Since the transition from the 2005 version to the 2017 version has started, I have received several comments regarding the ISO 17025:2017 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 seemed that impartiality was easy to understand and implement, but once it needed to be documented for a procedure, the challenge presented 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 ongoing basis?
3. How can I manage risk to impartiality implementation?
But luckily, after a good conversation with my assessor (I am very grateful for the way he delivered his assessment), I finally understood what was missing in my own way of understanding this process.
And in this post, I will present with you the following:
- ISO 17025:2017 Impartiality requirements
- Understanding Impartiality (terms and definitions)
- The risk to Impartiality related clause and requirements
- Commitment to impartiality
- Impartiality implementation procedure (in 4 steps)
- Identification and monitoring of risk to impartiality
- Analysis and evaluation of Risk to impartiality- risk assessment
- Addressing Risk – Eliminate and mitigate risk to impartiality
- Identification on an Ongoing Basis
- monitoring of risk to impartiality – maintaining impartiality
- 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 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 to be part of our work ethic.
To be impartial to the laboratory’s activities is to be 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 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:
- “The presence of objectivity.”
- 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.”
- are freedom from conflicts of interest,
- Freedom from bias
- freedom from prejudice,
- neutrality,
- Fairness,
- open-mindedness,
- even-handedness,
- detachment
- 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:
- If you transact with a customer who is an associate or a partner in business, an interest of associate.
- If you’re an employee that transacts with a supplier which is your relative, then there is an interest of relative.
- When you misuse any information from your job for personal gain.
- 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
- Laboratory activities shall be taken impartially structured and managed so as to safeguard impartiality
- The management shall be committed to impartiality
- The laboratory shall ensure impartiality in all its activities and not allow commercial, financial or other pressures to compromise impartiality.
- The laboratory shall Identify risks to impartiality on an ongoing basis;
- 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.
- No Conflict of interest – You are not auditing your own work during the scheduled internal audit
- Detachment –Technicians are not involved in marketing where they perform the calibration –
- Freedom from bias – You are not favoring any request that involves falsification of results
- Fairness –The company is not pressuring you financially
Commitment to Impartiality
So how can we show that the management is committed to implementing impartiality?
It is difficult to implement impartiality or take action to solve the identified Risk to Impartiality without the support of higher management.
The management should be committed to strengthen the support in the implementation
Ways to show commitment is by:
- Including a statement about impartiality in the quality policy which is signed by the management;
- Having a specific Impartiality policy where all personnel including top management will sign;
- Included in the discussions in the management review meeting;
- Included in the training program and performance review of the personnel during contract renewal.
ISO 17025:2017 Impartiality Procedure Implementation Requirements
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 its 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 Ongoing 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)
Read more about the techniques HERE
These techniques are:
- Document Review – as the name implies, we will review all related documents, for example, audit results, contract review, procedures, and many more.
- Information gathering through Brainstorming and interviewing – this is group work where we can extract inputs from the group during meetings or any scheduled meetups.
- Expert Judgement – this is where our related experience and understanding of the standards and processes in the laboratory are very helpful
- 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:
- Company-to-personnel relationship
- Laboratory activities to personnel relationship
- 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:
- 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 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 Eurolab’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:
- The higher the impact and the probability of occurrence require immediate action (orange to red).
- If the risk is minimal (yellow), decide if this 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 included in a watchlist for continuous monitoring.
3 – Addressing 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:
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:
- Review and analyze all identified risks to impartiality during the management review meeting
- Included in the Internal Audit
- Yearly performance review
Process Flow Chart
DO YOU NEED READY-MADE IMPARTIALITY PROCEDURES TO IMPLEMENT ALL THIS? Check out this link >>> IMPLEMENTING IMPARTIALITY PROCEDURE
The Impartiality procedure consist of the following templates:
1. Impartiality Procedure
2. Confidentiality and Impartiality Agreement for External Service Provider
3. Impartiality checklist form
4. Impartiality policy
5. Risk assessment sheet (Excel)
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:
- Impartiality requirements as per ISO 17025:2017
- Understanding Impartiality (terms and definitions)
- The risk to Impartiality related clause and requirements
- Commitment to impartiality
- Impartiality implementation Procedure
- Identification and monitoring of risk to impartiality
- Analysis and evaluation of Risk to impartiality- risk assessment
- Addressing Risk – Eliminate and mitigate risk to impartiality
- Identification on an Ongoing Basis
- monitoring of risk to impartiality – maintaining impartiality
- 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.
Have you identified Risks to Impartiality that you want to include here, please comment below.
If you liked this post, please share and subscribe.
You can also connect with me in my Facebook page.
Thank you.
Edwin
50 Responses
David
Great read as always! You’re a big help.
edsponce
Hi David,
Thank you for reading my post. I appreciate your comment.
Best regards,
Edwin
Alice Mosca
Dear Edwin,
Thank you for your post, it is a very good approache to one of the pillars of ISO 17025:2017.
Allow me to disagree with you in two points: if you identify a risk to impartiality you can not ignore it even if it is a small risk. The standard is clear and requires an action to eliminate or mitigate each risk to impartiality identified. For that reason I personally don’t use the risk matrix for impartiality risks.
Another point is the identification of risks to impartiality on an on going basis. This is not the same as periodically monitoring. If you monitor it on management review or during internal audit you are not doing it on an on going basis. You must be prepared to immediately identify risks to impartiality when they are prone to occurre and not wait until management review or internal audit.
I hope this comment will contribute somehow to clarify your great post.
Best regards and wishing you a fantastic 2020!
edsponce
Hi Ms. Alice,
Good day!
You are welcome. I appreciate the time for reading my post.
You are correct and I agree with you.
An identified risk is still a risk so it needs to be monitored in some way. I believe there are other tools out there that are still best to help us analyze and evaluate in a more simple way.
Thank you for these additional inputs. The on-going basis for me has a very broad meaning where I only mention a few points.
Your comments are highly valuable to clarify, I believe not clear to most. I appreciate it very much.
Thanks and Happy New Year!
Edwin
Fathia
Thank you very much for these information really I understand impartiality very good but I would like to clear the forms of impartiality which the ouditor will be assessed it
edsponce
Hi Fathia,
You are welcome.
I am not sure about the forms of impartiality that you are referring to but any activities that shows:
1. Bias
2. Conflict of interest
3. No objectivity
4. No detachment
And others that are the opposite of clause 3.1, Will be a risk to impartiality if it has an effect or influence on the results of the laboratory activities. This is mostly based on the evaluation we performed if such a risk is really a risk to impartiality.
As per my experience about the audit, first, the auditor will check if you performed risk to impartiality identification, then, they will verify if the identified risk that you have listed have corrective actions or measures that you have taken in order to mitigate or eliminate.
I hope I answered your question.
Best regards,
Edwin
Fathia
good morning I hope to fine ..,but l hope to clarify me how I can estimate the risk of impertiality please give me an example in the form .
Thanks very much
edsponce
Hi Fathia,
I am not using a form to estimate the risk to impartiality.
The process that I am doing is what I have shared here in my post. Based on your understanding, you can create a form if you know it will help you to accomplish this process.
Below are a much simple steps of what I have presented.
The first step is to identify the risk to impartiality:
1. conduct reviews of documents,
2. gather information through meetings, internal audits, and brainstorming
3. expert judgment in a specific activity or process in the lab
4. other activity that can provide information
>> It should be clear that all the documents above should be readily available
>> Prepare a record where you can list and summarize all the identified risk to impartiality –I use excel on this
The second step is to analyze the gathered risk to impartiality records or information:
1. One by one, review the listed identified risk
2. Use the Impact to Probability Matrix to assess and analyze the risk
The Third Step is to provide measures to prevent or control the identified risk
1. Issue a corrective or preventive action report
Finally, revisit all identified risks, especially the risk that is not eliminated, during meetings or regular audits and objective reviews.
See the below table for more details. You can copy this in excel for recording and reporting. You can also create a form with these details. (Click the link to view file)
Risk to Impartiality Assessment Monitoring Table
Remember that this is just an example, you can add more details that are based on the design of your process and your understanding as you progress.
I hope this helps,
Edwin
Sajid iqbal
Hi ,
Thank you for your post it very much appreciated
I have one question can you clarify me how to set objectives for Impartiality, competence and consistent operations of the lab
edsponce
Hi Sajid,
You are welcome.
One example that You can set as an objective under Impartiality is to “identify risk to impartiality on an ongoing basis”. As an example, at least 3 per quarter. Then once identified, you should address or close it all (100%) within the same period.
For “competence”, New personnel should reach the highest level, for example, level 4 at the end of each year.
Objectives for “Consistent operation of the lab” is very broad, make it more specific. This will fall to every department. Like handling complaints, and improving equipment (UUT) calibration turnaround time.
In setting objectives, always follow the SMART format: Specific, Measurable, Attainable, Reliable and Time-planned
I hope this helps,
Edwin
Mary Jean
Hi Ms. Alice,
I came across your comment about risk assessment. You said you are not using risk matrix as it is required in the standard to eliminate or mitigate the risk. With that, how would you prove that the risk is already eliminated? I am preparing for our laboratory accreditation and my concern is the laboratory Team Leader also handles the team sending samples from third party customers to our laboratory. I used risk matrix to show that we have our controls not to compromise impartiality in testing activities.
Hi Edsponce,
In our structure of organization, it’s visible that there is conflict of interest in our case. But the company’s goal is to provide better services to its customers by establishing an accredited laboratory instead of sending to third party laboratories. We have the signed Management Commitment to Impartiality, Employees’ Declaration of Impartiality and Risk Assessment on annual basis. Moreover, we have specified company’s commitment to impartiality in Laboratory Code of Conduct. Can you share with me your experience how auditors check on this item? With our case, would it be impossible to be certified?
Thanks,
MJ
edsponce
Hi Mary Jean,
My experience regarding this subject is not that hard but it is not simple. I admit that this was also new to me and I am still in the learning process.
The audit for me was simple, It is all based on the requirements of the standards. The requirements of the standards are: to identify the risk to impartiality, analyze the risk, mitigate or eliminate by providing measures or corrective actions, then to continuously improve as we go on. The auditor mostly focused on the identification part and the measures taken. Note that this is as per my experience, it may be different for you.
If you have implemented these requirements with the support you have, then I believe it is ok. If the action taken is not enough, then you will know only after the audit, this depends on the understanding and acceptance of the auditors. This is where we can learn from it. During the audit part, I was lucky enough to have an auditor or assessor that explains in detail what I am missing. I hope it would be the same for you.
Honestly, my Implementation in this process is not enough and therefore included as one of the non-conformance during the audit, but thankfully, it can be closed. So just be prepared and be confident with your implementation.
By saying this and looking at what you have implemented so far, I believe you can successfully achieve your accreditation.
Best Regards,
Edwin
vinod kumar
Great post. Thanks a lot.
edsponce
Hi Vinod,
You are welcome.
I am glad you liked it.
Thanks and regards,
Edwin
Jollin A Doshi
Practically speaking..it is difficult to identify on on going process.. practically…best way out identify whenever detected and name it at non conference ..see if capa applicable else consider it as a system lapse on part of cab..the clause is new it takes time to implement it…but over a period of time say around 2 to 3 system cycle of audit most risk will be covered..we cannot practically waste time on just thinking about risk .. identify.analyase implement…Jollin from Jems calibration.
edsponce
Hi Jollin,
Thank you for reading my post.
The ‘on-going basis’ is really a challenging part of this process. You are correct, it takes time to understand and fully implement.
I appreciate the additional inputs.
Thanks and regards,
Edwin
Cyra Lynn
Thank you Sir! It is such a great help to us.
edsponce
Hi Ms. Cyra,
You are welcome. Thank you for reading my post.
Thanks and regards,
Edwin
Kam
I read so meany posts on this issues, you brought the point home for me. Thank you. Now I know what I need to do for my lab in terms of impartiality issue. Cheers to you.
edsponce
Hi Kam,
You are welcome. Happy to know that my post has helped you. I appreciate your comment.
Good luck in solving your impartiality issue.
Thanks and regards,
Edwin
Mary Jean
Hi Edsponce,
This is great help!
Regarding the risk, the Owner is the Lab Manager, what would be your action?
thanks much,
MJ
edsponce
Hi Mary,
Thank you.
About your concern, below is my input.
Identified risk to impartiality is dependent on its impact or severity and the frequency of occurrence. The identified risk may have no impact or acceptable with regards to the final results of the calibration activity as per the evaluation performed.
But as an action step, he should be aware of the risk to impartiality that could arise in his position by signing or acknowledging the impartiality agreement.
He should also be trained regarding the conflict of interest that can be seen in his position and personally declare any conflict of interest that will arise while performing his duty in order to prevent such risk.
For example, one customer is his relative or his close friend. He should personally declare this situation to limit or monitor his involvement in the project.
There are still so many possibilities and instances that we need to evaluate regarding this situation. I hope my example answers your concern.
Thanks for reading my post.
Best Regards,
Edwin
Sreang Sreypov
Hello
May i ask about how to verification Certificate after i got from Calibration Laboratory.
Many thanks.
edsponce
Hi Sreang,
I am not sure what part of the calibration certificate that needs verification that you are looking for but I have good articles that I believe will answer your concern. Please visit below links.
1. How to Properly Use and Interpret an ISO 17025 Calibration Certificate
2. 5 Mistakes When Using a Calibration Certificate that You Need to Correct
3. 3 WAYS TO DETERMINE THE TOLERANCE OF INSTRUMENTS WITH A CALIBRATION CERTIFICATE – If the Tolerance is Not Given
I hope you will find the answer, if not, do not hesitate to comment further.
Thanks and regards,
Edwin
Um Rayan
Thanks sir very good brief all queries in my mind now clear thanks again.
I have a question this you explain for calibration lab is it the same as for testing lab
edsponce
Hi Um Rayan,
You are welcome. I am glad that it clears your concerns.
As per your question, YES, it is the same, ISO 17025 is also for testing lab. Almost everything is the same except for the methods execution and the format of the report (Testing compared with calibration certificate).
Thanks for reading my posts,
Edwin
Jean
Hi Edwin,
I was able to establish a procedure for Impartiality Assessment with your post. It’s a great help indeed. But I got stuck up in doing the evaluation of identified risks. What if the Laboratory Manager is reporting to a Team Leader who is also managing the team providing the samples, the inhouse customers? Is it possible to treat this risk?
edsponce
Hi Jean,
I am glad that my post has helped you in some way.
I am with you, It is really challenging to perform the evaluation of identified risks. There are a lot of doubts about whether it is valid or not. But the important thing is we perform an evaluation and we record it for further assessment as part of our risk identification to see if there is really a risk or not in order to mitigate or eliminate if possible.
There are no exact answer to your question. Because not all identified risks is a risk to impartiality that has an effect on the integrity and objectivity of results until proven with proper evaluation, a good guide question that I use are:
1. “If there is a bias regarding the output of a result that has a direct impact on the quality of the activity”, then a risk is highly probable. Does the Team leader approve his own work? Who should be at the top of the ladder where His judgment is objectively executed without being pressured by someone else at the lower level?
2. “In the first place, what questions come in your mind why you record it as a risk to impartiality”? – If after evaluation and assessment that there is no direct risk involved, then you can grade it as small/NO risk where no action is needed as per your final assessment, but subject for further monitoring since you evaluate it as a risk to impartiality. You can revisit this during the scheduled audits or inspections.
Regarding your question, if there is a risk, after your assessment or evaluation, for example, that there is a pressure created by the team leader for the Lab Manager to favor him to provide a favorable calibration or testing results, then there is a big risk. Based on the frequency and severity of the risk, then you need to take action for this.
As per my assessment, below are some possible corrective actions or treatment:
1. Perform awareness training about the risk to impartiality to inform them about their status.
2. Have them acknowledge the risks involved by signing a declaration regarding conflict of interest.
3. ReStructure the Org Chart(worst case).
Even if there is a small risk that you have identified, it is still good action, as a preventive measure, to perform #1 and #2.
I hope this helps,
Edwin
Mary
Hi Edwin,
Thanks for your reply. Therefore, it is still possible for the laboratory to operate even if there is conflict of interest based on ownership.
Thanks and All the best,
Mary
edsponce
Hi Mary,
Yes it is possible, but this is based on your execution for the corrective actions based on your final evaluation and assessment. Because our goal is to remove or mitigate the Risk to Impartiality once we have identified them.
There may be a conflict of interest identified, but if this conflict of interest does not affect the quality or judgment of the person involve in the results of the lab, then this risk maybe acceptable. But you need to have a treatment for this to lessen or remove the risk if necessary.
Failure to make an action about the Identified Risk to Impartiality will cause a Non-conformance during the audit.
I hope this clears your concern.
Edwin
Rose Gaffar
Hi Edwin
What evidence do you show for the below:
The integrity of the management system is maintained when changes to the management system are planned and implemented
edsponce
Hi Ms. Rose,
Integrity is seen or observed if there is impartiality that is taken for every implemented change in the management system, which includes honesty, fairness, and objectivity.
There are many ways to show integrity when changes to the management system are planned and implemented. If I will be asked for this, I will show one or all the below documents:
1. For changes in documents, processes, or procedures, a change request form is approved or reviewed by 2 or more relevant persons.
2. The organizational chart, where decisions are made not just by a single person but based on the approved structure.
3. The related audit results by internal auditor or a 3rd party audit if available.
4. The ‘risk to impartiality’ related documents.
I hope this helps.
Edwin
Rose Gaffar
Laboratory activities shall be carried out in such a way as to meet the requirements of this document, the laboratory’s customers, regulatory authorities and organizations providing recognition. This shall include laboratory activities performed in all its permanent facilities, at sites away from its permanent facilities, in associated temporary or mobile facilities or at a customer’s facility.
How is this done? Through our local country’s regulation? Or through the companies accreditation received? JCI certificate?
edsponce
Hi Ms. Rose,
As per the definition, the laboratory activities refers to calibration, testing, and sampling. When performing these laboratory activities, we should follow below guidelines or requirements from:
1. The requirements of this document, means, the ISO 17025 Standards – all of the applicable requirements
2. The customer’s requirements – as per contract review
3. Regulatory authorities – example the government and NIST or other equivalent authorities.
4. Organizations providing the recognition – the accreditation bodies
Mostly 3 or all of the above requirements should be present in the calibration or test reports.
The calibration or test reports contain:
1. The requirements of ISO Standards for a calibration/test report, for example, the content and structure of the report (see clause 7.8).
2. The procedure or method used follows the requirements from the government (if any), and is referenced to EURAMET or NIST, or any recognized international lab or organization.
3. The customer requirements which follow ISO 17025 under clause 7.1
4. The accreditation body LOGO which signifies an accredited lab.
These cover the calibration or test performed in other sites or locations as well, not just inside the lab.
Before the calibration or test reports are completed, we know that there are other important requirements of ISO 17025 that we need to follow.
I hope this helps,
Thank you for reading my post.
Edwin
Abdulsalaam Abdulganiy
Good day, Mr. Edwin.
I really benefit from your write up. I am a quality officer in a testing Laboratory. I have very little experience concerning my job. I believe you will be of great help. I have been tasked with the drafting of an impartiality and confidentiality policy. Please can you help me with a guide? I will so much appreciate your reply. You can reach on abdulsalaamganiy@gmail.com or
ganiyu.salaam@saagchemical.com
Thanks
Abdulsalaam A.O.
edsponce
Hi Mr. Abdulsalaam,
I am glad you have benefited from my posts, I appreciate it.
Actually, the article above is already a guide, you just need to make a little adjustment to align with your lab.
If you have an existing procedure, you can send it to my email and I will gladly review it for you. The confidentiality agreement is a different part.
Here is my email : edwin@calibrationawareness.com
Best regards,
Edwin
Abdul
Great explaination.
i do have one question if you dont mind. How can we measure the impartiality as an objective.? can we have an example for it
edsponce
Hi Abdul,
To measure risk to impartiality as an objective, below are my suggestions:
1. set a target of how many risk to impartiality that you can determine and evaluate within six month (or 1 year), then use this as an objective to complete the target or goal within the set date.
2. another is, once you have listed, for example 10 risk to impartiality, your objective now is to have all of it (100%) closed or assessed after a year or any date you set.
I hope this helps, thank for reading.
Edwin
rachel
Your explanation is clear and very helpful!
Very much appreciated.
Thank you.
edsponce
Hi Rachel,
You are welcome. I am glad you liked it.
Thanks for reading.
Best regards,
Edwin
J
This is one of the most helpful posts I have ever read! What a gift you have given! Reading the reader replies and your responses was also very instructive! Thank you!
edsponce
Hi J,
You are welcome. You gave me super motivation with your comment, I appreciate it.
Have a safe day,
Edwin
Manendra Liyanage
Very comprehensive Mr Edwin
Remarkable description about the standard requirement. Keep up your spirit very comprehensive
edsponce
Hi Manendra,
I am glad you liked it. Thank you.
Best regards,
Edwin
gagan
Hi,
Great post! I am able to understand the impartiality clause properly.
To implement this properly, do I have to document the procedure also? or just an excel sheet showing how have I done it to date?
Thanks!
edsponce
Hi Gagan,
Thank you. I appreciate your comments.
A procedure for this is not mandatory as long as you implemented the requirements of ISO 17025, but for standardization and for proper implementation, where there are exact documented steps and guidelines, it is better to have a written procedure.
And as per my experience, it is still asked by most auditors.
Have a great day!
Edwin
Rafeeq
Hi,
Great post! I
Could you please tell about Confidentiality.
Give me an idea about the terms to be communicate with our Customer as Confidentiality Statement.
edsponce
Hi Rafeeq,
With Confidentiality, we are not allowed to share any information that is gained, created, or obtained during the execution of our calibration service unless it is required by law or agreed to be shared between the lab and customers.
You can re-word clauses 4.2.1 to 4.2.4 of ISO 17025:2017 in order to come up with the terms to be communicated with your customers.
Below is an example that you can copy, this is not complete but a good start to cover the main points. You need a form where a signature must be available.
“LAB NAME shall be responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of laboratory activities. LAB NAME will inform the customer in advance, of the information it intends to place in the public domain. Except for information that the customer makes publicly available, or when agreed between the laboratory and the customer all other information is considered proprietary information and shall be regarded as confidential.”
I made a template that is included in the Impartiality procedure that you can purchase for a small fee in this link >> Impartiality and confidentiality
You need a little adjustment to align the template in your process. The confidentiality agreement is created for the service provider but it can be applied to both lab and customers as well.
I hope this helps,
Edwin
Mike
Hi,
Thanks for the great help there. You might not be realized that your good explanation has offered great assistance beyond 17025 but also its sister standard 15189 for medical testing laboratory that has just recently revised and with this impartiality requirement being equally fortified.
Really appreciate your help.
Mike
edsponce
Hi Mike,
You’re welcome. I am glad it helped you.
Thank you as well for visiting my site. I appreciate the feedback.
Thanks and regards,
Edwin