The Important Steps to Manage Personnel Competence According to ISO/IEC 17025

ISO 17025 is a standard developed by the International Organization for Standardization and the International Electro-technical Commission under the coordination of the ISO Conformity Assessment Committee, which establishes the requirements that testing and calibration laboratories must meet. Besides, this standard provides the requirements to be met by testing and calibration laboratories, facilitating the harmonization of quality criteria. The main objective of ISO 17025 is to confirm the technical capability and reliability of analytical results. The ISO/IEC 17025 standard, uses both management requirements and technical requirements that affect the improvement of the quality of the work carried out in the laboratories.

The ISO/IEC 17025 standard requirements are used as tools for the distribution of collective knowledge, which simplifies the integration of workers, offers flexibility in adjusting to changes in the environment, and allows issues to be detected for early resolution. For this reason, ISO 17025 standard is useful for any organization.

An appropriate method for managing personnel competence is defined in the following eight steps. ISO 17025 consultancy service can also help to manage personnel competence and these steps can be done by easy and faster. So, the eight steps to managing personnel competence are mentioned below:

Step 1: Maintain document for each laboratory activity that contributes to:

Technically valid results

Constant operation

Accomplishing other laboratory policies and goals.

Step 2: Maintain a document for the competence requirements for each function listed in step one. Also, it includes the essential competence level, education, qualification, skills, technical knowledge, training, and experience requirements. It reviews and revises the laboratory's job descriptions. While the focus is repeatedly on specific qualifications or technical abilities, it is also vital to consider general and soft skills.

Step 3: Document the procedure for choosing the personnel, training, supervision, permission, and monitoring competence.

Step 4: Evaluation of employee's appointments. Raise the job descriptions and personnel records and measure the correctness of existing employees. Also discuss specific responsibilities, duties, and authorities. Deliberate any gaps, opportunities for development, and training needs. Also, recruiting additional personnel or assigning existing personnel to different roles if there are risks that cannot be revised through training.

Step 5: Establish a proper training program for the laboratory employees. The training involves resources and funding, also planning for the budget for the upcoming financial year. Also, a training program should contain suitable information such as the activity, proposed dates, objectives, name of the trainer, trainee names, and a list of the resources needed.

Step 6: Create a training record for each activity. It also includes the principles to estimate training success. For a person, it indicates if the training was successful? If not, specify the action to be taken.

Step 7: Assess and assign a competence level. Establish a competence and authorization record for each person. Contain the information from the training record, also the competence details such as monitoring period and record of evaluation. Competence criteria should be linked to expected actions or abilities and expected outcomes for the laboratory.

Step 8: Monitor personnel competence to authorize consistent operation and improvement in the laboratory. Also, set goals for continuing or increasing the level of competence for all staff. Competence can effortlessly be assessed during two laboratory activities:

Internal audits, during the reviewing of the audits and observation of personnel

Management review

Iso 13485:2016 Medical Devices Quality Management System