Blog: Regulatory
ISO 17025 Documentation within a LIMS Solution using Xybion LIMS - Part 3
Part 3 - Competency Tracker and revisions to ISO 17025
25th October 2017
ISO/IEC 17025:2005 is used by laboratories to develop their management system for quality, administrative and technical operations. This series of articles examines how a well-configured LIMS, such as Xybion LIMS, can make a significant contribution to the fulfilment of ISO 17025 requirements in areas over and above the direct management of data related to sampling, testing and reporting. In Part 1 of the series, we looked at how Xybion LIMS can help with the management of documents, while Part 2 focused on the management of corrective and preventative actions (CAPA).
In this article, we look at the importance of ensuring that laboratory personnel are properly trained to conduct specific tests or use a particular piece of equipment, and how the Xybion LIMS LIMS can allow competency and training records to be maintained.
However, the laboratory environment has changed dramatically since ISO/IEC 17025:2005 was published in 2005, which has led to a decision to revise the standard and integrate significant changes. This revision is scheduled for publication at the end of 2017 and takes into account the activities and new ways of working of laboratories. There is a stronger focus on information technologies, recognizing and incorporating the use of computer systems, electronic records and the production of electronic results and reports. This means that LIMS is even more relevant to the new standard than ever before. The scope of the standard is being revised to cover all laboratory activities including testing, calibration and the sampling associated with subsequent calibration and testing.
ISO/IEC 17025 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. Naturally, the competency of personnel to carry out particular tests is an important part of this capability and is referenced in Sections 4.1.4, 4.1.5, 4.1.5 (f), 5.2.1 and 5.2.2 of the current standard, ISO/IEC 17025:2005.
Competency in the laboratory
The requirements for personnel competency are encapsulated in Section 5.2.1 of ISO 17025. This states: ‘The laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. When using staff who are undergoing training, appropriate supervision shall be provided. Personnel performing specific tasks shall be qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as required.’
This means making sure that any new personnel are fully trained as well as keeping current personnel up to date with any changes in procedures. This could involve changes in a test regime, a new test being introduced, a software upgrade to an analytical instrument or the introduction of a new piece of equipment.
Competency tracking using Xybion LIMS
Xybion LIMS Competency Tracker is a component of the Xybion LIMS Quality Management Suite. By using Competency Tracker, the capability of the LIMS can be further extended to include keeping full records of personnel skills and training. Training courses can be scheduled automatically and certificates of competency issued and stored to provide a historical record of skills acquired. Automatic renewal reminders can be issued for time-dependent qualifications. This functionality fits well with the requirements of Section 5.2.2 of ISO 17025. This states: ‘The management of the laboratory shall formulate the goals with respect to the education, training and skills of the laboratory personnel. The laboratory shall have a policy and procedures for identifying training needs and providing training of personnel. The training program shall be relevant to the present and anticipated tasks of the laboratory. The effectiveness of the training actions taken shall be evaluated.’ Having all personnel qualifications and competencies documented also allows easy matching of staff to the specific needs of the laboratory, so if a new test is introduced, for example, it would be easy to see who was qualified to perform it and who needs further training. In addition, since competency and training records can be maintained within Xybion LIMS, it is possible to prevent individuals from carrying out specific tasks if they do not have a valid training record. Competency Tracker’s structured reporting capabilities allow automated generation of reports on completed activities. Competency Tracker can be easily configured using the Autoscribe configuration tools, without the need for custom coding or scripting meaning that it can readily accommodate any future changes in training requirements.
Extending the reach of competency tracking
Since Competency Tracker is part of the Xybion LIMS Management Suite, it can be readily implemented as part of Autoscribe’s Business Information Management System (BIMS) and can easily be applied independently to skill level monitoring across any business environment. It can offer an organization a number of key benefits by preventing problems arising from inadequate training, including:
- Increased productivity and performance by matching key skills and abilities to the job role
- Improved employee development and training schedules for retention of quality staff
- Reduced costs associated with training schedules and required materials
It can go even go beyond internal use since it can offer external regulators and management insight into the skills gained in order to establish if further training is required.
You can catch up with Part 1 and Part 2 of this series and you can call the experts at +44 118 984 0610 to find out how Xybion LIMS could help your lab meet ISO 17025 requirements.
A copy of ISO 17025 can be purchased online at: https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-2:v1:en
