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  • ISO 45001 Lead auditor certification

    To gain certification as a lead auditor for ISO 45001, the new standard for the occupational health & safety management system, you will need to attend a lead auditor training course. These tend to be a week long course, and include a test at the end to assess your knowledge of ISO 45001 and your ability to audit the standard. These are offered by many different companies which you will need to search for in your area, but make sure that you choose a course which is accredited so that your certification will be recognized.

    You can learn more in the article: How to become an ISO 45001 lead auditor, https://advisera.com/45001academy/blog/2019/12/11/iso-45001-lead-auditor-how-to-get-certified/

  • Question about Annex 6.1

    Please note that you need to define a role responsibility whenever required in the document, not once. In our templates, you can easily identify where the definition of a role responsibility is required by the use of the expression job title between brackets ([job title]). Depending on the stated action you can define different job titles as responsible.

    This approach is enough to fulfill the requirement of ISO 27001.

  • Business continuity policy and objectives

    Recently ***, VP of ***, at our request, acquired the Spanish ISO 22301 Document Package (with expert support) through order No. ***. We heard about this service when we participated in a webinar taught by you recently. Thank you for the good product you have supplied us. At this moment, we are working on the Business Continuity Policy document and we want to ask you the following:

    We note that the template they propose does not contain a specific postulate or policy statement, as is the case for example in the case of ISO 9001-2015. Likewise, in the content of the title Definition of business continuity objectives, examples of these objectives are not defined or shown, but rather refers to an internal document that is not within the templates provided.

    Can you please provide us with written templates for the statement of business continuity policy and specific business continuity objectives?

    Please note that ISO 22301 does not require the definition of a statement of business continuity policy (defining one would only make the document unnecessarily more complex). The content of the Business continuity policy template covers all requirements needed for compliance with the ISO 22301 standard.
     
    Regarding the business continuity objectives, templates for them are not included in the toolkit because these depend on the specif context and business objectives of each organization, so providing generic templates applicable to all organizations would be unfeasible, and these may lead organizations on adopting objectives not aligned with their needs.
     
    General examples of business continuity objectives may be:

    • Comply with xyz law/regulation by December 31, 2017, using ISO 22301 methodology
    • Enter a new market in the next 12 months because of the ISO 22301 certificate
    • During 2021, improve our recovery time by 12 hours while not incurring new costs. 

    This article will provide you a further explanation about business continuity objectives:  

  • ISO 9001 Documents for certification

    There is mandatory documentation and non-mandatory documentation. Mandatory documentation in ISO 9001:2015 can be recognized by the wording “maintain documented information” and “retain documented information” in the standard.

    Non-mandatory documentation is each organization’s option, according to the “extent considered necessary”, please check clause 4.4.2.

    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/

    You can find more information about ISO 9001:2015 below:

  • ISO 9001 auditing and inspection guidelines

    Unfortunately, we do not have any guidelines about good auditing practices concentrated in a single document.

    What we have is distributed among courses, books, webinars  and articles. For example:

  • Implication of EU MDR Deadline on 26th May 2021

    You have to check that with Notify's body. Basically, certification under MDD is possible until May 2021, but Notify bodies to have their own dates until it is possible to certify the medical devices under the MDD.

    CE Certificate that will be issued before May 2021 under the MDD is valid until 26/05/2024. 

    However, be aware that periodic audits that will be performed after May 2021 – therefore period audits that will be performed under the MDR – will require certain documentation to be ready according to the MDR requirements. First of all, this refers to the Post-market surveillance system. This process needs to be in place in accordance with the MDR requirements on the first periodic audit. It means the following for example: if you receive an MDD audit in April 2021, your first-period audit will be in April 2022. On that periodic audit, your post-market surveillance system must be in place according to the MDR requirements.  

  • Required process documentation for certification

    What process documentation from across the company is required for certification?

  • Inventory management

    There is no direct requirement in the ISO 13485:2016 that cover inventory management. In requirement 5.1 Management commitment is stated that management must ensure the availability of resources. Furthermore, in 6.1 Provision of resources is stated that top management must determine and provide resources needed to implement the quality management system and to meet applicable regulatory and customer requirements.

    Inventory management usually considering to determine the vital stock levels. Following steps can be used to control your stock levels: establishing levels of operating stocks based on consumption/rate of usage; maintain periodically stock usage reports of each item kept in the store; establishing quantity, lead time, and availability of each item supplied on the market; keeping a record of all non-stock items received from suppliers, returned to suppliers and issued out to users.

    Of course, as inventory management important is to have under control shelf life of both raw and packaging material and final goods; to follow the FIFO (first in first out) or FEFO (first expire first out) principle, which you find most useful for your type of production. 

    The following article can be helpful:

    You can see how we describe this process in our procedure for warehousing in our ISO 13485:2016 documentation toolkit:

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