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  • Definição de escopo

    O escopo do Sistema de Gestão de Segurança da Informação (SGSI) pode ser definido em termos de informações, locais ou processos a serem protegidos. A definição por processos em geral é utilizada quando o escopo do SGSI envolve apenas parte da organização.

    Para maiores informações, vseja:

  • MDR Accessories

    1. If a part of a medical device is attached to the device, it becomes a component, but if the same part is provided separately to the user in order to fulfil the medical device`s intended purpose, it becomes an accessory. Is that correct?

    Yes, you are correct.   

    2. Considering the scope and requirements of the MDR, the components are a part of the medical device itself which goes through the certification process. If the components are manufactured in bulk, kept in stock, and attached to the final product to fulfil the orders requirements, is it required for them to have the date of manufacture on them, or would the date of manufacture provided on the medical device itself would suffice?

    The date of the manufacturer is optional and is put on the product only if there is no data for the expiry date. The expiry date of the medical device has to be the one that is shorter. So, if you have components that have an expiry date for example the 02/2022, and the medical device has the expiry date 10/2021, then the final expiry date will be 10/21. To ensure even more traceability, be sure that a lot of the component is visible.

    3. How about the accessories? Do they need to go through the same process as the medical device itself (e.g. have clinical evaluation, technical documentation, DoC, UDI, labelling in compliance with the MDR, PMS, etc.)? If in order to fulfil an order they are supplied separately and additionally to the medical device itself - in a separate bag, would the accessories need to have their CE mark, date of manufacture, and/or serial number on their label in order to be compliant, or is this not a requirement?

    If your product meets the definition of “accessory for a medical device” given in Article 2(2), then they are subject to all MDR regulatory requirements according to Article 1(1).

    For more information, see:

    • EU MDR Article 1 – Subject matter and scope https://advisera.com/13485academy/mdr/subject-matter-and-scope/
    • EU MDR Article 2 Definitions https://advisera.com/13485academy/mdr/definitions/

    • Appointing LSA

      If you are based in the UK and deliver digital services online without dealing with a specific EU country, you are free to select the country where to appoint the Lead Supervisory Authority (LSA). Verify if you need an EU representative so that you can select the Surveillance Authority based in the same country as your EU representative.

      Here you can find more information on the Lead Supervisory Authority:

      You can also consider enrolling in this free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

    • ISO Waste collection service

      This kind of question should be asked to certification bodies while determining the scope of the quality management system. According to my experience, different certification bodies have different interpretations. My answer is based on the specificity of the scope of the management system. If the scope is very clear and with "closed" borders, for example, collection of hospital waste, or collection of solid urban waste, clause 8.3 is not applicable. The service is already defined in advance.

      However, if the scope is more general and with "open" borders, for example, waste collection. Therefore, clause 8.3 is applicable. The company today may be doing the collection of solid urban waste and, later, decide that there is an interesting business opportunity and grow for the collection of a certain type of industrial waste. That service expansion must be designed with the help of clause 8.3.

      The following material will provide you more information about exclusions:

    • Validation and verification process

      It is true that the process of implementation whilst running a laboratory can be overwhelming. The toolkit along with the diagram of ISO 17025:2017 implementation process and the Project plan are great tools to assist you. The basic techniques for method validation as well as the required records are included in the toolkit. It is however the responsibility of the laboratory to choose the suitable technique, plan experiments, reference sector specific guidelines and meet specific regulatory and accreditation body requirements.  I agree it can be a challenge for those not yet experienced in these activities, when it comes to the technical skills or knowhow for activities such as method validation and assuring results through external proficiency testing.

      Let’s make this a smoother implementation for you - so I suggest we set up a remote consultation meeting, which is included in the toolkit package, to discuss the implementation challenges. Once I have a better understanding the specific tests you perform  I can provide some guidance within the scope of the consultation and point you to some further resources or support thereafter as needed.

    • Is Quality manual a mandatory requirement for ISO 17025?

      A Quality Manual is no longer a mandatory requirement for ISO 17025:2017. There are a number of reasons. One is that there is less requirement for stating policies on almost each activity, which was typically done in the manual. Another reason is that laboratories had different views on what the Quality Manual was and often it was found to not suite the purpose. Some laboratories considered it a collection of separate documents making up the QMS manual, whilst most a separate document, supported by separate procedures. In this last case, often it was too long and there was too much repeated between the manual and the specific procedures. Even worse, often contradictory policies and processes were documented. That said, if structured and written well, a Quality Manual is very useful and provides an efficient way to reference and interlink policies, systems, processes, documents and records of your management system. This interlinking is a requirement of ISO 17025 – see clause 8.2.4. The Advisera Quality Manual is structured to achieve that and guide personnel in awareness of how these processes interlink.

      For more information, read the whitepaper Clause-by-clause explanation of ISO 17025:2017, available for download from https://advisera.com/17025academy/free-downloads/ and preview the Quality Manual as part of the toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

      You may also benefit from reading these two articles in the ISO 9001 academy, which is also applicable to the concept of a Quality Manual in ISO 17025:

    • ISO 27001 and Job description

      I’m assuming that by Job Description you mean a document stating the essential job requirements, job duties, job responsibilities, and skills required to perform a specific role.

      Considering that, ISO 27001 does not prescribe the development of job descriptions, only that roles, responsibilities, and authorities related to information security are defined and communicated, and that required competencies (i.e., knowledge, skills, and experiences) are identified and gaps treated.

      These requirements are usually met by defining roles, responsibilities and authorities in various security policies and procedures; required competences are usually defined in a training & awareness plan.

      Such documents need to be approved by the top management, but not necessarily signed; on the employee side, there needs to be a proof that those were delivered - either through a document management system, or by signing a document where an employee confirms the documents are read.

      To see how a Statement of Acceptance of ISMS Documents looks like, please access the free demo of our template at this link: https://advisera.com/27001academy/documentation/statement-of-acceptance-of-isms-documents/

      This article will provide you a further explanation about roles and responsibilities:
      - How to document roles and responsibilities according to ISO 27001 https://advisera.com/27001academy/blog/2016/06/20/how-to-document-roles-and-responsibilities-according-to-iso-27001/

      These materials will also help you regarding roles and responsibilities:
      - Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
      - Free online training ISO 27001 Foundations Course https://advisera.com/training/iso-27001-foundations-course/

    • ISO 9001 and the QMS Manual

      Yes, ISO 9001:2015 does not mention the existence of a quality manual. Please check this article about mandatory documentation - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/

      So, it is not mandatory to have a quality manual, neither is forbidden to have one. So, if you find usefulness in a quality manual you can write one. I recommend organizations to have a quality manual, but it is just a recommendation. You can find a suggestion for the quality manual content in this article - The future of the Quality Manual in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/the-future-of-the-quality-manual-in-iso-90012015/

      The following material will provide you information about the quality manual:

    • EU GDPR interpretation and transferring data

      1. Binding Corporate rules - are these the only way to transfer data from inside the EU to outside the EU (to UK and EU)

      No, you can transfer data based on an adequacy decision under Article 45 GDPR. This applies when the transfer is towards one country that the EU Commission considers providing an adequate level of security for the freedom and rights of individuals.

      The European Commission has so far recognized Andorra, Argentina, Canada (commercial organizations), Faroe Islands, Guernsey, Israel, Isle of Man, Japan, Jersey, New Zealand, Switzerland, and Uruguay as providing adequate protection.

      Here you can monitor countries if new countries enter. There are ongoing talks with South Korea and the procedure for the adequacy decision of the UK has been launched on February 19th: https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/adequacy-decisions_en

      In case of an adequacy decision, you can transfer data (being compliant with all other GDPR requirements).

      In case the adequacy decision is missing you can either apply appropriate safeguards under article 46 GDPR adopting:

      • Standard contractual clauses approved by the EU Commission
      • Agreements approved by Surveillance Authorities
      • And (of course) Binding Corporate Rules.

      2.Which EU region has the toughest interpretation of GDPR?

      It is hard to say because the EU Surveillance Authorities of the 27 Member State meet in the European Data Protection Board (EDPB) where they adopt Guidelines to harmonize interpretation among EU countries and avoid different levels of interpretation.

      Here you can find more information on data transfer under GDPR:

      You can also consider enrolling in this free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

    • Predictive Maintenance

      There are many predictive maintenance methods and this topic is related to machine type. It is a type of oil analysis. Apart from that, it can be used in other methods such as vibration, heat, sound, ampere, voltage, etc
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