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    ISO/IEC 17025:2017 – General Requirements for the Competence of Testing and Calibration Laboratories

    Dec 6, 2021 | Articles, Other articles

    The purpose of ISO/IEC 17025:2017 and which organisations require it.

    ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. To assure testing quality and validity, laboratory-developed procedures are used. This standard applies to all organisations that undertake laboratory operations, regardless of staff size or breadth of testing and calibration processes. ISO/IEC 17025:2017 is used by laboratory customers, regulatory agencies, organisations, and programs that employ peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 when confirming or recognising the competence of laboratories.

    The Process of Attaining Certification

    1. The certification process begins by having a copy of the standard and knowledge of ISO 17025:2017.
    2. Contract an ISO 17025:2017 accreditation body and address their requirements.
    3. Plan your training since all people, especially those responsible for the management and technical operations as well as those working as internal auditors, must go through training.
    4. Define and document the laboratory activities for which you seek accreditation, along with the quality objectives of the laboratory. This gives the context to determine to what extent risks should be controlled and processes documented.
    5. Conduct a gap assessment between what your laboratory is doing and what the standard requires.
    6. Documentation – while not essential, a manual is an excellent place to record your laboratory’s policies and objectives. Various procedures are required, as well as several documents that must be linked, preserved, and maintained.
    7. The application process – Before you can apply for certification, you must first fulfil the certification body’s standards, have all necessary processes recorded, and have documents demonstrating that the implementation is complete. You must have an active internal audit program in place, as well as documentation of all management reviews and method validations.
    8. After a remote review of the documentation and activities, the certification body will approve the recommendation and schedule the certification audit. The assessors generally like to see about six months’ worth of activity and record-keeping (objective evidence) at the time of the audit, before recommending you for certification.

    The Benefits of Attaining Certification

    There are a lot of benefits to your company obtaining certification to ISO/IEC 17025:2017. Some of these include:

    • Your laboratory will be recognised on a global scale for its dedication to quality, expertise, and dependable outcomes. This implies that your company complies with a globally recognised standard, facilitating the flow of vital information throughout the world.
    • It is a method of assuring your clients that you have the technical expertise to offer dependable and accurate tests or calibration findings.
    • There is confirmation that your system meets all the criteria of ISO/IEC 17025:2017 and provides an independent guarantee that your laboratory is operating at peak efficiency.
    • It can set your laboratory apart from competitors and foster a sense of professionalism and pride. A third-party audit is difficult – but once completed, the auditee will experience a feeling of achievement and pride. Third-party certification instils pride in the entire organisation.
    • When your company achieves ISO/IEC 17025:2017 certification, you will be given an accreditation certificate that can be used in advertising, promotional literature, and stationery to demonstrate to current and potential customers that your laboratory has demonstrated technical competency to perform calibration or testing services.

    Mandatory Documents and Records for ISO 17025:2017

    Mandatory Documents

    According to ISO 17025:2017, the documents specified below are required. Remember that if you omit part of the phases from the scope of your implementation, the documentation for those clauses will not be required for your lab.

    Document and Record Control Procedure Quality Policy Competence, Training and Awareness Procedure Externally Provided Products and Services Procedures Facilities and Environtment Procedure Equipment and Calibration Procedure
    Customer Service Procedure Test and Calibration Method Procedure Quality Assurance Procedure Sampling Procedure Handling of Laboratory Test or Calibration Items Procedure Complaint, Nonconformity and Corrective Action Procedure
    Testing Report Procedure Calibration Report and Certificate Requirements Procedure

    Mandatory Documents and Records for ISO 17025:2017

    1. Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4)
    2. Quality Policy (Clauses 8.2.1 & 8.2.2)
    3. Competence, Training and Awareness Procedure (Clause 6. 2.5)
    4. Externally Provided Products and Services Procedure (Clause 6.6.2)
    5. Facilities and Environment Procedure (Clause 6.3)
    6. Equipment and Calibration Procedure (Clauses 6.4. 3 & 6.5)
    7. Customer Service Procedure (Clauses 7.1.1 & 8.6)
    8. Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
    9. Quality Assurance Procedure (Clauses 7.7.1 – 7.7.3)
    10. Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to laboratories that do sampling)
    11. Handling of Laboratory Test or Calibration Items Procedure (Clause 7.4)
    12. Compliance, Nonconformity, and Corrective Action Procedure (Clauses 7.9 – 7.10 & 8.7)
    13. Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to testing laboratories that write test reports)
    14. Calibration Report and Certificate Requirements Procedure (Clauses 7.8.2 and 7.8.4, applicable to calibration laboratories that write calibration certificates)

     

    Mandatory Records

    Records are created to indicate compliance with the standard and related internal procedures, as well as to serve as evidence during audits. The following are all the required records following ISO 17025:2017:

    1. List of Internal and External Documents (Clauses 8.2.4 & 8.3.1)
    2. List of Types of Records (Clause 8.4)
    3. Registry of Records for Detention/Central Archive (Clauses 8.3.2f & 8.4.1)
    4. Quality Objectives (Clauses 8.2.1 & 8.2.2)
    5. Training Program (Clause 6.2.3)
    6. Training Record and Performance Monitoring (Clause 6.2.2)
    7. Record of Attendance (Clause 6.2.2)
    8. Competence Approval and Authorization Record (Clauses 5.6 & 6.2.5e)
    9. Supplier Evaluation and Approval Record (Clause 6.6.2a)
    10. List of Approved Suppliers of Products and Services (Clause 6.6.2a)
    11. Record of Laboratory Environmental Controls (Clause 6.3.3)
    12. List of Laboratory Equipment (Clause 6.4.13a)
    13. Calibrated Equipment Record (Clause 6.4.13a)
    14. Calibration Record (Clause 6.4.13e)
    15. Equipment Maintenance Record (Clause 6.4.13g)
    16. Customer Order Review (Clause 7.1.1a)
    17. Method Verification, Validation and Development Record (Clauses 7.2.1 & 7.2.2)
    18. Sampling Plan (Clause 7.3.1) (as applicable)
    19. Sampling Report (Clause 7.3.3) (as applicable)
    20. Corrective Action Report (Clause 8.7.3)
    21. Compliance, Nonconformity and Corrective Action Report Log (Clause 8.7.3)
    22. Measurement Uncertainty Record (Clause 7.6.3)
    23. Audit Nonconformity Report (Clause 8.8.2d)
    24. Internal Audit Report (Clause 8.8.2e)
    25. Management Review Record (Clause 8.9.2)

    Commonly used non-mandatory ISO 17025:2017 documents and records

    You should also maintain any additional documents and records that you have identified as required to guarantee that your management system can be efficiently maintained and improved over time, such as:

    • Addressing Risks and Opportunities Procedure (Clauses 8.5.2 & 8.5.3)
    • Report of Customer Satisfaction (Clause 8.6.2)
    • Internal Audit Procedure (Clause 8.8.2)
    • Management Review Procedure (Clause 8.9)

    WWISE has assisted over 590 clients with implementing ISO standards. Should you need assistance with implementing ISO 17025:2017, send an email to dmin@wwise.co.za or contact us on 08610 99473 (WWISE) or 021 525 9159 (Cape Town).

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