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  • IS Cross Border Personal Data Transfer Procedure actual according to GDPR?

    If I correctly understand your question, you are asking if in your documentation you can mention the Directive 95/46/EC.

    As you correctly said, Directive 95/46/EC has been replaced by GDPR and it is not in force anymore. Therefore, it is not correct to mention Directive 95/46/EC in your documentation, you should refer to GDPR.

    GDPR does not mention “Data Importer” and “Data Exporter”, only the data controller and data processor.

    If you want to keep the definition of “Data Importer” and “Data Exporter” in your documentation, you should define it inside the GDPR framework (i.e. “Data Importer is a data processor under Article 28 GDPR which is located in a third country where the data are transferred with adequate safeguards according to Articles 44-50 GDPR”) and then you can keep using those definitions.

  • Procedures listed in equipment's manual

    1. 6.4.3 The laboratory shall have a procedure for handling, transport, storage, and use and planned maintenance of equipment, these procedures could they be the ones that listed in the equipment's manual? Or a procedure must be created according to the manual and the laboratory's policy?

    The mandatory requirement for ISO 17025:2017 is that your laboratory has a procedure and necessary records. I assume you are referring to you own equipment manual, which covers all your equipment. Yes, you could use you own equipment manual as your documented procedure and refer to the relevant sections of Suppliers manuals; as long as the references and information is up to date and controlled.

    Regarding your reference to “the laboratory's policy”, there is no need for a policy on management of your equipment. Your ISO 17025 management system must include an overall quality policy and specific objectives. How you meet the requirements for equipment management must be risk and opportunity based, to support your quality policy and to achieve your objectives.

    2. If the laboratory has a code of ethics and conducts, to which every employee signed his agreement to respect, does that prove the company's impartiality and confidentiality?"

    If the established code of ethics and conduct addresses the requirements to safeguard impartiality and confidentiality, this is evidence of management’s commitment to these topics. The purpose of a signed acknowledgment by an employee is to show that, firstly it has been communicated to them (again a requirement of management), they have received it and that they acknowledge the content of the code. Even if they declared by signing that they will abide by the code; this is not evidence of actual compliance with the policies. There is no objective evidence through acknowledging the code that impartiality and confidentiality is in fact upheld.

    Ensuring Impartiality and confidentiality is an activity that is ongoing. It is achieved through a process approach by knowing your process inputs and outputs and the factors that could affect your objective of safeguarding impartiality and confidentiality for every laboratory activity. Risk assessments should be performed upfront to identify and address any initial risks to impartiality and confidentiality. Then use surveillance activities such as audits, employee meetings/feedback and customer feedback on an ongoing basis to monitor compliance. Take appropriate action to mitigate any new or changed risks.

    For more information, have a look at the ISO 17025 Expert Advice Community answersAssuring impartiality and confidentiality - https://community.advisera.com/topic/assuring-impartiality-and-confidentiality/Compliance with the ISO/IEC 17025:2017 requirement for Impartiality - https://community.advisera.com/topic/compliance-with-the-isoiec-170252017-requirement-for-impartiality/Procedure for impartiality - https://community.advisera.com/topic/procedure-for-impartiality/

    Have a look to see how the following toolkit documents can assist you:Quality Policy, Quality Manual and procedure Addressing Risks and Opportunities.  Previews are available at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

  • SoA and selection of control A.11.2.9 Clear desk and clear screen policy

    1. How much there is room for modifying the procedure concerning the control, if there is only need for the clear screen policy but no need for a clear desk policy?

    The templates are fully editable, so you can modify them freely to fulfill your needs.

    2. Can one select the control as applicable on SoA and then write procedure concerning only the clear screen policy (or if required adapt the clear desk policy only concerning specific areas such as conference rooms, reception area, etc.?

    In a situation where you do not have relevant risks or legal requirements (e.g., laws, regulations, or contracts) related to the clear desk, you can write a procedure only related to a clear screen.

    You also can adapt the policy to have only a separate clear desk policy covering specific areas.

    But please note that separating the clear desk and clear screen in different policies does not make much sense and may add unnecessary administrative work to maintain both policies (most probably the places where you have information on both electronic and physical media will have sensitive information on both media, which can be treated by a single policy).

    This article will provide you a further explanation about the clear desk and clear screen:

  • How to become ISO/IEC 17025 certified and cost associated

    I do not know who can and how much it is to become certified 

    Please note that the correct term is accredited, not certified; as it involves formal recognition of competence.

    The process involves implementation of ISO/IEC 17025:2017 by establishing systems, processes and documentation; followed by evidence of implementation and maintenance in order to apply for accreditation.

    Accreditation involves contacting your national accreditation body or selecting one if you have a choice; application and then a competency assessment. The costs will depend on the accreditation body. You will need to request a quotation. In awarding accreditation, the accreditation body attests to your laboratory’s competence to provide consistently valid results through meet the requirements of 17025. An accreditation certificate, which details your scope of accreditation is then issued.

    how often we will need to be re-certified.

    There is an accreditation cycle of 4 to 5 years, with a number of followup assessments. The first is 6 to 12 months after initial accreditation is awarded. At the end of the cycle, a full re-assessment is made again (as if you were applying for the first time).

    Have a look at our free webinar on demand - What are the steps in the ISO 17025 accreditation process? It includes explanation of the application process, and the accreditation cycle, and is available at https://advisera.com/17025academy/webinar/what-are-the-steps-in-the-iso-17025-accreditation-process-free-webinar-on-demand/ 

  • EMS for wastewater treatment

    If you have a wastewater treatment that is operating effectively and complying with legislation and permits then develop an environment management system should be relatively straightforward.

    Start with a self-assessment compliance checklist to list the initial gaps between ISO 14001:2015 requirements and your organization’s current environmental practices and performance. As long as you have top management support, any sound environmental management system starts with a clear identification of environmental aspects and impacts and its evaluation, and with an identification of any compliance obligations. Then, you have to plan your implementation project about how to improve environmental aspects situations and meet your environmental objectives aligned with an environmental policy. For a wastewater treatment plant that is operating effectively your organization may have already implemented procedures for operation and control, for monitoring performance, for communicating performance to relevant interested parties, for preventing and responding to emergency situations.

    Please check this information concerning specifically wastewater treatment:

    If you are in a hurry to implement your environmental management system, perhaps our ISO 14001:2015 Documentation Toolkit - https://advisera.com/14001academy/iso-14001-documentation-toolkit/ can be useful.

    Please check this information below relevant for implementing an environmental management system::

  • ISO 14001 for all industries

    Yes, it is. According to ISO organization, ISO 14001:2015 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence considering a life cycle perspective.

     

    Please check below information about ISO 14001:2015:

  • Preparation to comply with ISO 27001:2018

    Please note that ISO 27001:2013 was last reviewed and confirmed in 2019, so the 2013 version remains current, without alterations.

    The document released in 2018 was ISO 27000, which is a supporting standard, covering Information Security vocabulary.

    Regarding preparation for ISO 27001 compliance, after getting support for your project (normally through approval of an ISMS project plan) and approval of a Procedure for Document and Record Control, you should consider these steps:

    1. defining ISMS basic framework (e.g., scope, objectives, organizational structure), by understanding the organizational context and requirements of interested parties;
    2. development of risk assessment and treatment methodology;
    3. perform a risk assessment and define the risk treatment plan;
    4.  controls implementation (e.g., policies and procedures documentation, acquisitions, etc.);
    5. people training and awareness;
    6. controls operation;
    7. performance monitoring and measurement;
    8. perform an internal audit;
    9. perform management critical review; and
    10. address nonconformities, corrective actions, and opportunities for improvement.

    This article will provide you a further explanation about ISMS implementation:

    To see how documents compliant with ISO 27001 looks like, I suggest you take a look at our ISO 27001 Documentation Toolkit at this link: https://advisera.com/27001academy/iso-27001-documentation-toolkit/

    These materials will also help you regarding ISO 27001 implementation:

  • Labeling Instruments with calibration information

    As far as I know, this requirement is from ISO/IEC 17025:2005(en) General requirements for the competence of testing and calibration laboratories.

    Since I am not the expert for this standard, for more information please see the following article:

    Also, you can see how some of the templates considering maintenance and calibration look like in our toolkit on the following link:

    For even more details, you can ask the ISO/IEC 17025 expert here: https://advisera.com/17025academy/free-consultation/

     

  • Clauses on document revisions and history

    As you know IATF 16949:2016 standard also covers ISO 9001:2015 requirements.

    ISO 9001: 2015 standard covers this subject. It is stated in section 7.5.2 Creating and Updating and 7.5.3.2 in the subparagraph c of control of changes section (e.g. version control).

    It is not necessary to keep the document history, but in practice, companies are applied for convenience.

    For more information, you can check out our IATF 16949:2016 Documentation Toolkit https://advisera.com/16949academy/iatf-16949-2016-documentation-toolkit/

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