4 Steps to Implement ISO 17025 Impartiality

Procedure
Since the transition from the 2005 version to the 2017 version has started, I have
received a number of comments regarding the ISO 17025 Impartiality procedure.

There is also a question like, “Is it Mandatory to have a procedure for impartiality?”

Just like many others, before I started to understand and create my own procedure, I
have a hard time understanding the requirements of the standard.

Even though this subject about impartiality is not new (yes, it is), which is already in the
old version, Still, once it was presented in the new version with a separate clause, it was
like it is my first time being exposed to it.

More so when I read the term “Risk Assessment “for the identified Risk to Impartiality.
When I started to create my process or procedure, I was stuck on what next to be done.
One more thing that overwhelmed me is the statement, “Ongoing basis”. 

When I was reading the standard, it seems that impartiality is easy to understand and
implement, but once it is needed to be documented for a procedure, the challenge is
now presenting itself.

The challenges are:

1. How can I identify the Risks to impartiality?

2. Once Identified, how can I perform evaluation or analysis?
3. How can I execute the Identification of risks to impartiality on an on-going basis?
4. How can I manage risk to impartiality implementation?

But luckily, after a good conversation with my assessor (which I am very grateful by the
way he delivers his assessment), I finally understood what is missing in my own way of
understanding this process.

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

1. Impartiality requirements as per ISO 17025:2017

a. Understanding Impartiality (terms and definitions)
b. The risk to Impartiality related clause and requirements
2. Commitment to impartiality
3. Impartiality implementation procedure (in 4 steps)
a. Identification and monitoring of risk to impartiality 
b. Analysis and evaluation of Risk to impartiality- risk assessment
 c. Addressing Risk – Eliminate and mitigate risk to impartiality 
d. Identification on an Ongoing Basis 
  monitoring of risk to impartiality – maintaining impartiality
4. Impartiality Process Flow Chart

The implementation that I will present here is not yet perfect. These are the things that I
have listed and implemented based on my understanding and design of the lab that I
am in this implementation is also new to me and therefore there is still more room for
improvement.
 
This may not apply in your laboratory so proper care or review must be implemented. I
hope that this will be a useful guide for you to understand and start to implement
within your lab. 

Understanding Impartiality and ISO 17025:2017 Impartiality

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

To be impartial to the laboratory’s activities is being free to exercise your professional

judgment and competency as per the actual data results that you have gathered using
the established procedures.

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

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

But being impartial to laboratory activities needs awareness in order to be understood

and implemented smoothly. This is not a single person’s responsibility.

But like any other activity, by following a certain procedure or a system makes it more
interesting and easy to implement (as it applies to me as per the system that I will share
below.. Read on)

To start understanding Impartiality, I have included its definition from the standard. As
per ISO 17025, clause 3.1 Impartiality means:

1. “The presence of objectivity.”

 a. note to 3.1, stating that “Objectivity is understood to mean that conflicts of
interest do not exist, or are resolved so as not to adversely influence the activities
of the laboratory.”
2. are freedom from conflicts of interest,
3. Freedom from bias
4. freedom from prejudice,
5. neutrality, 
6. Fairness,
7. open-mindedness,
8. even-handedness, 
9. detachment 
10. and balance

More About Conflict of Interest (COI)

I want to explain more about ‘Conflict of Interest’ because this term is confusing in

some way.

When we say ‘conflict of interest’, these are the ‘personal interest’ that tends to conflict
with our responsibilities and decision making in relation to the laboratory activities.
This can be an outside activity or within the company activity.

Below are some situations where Conflict of Interest could arise:

1. If you transact with a customer who is an associate or a partner in business, an

interest of associate.
2. If you’re an employee that transacts with a supplier which is your relative, then
there is an interest of relative.
3. When you misuse any information from your job for personal gain.
4. If you accept a gift from a customer that is “too much” in value (usually secretly
that temps you to do a favor) -also known as ‘Intimidation’

General Requirements for Impartiality

As per clause 4 of ISO 17025:2017 Standard, below are the General Requirements for
Impartiality

1. Laboratory activities shall be taken impartially structured and manage so as to

safeguard impartiality
2. The management shall be committed to impartiality
3. The laboratory shall ensure impartiality in all its activities and not allow
commercial, financial or other pressures to compromise impartiality.
4. The laboratory shall Identify risk to impartiality on an on-going basis;
5. Once a risk to impartiality is identified, the lab should demonstrate how to
minimize or eliminate such risk.

Examples of Impartiality

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

1. No Conflict of interest – You are not auditing your own work during the
scheduled internal audit
2. Detachment –Technicians are not involved in marketing where they perform the
calibration – 
3. Freedom from bias – You are not favoring any request that involves falsification
of results  
4. Fairness –The company is not pressuring you financially 

Commitment to Impartiality
So how can we show that the management is committed in implementing impartiality?
It is difficult to implement impartiality or taking an action to solve the identified Risk to
Impartiality without the support of the higher management.

The management should be committed in order to strengthen the support in the

implementation 

Ways to show commitment is by:

1. Including a statement about impartiality in the quality policy which is signed by

the management.
2. Included on the discussions in the management review meeting
3. Included in the training program and performance review of the personnel
during contract renewal.

Impartiality Procedure Implementation Requirements for ISO

17025:2017
The procedure for maintaining the impartiality of laboratory activities can be broken
down into different steps or stages in order to understand its implementation easily.

I put “4 Steps” in the title but as you learn through it, each step has more steps on each
own.

These steps are:

Step 1: Identify the risks to impartiality
Step 2: Analyze and Evaluate Identified Risks to Impartiality
Step 3: Addressing the Risk – Eliminate or Mitigate Identified Risk to Impartiality
Step 4: Identification to an On-going basis – monitoring

1 Identification of Risk to Impartiality

Now, this is where the main part where we need to sit and think. 

There are techniques to determine the risks to impartiality. I will present here the
techniques that I understand and make sense to me (and I hope for you too)

 These techniques are:

1. Document Review – as the name implies, we will review all related documents,
for example, audit results, contract review, procedures, and many more.
2. Information gathering through Brainstorming and interviewing – this is group
work where we can extract inputs from the group during meetings or any scheduled
meetups.
3. Expert Judgement – this is where our related experience and understanding of
the standards and processes in the laboratory are very helpful
4. Checklist – based on ISO 17025 requirements and a list of previously identified
risks 

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

Note that the identified risk is not necessarily the activities that ‘already occurred’. Since
we are in the identification stage, we will include even the potential risks that we
assessed that may happen.

Where can we use these techniques you may ask?

In addition to the examples that are provided, the ISO 17025 standard has given us a
guide where to look and identify those risks to impartiality. 

These areas or activities where we can start to investigate are the relationships that exist
inside the laboratory. We can use the techniques above on these relationships that
normally occur where the risk to Impartiality is highly likely to happen, these are:
1. Company to personnel relationship
2. Laboratory activities to personnel relationship
3. Personnel to customer relationships
After we perform the above techniques, we will then summarize all the identified risks
in a list and create a more defined impartiality risk assessment checklist.

Examples of Risk To Impartiality

Below are examples of identified risk to impartiality that you may include in your
checklist as a result of the relationships that exist while performing laboratory activities.

Relationships of Company Management to Personnel

1. Salary is based on the number of calibrated UUC, this is a form of financial pressure.
2. Quality is reporting under Technical (structural)
3  The owner is the Lab  Manager

Relationships of Laboratory Activities to Personnel 

1.Auditing your own work during internal audit activity

2. The lab technician is performing marketing.
3. Special favor during the customer contract review

Relationships of Personnel to Customer 

1. A special commission to favor the customer’s wants

2. The Customer request a specific technician or engineer to perform calibration
3. The technician performing calibration on the previous employer

And now, since we already identified them, it is now time to assess if the relationships
above have a risk to impartiality. These relationships may or may not pose a risk
depending on your assessment.  Risk means that it has an effect on the quality of lab
activities during the delivery of results. (calibration or test results)

2 Analyze and Evaluate Identified Risks to Impartiality

After we have recorded the identified risk to impartiality, the next step is to analyze and
assess its impact through an impartiality risk assessment process.

How to analyze the Identified risk to Impartiality?

Below are some guide questions:

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

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

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

The objective 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 that we can
implement. We can either eliminate or at least minimize if elimination is not possible.

Below is the sample analysis tool that I used from Euro lab’s Cook Book no 18. It is a
color-coding technique to show the significance and relationship of the Impact versus
Probability level. 

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

This will show us that:

1. The higher the impact and the probability of occurrence require immediate
action (orange to red).
2. If the risk is minimal (yellow), decide if this is an acceptable risk that can be
controlled.
3. If the risk is small (green), where there is no effect on our results, it can be
ignored but included in a watchlist for continuous monitoring.

Impartiality Risk Assessment Tool (Impact and Probability Matrix)

3Addressing the Risk to Impartiality – Eliminate or Mitigate

Once we have analyzed the risk to impartiality based on the color-coding above (impact
versus probability), it is now time to either eliminate it or minimize its effect.
Minimize in a way that even if the activity of risk is present, we can be assured that it
has no significant effect on our laboratory activity results.

We need to demonstrate how we can eliminate or minimize the identified risk to

impartiality. At this stage is where our corrective actions or opportunities for
improvement process or procedure will be used.

Below are some examples of Measures to address the Risk to Impartiality:

Measures to address the risk to impartiality

Residual Risk

Residual risk is those risks that remain after we addressed the identified risk. For those
risks that we cannot eliminate after addressing it, we need to perform continuous
monitoring to ensure that risk is controlled.
Some form of monitoring is to have proper recording or documentation of activity to be
reviewed or included in the Internal Audit schedule. See the last process step below,
read on.

4 The Risk to Impartiality Identification on an On-going Basis 

An on-going basis means that once you have identified the risk to impartiality and
finished addressing them, you still need to perform monitoring and analysis in order to
ensure that risk to impartiality is properly eliminated or controlled whenever there is a
new activity or new changes to the laboratory activity.

In addition to the monitoring process, in order to have a Risk Identification and

assessment in an on-going basis, it is advisable to include the impartiality process on
below activities:
1. Review and analyze all identified risks to impartiality during the management
review meeting
2. Included in the Internal Audit
3. Performance review

Process Flow Chart

The risk to Impartiality Process Flow chart

 Impartiality procedure (front page)

Conclusion
The risk to Impartiality identification is one of the requirements of ISO 17025:2017 that
is mandatory to be implemented. The ease of implementation is by having a system to
follow, In short, a Risk Analysis Impartiality Procedure 

In this post, I have presented the following:

1. Impartiality requirements as per ISO 17025:2017

a. Understanding Impartiality (terms and definitions)
b. The risk to Impartiality related clause and requirements
2. Commitment to impartiality
3. Impartiality implementation Procedure
a. Identification and monitoring of risk to impartiality 
b. Analysis and evaluation of Risk to impartiality- risk assessment
c. Addressing Risk – Eliminate and mitigate risk to impartiality 
d. Identification on an Ongoing Basis 
  monitoring of risk to impartiality – maintaining impartiality
4. Impartiality Process Flow Chart

This Impartiality Risk assessment procedure is also applicable to Risk and

Opportunities process implementation under Clause 8.5. The only difference now is
that we will focus on the laboratory activities regarding the risk assessment of the
overall operation of the laboratory.