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  • Effect of medical device class on ISO 13485 documentation

    I would like to know how the class of a medical device affect in the documentation required to implement a quality management system according to ISO13485:2016.  

    The class of medical device does not affect the documentation required to implement a quality management system according to ISO13485:2016. The Claas of medical device only affects the technical documentation necessary to prove compliance with Medical device regulative. 

    For more information, please see the following articles:

    I mean if we manufacturing the medical device of class IIa (specifically a gamma probe) what type of certifications should have it. (IEC60601 for electromedical equipment, electromagnetic compatibility, among other).

    Your medical device must be certified by the notify body and get the CE mark. If it is equipment that is active (need electricity for the operating) then it has to have IEC 60601 certificate for electromagnetic compatibility. If you have some software that drives the device, that it should be validated according to the IEC 62304:2006 Medical device software — Software life cycle processes. Is there any other standard, it is hard to know because I do not have enough data.

    It's possible to know all documentation that is necessary for design and manufacturing gamma probes? thanks 

    All documentation that is necessary for design and development of medical devices according to ISO 13485:2016 you can see in our ISO 13485:2016 Documentation toolkit on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

    At the end of the page under the title "Toolkit Documents", you can search for Design and development. There you will find all the necessary documents.

  • Risk Treatment Implementation and Risk Treatment Plan

    1. We are discussing the implementation steps and we are a bit confused about the Risk Treatment Implementation and the Risk Treatment Plan. Please what’s the difference between the two. When are the risks actually treated?

    In the risk treatment implementation, you need to define what to do with risks (e.g., risk mitigation, risk avoidance, risk acceptance, and risk transfer), while in the Risk Treatment Plan you define the actions, responsible, and deadlines to implement the chosen option. For example:

    • Risk: information loss due to virus
    • Risk Treatment: mitigate the risk
    • Risk treatment plan: The IT manager must develop and implement a backup policy in the following 90 days.

    These articles will provide you a further explanation about risk treatment and risk treatment plan:

    2. Also, what’s the difference between the risk treatment methodology and the risk treatment plan?

    The risk treatment methodology refers to the rules (e.g., steps and criteria) to be followed when performing the risk treatment, while the Risk Treatment Plan is one of the outputs of the risk assessment and risk treatment process as a whole (together with the Statement of Applicability). Please note that the most common reference you will find is about the Risk Assessment and Risk Treatment Methodology because ISO 27001 requires the definition of processes for both risk assessment and risk treatment.

    These articles will provide you a further explanation about risk management process and risk treatment methodology:

    These materials will also help you regarding risk management:

  • Changing certification bodies

    First, were those unavoidable circumstances related with the certification body? Let us consider that the answer is no.

    Second, the certification body while revoking certification was just following known procedure.

    Third, while choosing the certification body for the first time did your organization followed this set of rules in the article – How to choose a certification body? https://advisera.com/blog/2021/01/11/how-to-choose-an-iso-certification-body/

    Fourth, how did your organization feel during the revoke process? Were they clear, were they reasonable, were they treating your organization fairly?

    If during the revoking process they were clear, reasonable, approachable, and fair, and if they were the right choice at the first time, and since they already know your organization and your organization knows them perhaps pursuing certification from the same certifying body could be a decision to follow.

     

  • Visionary leadership

    Considering the strategic orientation of your organization, what can be expected as consequences, as results of having a visionary leadership? Once defined those consequences or results, you can compare the actual results with the expected or required results.

    For example, a visionary leadership may conclude that an organization should prepare itself for leaving a particular market because of low prices and hypercompetition and start working for a premium segment with premium prices and margins. Now, imagine that the organization followed that path and two years later is enjoying a nice rise in new premium clients, and prices and margins while the old market is in turbulence with price competition. You may call that leadership as visionary for that organization.

    The following material will provide you more information:

  • Document formatting change

    As long as you avoid obsolete documents in use there should be no problem with that. Be sure to inform people about the change. Personally, I have done that several times in different organizations. The purpose of the revision number is to make easier the verification that the version in use is the last version.

     

    The following material will provide you more information:

  • EMS Audits

    Targets are benchmarks that help us check effectiveness. When targets are defined, they represent the best of our knowledge. We believe that meeting those targets is the best for the organization.

    When the due time arrives, we can compare actual performance with the desired performance. In this case the target was 3 audits, but only 1 audit was performed.

    Why the difference?

    • Lack of resources?
    • Lack of commitment?
    • Bad target?
    • Bad control?

    Was that audit enough? Were all areas of the environmental management system audited?

    Should your organization improve target definition for the future? Or should your organization improve resources, commitment and control about audits?

    Whatever the reason, acting this way your organization will be learning.

    Please check this information below with more detailed answers:

  • ISO 14001 value

    Implementing an environmental management system can bring benefits such as:

    • Improve your image and credibility allowing your organization to win customers that value the relationship with the environment;
    • Help your organization in complying with legal requirements by having a method in place to identify new or revised legal requirements, determine their applicability and translating them into the organization’s activities;
    • Improve cost control through higher efficiency and less waste. 

    Please check this information below with more detailed answers:

  • What is the efficient way and tricks to address, handle and treat the risk and opportunity?

    The most efficient way to address, handle and treat the risk and opportunity is to start by knowing what ISO 17025 requires and keep it simple!

    ISO 17025:2017 does not require a formal risk management program nor documented risk management process.  What it requires, as a minimum, is for laboratories to consider and address risks and opportunities that may impact (negatively and positively), on its activities and objectives including the validity of results. Address the activity bearing in mind, at all times, that the objective is to safeguard competence, impartiality and consistent operation of your laboratory.

    The goal is to create a structure where the management system is shielded from “upsets” i.e. nonconforming events; and opportunities to drive improvement are enhanced. I suggest initially coming up with a method to consider and address risks first. Then adapt or integrate opportunities into your approach.

    You can approach this activity through a sequence of simple steps, whilst using a spreadsheet as a register / risk index.

    The steps and measures taken to address risks and opportunities will vary depending on the context of your laboratory. Remember this is an activity that is iterative – it will involve getting started then repeating the cycle to improve the process and adjust the risks and controls as your management system evolves.

    As a general overview, considering and addressing risks to meet ISO 17025 involves five steps:.

    Step 1: Identifying risks (What can happen, when, where why and how?).

    Step 2: Evaluating the risk (Determine existing controls, determine likelihood and consequences leading to estimate level of risk).

    Step 3: Ranking the risks (Determine which is to be addressed first, then second, and so on).

    Step 4: Determining actions to be taken (Compare against criteria, Identify and weigh options, dependent on availability of resources and the costs to address the risk. Decide on response and establish priorities).

    Step 5: Implementing, monitoring and following up (Selected actions must then be implemented within the laboratory. Laboratory management will be responsible for ensuring that resources are provided, that the proposed actions are taken, and that they are having the desired effect).

    I shall be sharing more detailed methods and tips in the Free ISO17025 Academy webinar – How to manage risks in laboratories according to ISO 17025. You can register at https://advisera.com/17025academy/webinar/iso-17025-risk-management-how-to-manage-it-free-webinar-on-demand/ to attend on the 1 July 2020.

    For more information regarding  actions to address risks and opportunities, see the ISO 17025 toolkit document template: Addressing Risks and Opportunities Procedure - https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/ 
    and for more information on the five steps to address risks, see the article Five-step laboratory risk management according to ISO 17025:2017 - https://advisera.com/17025academy/blog/2019/12/05/iso-17025-risk-management-in-five-steps/

  • Similarities between ISO 14001, ISO 9001, ISO 45001 (previous BS OHSAS 18001), and ISO 19011?

    Yes

  • Parent Company Processes

    No, it is not necessary to have different processes from the parent company. A division can have the same processes or a different set of processes.

    The following material will provide you more information:
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