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CookBook 06 How-to-Assess-Competence-Staff - 10-2018

The document provides guidance on assessing the competence of staff in laboratories according to ISO 17025. It outlines that laboratories must define competence requirements for all staff roles, evaluate staff qualifications against these requirements, and provide training to ensure competence. Laboratories should maintain records of staff qualifications like degrees, training, experience, and evaluations to demonstrate competence. Competence requirements and staff qualifications should be regularly reviewed to ensure they meet the laboratory's needs and technical requirements. The overall goal is to have a process that reliably determines if staff are capable of producing valid test results.

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170 views2 pages

CookBook 06 How-to-Assess-Competence-Staff - 10-2018

The document provides guidance on assessing the competence of staff in laboratories according to ISO 17025. It outlines that laboratories must define competence requirements for all staff roles, evaluate staff qualifications against these requirements, and provide training to ensure competence. Laboratories should maintain records of staff qualifications like degrees, training, experience, and evaluations to demonstrate competence. Competence requirements and staff qualifications should be regularly reviewed to ensure they meet the laboratory's needs and technical requirements. The overall goal is to have a process that reliably determines if staff are capable of producing valid test results.

Uploaded by

Jacek Sobczyk
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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EUROLAB “Cook Book” – Doc No.

HOW TO ASSESS THE COMPETENCE OF STAFF


Background
Most of the requirements of ISO 17025 [1] upon competence are detailed in its § 5 and 6,
expressing requirements for:
− personnel qualification and competence and their documentation including requirements for
education, qualification, training, technical knowledge, skills and experience;
− responsibility, authority and interrelationship of all personnel who manage, perform or verify
work affecting the results of laboratory activities;
− appointed personnel responsible for handling the management system;
− additional personnel;
− job descriptions;
− procedures and records for determining competence requirements, selection of personnel,
training of personnel, supervision of personnel, authorisation of personnel and monitoring of
competence of personnel.
Like any conformity assessment, the assessment of competence has to be done according to
specifications.

Specifications
The laboratory management has to ensure the competence of and authorise all who operate
specific equipment, perform tests and/or calibrations, develop methods, evaluate and analyse
results, confirm conformity, provide opinions and interpretations, and sign test reports and
calibration certificates.
First, the laboratory has to formulate the necessary requirements (for example, in higher-level
functional or individual job descriptions) that provide information on required expertise and
experience; required diploma; required qualifications and training programmes; access to
knowledge databases in networks; and other topics (human behaviour, language skills…).
Examples
- It is helpful in the training program to define what is relevant for initial training and further
training.
- For repetitive but not frequent activities: very detailed testing or calibration procedures can be
used to reduce the training program to the verification of good understanding of the procedure
before use by the staff.
- A required educational level may be accompanied by a procedure to ensure its good
understanding
- interval for requalification, where applicable

Evaluation and qualification


Then, the laboratory has to evaluate the correspondence between job description and staff
knowledge by reviewing the adequacy of education, training, experience and/or demonstrated
skills. If evidence is available to demonstrate that a person meets all the criteria, he/she is
considered qualified.
If not, training measures have to be taken and the training program has to include the evaluation of
the new competence (conducting a test with a supervisor, using questionnaires, recorded
interviews, internal comparisons with reference materials,) and supporting evidence of these
evaluations have to be recorded. These evidences can consist, where applicable, of:
− technical degree, certificate, diploma;
− involvement in publications;
− records of the involvement in calibration or testing operations and assessment of the
participation;
Rev 2018
EUROLAB “Cook Book” – Doc No. 6

− record of involvement in internal or external comparisons;


− record of involvement in research partnership/research networks;
− record of involvement in standardization work;
− records of specific evaluation;
− for non-frequent activities (>12 month), records of the performance of “reference” tests;
− others.
The use of a database can improve the laboratory’s capability to quickly identify the right person for
a particular job.
Review and improvements
Both specifications and qualifications have to be reviewed on a regular basis, taking into account
the current needs of the laboratory and its customers as well as future needs. This may require a
re-evaluation of competence. Training and qualification programs can be outputs of research and
technical development activities of a laboratory.
Review of the assessment of the competence process:
Internal audits are conducted to verify that the operations continue to comply with the requirements
of the management system and ISO/IEC 17025.
Conclusions
The assessment of the competence of staff has to be fit for purpose that is to determine if the staff
is capable of generating technically valid results. The better the competence specifications are
defined, the easier will it be to demonstrate the fulfilment of these competence requirements. It is
the responsibility of the laboratory to find a good balance between competence assessment of the
staff and other quality requirements that have an impact on the test result. The assessment and
the competence of staff have to be continuously improved for the benefits of the laboratories and
their clients.
References
[1] ISO/IEC 17025:2017, “General requirements for the competence of testing and calibration laboratories”

Rev 2018

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