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Entender los requisitos de la Norma 17025 y cómo se aplica en el control de calidad para pruebas experimentales.

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Capacitarse en las etapas necesarias para desarrollar pruebas experimentales en el LSC, específicamente en sistemas de combustión de combustibles líquidos y gaseosos.

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Saber cómo analizar y documentar los resultados de las pruebas para cumplir con la Norma 17025.

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¿Cuáles son las etapas clave para desarrollar pruebas experimentales en el LSC según la Norma 17025?

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Explicación de los conceptos clave de la Norma 17025 y su importancia en el control de calidad. Aquí se utilizará una presentación para detallar cada etapa de las pruebas experimentales.

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Presentation on ISO-IEC 17025-2017.pptx - Download as a PDF or view online for free

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Dividir la clase en grupos pequeños para discutir y planificar las etapas de una prueba experimental siguiendo un estudio de caso.

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Asignar una tarea individual donde los estudiantes deben desarrollar un plan de prueba experimental completo, incluyendo todos los pasos necesarios según la Norma 17025.

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A well-designed test plan is important in enabling effective planning, coordination, and execution of testing activities. It is more than just documentation, as it directly contributes to achieving better software quality and raising customer satisfaction.

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Proporcionar recursos adicionales como lecturas complementarias y plantillas de planificación para suportar a los estudiantes con diferentes niveles de comprensión.

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Introduction

Clause 6 of ISO 17025 is titled "Resource requirements" and specifies the requirements for the resources that an organization must have in order to operate a competence-based laboratory. These resources include personnel, facilities, equipment, materials, and quality management systems.

The clause outlines the general requirements for personnel, including the need for qualified and trained staff, as well as requirements for the facilities, such as adequate size, cleanliness, and safety. It also specifies the need for appropriate equipment and materials, including the requirement that the equipment be properly calibrated and maintained.

Moreover, the clause outlines the requirements for a quality management system, including the need for documented procedures and documentation control, as well as the requirement for ongoing improvement of the system.

Laboratory Resource Requirements for ISO 17025 | Clause 6.1: General

To be able to achieve accreditation, organizations must have laboratories in line with the following criteria:

Competent personnel

Suitable facilities

Calibrated and equipment in good working order

Policies and forms to ensure good traceability

Support services such as administration and technical

Laboratory Resource Requirements for ISO 17025 | Clause 6.2: Personnel

In terms of personnel, the standard requires that laboratories have qualified and trained staff who are able to perform their duties effectively. This includes having personnel with the necessary education, training, and experience to carry out the work. It also requires that there be sufficient staffing levels to ensure that the laboratory is able to meet its commitments and produce reliable results.

All personnel working within the laboratory must document every necessary step that is taken for transparency purposes. They must also have the competency for each function influencing the results of laboratory activities, including education, qualifications, training, technical knowledge, skills, and experience.

Thus, the laboratory shall have procedures in place and keep records for:

1. Deciding the competence requirements - Job descriptions with established criteria;

2. Choice of personnel - Recruitment procedure;

3. Training of personnel - Training procedure, including all necessary records;

4. Supervision of personnel - Training records;

5. Authorization of personnel - Authorisation of competence;

6. Monitoring competence of personnel - Ability or interlab exercise.

Furthermore, the laboratory shall have a procedure to authorize personnel to perform laboratory activities such as:

1. Development, modification, verification and validation of methods;

2. The analysis of results, including statements of conformity or opinions and interpretations;

3. Report, review and authorization of results.

Laboratory Resource Requirements for ISO 17025 | Clause 6.3: Facilities and Environmental Conditions

The standard also requires that laboratories have suitable facilities that are of appropriate size, cleanliness, and safety. This includes having the necessary infrastructure, such as electricity, water, and heating, as well as appropriate ventilation and lighting.

The premises, including environmental conditions, shall be suitable for the activities and shall in no way affect the validity of results. This is dependent on the type of activities taking place, which may include microbiological analysis, which will require specific sterility conditions or chemical analysis, which shall require humidity and temperature control for certain reactions to take place. These requirements shall be controlled, recorded and monitored in accordance with relevant standards or where they affect the results.

Laboratory Resource Requirements for ISO 17025 | Clause 6.4: Equipment

Equipment and materials are also an important resource for a laboratory. The standard requires that laboratories have appropriate equipment that is calibrated and maintained to ensure its accuracy and reliability. It also requires that laboratories have access to the necessary materials and supplies to perform their work.

The laboratory shall have access to several equipment that shall aid or complement their activities. This equipment should have a procedure documenting the handling, transport, storage, use, and planned maintenance of the equipment, to ensure it is properly functioning and to prevent contamination or deterioration. Before using or returning to service, the laboratory shall have a document detailing the specified requirements, to which the equipment should conform to.

Equipment should be verified and confirmed by ensuring that the equipment fits its purpose within the laboratory's activities. Responsible personnel should calibrate this measuring equipment and ensure that it fits the measurement uncertainty budgets, stipulated within the quality policies. Maintenance and calibration planners should be documented and reviewed periodically to adjust as necessary, to keep confidence in the status of calibration. Such calibration validity is to be clearly labeled and coded to allow the equipment user to find the calibration status or period of validity.

Furthermore, in cases where calibration and reference materials include reference values or corrective factors, a procedure should allow the updating of these values, and ensure that they are implemented correctly. On the other hand, management should also prevent unintended adjustments of equipment, which may result in the invalidating of reports.

If, for any reason, the equipment gives questionable results, due to mishandling or overloading, the said equipment must be removed from use, and, if permissible, isolated to prevent the use, or at least clearly labeled. The same equipment must only be returned to service, upon verification and fulfilling the criteria as set up within the lab's policy. If upon further investigation, the laboratory finds deviations from specified requirements, management should start the process of nonconforming work procedure.

Equipment logs shall be recorded, including the following:

1. A unique code to identify the equipment, including software and firmware version

2. The name of the manufacturer, the model or serial number, and any other unique identification;

3. Evidence of verification that equipment conforms with the specified requirements;

4. Location;

5. Calibration dates, results, adjustments, acceptance criteria, and the due date of the next calibration;

6. Documentation of reference materials, results, acceptance criteria, and relevant dates;

7. Maintenance plan and a maintenance log, where relevant to the performance of the equipment;

8. Details of any functional problems with the equipment, and any maintenance is done on the equipment.

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6 Powerful Laboratory Resource Requirements for ISO 17025

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Click to learn more about laboratory resource requirements for ISO 17025. Clause 6 of ISO 17025 interprets the requirements for the resources of a laboratory.

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Observación y discusión durante la práctica guiada para evaluar la comprensión de los estudiantes sobre las etapas de las pruebas experimentales.

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Presentación de los planes completos de pruebas experimentales como proyectos finales para evaluarlos según la Norma 17025.

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Realizar una discusión grupal para que los estudiantes compartan lo que aprendieron y cómo aplicarán estos conocimientos en el futuro.

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Cada estudiante debe escribir un breve resumen de lo que aprendió y entregar un "ticket de salida" antes de salir de clase.

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Desarrollar un proyecto de prueba experimental en casa, aplicado a un sistema de combustión de combustibles líquidos o gaseosos, incluyendo un reporte escrito que siga la Norma 17025.

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Below is a sample lab report assignment from a UW-Madison bacteriology course.
We will be using a format for the lab reports which is similar (but modified) to formats for scientific papers. That is, you must include an abstract, introduction, materials and methods section, results section, discussion, and literature citations. Your grade on the reports will depend on completeness, scientific accuracy and insight, organization, and writing skills. We will discuss this more in lab. We expect lab reports to be prepared using modern word-processing programs.

The format is as follows - point totals for each section are for a 100 point report. For partial or 150 point reports they will be adjusted as needed.
1. Abstract of experiment. (10 points)
This is a summary of the basic content of the experiment. It should state the purpose of the experiment, mention the techniques used, report results obtained, and give conclusions. The point of the abstract is to give a concise summary of the whole report. The most common mistake that students make is not including summary data. Example:

Chromosomal DNA was successfully isolated from Bacillus subtilis strain 151 using a modification of the Marmur technique. Spectrophotometric analysis revealed some contamination with protein, but little RNA contamination. The pure DNA had a concentration of 1.05 mg/ml with a 10.3 mg total yield. The DNA was sterile, as judged by streaking onto penassay agar.
2. Introduction. (20 points)
An introduction gives focus to the report similar to the "Purpose" written in the lab notebook, but also should put the experiment into context and provide the reader with information necessary to understand the scientific basis of the experiment and the techniques used. In most cases, you should include background information on the organisms used and explain the theory behind the techniques. Much of the introductory material should be referenced and references have been put on reserve for you at Steenbock Library. You are encouraged to also search the library for other relevant references.
3. Materials and Methods. (30 points)
This is a section which will be a major deviation from scientific papers. Instead of asking you to tediously rewrite all your lab notes into a materials and methods format, we instead want you to include your lab notes in lieu of materials and methods. The lab notes should be complete, including all raw data, observations, calculations and appropriate graphs.

We do not expect (nor do we want) rewritten notes.
4. Results. (15 points)
Separate from the lab notes, include a section containing a summary of the final data, presented in a form that is most useful for interpreting the results. A short paragraph should be sufficient, along with any relevant charts and graphs labeled well. Remember to title and provide legends for all graphs and tables. The graphs and tables should be comprehenable independently of their association with the text.
5. Discussion. (25 points)
Discuss the experiment and the results obtained. This does not mean you simply report the results again, but rather interpret and discuss their significance. Results should also be compared with those in the literature, if possible. (Be sure to give proper citations). If problems were encountered during the course of the experiment, how might they be rectified in the future? Are there any other things we could do to make this a better experiment or to more specifically address the initial question posed? Are there any better techniques available that would allow one to more accurately generate data? Is there more than one way to explain the results? Your results may support your initial hypothesis, but there may be more than one conclusion that could be drawn from your results. Lastly, do not spend enormous amounts of time explaining data that cannot be explained!
6. Reference Citations
As required in all scientific literature, statements of fact, not considered "common" knowledge, must be properly referenced. Relevant articles for each of our experiments are on reserve in Steenbock Library.

Give complete citations of all literature cited in the report. What's complete? Here are some examples:

Articles in Journals:

Marmur, J. 1961. A procedure for the isolation of deoxyribonucleic acid from

microorganisms. J. Mol. Biol. 3:208-218.

Articles in Books:

Coakley, W.T., A.J. Bates and D. Lloyd. 1977. Disruption of bacterial cells. p279-341. In A.H.

Rose and D.W. Tempest (ed.), Advances in Microbial Physiology, Vol. 16. Academic Press, London and New York.

Tim Paustian
Department of Bacteriology
University of Wisconsin-Madison

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Below is a sample lab report assignment from a UW-Madison bacteriology course. We will be using a format for the lab reports which is similar (but modified) to formats for scientific papers. That is, you must include an abstract, introduction, materials and methods section, results section, discussion, and literature citations.

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Utilizar un juego en línea para reforzar los conceptos aprendidos en clase sobre la Norma 17025.

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conceptos basicos acerca de la norma ISO 17025

Creada por

1. Edgar Alejandro Lema Hoyos

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Recursos educativos (Test): ISO 17025 (calidad) - conceptos basicos acerca de la norma ISO 17025