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  • Changing calibration frequency

    A Calibration record is used to record the Calibration Dates. This is available as part of the Advisera ISO 17025 Toolkit as 08.3_Appendix_3_Calibration_Record. Then you should record the decision in your Registry of Key Risks and Opportunities, provided as part of the Advisera ISO 17025 Toolkit as 05.1_Appendix_1_Registry_of_Key_Risks_and_Opportunities.

    One risk I suggest you consider is financial risk of such a frequent calibration interval. I do not know what type of field testing you do, however you refer to temperature. It seems unnecessary to have such a frequent calibration of a thermometer or thermocouple device (depending on factors such as handling / stability), as typically for a testing laboratory you will calculate you MU based on the most recent calibration certificate for equipment used. Then you include your method imprecision during repeated use of the device in the field.

    For more information see:
    The answer to a question on calibration intervals, Re-calibration time at https://community.advisera.com/topic/re-calibration-time/, which includes links to resources.
    The ISO 17025 document template Equipment and Calibration Procedure available at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure/

  • 15.1. Control Document

    The template Supplier Security Policy was developed to also cover control A.15.1.3 (on sections 3.1 – Identifying risks, and 3.3 - Contracts).

    To take a look to see if it can fulfill your needs, please access the free demo in this link: https://advisera.com/27001academy/documentation/supplier-security-policy/

    This article will provide you a further explanation about supplier security:
    - 6-step process for handling supplier security according to ISO 27001 https://advisera.com/27001academy/blog/2014/06/30/6-step-process-for-handling-supplier-security-according-to-iso-27001/

  • Lab Software

    I am wondering if you could tell me which standards would be required for a piece of lab software. The software tracks actions include cell culture trees, electronic lab notebook, cell line inventory, collaboration, and gene sequencing capabilities.

  • CAN I EXCLUDE CHAPTER 8.3 ON DESIGN AND DEVELOPMENT FROM THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM?

    According to your description, and if your quality management system’s scope includes only this kind of service to clients, I think that clause 8.3 is not applicable.

    For more information about exclusion consider the following:

  • PUEDO EXCLUIR DEL ALCANSE DEL SISTEMA DE GESTION DE CALIDAD EL CAPITULO 8.3 DE DISEÑO Y DESARROLLO

    Si su empresa no hace ninguna modificación en el diseño, simplemente lo verifica entonces podría excluir el requisito 8.3 de diseño y desarrollo. Sin embargo, si su organización hace alguna modificación del mismo debería de incluir el diseño y desarrollo dentro del alcance de su SGC.

    Para más información sobre la aplicabilidad de la cláusula de diseño y desarrollo, vea los siguientes materiales:

    - What clauses can be excluded in ISO 9001:2015: https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/

    - ISO 9001 design process explained: https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/

    - Curso de fundamentos de la norma ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

    - Libro - Discover ISO 90001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

     

  • LSA

    The Leading Supervisory Authority (LSA) is the Supervisory Authority that a data controller selects when is established in more than one Member State. So if your company is based in the EU, your Supervisory Authority will be the Data Protection Authority of the Member State where your EU company is established (i.e. Ireland). If you are established in more than one Member State (i.e., Ireland and France), you can appoint the Irish Data Protection Authority as your LSA and inform the French Data Protection Authority about it.

    Here you can find more information about the LSA:

    You can also consider enrolling in this free EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course/

  • ISO 45001 in a virtual or hybrid work environment

    As an international standard that is applicable to any organization of any size anywhere in the world, ISO 45001 is written in such a way that the requirements are descriptive but not prescriptive; meaning the requirements tell you what needs to be done for the processes of the OHSMS, but not how to do the processes. As such, there is a lot of flexibility in how you meet the requirements in any particular organization to allow for differences in industry or legal requirements among other variations.

    SO, a virtual or hybrid working environment is one of these variables that can be accommodated. For instance, ISO 45001 asks you to identify the hazards and OH&S risks in your organizational processes, and you would need to consider the virtual or hybrid working environment and identify the hazards in this way of working. You can then identify the unique controls for your working processes. This is true for all requirements of ISO 45001.

     

    You can learn more about the requirements for the OHSMS in ISO 45001 in a plain English fashion in our whitepaper: Clause-by-clause explanation of ISO 45001:2018, https://info.advisera.com/45001academy/free-download/clause-by-clause-explanation-of-iso-45001

  • What is the acceptable range of RH for a laboratory? 

    Specific requirements are determined by tolerance is specified in test methods being performed and or regulatory requirements depending on the test or calibration sector.  The two primary factors in creating an ideal laboratory condition are temperature and humidity. Note that often with the use of air conditioners, there is a drying effect and relative humidity is reduced. 
    Laboratories should be equipped with suitable climate and ventilation control. The laboratory must look at risks – personnel comfort and risk to validity or results. The starting point is that the temperature and humidity must be kept within limits for the proper performance of each test performed and according to the manufacturer’s specifications for the proper operation of equipment.

    Certain organisations, such as the FDA in the USA, have guidelines for general conditions. For example, a comfortable working environment is considered 20 to 25 Degrees Celsius with a relative humidity, depending on geographical area, of 35 to 50%.

    For more information, see the Advisera ISO 17025 toolkit Facilities and Environmental Condition Procedure at https://advisera.com/17025academy/documentation/facilities-and-environmental-condition-procedure/

    For more information and links to Advisera resources, have a look at a similar topic Environmental conditions for testing and calibration laboratories at https://community.advisera.com/topic/environmental-conditions-for-testing-and-calibration-laboratories/

  • Measurement uncertainty and lab validation

    You asked

    "If tests come with accepted tolerance ranges do you still do measurement uncertainty?

    I assume, based on you next question you are referring to a Standard test method. ISO 17025 states in clause 7.6.3, note 1 that if a laboratory follows a well-recognized test method that specifies limits to the values of the major sources of measurement uncertainty and specifies the form of presentation of the calculated results; and the laboratory follows reporting instructions, the laboratory is considered to have satisfied requirements of clause 7.6.3 to evaluate measurement uncertainty. So if this is the case, you will not need to perform MU as a testing Laboratory. Note that in all cases however you need to assess the risk of misrepresenting the results to clients. Furthermore calibration laboratories must always report the MU on a calibration certificate.

    You also asked

    Also if you use international standards which are validated already do you still need to validate the method in the lab?"

    You must meet the requirements of ISO 17025:2017 Clause 7.2, meaning if it is standard method your extent of validation is to verify that your laboratory can meet the performance criteria of the standard test with you conditions of venue, equipment and personnel. This could be, for example the required sensitivity, specificity, or other parameters stated.  
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