![Advisera Tracey Evans](https://advisera.com/wp-content/uploads/blog_authors/traceyevans.jpg)
May 26, 2021
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.
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.
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:
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Knowledge and skills of external providers of products and services:
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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.
A suitable approach for managing personnel competence is defined in the following eight steps.
Step 1: Document each key laboratory activity that contributes to:
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 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:
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.
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.