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Project to implement ISO 27001

How to propose and sell to our client the project to implement ISO 27001?
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I suggest you use as a basis for your proposal our free template "Project proposal for ISO 27001 / ISO 22301 implementation". You can download a copy at this link: https://info.advisera.com/27001academy/free-download/project-proposal-for-iso-27001-iso-22301-implementation-msword)

Additionally, you can prepare a presentation based on the template "Project proposal for ISO 27001 implementation". You can download a copy at this link: https://info.advisera.com/27001academy/free-download/project-proposal-for-iso-27001-implementation-powerpoint

This material is a presentation to show them clearly and succinctly why this project is important for their company.

Validation Procedure

No, our pack does not include a Validation procedure. It is covered in the procedure 11_Procedure_for_Production_and_Service_Provision_Premium_EN, under section 3.2.3.

Since processes that need validation are very different it is not possible to make a uniform procedure for them all. Also, some processes have their own rules and standards on how validation must be performed (eg. each type of the sterilization has its own standard for the validation:

• ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation, and routine control of a sterilization process for medical devices
• ISO 11137-1:2006(en) - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

For more information on validation, you can see the following articles:

• Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
• Production and service provision process in ISO 13485 - https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

• ISO 14001 Ciclo de vida de um produto complexo

  Não creio que seja possível estipular uma abordagem standard, cada caso é um caso. Sugiro que para um produto complexo se desenhem círculos de influência e se trabalhe primeiro ao nível dos componentes sobre os quais se tem maior poder ou influência junto de fornecedores ou distribuidores.

  Talvez esta informação seja útil:

  • How does product life cycle influence environmental aspects according to ISO 14001:2015? - https://advisera.com/14001academy/blog/2016/03/21/how-does-product-life-cycle-influence-environmental-aspects-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 – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/

• Lista contatti crm

  Da un punto di vista di stretta compliance, non dovreste usare contatti se non siete certi che tali contatti siano stati acquisiti in modo conforme alle normative sulla privacy previgenti. Infatti, il principio di accountability richiede che il titolare del trattamento sia in grado di dimostrare la conformità. Tuttavia, le Autorità di Controllo sanno perfettamente che il principio di accountability è stato introdotto dal GDPR ed è possibile chiedere il consenso ai clienti e lead presenti nel proprio database. La struttura dell’email dovrebbe essere inversa rispetto a quella indicata nel messaggio.

  Dovreste dire qualcosa del tipo: “Le scriviamo perché in passato è stato in contatto con noi, come cliente o lead, le chiediamo il consenso a contattarla per le seguenti finalità (marketing, newsletter, promozioni, etc., ricordatevi di inserire scopi che effettivamente andrete a raggiungere e non abbondare, perché il Garante non approva che si chieda il consenso per più cose rispetto a quelle che effettivamente si svolgono). Se vuole rimanere in contatto con noi, per favore compili il seguente form. Naturalmente potete personalizzare il messaggio, questo è solo un esempio della struttura.

  L’articolo 12 GDPR, infatti, richiede che ogni informazione data all’interessato del trattamento deve essere data in modo conciso, trasparente, intellegibile e facilmente accessibile, usando un linguaggio chiaro e semplice.” Bisogna anche ottenere il consenso prima di iniziare il trattamento dei dati. Pertanto la struttura è: informazione  consenso  trattamento dati.

  Qui potete trovare alcuni articoli interessanti:

  • Quattro domande principali per ottenere e gestire il consenso degli interessati ai sensi del GDPR https://advisera.com/eugdpracademy/it/knowledgebase/quattro-domande-principali-per-ottenere-e-gestire-il-consenso-degli-interessati-ai-sensi-del-gdpr/
  • Email marketing in the era of GDPR – How to ensure compliance? https://advisera.com/eugdpracademy/blog/2019/05/27/gdpr-and-email-marketing-rules-for-compliant-campaigns/

  Puoi considerare l'iscrizione al nostro corso gratuito:

  • EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//  

  • EU medical device regulation

    From the EU point of view, you do not need to be certified according to the ISO 13485. However, the FDA has in 2018. decide to harmonize and modernize the Quality System Regulations (QSR) under 21 CFR Part 820 to more closely align with the international ISO 13485:2016. This decision was due to the fact that ISO 13485 quality standard forms the basis for quality management system requirements in the European Union, Japan, Canada, and other medical device markets. The latest information that is published is that the FDA plans to issue a notice of proposed rulemaking in October 2020. 

    So, please check regularly FDA page because the final answer is expected at any moment. 

    In the meantime, the following articles can be useful:

    • What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
    • How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
    • Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
    • Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/

    If you will need any other assistance with ISO 13485:2016 assistance, please do not hesitate to contact us.

  • ISO 13485:2016 - Complaints Handling

    According to the ISO 13485:2016, section 3 Terms and definitions complaint is written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device or related to a service that affects the performance of such medical devices. 

    Please be careful here with understanding, because sometimes the medical device is service, like installation of service of a medical device in case of some malfunction or break.

    So, information from the customers on late deliveries, wrong billing, and similar can be considered as feedback. 

    For more information regarding customer complaints, please see the following articles:

    • How to comply with ISO 13485:2016 requirements for handling complaints https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/
    • Effective complaints management in a QMS https://advisera.com/9001academy/blog/2014/09/16/effective-complaints-management-qms/

    • ISO 9001 implementation steps

      Key steps to successful ISO 9001 implementation? 

      Answer:
      Please check this 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/

      • Perhaps these articles are also useful:
        Checklist of ISO 9001 implementation & certification steps - https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
      • ISO 9001 Implementation diagram - https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram

      How improve a Customer Centricity culture? 

      Answer:

      • Customer centricity is wording not seen in ISO 9001:2015. What we can see are customer focus, interested parties, and customer satisfaction. Perhaps these articles can help:
      • Handling customer satisfaction with code of conduct and complaints procedure -https://advisera.com/9001academy/blog/2014/07/15/handling-customer-satisfaction-code-conduct-complaints-procedure/
      • How the ISO 9001:2015 standard can help improve relationships with your customers -https://advisera.com/9001academy/blog/2016/02/23/how-the-iso-90012015-standard-can-help-improve-relationships-with-your-customers/
      • Main elements of handling customer satisfaction in ISO 9001 - https://advisera.com/9001academy/blog/2014/07/01/main-elements-handling-customer-satisfaction-iso-9001/

      One of the major reasons for implementing ISO 9001:2015 is to enhance customer satisfaction. Customer satisfaction (clause 9.1.2) is about focusing (clause 5.1.2) on target customers’ needs and expectations (clause 4.2)

      About KPIs, Where should we start to measure?

      Answer:
      Please check this free webinar on-demand – Measurement, analysis, and improvement according to ISO 9001:2015 -https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/

      Tool to fix Bad habits? 

      Answer:
      Unfortunately, I cannot recommend any easy fix for that. Just promoting the critical spirit of people, and inviting participation for empowering.

    • ISO 14001- handling required training and teamwork during COVID-19

      I see organizations:

      • doing more “on the job training”
      • using smaller training groups with more space between people
      • doing training in smaller groups and in the open air

      Not so common with environmental topics, but I also see organizations using online training much more. One interesting experience I had with environmental topics was about using a game to train people in waste segregation at a shop floor.

      You can find more information and examples below:

      • How to organize a training program for ISO 14001 - https://advisera.com/14001academy/blog/2019/10/08/iso-14001-training-program-organize-it-in-6-simple-steps/
      • Free webinar on demand - ISO 14001: Identification and evaluation of environmental aspects - https://advisera.com/14001academy/webinar/iso-14001-identification-and-evaluation-of-environmental-aspects-free-webinar-on-demand/
      • 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/

    • ITIL - Change Management

      Change Manager is usually the person who will provide inputs for PIR.
      This is the article with more details about PIR "Post Implementation Review – Buzzword, or mighty tool?“ https://advisera.com/20000academy/blog/2015/02/03/post-implementation-review-buzzword-or-mighty-tool/
      And, this free webinar can help you generally with Change management "An overview of the ITIL Change Management Process“ https://advisera.com/20000academy/webinar/an-overview-of-the-itil-change-management-process-free-webinar-on-demand/