ISO/IEC 17025:2017 Clause 6.2.1 to 6.2.3

 

6.2 Personnel

At the heart of any flourishing organization are the individuals who contribute to its day-to-day operations. In the context of ISO/IEC 17025:2017 compliance, personnel play a key role, and their experience, skills, education, and training are vital components. Achieving and maintaining appropriate levels of competency for each function within the organization is essential. ISO/IEC 17025 (6.2) outlines the necessity for adequate supervision during the initial training phase until employees reach the required competency levels.

For a laboratory to meet these standards, it must invest in effective training programs and ensure continuous supervision, particularly as technology evolves. As the laboratory expands, it becomes increasingly important to adapt training and supervision to keep pace with advancements. Laboratories aspiring to attain or uphold ISO/IEC 17025:2017 accreditation should view this as an on-going process. Sustaining a commitment to continuous improvement is contingent on cultivating a highly skilled and well-trained employee base. In essence, the success of a laboratory hinges on its people and their dedication to maintaining the highest standards of competence and compliance.

6.2.1

This clause emphasizes the importance of impartiality, competence, and adherence to the laboratory's management system for all personnel associated with the laboratory, whether they are internal or external.

Impartiality:  All personnel, regardless of their role or position within or outside the laboratory, are expected to act impartially. This means they must avoid favouritism, bias, or any conflicts of interest that could compromise the integrity and objectivity of laboratory activities.

Competence: Personnel are required to possess the necessary skills, knowledge, and qualifications to effectively carry out their responsibilities within the laboratory. Competence ensures that tasks are performed accurately, reliably, and in compliance with established standards and procedures.

Adherence to the Laboratory's Management System: Personnel are expected to work in accordance with the laboratory's management system. This involves following the documented policies, procedures, and processes that govern the laboratory's operations. Adhering to the management system helps maintain consistency, quality, and compliance with relevant standards.

Internal and External Personnel: It includes both internal and external personnel. Internal personnel are those directly employed by the laboratory, such as laboratory personnel and management. External personnel may include contractors, consultants, or individuals from accreditation bodies who interact with the laboratory.

6.2.2

This clause emphasizes the importance of documenting the competence requirements for each function within a laboratory that has an impact on the results of laboratory activities. The aim is to ensure that individuals performing various roles possess the necessary qualifications and skills to carry out their responsibilities effectively.

Competence Requirements: The term "competence" refers to the ability of individuals to perform their tasks accurately and reliably. The laboratory needs to define the specific competence requirements for each function, ensuring that personnel have the necessary attributes to fulfill their roles.

Functions Influencing Results: The competence requirements are specified for functions that have a direct impact on the results of laboratory activities. This could include activities related to sample handling, testing procedures, data analysis, and reporting.

Documentation: The laboratory is required to document these competence requirements systematically. Documentation is a crucial aspect of quality management, providing a clear and transparent framework for understanding the skills and qualifications needed for each role.

Education, Qualification, Training, Technical Knowledge, Skills, and Experience: The components of competence outlined in the statement include education, qualification, training, technical knowledge, skills, and experience. These factors collectively contribute to the overall competence of personnel. Education and qualification ensure a foundational understanding of relevant concepts, while training and experience contribute to practical skills and knowledge.

Personalised to Each Function: Recognizing that different functions within a laboratory may require distinct skill sets, the competence requirements are not generic but tailored to the specific demands of each role. This ensures that personnel are adequately equipped for their particular responsibilities.

Continuous Improvement: Establishing and documenting competence requirements is not a one-time task. It is an ongoing process that should be subject to periodic review and update. Continuous improvement ensures that the competence requirements remain aligned with evolving industry standards, technologies, and best practices.

6.2.3

This clause highlights the responsibility of the laboratory to ensure that its personnel possess the necessary competence to carry out specific laboratory activities assigned to them. Additionally, it highlights the importance of personnel being able to assess and understand the significance of any deviations that may occur during these activities.

Competence of Personnel:  The laboratory is accountable for confirming that its personnel have the required competence for the tasks assigned to them. Competence encompasses a combination of education, training, skills, knowledge, and experience necessary to perform laboratory activities accurately and reliably.

Specific Responsibilities: Personnel are expected to be competent in the specific laboratory activities for which they are responsible. This includes tasks such as conducting tests, handling samples, and interpreting results. The aim is to ensure that each individual is well-equipped to perform their assigned duties effectively.

Evaluation of Deviations: In addition to task-specific competence, personnel should also be capable of evaluating the significance of deviations. Deviations refer to instances where actual outcomes differ from expected or established norms. The ability to assess the importance of such deviations is crucial for maintaining the quality and reliability of laboratory results.

Problem Recognition and Resolution:  Competent personnel are not only proficient in their routine tasks but are also proficient at recognizing and addressing deviations. This involves understanding the potential impact of deviations on the accuracy and reliability of results and taking appropriate actions to rectify or mitigate these issues.

Continuous Competence Development:  Competence is not a static attribute but should evolve with changing technologies, methodologies, and industry standards. The laboratory is encouraged to foster an environment that supports continuous learning and development, ensuring that personnel stay abreast of advancements in their field.

 

 

 

 © [2024] [The Food Analyst]. All rights reserved.

This content is protected by copyright law. No part of this post may be reproduced or transmitted in any form or by any means without the prior written permission of the copyright owner. For permission requests, please contact the copyright owner at [inquiryfoodanalyst@gmail.com].