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

with 18 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.  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
        • Authorization/ Appointment Letter
        • Responsibilities List
        • Job description List
        • qualifications List
        • 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

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Best Regards,

Edwin

18 Responses

  1. Arturo Difuntorum
    | Reply

    Edwin,
    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,
      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.

    • 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, edwin@calibrationawareness.com

      Thanks and regards,
      Edwin

  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 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?

    • 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,
      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

    • 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,
      Edwin

  6. Ganesh
    | Reply

    Cant thank you enough for the list .

    • edsponce
      | Reply

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

      Best Regards,
      Edwin

  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,|
      Edwin

  8. Aris Rahman
    | Reply

    Hi Mr. Edwin

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

    Aris

    • 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,
      Edwin

  9. Nino Martinez
    | Reply

    nice one padli..helpful daytoy..ag 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!!!

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