ISO/IEC 17025:2017 Requirements: List of Documents Outline and Summary

with 65 Comments

One of the most challenging parts during establishing a calibration or testing lab is to start the documentation requirements, even if there is an established guide (ISO 17025) that we can read and follow.

 My first time reading it (ISO 17025 Standard) is very overwhelming. It seems that after reading the manual, you easily forget the next requirements to do.

I have created this outline as per my experience during the assessments (ISO 17025 Accreditation).  You can use this outline to format your Calibration Quality Manual or Quality Management System and create the necessary documents records, procedures, and forms as per the requirements of ISO 17025: 2017 Standards.

The outlines are designed where a related form and records are included under each procedure.

Accreditation to ISO 17025 is very challenging. If you are planning to establish or manage a calibration laboratory as per ISO/IEC 17025 Standard, this is a good outline to guide you in completing your documentation requirements and to make sure you follow the mandatory procedures of ISO 17025:2017.

The requirements here are not 100% complete, every lab has its unique design in terms of documenting the implementation of ISO 17025 requirements but it is a good start to have a Calibration Laboratory Management System that is in alignment to the mandatory procedures ISO 17025.

You can copy and create a calibration audit checklist based on the below outline. Improvement is welcome so please feel free to comment.

 

 ISO 17025 QUALITY REQUIREMENTS

    1.  Structural requirements
        •  Legal Documents (evidence of ownership and registrations)
        •  Scope of work (scope of accreditation)
        •  Organizational chart
        •  Authorizations 

           

    2.     Management System Requirements
      1. Impartiality and confidentiality Procedure
        • Confidentiality  Acceptance form
        • Impartiality agreement
        • Risk Assessment records 
      2. Management system documentation
        1.  Quality manual – contains links of Management System Requirements (process and procedures) which includes: 
          • Quality policy
          • Impartiality Policy
          • Quality objectives
            • Quality objectives monitoring sheet

               

      3. Documents control procedure
          • Change request form
          • Document for archive or disposal form
          • Masterlist and distribution list of documents

             

      4. Records Control Procedure
          • List of records
          • Locations and retention period record

             

      5. Internal Audit Procedure
          • Internal Audit report
          • Internal Audit non-conformity report
          • Corrective and preventive action form
          •  Audit plan

             

      6. Management Review Meeting Procedure
          • Management Review meeting form (agenda with attendance)
          • Minutes of meeting

             

      7. Corrective Action Procedure
          • Corrective action form

             

      8. Actions to Address risks and Opportunities Procedure
          • Risk assessment database file
          • Risk and Opportunity for Improvement Form

             

      9. Improvement Procedure
          • Improvement monitoring sheet

             

    3. Process Requirements
      1. Externally provided products and services procedure
        • List of approve suppliers
        • Supplier Evaluation Form
        • Supplier Re-Evaluation Form
        • Purchase Request Form
        • Inspection form for Incoming Critical Supplies/Equipment

           

      2. Review of requests, tenders and contracts Procedure
        • Customer Service Request Form

           

      3. Complaints Procedure
        • Complaints and feedback form
        • Corrective and preventive action form

           

      4. Control of Non-conforming Procedure
        • Hold and release tag
        • Service Report Form

           

      5. Control of data and information management Procedure
        • Software Validation record

  1. ISO 17025 Technical  Requirements

    1. Personnel  Procedure
      1. Training
        • Training calendar
        • Training report
        • Technical training effectiveness evaluation
        • Skill Matrix
      2. Authorization/ Appointment Letter
      3. Responsibilities List
      4. Job description List
      5. qualifications List
      6. List of Competence requirements

         

    2. Equipment Procedure
      1. Traceability information (Metrological Traceability)
      2. Equipment Master list
      3. Details and calibration status of equipment form
      4.  Preventive Maintenance Plan
      5. Calibration Plan
      6. Statistical techniques Report
        • Control chart

           

    3. Facilities and Environmental Conditions Monitoring Procedure
      1. Environmental conditions monitoring form
      2. Security Procedure   
      3. Safety procedure
      4. Housekeeping Checklist

         

    4. Process Requirements
      1. Handling, transport and storage procedure
        • Equipment Tag

           

      2. Receiving and releasing procedure
        1. Incoming and Outgoing register
        2. Receiving Record
        3. Releasing Record
        4. Equipment Control Tag
        5. Certificate Receive form

           

      3. Technical records
        1. Accomplished Measurement Data Sheets
        2. Calibration Certificates
        3. Measurement Uncertainty calculation
        4. Amended Calibration Reports


      4. Selection and Verification of Methods Procedure
        1. Verification and Validation Form
        2. Calibration Procedure List
        3. Technical worksheets (Measurement Data Record Sheet )
        4. Operating instructions/work instructions list
        5. International / National Standards List

           

      5. Validation of Methods Procedure
        1. Validation Check form
        2. Validation Report and Approval Form

           

      6. Evaluation of Measurement Uncertainty Procedure
        1. Measurement uncertainty budget  and calculator

           

      7. Ensuring the validity of results
        1. Intermediate check procedure
          • Intermediate check form
          • Intermediate check records


        2. Preventive maintenance procedure
          • Preventive maintenance plan
          • Preventive maintenance records
          • Equipment History Card

             

        3. PT/ILC  results
          • PT/ILC Plan
          • PT/ILC Analysis report

             

        4. Functionality check form

           

        5. Control Charts –see under Equipment

           

        6. Replicate Test Results

           

        7. Repeatability and Reproducibility Results

           

      8. Reporting of Results  – requirements for certificates
        1. Calibration results (Measurement Data Sheet)

           

        2. Calibration certificate format  which includes:
          • Reporting statements of conformity guide
          • Reporting opinions and interpretations guide

             

        3. Amendments procedure

           

  2. Other Records  and Forms which are used depending on the Laboratory Design

Thank you for visiting my site.

Check also my related post in this link >> Elements in Implementing an Internal Calibration Laboratory

Please comment and subscribe.

You can also connect with me on my Facebook page.

Best Regards,

Edwin

Opt In Image
Get Notified On My Latest Post
Let Us Learn Together

Your Information is secured and will not be shared to anyone else.

65 Responses

  1. Edwin,
    This is most helpful. It’s good to know that someone has been there and has marked the path. Thanks a lot.

    • Hi Mr. Arturo,

      You are welcome. Thank you also for reading my post. Happy to help.

      Best regards,
      Edwin

  2. Abdulmalik Salih Shaheen
    | Reply

    Good Day, Mr. Edwin,

    Thank you for listing the above lists in this organized style, mush appreciated.

    I have a few general points I need to discuss it with someone who has experienced the ISO17025 accreditation.

    Please allow me to discuss these points with you if you don’t mind.

    Thank you.

    • Dear Mr. Abdulmalik,
      Greetings! Thank you for reading my post. I also appreciate it.

      I would be glad to discuss with you a few of the general terms that you have some concerns with.
      You can message me in this email, edwin@calibrationawareness.com

      Thanks and regards,
      Edwin

  3. I just want to share my response to a question from a Facebook group. Below is the question…

    Thank you guy its very useful. The first time i read 17025 is like you sad “forget”. My lab is already under 17025 and im trying to manage and improve it. Also still has something mismatched. And about supplier evaluation form, could you give an example for this form. As I know we evaluate supplier (calibration) through their scope, CMC right? And each our equipment has a tolerance requirement base on our method.so how can you create supplier evaluation form?

    My response…..
    Thank you for reading my post and appreciate your comment agreeing with me.

    Yes, you are right, part of what we evaluate if we are to have our reference standards to be calibrated by a calibration supplier is the CMC, but that is just 1 part.

    The standard does not provide a format on how to evaluate the suppliers. It only gives guidelines to follow in order to ensure that the product or services that we receive will be suited to our requirements or for our customers’ requirements.
    The evaluation form is not a must to have as long as you can show that you are following the requirements of the standards and you can show evidence of implementation.

    But having the supplier evaluation form will organize your process and can be used as the evidence of implementing or following the requirements of ISO 17025.

    If you will create an evaluation form to evaluate a supplier, it is like an audit checklist that you can send to the suppliers for them to accomplish (or depending on your procedure if you want to personally visit them), but focused on the following:

    1. The background of the company which includes legal documents to be reviewed like:

    a. their accreditations with scope
    b. Business registrations
    c. others

    2. Quality Background – accreditations or certifications
    3. Technical capabilities:

    a. Manpower, service or delivery time, support.
    b. the products and services to be provided;
    c. the acceptance criteria;
    d. competence, including any required qualification of personnel;
    e. Activities that the laboratory, or its customer, intends to perform at the external provider’s premises.

    4. And other important things that you think it will help you to evaluate the suppliers.

    With regards to tolerances and acceptance criteria requirements, you may not need to include that in the form or during supplier evaluation because you may implement it for review during the RFQ process or release of Purchase Order (considering that you already determine their CMC). You can state there all your requirements before accepting their service.

    This is how flexible the new standard is, as long as you can show the implementation of the requirements, you are good to go with the auditors.

    My interpretations of the Standards has still more room for improvement but this will at least give you a strong start for implementation.

    I hope this long explanation helps.
    You can PM me for more clarifications.
    Edwin

  4. Rheabelle Acuin
    | Reply

    Hi,

    The new requirements
    7.8.6 Reporting statements of conformity
    7.8.6.1 When a statement of conformity to a specification or standard is provided, the laboratory shall document the decision rule employed, taking into account the level of risk (such as false accept and false reject and statistical assumptions) associated with the decision rule employed, and apply the decision rule.

    How do you account this in the process implementation?

    • Hello Rheabelle,
      If no customer requirements and a decision rule are not relevant, then a statement of compliance is not necessary.

      But during the reporting of results where the customer requires a pass or failed results, we use directly their tolerance limits. This is as per the included NOTE:
      Where the decision rule is prescribed by the customer, regulations or normative documents, further consideration of the level of risk is not necessary.

      But if you want a more thorough documentation process of a decision rule you can apply or use the guide ILAC G8-03 or ANSI/NCSL Z540.3.

      I would appreciate if you can share your process implementation if you have one for more discussions and learnings.

      Thanks for visiting my site.
      Best Regards,
      Edwin

  5. Melvin Matanos
    | Reply

    Hi Edwin,

    Thank you for documenting it. We are in the preparation stage of accreditation and the list provided is very helpful for us.

    Can I contact you for further discussion?

    Thanks,
    Melvin

    • Hi Melvin,

      I am glad that this post is helpful to you. Congratulations on implementing ISO 17025 in your lab. Good luck with your preparation for accreditation. I would be happy to discuss any related concern with you. I will connect with you in your email.

      Best regards,
      Edwin

  6. Ganesh
    | Reply

    Cant thank you enough for the list .

    • You are welcome Ganesh. Thank you for visiting my site.

      Best Regards,
      Edwin

  7. Thank you so much for the information for sharing such a important information.

    Could i get more help from you?

    • Hi Mr. Abdur,

      You are welcome. Happy to help.
      Yes, you can message me or comment here anytime.

      Thanks and regards,|
      Edwin

  8. Aris Rahman
    | Reply

    Hi Mr. Edwin

    Could you give an example for Confidentiality Acceptance form? Thanks for your help

    Aris

    • Hi Aris,
      Thank you for visiting my site.

      Confidentiality Acceptance form is the same as the Confidentiality Agreement.
      It is a binding contract where you accept and signed an agreement not to disclose any information related during the performance of laboratory activities while under contract with the company.

      I have seen a good example and tempalte in this link>> Confidentiality Acceptance Form

      Just remember, make it simple and include only what is applicable to your organization.

      I hope this helps,
      Edwin

  9. Nino Martinez
    | Reply

    nice one padli..helpful daytoy..ag pa burger kan..

  10. Victor Emmanuel Dumotan
    | Reply

    Appreciate to receive your confidentiality and impartiality procedure for my guidance in updating our ISO 17025:2017 from 2005. I was into testing laboratory.
    Thanks in advance sir Edwin!!!

  11. DIPENDRA
    | Reply

    THANK YOU SIR SO MUCH.
    AS IT HELP US TO PREPARE UPGRADATION DOCUMNET.

    • Hi Dipendra,
      You are welcome. Appreciate your time reading my post.

      Thanks and regards,
      Edwin

  12. Natalia Georgia
    | Reply

    Thank you very much for you information you shared.

    Withe best regards,

    Natalia

    • Hi Natalia,
      You are welcome. Thank you for reading my post.

      Best Regards,
      Edwin

  13. LIM
    | Reply

    Hi Edwin,

    Do you have any idea on including the decision rule as per requirement of iso17025:2017.
    As for now we are practicing whereby the calibration results + uncertainties between the tolerance.
    There is somehow might be some cases where the calibration results + uncertainties were found out of tolerance on the high side or low side. (the calibration measured value is between tolerance) (the uncertainties caused the value to be out of tolerance)
    Do you have any guidance where i could study on how should we apply these decision rule for our lab requirement.

    • Hellow Lim,
      Good day!
      I have read a good guide that you may implement and it is the same on what you have implemented.
      You may check this guide:
      >> ILAC G8-03 or ANSI/NCSL Z540.3.

      I hope this helps,
      Edwin

  14. Hi Edwin. We are in a measuring microscope industry doing mainly on sales and after sales service( such as calibration), currently in the midst of obtaining 17025:2017. Im quite confused whether the “equipment” and “uncertainty calculation” in 17025 accreditation is just referring to the master equipment used for calibration at customer sites or the actual calibration process we perform or its required at both ends? Our master equipment is certified at a a2la certified lab based at our parent company. Master equipment are step gauges and glass grid reticle plate. Will need your enlightenment on this. Thank you

    • Hi Ong,
      Thanks again for reading my post.
      Uncertainty calculation or uncertainty results are a requirement of ISO 17025 in two different applications or requirements.

      The first requirement is the Traceability under clause 6.5. Traceability is applicable to our Master standards. One way to determine traceability is to have uncertainty results that is reflected on the calibration certificates of our master or reference standards.

      The second requirement is to Evaluate Measurement Uncertainty under clause 7.6. This is referring to the instruments of the customers that you will be calibrating.
      But you must understand that during the evaluation of measurement uncertainty, there are two types of contributors that we need to evaluate, the Type A and Type B.
      Uncertainty from the reference standard (reported in its calibration certificate) is a Type B contributor and this is the main contributor that is required to be included in the uncertainty budget.

      And as we can see, uncertainty results are required at both ends, uncertainty results that are reflected on the calibration certificate of your reference standards (calculation performed by the higher lab), and uncertainty results reflected in the calibration certificate that you will issue to your customers (calculation performed by your lab).

      I hope you understand my explanation.

      Best regards,
      Edwin

      • Ong Zheng Da
        | Reply

        Thank you for your clarification. You are a great help !

        • Hi Ong,

          You are welcome. Happy to help.

          Best Regards,
          Edwin

  15. Ong Zheng Da
    | Reply

    Hi Edwin. I have 2 questions.

    1. For the list of documents under Personnel Procedure, are those mandatory requirements to follow? If yes, would you have any reference samples to follow?

    2. In the earlier post you mention:
    The evaluation form is not a must to have as long as you can show that you are following the requirements of the standards and you can show evidence of implementation.
    But having the supplier evaluation form will organize your process and can be used as the evidence of implementing or following the requirements of ISO 17025.

    Do you mean by just documenting the supplier evaluation form without filling in is sufficient to show evidence of following requirements of ISO 17025? We are currently the sole provider for calibration service and do not have any suppliers.

    • Hi Ong,

      Below are my inputs for your questions.

      1. Answer for question #1.

      Basing it on the requirements of ISO 17025:2017 under clause 6.2, yes they are mandatory requirements.

      Except for training related activities as per clause 6.2.5, other documents can be just records to show the implementation of the requirements like the responsibilities, authorization or appointment letter and Job description. A simple letter or excel worksheet is ok. I will try if I can link a sample reference.

      2. Answer for question #2
      Having the form alone without using it is not sufficient to show evidence. You should send it to them to be accomplished or interview your supplier using that form. It is not a must, because there is another way to evaluate a supplier like performing an audit to them personally on their site using a defined checklist.

      The purpose of evaluating a supplier is to determine if they can meet your requirements and the requirements of the standards in support of your calibration activities.

      Any outside services that you procure to support your operation are considered a supplier. In general, it is termed as ‘Externally provided products and services’ by the ISO 17025:2017 Standards under clause 6.6.
      These includes:
      1. The third party lab
      2. A national lab or a higher lab where you send your master standard for calibration
      3. If you hired temporary personnel to perform calibration on your behalf.

      Thanks again for visiting my site, I hope this helps.

      Thanks and regards,
      Edwin

  16. Ong Zheng Da
    | Reply

    Hi Edwin,

    I have some question regarding the calibration. We are using our own software to do calibration where the software generates calibration result and later on calculate uncertainty using excel. What and where are the things that need to be mention in the manual? Do we need to mention validity and traceability of excel? Also, if one of our software is not yet accredited by any standard bodies, is there any way to get it validated?

    Thank you
    Best regards
    Ong Zheng Da

    • Hello Ong,

      Software is considered under ‘Equipment’ (See clause 6.4.1) and therefore treated the same as a physical reference standard. It should be monitored, calibrated, verified and validated to meet your specified requirements before putting it into service as per clause 6.4.4.

      As per my implementation, there is no need to mention in the manual, I just need to include it in the list where I can monitor it, for example in the calibration program. And, of course, it has a documented calibration procedure.

      During an audit, you only need to show the evidence that it was validated before use. Validation requires calibration and verification (Check my other post here about validation). You need to show that it meets specified requirements.

      In my knowledge, the software does not need any accreditations, only validation. What can be accredited is the competency that you can perform the calibration using, for example, the Measurescope as your standard with the indicated range and CMC.

      If the excel you are referring is a form of a document, after performing validation, then it only needs to be controlled.

      One way to validate your excel, software or the whole method itself which includes traceability is to compare it to other software or related procedure available to other accredited labs. One form of comparison is through a Proficiency Test (PT) program or an Inter-lab comparison. Look for a provider of these programs.

      I hope this helps,
      Edwin

  17. Ong Zheng Da
    | Reply

    Hi Edwin,

    Would you advise for machines such as profile projectors and microscope that took reference from JIS standard(JIS7153-1995, JIS7184-1999), what are the items that is mandatory to be addressed? Inside the documents there was a table that list down all the performance, im not too sure what are the items that need to be reference to 17025 document. Would there be any clause or guidelines?

    Thank you

    • Hi Ong,

      First of all, ISO 17025 does not require any methods, a format, or content of a calibration method to be used for a specific calibration parameter. In fact, as per the ‘note’ under clause 7.2.1.3, it states that:

      International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform laboratory activities do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used by the operating personnel in a laboratory. It can be necessary to provide additional documentation for optional steps in the method or additional details.”

      >> it means that if a method you choose is made exactly the way you need it, or the procedure presented is sufficient to perform the calibration, it does not need to be rewritten or revised. In other words, you can use it directly.

      There are Three Classifications of Methods (or Two):
      1. Standard Methods, from International, regional or national standards or other recognized specifications. Which is the one you just mentioned.
      2. Non-Standard methods, like:
      a. Laboratory-developed methods
      3. Standard methods used outside their intended scope or otherwise modified.

      >> Your Method Classification may fall on number 1 or number 3.

      If you will modify the procedure, just ensure it is aligned with your requirements or the requirements of your customer. If I will be the one modifying the procedure, I will focus on the physical check part and the main calibration/verification procedure including the acceptance criteria. I will include the document (JIS Standard) as my reference and perform validation afterward.

      Method selection is based on:
      1. The available method in your country (regional or national)
      2. The International standards (if no regional or national is available)
      3. Required by your accreditation body.
      4. Special Request of a customer
      5. The study based on the capability of the Standard Instrument (reference standard) – non-standard method

      The things that need to be addressed with regards to the method used are the following:
      1. If you modified the standard method. You need to perform validation as per clause 7.2.2.1 (even a standard method is not modified, it is still advisable to perform validation).
      2. If you created a non-standard method, you need to perform validation as per clause 7.2.2.1
      3. Ensure that the method that you choose is the updated version as per clause 7.2.1.3
      4. You can use the old version if this is required or specified by customer as per clause 7.2.1.4
      5. And all other requirements that are stated under ISO 17025:2017 clause 7.2.1, Selection and Verification of Methods.

      Clause 7.2, Selection, verification and validation of methods, should be the guidelines that you need to follow.

      I have answered your concern in a more general view to include all methods or procedures, I hope it helps.

      Thanks and regards,
      Edwin

  18. VINOD KUMAR
    | Reply

    Dear Edwin,
    I am working at testing and calibration laboratories past 2.5 years onwards and currently as like a fresher, I need some guidance from you. Please could you help me, I know the process but i want to learn briefly about 17025:2017 I am studying the standards but some of the clauses I couldn’t understood if any reference is available? Please explain me.

    • H Vinod,
      I feel your frustrations. I’ve been there, that is one of the reasons that I built this blog, to share my knowledge and to learn also from you too.

      Any specific concerns or clauses from the standard you need some clarifications, just comment it here and I will try my best to answer or interpret it for you.

      Best regards,
      Edwin

  19. Pauline
    | Reply

    Thank you so much, i found this quite helpful. I have a question though, are there any specific requirements for the physical layout of the lab? I am in process of setting up a lab at home and was wondering if there are any specifications as to the physical layout of it.

    Thank you,

    • Hi Pauline,

      You are welcome. I am glad that my post has helped you in some way.

      Regarding your questions, there are no specific requirements for the physical layout of a lab that I am aware of.

      But there are requirements that we need to follow when choosing a lab, but are focus or concerned in the effect on the validity of results. This depends on the field or parameters that you will calibrate and the instruments/standards that comes with it.

      For example, if your designing a lab that serve mass calibration, ensure that it is located on the ground floor to minimize the effect of vibration during calibration.

      There are requirements that a lab must have as per ISO 17025: 2017, under clause 6.3 Facilities and environmental conditions.
      Some requirements to consider that are related to the physical design of a lab are:
      1. A room with a stable and clean environment.
      2. There is enough space for proper separation or segregation in order to:
      a. avoid confusion on what parameters to be calibrated during staging of instrument for calibration.
      b. proper segration or separation should be observed to avoid cross contamination.
      c. Some instruments or reference standards need to have a separate space because they are sensitive to temperature or humidity or other environmental factors. This can contribute to error in results and therefore needs to be separated. Example, temperature instruments cannot be mixed with the dimensional instruments.

      3. Controlled access to ensure security and confidentiality.

      I hope this helps,
      Edwin

  20. Pauline
    | Reply

    Hi Edwin,

    Me again, thank you for the response and advise, i think i left a thank you comment in the wrong section :). I have another question for you, if I may. Where could I find various methods to which I can work my procedures from for my lab? Is there a specific website I can visit for this? I am in mass (digital weighing scales) and in thermometry (cold rooms and theremometers). I would really appreciate your help.

    Thank you again.
    Pauline

    • Hi Pauline,

      You are welcome, nice to see your message again.

      Regarding your concern about the methods or procedures that you need, below are my suggestions:
      1. Check the national lab in your area and check their websites for existing methods that they use or recommend.
      2. If you are applying for accreditations, check also the requirements of the accreditation body. Usually, they have specific requirements about this matter.
      3. And lastly, about weighing scales and temperature, there are many reference guides out there. Some are free and some need to be purchased. You may want to visit their websites like ASTM, BIPM, EURAMET, NIST, and others.

      Below are some of the specific guides that you can start with (I Have inserted the links).
      a. Euramet guides like Euramet cg-20 and Euramet cg-11 for temperatures
      b. Euramet cg-18 for weighing scales
      c. OIML R 111-1 (E) Edition 2004 for weights and weighing scales

      I hope this helps.

      Best regards,
      Edwin

      • Pauline
        | Reply

        Thank you ever so much Edwin, really do appreciate your assistance and effort!

        • Hi Pauline,

          You are welcome. Happy to help.

          Best regards,
          Edwin

  21. Ong Zheng Da
    | Reply

    Hi Edwin,

    Regarding uncertainty calculation, is there a guideline to determine what are the compulsory sources of uncertainty?
    We are accrediting on field calibration and our product is in the category of optical CMM and will be using grid plate and step gauge to calibrate XYZ.

    We are accrediting through ANAB and the reference guideline is mostly on expressing the uncertainty factors. I’m pretty lost as to determine what are the significant factors to include in the uncertainty budget. Would you advise how should i progress?

    Thank you
    Ong Zheng Da

    • Hi Ong,

      Nice to see your comments again. I understand what you feel but just push through and you can do this.

      Yes, there are many guidelines that are given based on the calibration procedure that you follow if there is available but you need the patience to search for them.

      But what if there are no guidelines available? This is where the process of method validation takes place. It involves your knowledge, skills, and familiarity with the procedure you are implementing.

      The good news is, In measurement uncertainty calculation, you do not need a complete list to come up with perfect significant factors to include in the uncertainty budget. This is why there is a term ‘Estimate’ on it. It is based on your knowledge and experience, which is why it is important that the person who will conduct the method validation and calculation of uncertainty should be knowledgeable and experienced.

      During your assessment and evaluation stage, you can use different guidelines as a reference with related characteristics with your measurement process. Below are some of my suggestions:

      1. As per the compulsory contributors, the following lists are what I observe and based on my past experience in calibrating a CMM:

      a. Resolution of the standard and UUC
      b. Repeatability
      c. Reproducibility
      d. Uncertainty of STD from its calibration certificate
      e. Drift of the standards

      >> Please note that uncertainty calculation is separately done for Step gauge and grid plate- separate for XY and Z since they have different standards.

      2. Check for related measurement process with other guides, for example, the gauge block calibration guide, some properties of the gauge blocks are applicable to the step gauge if the step gauge has the same material with the gauge block. Examples of these contributors are: the coefficient of thermal expansion, effects of temperature difference, the accuracy or MPE, effects of difference in coefficient of thermal expansion and other related contributors.

      3. Look for related guides and articles about the reference standards you are using to give you a reference for its characteristics. You may want to visit the website like ASTM, NIST, BIPM, JIS, and others.
      4. You may also contact the producer of your reference standard for any related procedure or guides that they can provide.

      5. Another is to contact your national lab, there is also a possibility that they have the methods. In my country, the national lab is also providing specific training.

      6. Lastly, try to read the guide JCGM 100:2008 or EA 4/02, it has a lot of details on it.

      Once you have completed your uncertainty calculation, try to participate in an Interlab-Comparison (ILC) activity, or much better, Proficiency Test (PT) to see if your uncertainty results are within the acceptable range. This is also a good part of method validation.

      I hope this helps.

      • Ong Zheng Da
        | Reply

        Hi Edwin,

        Thank you for your valuable feedback. I have a better perspective now. Cheers

        • Hi Ong Zheng Da,

          You are welcome. Happy to help. I am glad to know that you have now a better perspective. I hope that you can complete now your accreditation process.

          Best Regards,
          Edwin

  22. Ashish Awasthi
    | Reply

    Hello sir ,

    I want to know that single person can become owner, quality cum technical manager in iso 17025 …

    • Hi Ashish,

      As per my experience, it is not possible because you will be facing a non-conformances with regards to Risk to Impartiality. Learn more about Risk to Impartiality Here>> Risk to Impartiality

      There will be a lot of Risk to Impartiality along the way to consider, specially ‘conflict of interest’, if only a single person will perform the positions you have just stated.

      2 persons as I see is possible (depending on scope), with additional person needed during internal audits, for a total of 3.

      I hope this helps.
      Edwin

  23. Kaja
    | Reply

    Hello.
    I have a question regarding monitoring of temperature and humidity in laboratories… If we have our cleanrooms and other rooms in microbiological lab connected to SCADA system… Do we also need to monitor the conditions with thermometer/hygrometer? Or is the system enough? And while we do analyses of products… do we have to monitor temeprature and humidity during analysis with thermometer/hygrometer?
    Is that mentioned in his standard? Or are there any other guidelines regarding this?

    Thank you
    Best regards

    • Hi Kaja,

      My answer to your question is YES, it is enough and no need for other monitoring if you can meet or ensure the below criteria:
      1. Is the temperature and humidity sensors/transmitters connected to the SCADA calibrated?
      2. Can the temperature and humidity be easily accessed in real-time during the performance of calibration/analysis to be recorded in the datasheet?
      3. Can you extract the previous data for review or if requested?
      4. Is the data can be recorded and stored for a defined period of time?

      It is not directly stated to use a thermometer or hygrometer but some auditors are requiring a continues recorder of temperature and humidity that is directly seen or observed inside the lab. As long as you can demonstrate that the SCADA meets the above criteria and can perform below requirements, then I believe it is ok.

      But as per my observation and experience, the location of the SCADA (temperature and humidity display) is in a remote area of the facility, and therefore, it is hard to obtain the real-time value of the temperature and humidity during recording and actual performance of measurements. If this is not the case for you then it is not a problem.

      My suggestion as part of quality control, you may implement to have a separate thermo-hygrometer, it can be a handheld type, wherein you schedule a period to check the temperature and humidity of a specific room that is critical in your process in addition to the SCADA monitoring.

      During the analysis, YES, it is important to include the temperature and humidity in your record. See number 2 below for more details.

      The monitoring of environmental conditions is a requirement under ISO 17025:2017. Below are the clauses:
      1. Clause 6.3 Facilities and environmental conditions, with sub-clauses:

      a. 6.3.1 The facilities and environmental conditions shall be suitable for the laboratory activities and shall not adversely affect the validity of results.
      b. 6.3.2 The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities shall be documented.
      c. 6.3.3 The laboratory shall monitor, control and record environmental conditions in accordance with relevant specifications, methods or procedures or where they influence the validity of the results.

      >> Environmental conditions such as temperature and humidity should be monitored and controlled where it cannot affect the validity of results. It should be properly documented. You need to specify the acceptable environmental conditions of the lab then ensure that the environmental conditions should be within these specifications.

      2.Clause 7.8.4 Specific requirements for calibration certificates

      a. Calibration certificate shall include b) the conditions (e.g. environmental) under which the calibrations were made that have an influence on the measurement results;

      >> Calibration certificates, test reports or simply measurement reports should reflect the environmental conditions at the time of performing the measurement.

      I hope this helps,
      Thanks for reading my post.
      Edwin

  24. santhosh
    | Reply

    hi anyone can explain 7.9.6 clause

    • Hi Santhosh,

      Bellow is the requirement of clause 7.9.6:

      7.9.6 The outcomes to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not involved in the original laboratory activities in question.
      NOTE This can be performed by external personnel.

      If you encounter complaints, there should be a person either an employee of the company or external personnel that will handle the complaints. He will be the one who will perform the investigation. This person is not in any way related to or connected in the complaint.

      The complaints cannot be designated or cannot be handled by the person who has involvement in the complaints. This is one way of observing impartiality (or to remove the ‘risk to impartiality’).

      I hope this helps.
      Edwin

  25. ramesh
    | Reply

    please share me the samples of risk assessment records for requirements of ISO 17025:2017

    • Hi Ramesh,
      Risk assessment records are the recorded identified risks, either for risk to impartiality or risk related to laboratory activities.

      For a ‘risk to impartiality records’, I have given an example of recorded identified risk with the assessment based on the source of risk, identified risk, assessment level, preventive measures, and final evaluation, check it out in this <link>, This is recorded in an excel sheet and can be our risk assessment record.

      Please note that this is just an example. You can design your assessment records based on your understanding and your needs.

      For other details about the ‘risk to impartiality’ implementation, please visit my other post in this link >> Risk to Impartiality

      I hope this helps,

      Edwin

  26. divya
    | Reply

    Dear Edwin
    Our material testing lab is in the preparation stage for accreditation.Actually we are confused regarding calibration.
    For example.for bitumen testing equipment,the apparatus contains many accessories with specified requirements.For example,for softening point test ,there are steel balls of specified weights and diameter.the parameter we are measuring in the test is temperature.my doubt is do we need to go calibration from an accredited lab for all these.or simply temperature only.

    Divya

    • Hi Divya,

      It is really confusing if you are handling an instrument with many parameters associated with it. I encountered that a lot, but luckily, I have determined how to access if it needs calibration or not by using the below guidelines.

      I am not familiar with your instrument and procedure but in order to identify if it needs calibration or not, below are some of my suggestions.

      1. Determine its criticality as per usage. Does it have an effect on the validity when testing your sample? For example, the steel balls, if it has a direct effect that contributes to the results to be tested, then it needs calibration.

      2. Is there a requirement from the procedure that requires a specific size or weight before use? If none, no need to calibrate.

      3. You may also perform a simple verification, there is no need for an accredited lab for this. For example, the steel balls, if there is a requirement of size or weight, you just need to purchase a caliper or a weighing scale wherein every time you use the steel ball, just measure its mass or diameter. Just keep its record. Be sure that the caliper or balance is calibrated.

      I have a post on how to determine instruments if it needs calibration or not. I suggest you read it.. Check this link>> calibration Not required

      I hope this helps,
      Edwin

  27. Khaliza
    | Reply

    Highly appreciate the valuable input.
    Thank you so much!

    • Hi Khaliza,
      You are welcome. Thanks for the appreciation.

      Best regards,
      Edwin

      • Hi Edwin,

        To my understanding, intermediate check is as same as QC procedure where we need to ensure our measuring equipment are working properly in between calibration interval by any means of QC test.

        Anyway, after read your article, I thought that I might misunderstood the purposes and difference. As per your explanation, intermediate checks is refer to test done on calibration source/ reference item to ensure its integrity in providing a reliable calibration data.

        FYI, our laboratory performs radioactivity testing where we use radioactive sources to calibrate our counting system. Then, how to relate this intermediate check to our operation when the calibration sources we use are totally depends on theoretical calculation of radioactive decay? In this case, can we assume that our QC check program (test on equipment, not calibration item) is complying to this 6.4.10? Example of our QC check: peak shift test, single point check, contamination check. For your further understanding, for example we use calibration source/ref item to check the counting equipment performance. We shall ensure that the signal peak is located at the specific channel. If shifted, we re-calibrate the system. While for the calibration item itself the performance totally depends on radioactivity level. If the source decayed to certain level, we purchase new source

        Please advice

        Thank you in advance.
        Khaliza

        Note: I tried to sent this query many times but unfortunately my comment did not appear. If you received this many times please reply to only one and delete or ignore the rest.

        • Hi Khaliza,

          Good day!

          Yes, you are correct about intermediate checks, it is a QC check which is a scheduled activity to ensure equipment is working properly while the equipment is still within the valid calibration interval (calibration due date).

          There are no set standards about this process, as long as you are checking the confidence of the equipment performance, you are implementing an intermediate check.

          It applies to specific situations or processes. In my post, I focus on implementing it during or if the equipment is used or brought outside the lab. I also include a part of preventive maintenance.

          When we are talking about intermediate checks, in addition to functionality check (check of physical appearance, display, etc.) the main concern is the accuracy of measurement results, the process of calibration is still performed, where there is a comparison of a standard and a UUC.

          After comparison, we will verify the results if it is within the tolerance or specifications we defined. If your process is showing these results, then you already implemented the process of intermediate checks.

          In relation to your query and example, the part where you use a reference standard to check the accuracy of the test equipment, either on counting performance or radioactivity level, wherein you use a reference standard to determine any errors, this is where the main part of the intermediate check is performed.

          You have stated that the reference value you use is based on a theoretical calculation, if you have a reference document for this to prove it as a valid source of reference that is recognized internationally, then I believe it is ok.

          I am not familiar with your equipment so this is just my suggestion as per my understanding.

          I hope this helps.

          Thank you for reading my posts.
          Edwin

  28. Vinod
    | Reply

    Dear Edvin,

    Can you suggest what is necessity of intra-laboratory comparison as per ISO/IEC 17025:2017. Is it essential for every laboratory or optional? Is compulsory then what procedure is there for intra-laboratory comparison? It will be beneficial if you can explain it.

    • Intra laboratory or inter-lab is one of the laboratory quality control. As per ISO 17025:2017, it is not mandatory as long as you perform other quality control procedures for validation of results.

      If you have a new procedure and want to know if the procedure is acceptable to be used as per your capability, an intra-lab is a good way to validate it which is one of the requirements of ISO 17025 regarding a calibration or test procedure validation.

      Intra-lab comparison will give you more confidence that the results you have during calibration are acceptable especially the measurement uncertainty results.

      The procedure is to compare your results with other labs. The steps are below:
      1. Agree on what instruments you need to perform an intra-lab.
      2. 1 lab should be the reference lab
      3. Calibrate the instrument as per the normal procedure.
      4. The instrument will be circulated to all labs.
      5. Then calculate results based on EN ratio or Z-score criteria to determine a pass or failed results. See below En ratio (normalize error) formula.

      En ratio formula and acceptance criteria

      >> When the value of |En| ≤ 1 (i.e. between -1 and +1), the results are passed.

      >> When the value of |En| > 1 (i.e. greater than +1 or less than -1), the results are failed.

      The methods or procedures used could be the same or different, including the reference standards. The main point is to compare results if it is in the acceptable range as per the formula used for calculation.

      You can read more about this in ISO 17043 Standards: Conformity assessment — General requirements for proficiency testing.

      If you are applying for accreditation, it is a mandatory activity that is required by the accreditation body specifically inter-lab comparison and/or Proficiency Testing or PT.

      I hope this helps,
      Edwin

  29. Ong Zheng Da
    | Reply

    Dear Edwin,

    Do you have any idea of as found verification requirement? There seems to be no particular clause that address this.

    Please advise

    Thank you
    Best Regards
    Ong Zheng Da

    • Hi Ong,
      Good day to you!

      Do you mean the ‘as found’ results reported in a calibration certificate? This is a requirement under clause 7.8.4.1 (d) where we will report the results after any adjustments or repair.

      During verification, our objective is to determine if the instrument has passed or failed based on the specifications provided, specifically the tolerance.

      My idea regarding the ‘as-found’ verification requirement is the same as the ‘as-left’ requirement.

      Before we will start our calibration process, it should be clear to us what the value of tolerance to be used. You can use the ‘clause 7.8.6– Reporting Statement of Conformity’ as guidance.

      With the term verification, we are now in the process of determining conformance to specification, which in turn will point us to the requirements of using a decision rule.

      I hope this answers your question.
      Edwin

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.