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  • Standard for protective equipment

    It depends, first of all, what protective equipment manufacture produce, because on that list are standards for both masks, gloves and protective cloths. Therefore, the manufacturer must declare on its Declaration of Conformity the standards by which his products are made.

    If you are distributor and wholesale, your suppliers are responsible for placing medical devices on the market. Your suppliers must provide you CE certificate of the medical device and optionaly ISO 13485 certificate. 

    Which standards are now free to donwload, please see the following link: EU standards for protective equipment – available now for free https://advisera.com/13485academy/blog/2020/04/14/free-access-to-iso-13485/ 

  • ISO 9001 in a pandemic

    During the pandemic event:

    • supply chains may be disrupted;
    • operations need to practice social distancing and prevent loss of employees;
    • normal distribution channels may be disrupted;
    • customers may be closed or only accessible through new distribution channels.

    Some organizations see their workloads drop significantly. Organizations that nevertheless continue to function can take advantage of the period to train employees, to develop experiences in production that would otherwise be difficult, to maintain equipment, to change layout, to develop improvement actions.

    Some organizations continue to work and have to find alternative suppliers without jeopardizing quality. So, new suppliers have to be tested, trained and monitored.

    Organizations that continue to work should train employees so that they can be versatile and perform functions for which they are not prepared, to replace any colleague who becomes infected.

    Organizations that continue to work may have to change space and tools use to practice social distancing. So, new practices may have to be implemented and work instructions changed. Some organizations will need remote audits to check that these changes are in place and effective.

    Organizations that continue to work may be forced to change to use new distribution channels. That may require training and setting new payment systems.

    Some organizations will need help in migrating for internet meetings and communication with suppliers, customers and sales force.

    These are some examples of how a consulting company can still help organizations during this pandemic event with ISO 9001:

    Please consider this article - How to use ISO standards to address a pandemic - https://advisera.com/articles/how-to-use-iso-standards-to-address-a-pandemic/

     

  • Explanation of quality objectives

    A quality objective is a result that the quality management system intends to achieve. Good quality objectives stem from the quality policy. A good quality policy is appropriate to the purpose and context of the organization and supports its strategic orientation.

    So, a good template to write a quality objective should test this condition: which commitment of the quality policy is executed through this quality objective?

    So, if a construction company follows a strategy based on working for a particular niche of customers, a good quality policy will consider those particular customer requirements as priority for improvement. For example, our company wants to be viewed as the experts, the tailors in working with long glass surfaces. That way, a quality objective may be: “rate of long glass surfaces projects won”.

    Good objectives should comply with the S.M.A.R.T (specific, measurable, achievable, realistic and time-based) test. A good template should test these conditions.

    In my work with organizations I also include a time chart to answer to three important questions: what to do, by whom and until when.

    A good template should also clarify upfront what resources are available to meet the objective.

    About developing good departmental objectives and using the process approach. Please check these two free webinars on demand:

    Below, you can find more information about quality objectives:

  • ISO 9001 Car manufacturing

    I believe all ISO 9001:2015 clauses are applicable to your organization.

    Your organization:

    • Develops commercial activity – clause 8.2
    • Designs the car – clause 8.3
    • Buys products, services and processes – clause 8.4
    • Have a set of operations – clause 8.5
    • Control product quality – clause 8.6
    • Treat product nonconformities – clause 8.7

    In 3 years from now, when your organizations already manufactures your own cars what will change is the scope of the set of operations.

    The following material will provide you more information about scope and exclusions:

  • Checklist ISO 22301:2019 content

    Please note that although this clause requires post-exercise reports to be produced, this clause does not require a report to be documented. In theory, such report could be delivered verbally (e.g. for smaller exercises that might be performed on daily level), although in practice such report is almost always written as a document.

  • Marketing in QMS

    ISO 9001:2015 is not about departments. ISO 9001:2015 promotes the process approach. So, while modelling your organization as a set of processes you may decide to not include the Financial or the Marketing departments. The only requirement is that applicable ISO 9001:2015 clauses are treated in your processes and procedures or instructions.

  • ITIL vs ISO 20000

    ITIL Expert is highest personal certification (according to the, previous, v3). ISO 20000 is international standard for IT Service Management aimed for the organizations (although, individuals can be also educated and certified in ISO 20000). So, if you are an ITIL Expert, that doesn't mean your organization is ready to be ISO 20000 certified. But, being ITIL Expert can help a lot if you are implementing ISO 20000.

    This article can help you clarify differences (and similarities) between ITIL and ISO 20000 " ITIL vs. ISO/IEC 20000: Similarities and Differences & Process Mapping" https://info.advisera.com/20000academy/free-download/itil-vs-iso-iec-20000-similarities-and-differences-process-mapping

  • Effectiveness of the EMS

    First, what does effectiveness stand for? Effectiveness is about achieving planned results.
    What are the main planned results for an environmental management system? Its environmental objectives.

    So, does your organization have good environmental objectives? Are those environmental objectives in line with the environmental policy commitments (Continual improvement, Prevention of pollution, compliance with legal and other requirements)? Are those environmental objectives about the most significant environmental aspects and impacts of your organization? Fuel consumption? CO2 emissions? Used lubricant oils? Used tires and other wastes?
    Are your environmental objectives being met?

    The following material will provide you information about environmental management systems:

  • Standard changes under ITIL

    Acctually, ITIL defines standard changes as low cost - low risk changes. So, for example, if you have routine software update (usually low cost / low risk task) - you need to define roles and responsibilities, flow of activities but you don't need to approach it like you described (many successfull updates and than it's - standard change).

    Here is more about standard changes "Tips and tricks for using the ITIL standard change mechanism" https://advisera.com/20000academy/blog/2017/06/27/tips-and-tricks-for-using-the-itil-standard-change-mechanism/

  • BCP

    According to ISO 22301, a Business Continuity Plan must contain:

    • Purpose, scope, and users
    • Reference documents
    • Assumptions
    • Roles and responsibilities
    • Key contacts
    • Plan activation and deactivation
    • Communication plan
    • Incident response
    • Physical sites and transportation
    • Order of recovery for activities
    • Recovery plans for activities
    • Disaster recovery plan
    • Required resources
    • Restoring and resuming activities from temporary measures

    This article will provide you further explanation about BCP content:

    This material will also help you regarding BCP content:
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