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  • CE mark

    Yes we have a procedure for a Post-market surveillance system. You can see its preview on the following link:

    • Procedure for Post-Market Surveillance System https://advisera.com/13485academy/documentation/procedure-for-post-market-surveilance/

    • Method validation

      I recommend you refer to, for example the FAO (Food and Agriculture Organization of the United Nations) Validation of Analytical Methods For Food Control available from https://www.fao.org/. Also refer to your accrediiton body's requirements for your programme.

    • Responsibilities of an ISO 17025 lab about informing clients if its accreditation is in jeopardy

      It seems the situation refers to laboratory that was accredited and is able unable to keep accreditation for a method? In that case it is necessary to remove that activity from your scope. All accreditation bodies have all accreditation bodies have policies related to statements and claims that can be made regarding accreditation, and it is the responsibility of the laboratory to comply with those requirements.  The accreditation body must be informed. As ISO 17025 accreditation is an assurance to customers, it would be misleading not to inform them.

      There is however no regulation in 17025 that states that you must inform them.  Note what is required by 17025 is to comply with reporting requirements of clause 7.8,  so your statements and disclaimers on your report would need to change.

    • Where do requirements in the area of 'Specifying mandatory safeguards' go?

      Please note that this 'Specifying mandatory safeguards' refers to the SoA document as a whole, so it will not appear in a specific control. The user needs to read the specific requirement of interest related to this area to understand which exact control(s) is(are) required to be implemented. You can use the “Description of the requirement” to identify specific controls to be applied in the ISMS.

    • Query on ISO 17025

      You asked

      "I would like to enquiry in ISO 17025 there is one clause 8.7 corrective action. If we are to incorporate the requirement corrective action in our procedure of nonconformance SOP.

      it is practical to document the nonconformances and corrective action process in one SOP. A number of laboratories include handling complaints in the same SOP as well 

      You also asked

      Do we still need a corrective action and preventive action CAPA procedure ? As CAPA is a standard industrial practice, do we still need a CAPA?"

      CAPA is an acronym no longer used in ISO 17025 laboratories. This is because all corrective actions are intended to prevent a reoccurrence of the nonconformity. Preventive action does not follow the reactive corrective action. Preventive action is proactive, routinely dealt with as part of addressing risks in ISO 17025.

      Although it is not mandatory to have a procedure on how to address risks and opportunities, it is a recommended procedure. This is because performing quality risk assessments is still a new activity for many laboratory personnel.

      You can download the Diagram of the ISO 17025 Risk Management Process at  https://info.advisera.com/17025academy/free-download/diagram-of-the-iso-17025-risk-management-process

      and have a look at the article Corrective actions principles and root cause analysis in ISO 17025 at https://advisera.com/17025academy/blog/2020/11/04/corrective-actions-principles-and-root-cause-analysis-in-iso-17025/ for more information.

    • Equipment Handling

      The 17025 manual is written as a commitment of the laboratory that certain processes are in place to meet requirement and they are documented suitably with the necessary records to provide evidence of compliance. It is the documented procedure which provides more detail of the actual process.

      Quality management toolkit procedures vary in the detail they provide as the specific needs and precise process will vary from laboratory to laboratory. Toolkit procedures are a framework providing the overall procedure to meet the basic requirement of ISO 17025. The laboratory must decide if it is necessary to document the specific detail of a process followed in your workplace, or simply have the detail of the process established, communicated, understood and followed with additional documentation. This would depend on the need to standardise the process by considering the users (personnel),  complexity and sensitivity of the equipment, its use, and transport needs. If for example, fragile equipment needs to be used in the field, or transported by air, then it would be necessary to add the standardised process to the procedure. For example, the use of a padded aluminum case for transport. If a particular requirement is critical to control method validity risk, then records should also be available to prove the procedure was followed. This is typically a checklist or completed form.

      For more information see the Article What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/

    • Accreditation of ETL lab

      I assume you are referring to setting up an Environmental Testing Laboratories and you asking whether it's necessary to have equipment calibrated by a 17025 calibration laboratory ? It all depends on the performance requirement you need from that equipment and if you need to have a calculated measurement of uncertainty provided by the calibration laboratory. If the equipment has a big impact on the performance of your method, then it is recommended to have external calibration regularly followed by intermediate verification that you would perform in your own laboratory using certified standard.

      For more information, have a look at have a look at my response to a similar question at https://community.advisera.com/topic/calibration-of-laboratory-equipment/

    • Responsibilities of an ISO 17025 lab about informing clients if its accreditation is in jeopardy

      You asked

      "Does an ISO 17025 accredited lab have the responsibility to notify its clients if its accreditation is in jeopardy for whatever reason as noted in NEI14-05A (e): The customer must be notified of any condition that adversely impacts the laboratory’s ability to maintain the scope of accreditation. Is this type of statement in the ISO 17025 documentation or is it implied?"

      It seems the situation refers to laboratory that was accredited and is able unable to keep accreditation for a method? In that case it is necessary to remove that activity from your scope. All accreditation bodies have policies related to statements and claims that laboratories can make regarding accreditation. It is the responsibility of the laboratory to comply with those requirements.

      The accreditation body must be informed. As ISO 17025 accreditation is an assurance to customers, it would be misleading not to inform them. There is however no regulation in 17025 that states that you must inform them.  Note that what is required by 17025, is to comply with reporting requirements of clause 8.7 so your statements and disclaimers on your report would need to change.

    • Criteria to prove no significant difference on duplicate sample

      I am not informed about the details related to your method so I can only reply with a general comment. It all depends on the of the duplicates, the purpose of your method and the type of test that you perform.  The variation (imprecision) between duplicate results of a sample tested at the same time should be smaller than the longer-term imprecision of your method. What method performance is needed (e.g. sensitivity of calibration curve and long-term precision) must be based on client requirements and capability of the method. For example, the reason for duplicates, and acceptable level of imprecision and target measurement of uncertainty could be influenced by the sample matrix. The target performance either comes from your standard method, sector regulations or is established during method validation. 

      I suggest you look at resources related to your sector and basic statistical guidelines. For example, the Eurachem guidelines, available at https://www.eurachem.org/index.php/publications/guides are useful to assist with analytical measurement evaluation.

    • ISO 27001 Toolkit Support

      First is important to note that guidance provided by ISO 27002 is not mandatory to be implemented when implementing ISO 27001, so auditors cannot raise non-conformities based on ISO 27002 when auditing against ISO 27001.

      Specifically for control A.6.5 Responsibilities after termination or change of employment, the auditor needs to look for, and only for, responsibilities and duties defined for those that are no longer working for the organization, or that changed activity, how these are enforced, and how these are communicated to relevant personnel and interested parties (the Confidentiality Statement cover these requirements). It does not prescribe the development of a leaving procedure, nor which roles need to develop or review the way the control is implemented.

      Considering that, the comment "The leaving procedure of people is only technical; Must be reviewed with HR point of view." Can be at most an opportunity for improvement, not a non-conformity.

      As for the other situations you have, a tip for evaluating them is to compare the auditor’s comments considering only what is required by ISO 27001.

      This article will provide you with further explanation about nonconformities:

      These materials will also help you regarding internal audit:
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