Abstract 3D checklist icons symbolizing compliance and quality assurance, representing ISO/IEC 17025 accreditation requirements.

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Preparing for an ISO/IEC 17025 Accreditation Assessment

Ensure your lab meets ISO/IEC 17025 standards. Explore steps for internal audits, addressing non-conformities, and improving lab practices

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ISO/IEC 17025 is the international standard for testing and calibration laboratories, establishing requirements for the competence of laboratories in these fields. Laboratories that adhere to this standard are assessed on their ability to produce accurate and reliable results. The ISO 17025 assessment process is critical to ensuring that laboratories remain compliant with the standard, maintain their accreditation, and continue to improve their practices.

When the external assessment is scheduled by the accrediting body (AB), it often generates anxiety and urgency for correcting any non-compliant activities in the laboratory. Management and staff will work long hours up to the assessment date. This is typically evident to the assessor by the volume of recently approved procedures.

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Planning ahead will help avoid the flurry of activities, lack of sleep, and the pitfalls of poor preparation. The best planning tool for an accreditation assessment is an internal audit, but itis rarely given the attention needed to improve the laboratory’s compliance.

The internal audit must cover the laboratory management system and the technical requirements of ISO/IEC 17025:

  • Management requirements relate to the laboratory’s organizational structure, policies, and procedures. They include areas such as quality management, document control, contract review, purchasing, personnel competency, and internal audits.
  • Technical requirements focus on the laboratory’s operations, such as testing and calibration methods, equipment management, traceability of measurements, data integrity, and the handling of test samples.  These requirements address the methods cited on the laboratory’s current scope of accreditation.

Many laboratories tend to exclude areas in their internal audits or quickly perform an overview, which results in findings in their external assessment. Laboratories do not include all the management requirements and only perform desk audits for the methods on their scope, which is not the ideal performance of the internal audit.

  1. The internal audit

Before the internal audit, review the schedule to ensure all areas of the standard are addressed.

  • Scheduled tasks defined in the laboratory’s procedures. These may include the timing of the management review or the internal audit. Failure to meet schedules could result in not complying with the laboratory’s own requirements, which are auditable.
  • Review of the ISO/IEC 17025 checklist, which is typically provided by the accrediting body of the laboratory or a review of the standard. Where are records required?  Where are procedures required? This can be done easily by searching the documents and highlighting the required procedures and records.

The internal audit should be performed impartially. If the auditor performs or supervises the activities, there may be a conflict of interest. This is difficult to avoid in small laboratories but can be managed by documentation and records of the audit.

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Focus on all management requirements, which include areas that are typically missed such as contract review, purchasing, risk management, and nonconforming work. The internal auditor should be reviewing documentation, records, and interviewing personnel directly responsible for the management activities.

The technical portion of the audit should include a desk audit reviewing the methods against any reference methods and any laboratory developed methods and associated validation records. Once the desk audit is complete, the auditor should observe the analyst performing the procedures and reviewing records.

Key components to review during the internal audit include:

  • Documentation and records: Ensure that all necessary documentation, such as quality manuals, standard operating procedures (SOPs), and test records are up-to-date and accessible.
  • Competence of personnel: Verify that staff qualifications, training records, and competency assessments are in place. This includes observing and interviewing the analyst performing the methods.
  • Equipment calibration and maintenance: Review records of equipment calibration, maintenance, and performance to ensure compliance.
  • Traceability of measurements: Confirm that traceability of measurements is maintained and documented, which is critical for meeting technical requirements.

A thorough internal audit allows you to rectify any issues before the formal audit, making it easier to demonstrate compliance during the audit process.

2. Address non-conformities

If the internal audit uncovers any non-conformities or areas where the laboratory does not meet ISO 17025 requirements, take the necessary steps to address them. Non-conformities can range from minor issues (e.g., outdated procedures) to major problems (e.g., failure to comply with traceability requirements).

Document the corrective actions for each identified non-conformity and ensure that these actions are fully implemented before the audit. If the audit uncovers non-conformities that were not identified during the self-assessment, it could lead to a less favorable outcome and delays in certification.

3. Review past audit results

Review the results of previous audits (if applicable) to understand any recurring issues. This helps ensure that corrective actions have been taken to address previous concerns and shows the auditor that your laboratory is committed to continuous improvement.

4. Ensure all documentation is in order

Proper documentation is at the heart of ISO 17025 compliance. During the accreditation assessment, the assessor will closely examine the laboratory’s documentation to ensure it is comprehensive, up-to-date, and accurate.

Documents that assessors typically review include:

  • Quality manual: The overarching document that outlines the laboratory’s commitment to quality and compliance with ISO 17025.
  • Quality records: Include internal audit schedules, proficiency testing, data review, management review, corrective actions, and complaints.
  • Standard operating procedures (SOPs): These should be clear, detailed, and followed consistently to ensure reliable results.
  • Records of equipment calibration and maintenance: These documents demonstrate the reliability of your equipment and are essential for meeting the technical requirements of ISO 17025.
  • Training and competency records: These documents show that laboratory personnel have the appropriate qualifications and are competent in the tasks they perform.
  • Test and calibration records: Detailed records of tests performed, including results and any deviations, are critical for demonstrating technical competence.

Ensure that all documents are easy to locate and that they comply with ISO 17025’s requirements for version control and document retention. Keep a checklist to verify that all necessary documentation is prepared for review.

5. Prepare your staff

An ISO 17025 assessment is not only an evaluation of the laboratory’s processes but also the staff’s competence in implementing those processes. It is essential that laboratory staff members are adequately prepared for the assessment, especially those who will interact directly with the assessors.

Key steps to prepare staff include:

  • Training: Ensure that all staff are familiar with the ISO 17025 standard, laboratory policies, and procedures. Conduct training sessions to reinforce the importance of ISO 17025 and the role of each staff member in the audit process.
  • Role-playing: Conduct mock audits or role-playing exercises to simulate interactions with auditors. This can help staff become comfortable with the audit process and improve their confidence in answering questions.  The internal audit process is excellent for training personnel for future assessments.
  • Clarifying expectations: Ensure that staff understand the assessment process and their responsibilities. Staff members should know what documents or information they may need to present, as well as how to handle questions from auditors.

6. Review assessment procedures and schedule

Before the assessment, review the assessment procedures and ensure that everything is in place for the auditor’s arrival. This includes:

  • Assessment schedule: Ensure that an assessment schedule has been agreed upon and that all relevant staff are available during the assessment.
  • Facilities: Ensure that the laboratory environment is clean, organized, and free of any safety hazards. This includes reviewing equipment calibration records and ensuring that all necessary test equipment is ready for inspection.
  • Access to key personnel: Ensure that key personnel, such as laboratory managers and technical staff, are available to speak with auditors and provide any required information.

Confirm the logistics of the assessment and address any practical details beforehand to prevent disruptions during the assessment process.

7. Conduct a pre-assessment meeting

Before the official assessment begins, it can be beneficial to hold a pre-assessment meeting with all relevant personnel to help minimize any surprises. During this meeting, you can:

  • Review the goals and scope of the assessment.
  • Discuss key areas of focus based on previous assessments or internal audits.
  • Identify any specific concerns or areas where the laboratory may require additional attention.

Striving for continuous improvement

The goal of an ISO 17025 assessment is not only to maintain accreditation but also to ensure that your laboratory continuously improves its practices. With the right preparation, the assessment process can be a valuable opportunity to identify areas for growth and enhance the laboratory’s ability to deliver high-quality, reliable results.

About the Author

  • Jeanné Mensingh

    Jeanné Mensingh has over 35+ years’ experience as an analytical chemist, lab manager, quality systems manager, consultant, and lead assessor. She has an ACS Certified BS in Chemistry from Northeast Louisiana University (now University of Louisiana at Monroe) and post graduate work in Chemical Engineering at Louisiana Tech University. She is an American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified HACCP Auditor (CHA), and a Certified Software Quality Engineer (SQE). She is also a certified ISO 9001:2000 lead auditor, EPA Certified Drinking Water Microbiology, Inorganics and Organics, ISO 17025 Lead Assessor (A2LA, NELAP/AOAC/QSM), and is a Lead Assessor for NELAP (TCEQ, MNELAP, FL DoH, and LDEQ). She has received training in good laboratory practices, good manufacturing practices, software validation for GMP environment, and International Pharmaceutical Excipient Council good manufacturing practices for excipients. Jeanné has provided QA and LIMS support to companies who must comply with good manufacturing practices, good laboratory practices, EPA drinking water regulations, ISO 9001, ISO 17025, and TNI standard. She has extensive experience in wet chemistry, chromatography, and spectroscopy.

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