understand its implementation easily.

These steps are:

Step 1: Identify risks to impartiality

Step 2: Analyze and evaluate identified risks to impartiality

Step 3: Address the risk: eliminate or mitigate the identified risk to impartiality

Step 4: continuous identification – monitoring

1. IDENTIFICATION OF RISK TO IMPARTIALITY

Document Review: As the name suggests, we will review all related documents, for example,
audit results, contract review, procedures and many more.

Information Gathering through Brainstorming and Interviews: This is a group work where we
can draw input from the group during meetings or any scheduled meeting.

Expert Judgment – This is where our related experience and understanding of the standards
and processes in the laboratory come in very handy.

Checklist: a list of previously identified risks

Remember that at this stage, we need to identify activities where impartiality could be at risk.
We need to list everything we can identify.

Note that the risk identified is not necessarily the activities that "already occurred." As we are
in the identification stage, we will even include the potential risks that we assess may happen.

Where can we use these techniques you may ask?

In addition to the examples provided, ISO 17025 has given us guidance on where to look for
and identify those risks to impartiality.
These areas or activities where we can begin to investigate are the relationships that exist
within the laboratory. We can use the above techniques in these relationships that normally
occur when the risk of Impartiality is very likely, these are:

Company to staff relationship

Laboratory activities with personal relationship

Personal to client relations

After performing the above techniques, we will summarize all the identified risks into a list and
create a more defined fairness risk assessment checklist.

Below are examples of identified risks to impartiality that you can include in your checklist as a
result of the relationships that exist when performing laboratory activities.

Relationships between company management and staff

1. Salary is based on the number of calibrated UUC, this is a form of financial pressure.

2. Quality is reporting low Technical (structural)

3. The owner is the manager of the laboratory

Relationships of laboratory activities with personnel

1. Audit your own work during the internal audit activity

2. The lab technician is doing marketing.

3. Special favor during client contract review

Staff relations with clients

1. A special commission to favor the client's wishes.

2. Customer requests a specific technician or engineer to perform calibration

3. The technician performing the calibration from the previous employer.

And now, since we've already identified them, it's time to evaluate whether previous
relationships have a risk of impartiality. These relationships may or may not represent a risk
depending on your assessment. Risk means that it has an effect on the quality of laboratory
activities during the delivery of results. (calibration or test results)

2. ANALYZE AND EVALUATE THE IDENTIFIED RISKS TO IMPARTIALITY

After you have recorded the identified risk to impartiality, the next step is to analyze its
impact.
How to analyze the identified risk of impartiality?
Below are some guiding questions:

What is the level of impact in relation to laboratory results?

How often does this identified risk occur in the process?
Can this identified risk be ignored or accepted?
There are tools that we can use to analyze and evaluate the identified risk to the impartiality or
reliability of laboratory results.

The standard does not specify any risk assessment tool. And in this regard, I will share only the
tool that I know and understand.

The goal of why we perform the analysis is to identify its impact on our process, and from this
analysis, we can now evaluate what action or prevention we can implement. We can remove
or at least minimize if removal is not possible.

In a color coding technique that shows the importance and relationship of the Impact versus
Probability level.

We can call this the “Impact vs. Probability” assessment tool (see image below).

This will show us that:

The greater the impact and probability of occurrence, the greater the immediate action is
required (orange to red).
If the risk is minimal (yellow), decide if it is an acceptable risk that can be controlled.
If the risk is small (green), where there is no effect on our results, it can be ignored but placed
on a watchlist for continued monitoring.

3. ADDRESSING THE RISK OF IMPARTIALITY: ELIMINATE OR MITIGATE

Once we have analyzed the fairness risk based on the color coding above (impact vs.
probability), it is time to eliminate it or minimize its effect.

Minimize so that even if the risk activity is present, we can be sure that it does not have a
significant effect on the results of our laboratory activity.

We need to demonstrate how we can eliminate or minimize the identified risk to impartiality.
This stage is where our corrective actions or opportunities for the improvement process or
procedure will be used.

Below are some examples of measures to address the risk of impartiality:

Residual risk

Residual risk is those risks that remain after the identified risk is addressed. For those risks that
we cannot eliminate after addressing it, we must conduct continuous monitoring to ensure
that the risk is controlled.

Some form of monitoring is to have a recording or adequate documentation of the activity to

be reviewed or included in the Internal Audit program. See the related process below, read on

The risk of fairness identification on an ongoing basis.

A continuous basis means that once you have identified the risk to impartiality and finished
addressing them, you must still perform monitoring and analysis to ensure that the risk to
impartiality is eliminated or adequately controlled each time there is new activity or new
changes.

In addition to the monitoring process, to have a continuous identification and evaluation of

risks a, it is advisable to include the impartiality process in the following activities:

Review and analyze all identified risks to impartiality during the management review meeting
including in the:
 Internal audit
 Performance review
This Impartiality Risk assessment procedure is also applicable to the implementation of the
Risks and Opportunities process under Clause 8.5. The only difference now is that we will
focus on laboratory activities with respect to risk assessment of the overall laboratory
operation.