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KPIs related to consultancy

From your question, I do not know what kind of consultancy team you need. In my opinion, in defining KPIs, the best is to start from the end, what does your organization want from the consultancy team, and in what time period. To give you more advice, I need to have more data about what kind of consultancy team you need. 

The following articles can help you:

• How to define Key Performance Indicators for a QMS based on ISO 9001 https://advisera.com/9001academy/24/define-key-performance-indicators-qms-based-iso-9001/-iso-9001/
• ISO 9001 document template: Matrix of Key Performance Indicators - https://advisera.com/9001academy/documentation/matrix-key-performance-indicators/
• How to choose an ISO 9001 consultant https://advisera.com/9001academy/blog/2019/11/12/iso-9001-consultant-how-to-hire-the-right-one/
• How to choose a consultant for ISO 13485 implementation https://advisera.com/13485academy/blog/2019/04/04/how-to-choose-a-consultant-for-iso-13485-implementation/
• Free webinar - How to sell ISO consulting services https://advisera.com/14001academy/webinar/how-to-sell-iso-consulting-services-free-webinar-on-demand/

• First in Human Feasibility Study (4 to 8 patients) conducted prior to ISO 13485 Certification

  You can conduct, prior to the ISO 13485:2016 certification, first in human feasibility study according to the Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-device-exemptions-ides-early-feasibility-medical-device-clinical-studies-including

  This way you will be sure that your medical device has proper intended use and be sure that it is a medical device. After you get that approval, you can go to the ISO 13485:2016 certification. However, certain steps in this feasibility study will be covered by requirement 7.3 Design and development, so be sure that you have records of each step that is required. 

  For more information on managing the design, please see the following link:

  • How to manage design and development of medical devices according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/<

  Also, you can see how records about design and development look lin in ISO 13485:2016 Documentation toolkit on the following link:

  • Design and Development File - https://advisera.com/13485academy/documentation/design-and-development-file-iso-13485-2016/

  • MANAGING RECORDS KEPT ON THE BASIS OF THIS DOCUMENT

    Please note that this section consolidates information about how to handle records mentioned in the content of the document (e.g., who is responsible for them, where they are stored, for how long they need to be kept, etc.). This information is needed to help fulfill requirements from section 7.5 of the standard (Documented Information).

    So our recommendation is for you to keep this section (the alternative would be to include the above-mentioned information in the place where the record is mentioned, what would turn the document more complex to read).

    This article will provide you a further explanation about documents:

    • How detailed should the ISO 27001 documents be? https://advisera.com/27001academy/blog/2014/09/22/detailed-iso-27001-documents/

    This material will also help you regarding document management:

    • Managing ISO Documentation: A Plain English Guide https://advisera.com/books/managing-iso-documentation-plain-english-guide/

  • Incident Management - Capturing the incident

    First is important to note that ISO 27001 only requires incident management related documents and records if controls from section A.16 are stared as applicable in the Statement of Applicability.

    Considering that, provided that your implemented solution (help desk system) fulfills the standard's requirements for incident management, you do not need to implement a specific incident management form.

    These articles will provide you a further explanation about the incident management:

    • How to handle incidents according to ISO 27001 A.16 https://advisera.com/27001academy/blog/2015/10/26/how-to-handle-incidents-according-to-iso-27001-a-16/
    • Using ITIL to implement ISO 27001 incident management https://advisera.com/27001academy/blog/2015/11/10/using-itil-to-implement-iso-27001-incident-management/t/

  • Copyright design

    8.5.3 it is applicable because certified organizations should take care and protect customers’ intellectual property.

    7.5.3 may be applicable because of the need to control relevant documents of external origin.

    The following material will provide you more information:

    • Managing Production and Service Provision using ISO 9001 - https://advisera.com/9001academy/blog/2017/11/21/managing-production-and-service-provision-using-iso-9001/
    • What does “external documents control” mean in ISO 9001? - https://advisera.com/9001academy/blog/2019/02/04/what-does-external-documents-control-mean-in-iso-9001/
    • Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
    • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

  • 2-factor authentication for Virtual Private Network

    ISO 27001 does not prescribe the use of 2FA on VPNs. To identify if such implementation is needed you have the verify the results of risk assessment and applicable legal requirements (e.g., laws, regulations, and contracts), to see if such implementation will properly treat relevant risk, or fulfill legal clauses.

    These articles will provide you a further explanation about the selection of controls and 2FA:

    • The basic logic of ISO 27001: How does information security work? https://advisera.com/27001academy/knowledgebase/the-basic-logic-of-iso-27001-how-does-information-security-work/
    • How two-factor authentication enables compliance with ISO 27001 access controls https://advisera.com/27001academy/blog/2017/01/16/how-two-factor-authentication-enables-compliance-with-iso-27001-access-controls/

  • Signatures in documents

    ISO 27001 does not prescribe signatures for documents, only that documents are approved before use. Considering that, provided you can ensure that documents content, in physical or electronic format, are approved before use you can adopt any approach you see fit (e.g., signing the front page of each document, keeping electronic versions of approved documents in a specific folder, etc.).

    Signing a single document for all processes like you suggested is acceptable but not recommended, because users of documents won't be able to easily check if the document they have on hand is an approved version (signing the front page, or use of specific electronic folder,  are examples which provides a balance between the need for signing and easiness of approval verification)

    This material will also help you regarding document control:

    • Managing ISO Documentation: A Plain English Guide https://advisera.com/books/managing-iso-documentation-plain-english-guide/

  • ISMS scope document

    1. What is to be included in the scoping document beyond simply stating the locations that are 'In-scope for the ISMS?

    The most important information to be included in the ISMS scope is the information the ISMS is intended to protect. Information like location, processes, or business units included in the scope helps clarify the scope.

    To see how an ISMS scope document looks like, I suggest you take a look at the free demo of our ISMS scope document at this link: https://advisera.com/27001academy/documentation/isms-scope-document/

    For more information, see:

    • How to define the ISMS scope https://advisera.com/27001academy/knowledgebase/how-to-define-the-isms-scope/
    • Problems with defining the scope in ISO 27001 https://advisera.com/27001academy/blog/2010/06/29/problems-with-defining-the-scope-in-iso-27001/

    2. and when does this document need to be created - before the Project Plan Is signed off?

    The ISMS scope is created after the Project Plan is signed off.

    This article will provide you a further explanation about ISO 27001 implementation steps:

    • ISO 27001 implementation checklist https://advisera.com/27001academy/knowledgebase/iso-27001-implementation-checklist/

    This material will also help you regarding ISO 27001:

    • ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

  • Is the book still compliant with the latest amendment of ISO 22301?

    At this moment we are working on updating the book according to the 2019 version of ISO 22301 (to be released soon), but we already can say that this new version of the standard has fewer changes in terms of additions (reviewers work heavily on making ISO 22301 lighter in terms of documentation requirements)

    These articles will provide you a further explanation about changes in new ISO 22301:

    • Infographic: ISO 22301:2012 vs. ISO 22301:2019 revision – What has changed? https://advisera.com/27001academy/blog/2019/12/02/iso-22301-2019-vs-iso-22301-2012-key-changes-infographic/
    • Do we need to make the transition from ISO 22301:2012 to the 2019 revision? https://advisera.com/27001academy/blog/2019/11/05/iso-22301-transition-from-2012-to-2019-revision-is-it-needed/

  • ISO that regulates the Guideline from the application of ISO 17025

    Your questions is not very clear to me. If you are asking if there are any other ISO standards that require mandatory ISO 17025 accreditation, as part of their requirements; then the answer is no. There are a number of standards or programmes, either mandatory or voluntary for certain sectors, that may require that any required testing or calibration activity is performed by an ISO 17025 laboratory. An example is GLOBALG.A.P. - The Worldwide Standard for Good Agricultural Practices.

    ISO 17025 is part of the Conformity assessment family of standards (ISO 17000 family), however each has it’s own specific purpose. ISO 17025 promotes confidence in the operation of laboratories through a guideline of requirements to support the competence, impartiality and consistent operation of laboratories. Accreditation bodies attest to the competency of laboratories through the process of accreditation.