Search results

Legal and statutory requirements

If you check ISO 9001:2015 clause 0.4 you can find something like: ISO 9001:2015 does not include specific requirements from what could be from other management systems like environmental management, Health and Safety or finance management.

So, when it comes to legal and statutory requirements an ISO 9001 certification auditor will check if your organization identified and complies with those that are applicable to your organization’s products or services and contracts with customers, and processes. For example, you may have to comply to legal requirements about the qualifications of someone doing a particular job or function.

The following material will provide you more information about ISO 9001:2015:

• Article - How to include statutory and regulatory requirements in your QMS - https://advisera.com/9001academy/blog/2017/02/14/how-to-include-statutory-and-regulatory-requirements-in-your-qms/
• Enroll for free course - ISO 9001:2015 Lead Implementer Course - https://advisera.com/training/iso-9001-lead-implementer-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

QMS in a town hall

No, it is not difficult to implement a quality management system in a town hall. The point is that one does not implement a quality management system generically to all activities of a town hall. One has to define the scope of activities to be included. For example, a town near where I live has the town hall certified with the following scope:

• Urban Solid Waste Collection;
• Management of the Eco-center and Transfer Station;
• Urban Hygiene and Cleaning;
• Maintenance of Green Spaces. 

The following material will provide you more information about ISO 9001:2015:

• Article - ISO 9001 – How to define the scope of the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
• Article – Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
• Free webinar on demand - Overview of ISO 9001 implementation steps - https://advisera.com/9001academy/webinar/overview-of-iso-9001-implementation-steps-free-webinar-on-demand/
• 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/
   

Involving employees in the implementation process

Ensuring employee participation and consultation is an important part of the ISO 45001 standard, but remember that this does not mean that every employee needs to be part of the implementation process. I would suggest that you have different departments decide on representatives to aid in the implementation, much like some joint health & safety committees are formed, as this would give all employees a voice in the implementation process and a contact for questions and feedback.

You can read more about the Iso 45001 requirements in the article: How to meet participation and consultation requirements in ISO 45001, https://advisera.com/45001academy/blog/2016/03/16/how-to-meet-participation-and-consultation-requirements-in-iso-45001/

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/