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

with 2 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.

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 place.

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 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

           

      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

2 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

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