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

with 35 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.



    1.  Quality manual – contains links of Management System Requirements (process and procedures) which includes: 
      1. Quality policy
      2. Quality objectives
        • Quality objectives monitoring sheet
      3.  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 policy
        • Risk to impartiality monitoring sheet
        • Risk Assessment records


      2. Management system documentation
        1. Documents control procedure
          • Change request form
          • Document for archive or disposal form
          • Master list and distribution list of documents


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


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


        4. Management Review MeetingProcedure
          • Management Review meeting form (agenda with attendance)
          • Minutes of meeting


        5. Corrective Action Procedure
          • Corrective action form


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


        7. Improvement Procedure
          • Improvement monitoring sheet


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


        9. Customer Complaints Procedure
          • Complaints and feedback form


    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 Record Form
        • Corrective and preventive action form


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

  1. ISO 17025 Technical  Requirements

    1. Personnel  Procedure
      1. Trainings
        • 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. Impartiality agreement
      7. 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. Cleaning and 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. Intermediate check records
        5. Preventive Maintenance Records
        6. Validation Records


      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


        2. Preventive maintenance procedure
          • Preventive maintenance plan
          • 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,


35 Responses

  1. Arturo Difuntorum
    | Reply

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

    • edsponce
      | Reply

      Hi Mr. Arturo,

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

      Best regards,

  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.

    • edsponce
      | Reply

      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,

      Thanks and regards,

  3. edsponce
    | Reply

    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 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.

  4. Rheabelle Acuin
    | Reply


    The new requirements
    7.8.6 Reporting statements of conformity 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?

    • edsponce
      | Reply

      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,

  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?


    • edsponce
      | Reply

      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,

  6. Ganesh
    | Reply

    Cant thank you enough for the list .

    • edsponce
      | Reply

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

      Best Regards,

  7. Abdur Rab
    | Reply

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

    Could i get more help from you?

    • edsponce
      | Reply

      Hi Mr. Abdur,

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

      Thanks and regards,|

  8. Aris Rahman
    | Reply

    Hi Mr. Edwin

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


    • edsponce
      | Reply

      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,

  9. Nino Martinez
    | Reply

    nice one padli..helpful pa burger kan..

    • edsponce
      | Reply

      Hehe, thanks Padli! sika a koma ag pa burger.

  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!!!

    • edsponce
      | Reply

      Hi Victor,
      Good Day!
      Finally, I have written a post regarding impartiality. Please visit the below link and tell me what you think.
      ISO 17025 Impartiality Procedure

      Thanks and regards,

    | Reply


    • edsponce
      | Reply

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

      Thanks and regards,

  12. Natalia Georgia
    | Reply

    Thank you very much for you information you shared.

    Withe best regards,


    • edsponce
      | Reply

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

      Best Regards,

  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.

    • edsponce
      | Reply

      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,

  14. Ong Zheng Da
    | Reply

    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

    • edsponce
      | Reply

      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,

      • Ong Zheng Da
        | Reply

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

        • edsponce
          | Reply

          Hi Ong,

          You are welcome. Happy to help.

          Best Regards,

  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.

    • edsponce
      | Reply

      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,

  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

    • edsponce
      | Reply

      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,

  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

    • edsponce
      | Reply

      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, 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 (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
      3. Ensure that the method that you choose is the updated version as per clause
      4. You can use the old version if this is required or specified by customer as per clause
      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,

Leave a Reply

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