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ISO/IEC 17025 Blog

How to manage competence in a laboratory according to ISO 17025

The primary purpose of ISO 17025 is to guide laboratories to be competent – meaning they can generate valid test or calibration results and work consistently. The challenge is how to manage competence. This is because, in ISO 17025, the term refers to all aspects of laboratory competence, and a specific approach is not prescribed. There may also be differences in language interpretations and translations.
This article will help by providing an overview of what is needed to comply with ISO 17025 requirements for competence, focusing on personnel competence.

How to manage personnel competence according to ISO 17025:
  1. Document each key laboratory activity.
  2. Document the competence requirements.
  3. Document the procedure.
  4. Review personnel appointments.
  5. Establish a training program.
  6. Establish a training record.
  7. Evaluate and assign a competence level.
  8. Monitor personnel competence.

What does it mean to manage competence in a laboratory?

Let us start by understanding what competence is. As one of the core definitions of ISO Quality Management System standards, competence is “the ability to apply knowledge and skills to achieve intended results” ISO 9000:2015 Quality management systems – Fundamentals and vocabulary).
Ensuring competence is crucial for implementing and maintaining compliance with ISO 17025 regulatory and safety requirements.

General requirements for the competence of testing and calibration laboratories

A laboratory must manage both internal and external competence. Internal competence involves the laboratory’s skills and knowledge. On the other hand, external competence is ensuring the skills of the laboratory’s service providers.
The table below represents the internal and external competence requirements of a laboratory.

Internal competence (ISO 17025 clause 6.2) External competence (ISO 17025 clause 6.6)
Knowledge and skills of laboratory personnel to:

  • Perform customer-requested laboratory tests or calibrations
  • Operate equipment
  • Develop, change, verify, and validate methods
  • Use suitable reference standards
  • Analyze test or calibration results, including statements of conformity and interpretations
  • Record, review, and authorize the release of results
  • Perform internal audits
Knowledge and skills of external providers of products and services:

  • Calibration laboratories performing calibrations for testing laboratories
  • Reference material producers (RMPs)
  • Proficiency and interlaboratory testing schemes providers
  • General service providers (g., training providers’ qualifications)

 

 

Use personnel competence levels as a methodology to manage competence

The mandatory ISO 17025 requirements for managing personnel are some of the most prescriptive in the standard. This is because people are a key contributor to the overall competence of a laboratory. In a laboratory, you typically need a range of competences. It helps to assign competence levels from basic to expert level to each job function.
8 steps to manage iso 17025 competence of personnel

8 steps to manage personnel competence

A suitable approach for managing personnel competence is defined in the following eight steps.
Step 1: Document each key laboratory activity that contributes to:

    • Technically valid results (e.g., method development, validation, metrological traceability, quality control, proficiency testing),
    • Consistent operation (e.g., proactive and monitoring activities – equipment maintenance, risk assessments, internal audits), and
    • Achieving other laboratory policies and goals (e.g., safety, marketing).

Step 2: Document the competence requirements for each function listed in step one. Include the required competence level, education, qualification, skills, technical knowledge, training, and experience requirements. Review and revise the laboratory’s job descriptions. While the focus is often on specific qualifications or technical abilities, it is also important to consider general and soft skills. For example, an internal auditor needs to be an effective communicator, a good listener, and an observer.



Step 3: Document the procedure for selection of personnel, training, supervision, authorization, and monitoring competence.

Step 4: Review personnel appointments. Refer to job descriptions and personnel records (detailed curriculum vitae, training, and competence) and assess the suitability of existing personnel. Meet with each person and discuss specific responsibilities, duties, and authorities. Discuss any gaps, opportunities for development, and training needs.
Consider recruiting additional personnel or assigning existing personnel to different roles if there are risks that cannot be corrected through training.

Step 5: Establish a training program for the laboratory. Because training requires resources and funding, plan in time to budget for the following financial year. A training program record should include suitable information such as the activity, proposed dates, objectives, name of trainer, trainee names, and a list of the resources needed (for example, financial, venue).

Step 6: Establish a training record for each activity. Include the criteria to deem training successful (e.g., passed test with >85%). For each person, indicate if the training was successful. If not, specify the action to be taken.

Step 7: Evaluate and assign a competence level. Establish a competence and authorization record for each person. Include the information from the training record, plus the competence details such as monitoring period and record of evaluation. Competence criteria should be linked to expected behaviors or abilities and expected outcomes for the laboratory.
An example of a behavioral (non-technical) personnel competence is client focus. Here, one of the competence criteria would be the person’s ability to understand clients’ needs and provide advice. The demonstrated competence will come from observation and feedback from clients.
An example of technical competence is accurate testing and reporting. Competence can be demonstrated by the technician’s participation in a proficiency testing scheme, where the technician achieves an acceptable performance as defined by the provider and/or laboratory.

Step 8: Monitor personnel competence to ensure consistent operation and improvement in the laboratory. Set goals for maintaining or increasing the level of competence for all personnel.
Competence can easily be assessed during two existing laboratory activities:

    • Internal audits, during witnessing of audits and observation of personnel
    • Management review – review the risks and plan training or other actions to reduce risk; for example, by automating a system, you could reduce the skill required to perform the task

For further support, have a look at the Advisera ISO 17025 toolkit documents, where you can preview the Competence, Training and Awareness Procedure, and the four appendices Training Program, Training Record and Performance Monitoring, Record of Attendance and Competence Approval and Authorization Record.

The reward for your effort is a robust management system

By setting aside time to manage your laboratory competence requirements systematically, you can rest assured: your entire management system will benefit from fewer nonconforming events. By following these eight steps, the management system will be more robust, and personnel more confident that they can contribute to the laboratory’s goals.

To learn more about competence and other ISO 17025 requirements, download this free white paper: Clause-by-clause explanation of ISO 17025:2017.

Advisera Tracey Evans
Author
Tracey Evans
Tracey Evans is an ISO 17025 expert with an MSc degree in Biochemistry, and more than 15 years’ experience in Laboratory Management Systems. This experience includes a variety of testing and calibration laboratories in the pharmaceutical, biotechnology, medical pathology, veterinary, engineering, mining, water and agricultural sectors. Tracey has used her insight into ISO 17025 and ISO 9001 to assist clients in developing and implementing systems, performing method validation and internal audits, addressing risks and opportunities, and achieving ISO 17025 accreditation. Tracey also has a working knowledge of GLP and GCP, and has expertise as an internal auditor for a GCP laboratory.