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  • IS ISO 13485:2016 latest version?

    Yes, so far ISO 13485:2016 is the latest version. There is an explanation on the web page of the ISO organization that this standard was reviewed and confirmed in 2020, and that this version ISO 13485:2016 remains valid.

    You can see it on this link: https://www.iso.org/standard/59752.html 

    In section 1. Scope of this standard, it is stated that if any requirement from Clause 6, 7, and 8 is not applicable, the organization does not need to include that requirement in the quality management system.

    Here you can find the Checklist of ISO 13485:2016 Implementation steps: https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

    Also, you may find useful our ISO 13485:2016 documentation toolkit: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

  • ISO 9001 and temporary unit closing

    If an ISO 9001 certified unit closes down temporarily, you should communicate this to the certification body. Most likely your organization’s contract with the certification body includes a clause where your organization assumes the notification of the certification body, as soon as possible, of any significant changes to the organization and/or its activities. For example, change of physical location, change of ownership, or commercial viability. I work with organizations that closed down temporarily due to pandemic, communicated that to the certification body and life went on when they started to resume operations.

  • OHSAS 18001 to ISO 45001 transition

    The timeline for transitioning from OHSAS 18001 to ISO 45001 will differ from company to company depending on size, complexity of processes, number of people doing transition and availability of resources, etc. For instance, the greater the number of people to train on the changes the longer it will take, however, many companies can transition in less than 6 months. The best way to reduce the length of time it takes is to follow a systematic process to ensure that what you already have in place is utilized to reduce the amount of work that is needed.

    You can learn more about the transition process in the whitepaper: Twelve-step transition process from OHSAS 18001 to ISO 45001, https://info.advisera.com/45001academy/free-download/twelve-step-transition-process-from-ohsas-18001-to-iso-45001

  • ISO 9001 benefits, requirements and implementation

    which business requires a QMS implementation

    Answer:

    Implementing a QMS is beneficial for any kind of organization. I dare say that every organization should have a QMS, some more complex and some more simple.

    How QMS will be beneficial for my company

    Answer:

    Please check this article about the benefits of implementing a QMS - Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/

    QMS requirements trending over the last 10/15 years

    Answer:

    I can remember the progress of the process approach and more recently the introduction of the risk-based approach

    You can find more information below:

  • ISO 9001 principles, requirements and implementation

    QMS principles?
    Which business requires a QMS implementation?
    How QMS will be beneficial for my company?
    QMS requirements trending over the last 10/15 years?

  • ISO 9001 and setting quality objectives

    Quality objectives should be a set of measurable challenges that stem from the quality policy. Good quality objectives stem from a good quality policy.

    If a quality policy complies with ISO 9001:2015 clause 5.2.1 a) it will include challenges relevant for an organization. For example, an organization that competes on the market based on innovation may include in its quality policy the ability to:

    • be the first to market with new innovative products,
    • develop patents,
    • improve brand awareness.

    From there you can translate that into measurable objectives.

    For example, an organization that competes on the market based on cost may include in its quality policy the ability to:

    • be efficient,
    • buy very well,
    • comply with delivery dates

    From there you can translate that into measurable objectives.

    The following material will provide you more information:

  • ISO 14001 Setting up a management system

    Since you are using the term automated, I assume that you are mentioning the use of the Documentation Toolkit.

    According to Advisera’s experience

    • Companies of up to 10 employees - up to 3 months
    • Up to 50 employees - 3 to 6 months
    • Up to 200 employees - 6 to 10 months
    • More than 200 employees - 10 to 20 months

    Please check this information below with more detailed answer:

  • A.5 Information Security Policies

    First of all, I'm sorry about this confusion.

    Please note that the link between the controls from section A.5 and the documents in folder 08 Annex A is stated in the Statement of Applicability document, located on folder 06 Applicability of Controls:

    • Implementation method for control A.5.1.1: "All policies referred to below in this column." (i.e. the Information Security Policy, and policies included in folder 08 Annex A)
    • Implementation method for control A.5.1.2: "Each policy has a designated owner who has to review the document at planned interval
    Considering that, there is no need to include a reference to these controls in each document, because the reference is already made in the SoA.

  • ISO 13485 implementation

    The first thing I would do myself is to implement a general procedure to keep track of actions and agreements within the organization. I do not see it? Why? How to do it?

    In ISO 13485:2016, there is no direct requirement to have a documented procedure to keep track of actions and agreements. In requirement 7.4.2 Purchasing information is stated there is a necessity for a written agreement that supplier. To the extent required for traceability given in 7.5.9, the organization shall maintain relevant purchasing information in the form of documents (see 4.2.4) and records (see 4.2.5). There fore, it is up to you how you will document this. You can write a procedure for managing outsourced processes where you will state methods and frequency of the control over the outsourced processes, or add this section in the Purchasing documented procedure.

    Following article can provide you more information about critical suppliers:

    You can see how our Quality Agreement for Critical Supplier looks like on the following link: https://advisera.com/13485academy/documentation/quality-agreement-for-critical-supplier/

    We are a very small startup for a simple small noninvasive medical device. Both my partner and myself are very experienced in MRI (***), CT (***), etc, although it is 20 years since we worked in a QMS. I want to define Research and predevelopment as a process outside the QMS, then Design transfer to a clinical trial process and to subcontractors inside the QMS We will subcontract engineering/development, manufacturing, service, logistics to ISO13485 certified high-quality partners. We will have these partners audited regularly by consultants we contract and sign the audit reports ourselves after review. Can we somewhere buy a core (just enough) QMS that complies with ISO13485? Your toolkit is much more than we need, do you have a core toolkit as well?

    Our ISO 13485:2016 is a basic toolkit that covers all mandatory documents required by the standard. You can buy the whole toolkit, or you can buy separately documents that you considered that you need. If you go to the end of this web page, you can see each document and purchased what is necessary for you: https://advisera.com/13485academy/iso-13485-documentation-toolkit/ 

    But please be aware that no matter that you are outsourced some processes, you are still responsible for them. In the eyes of the auditor from the certification body, you need to have at least the list of the documents form the outsourced companies. All outsourced processes also need to be stated in the Quality manual together with the connection to your processes. 

    For more information on controlling the outsourced processes using ISO 9001 see this article:

    Do you have a service that adapts your toolkit to our needs? Including filling in of company name etc.

    When buying the toolkit, depending on the type of toolkit that you buy, you can get support in the following ways:

    • 10 questions via email per month or Unlimited email support
    • 1, 5, or 15 hours of one-on-one support with an ISO 13485 expert
    • Expert review of 1, 5, or 15 completed documents
    • Pre-audit check (1-hour call where we can check the most important items that the certification auditor will be looking for)

    For more details about options when buying a toolkit, please see the following link - https://advisera.com/13485academy/iso-13485-documentation-toolkit/ and go to the end of the page.

  • ISO 9001 Internal Audit

    I do not have all the information. One possible clause is 7.1.5.2 b).

    The organization considered that calibration was relevant. The organization scheduled the calibration but then did not perform, did not ensure that equipment was calibrated.

    You can find more information below:
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