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GDPR recognition in Jordan

No, the countries considered as providing adequate protection are listed by the EU Commission and currently are Andorra, Argentina, Canada (commercial organizations), Faroe Islands, Guernsey, Israel, Isle of Man, Japan, Jersey, New Zealand, Switzerland, and Uruguay.Adequacy talks are ongoing with South Korea.

You can verify the list at the following link: https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/adequacy-decisions_en

Of course, data transfers to or from Jordan can be based on Standard Contractual Clauses (SCC). You will need a data protection agreement between the controller and the processor with the SCC included.

Here you can find a free template of Standard Contractual Clauses as required from the EU Commission:

• Standard Contractual Clauses Annexes Download free template (MS Word) https://info.advisera.com/eugdpracademy/free-download/standard-contractual-clauses-annexes

Here you can find more information:

• 3 steps for data transfers according to GDPR https://advisera.com/articles/3-steps-for-data-transfers-according-to-gdpr/
• Free webinar – How to make personal data transfers to other countries compliant with GDPR https://advisera.com/webinars/how-to-make-personal-data-transfers-compliant-with-gdpr-free-webinar-on-demand/

To have a deeper idea of the list of requirements of GDPR you can consider enrolling in our free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

ISO 17025 latest version

If your question relates to laboratories that are currently accredited to ISO 17025:2005, currently the certificates of accreditation to the 2005 version are valid; however accredited laboratories must transition before their certificate expires or by the latest, 1 June 2021. Accreditation bodies will arrange assessments against ISO17025:2017 before the deadline. That means that they need to be in the process of meeting ISO 17025:2017 requirements; thus making the old version of the Standard obsolete.

If you are busy implementing ISO 17025 and have not yet applied for accreditation, then no, ISO 17025:2005 is not applicable. The laboratory must implement to meet ISO 17025:2017 requirements.

For further information see

• The whitepapers
  Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/
  Checklist of mandatory documents required by ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/checklist-of-mandatory-documents-required-by-iso-17025
• The ISO 17025 Toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/
• The ILAC News (11 June 2020) at https://ilac.org/latest_ilac_news/transition-period-for-iso-iec-17025-extended/

Implemantation of 17025

If you are referring to the Complaints procedure being separate from the Nonconformance and corrective action procedure, yes of course it can be separate. Laboratories generally combine documented procedures where possible to reduce the number of documents, however it is your choice; as long as it is effective and efficient to do it that way.

ISO 17025 has a requirement that you have a description of the complaint handling process that can be given to a complainant or other interested party. This could be a basic process flow diagram or a simple, clear step by step explanation. Because there is a need for this, you could as an option include any other information; which you want to keep for inhouse knowledge only; either in the quality manual section on complaints, or in a combined Complaints, Noncorformance and corrective action procedure.

The following may be of interest:

• The whitepapers
  Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/
  Checklist of mandatory documents required by ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/checklist-of-mandatory-documents-required-by-iso-17025
• The toolkit Complaint, Nonconformity and Corrective Action Procedure at https://advisera.com/17025academy/documentation/complaint-nonconformity-and-corrective-action-procedure/

Planning a gage R&r Studies for all instruments

It would not be correct to carry out the classical Gauge R&R study for measurement systems where human influences and errors do not occur due to the measurer.

Instead, it may be more accurate to perform bias, linearity, and/or stability studies with master samples. 

List of certifying bodies for ISO 13485

Here on this link are notify bodies that are so far accredited for MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

This means that they also have accreditation for ISO 13485. On this list, you have 6 notify bodies from Germany.

For more information on choosing a certification body, please see following:

• How to choose a certification body https://advisera.com/blog/2021/01/11/how-to-choose-an-iso-certification-body/

• Certification of QMS

  Yes, you are right, in the MDR there is no request that the quality management system must be certified. But, as I told yesterday on the webinar, the quality management system will be audited together with the MDR audit. So, once you will receive the MDR certificate it will mean that you have implemented and maintained the quality management system. For more information, see:

  • EU MDR Article 5 – Placing on the market and putting into service https://advisera.com/13485academy/mdr/placing-on-the-market-and-putting-into-service/
  • EU MDR Article 10 – General obligations of manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/

  • Need for ISO 13485 certification for PRRC

    ISO 13485 is a standard for manufacturing medical devices. So, this is not applicable to you. Your company can be certified according to ISO 9001. However, you need to have proof that you are familiar with ISO 13485. This you can obtain by attending a course for ISO 13485 or become a Lead auditor or internal auditor for ISO 13485.

    In MDR, in Article 15 – Person responsible for regulatory compliance is stated which competencies this person need to have a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.

    For a detailed explanation, see:

    • EU MDR Article 15 https://advisera.com/13485academy/mdr/person-responsible-for-regulatory-compliance/

    • ISO 14001 requirements for GreenHouse Gas

      By GHG you mean GreenHouse Gas.

      Specific requirements about GHG will depend on compliance obligations from country to country. For example, European countries within the European Union have to comply with a regulation stating requirements like these:

      • Control on the use of refrigerant substances or fluids that contain greenhouse gases
      • Survey of equipment with refrigeration systems, identification of fluorinated greenhouse gases, and verify whether or not it is a controlled substance
      • Survey of refrigerant quantities / Preparation of inventory of equipment that may contain GHG
      • Compliance with the Plan for annual verification of equipment with a quantity of regulated refrigerant equal to or exceeding 5 ton CO2 eq.
      • Verification carried out by certified technician/entity, the existence of records
      • Annual data communication to national environmental Agency until the end of the 1st quarter.

       

      Please consider the following information:

      • What is evaluation of compliance and how to do it according to ISO 14001? - https://advisera.com/14001academy/blog/2020/12/01/what-is-evaluation-of-compliance-and-how-to-do-it-according-to-iso-14001/
      • Environmental performance evaluation - https://advisera.com/14001academy/blog/2015/07/06/environmental-performance-evaluation/
      • How to perform communication related to the EMS - https://advisera.com/14001academy/blog/2015/08/31/how-to-perform-communication-related-to-the-ems/
      • Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
      • Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/

    • Internal audit schedule

      I agree with you that all processes feel important. However, according to requirement 4.1.2, it is necessary to apply a risk-based approach to control the appropriate process. So risk approach can be your guideline to decide the priority of your processes for internal audits. First of all, manufacturing is the most important process. Then is purchasing because you need to be sure that the purchase of raw material and packaging is under control. If you have a sterile medical device, the sterilization process is definitively an important process.

      For more information on this topic, please see the following articles:

      • Five main steps in the ISO 13485:2016 internal audit https://advisera.com/13485academy/knowledgebase/five-main-steps-in-the-iso-134852016-internal-audit/
      • How to create a checklist for an ISO 13485 internal audit for your QMS https://advisera.com/13485academy/knowledgebase/how-to-create-a-checklist-for-an-iso-13485-internal-audit-for-your-qms/
      • Five Main Steps in ISO 9001 Internal Audit https://advisera.com/9001academy/knowledgebase/five-main-steps-in-iso-9001-internal-audit/

      • Continual improvement

        Continual improvement is a recurring activity to enhance performance. One can see evidences of continual improvement when we see establishing more demanding environmental objectives, when we see effective corrective actions to minimize or eliminate non-conformities or to improve performance trends. One cannot improve all parts of an environmental management system (EMS) at once, there are not enough resources and there are different priorities. So continual improvement is used to systematically improve different processes within the EMS in order to provide improvements overall according to resources available and priorities.

        You can find more information below:

        • How to achieve continual improvement of your EMS according to ISO 14001:2015 - https://advisera.com/14001academy/blog/2016/02/22/how-to-achieve-continual-improvement-of-your-ems-according-to-iso-140012015/
        • Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
        • Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/