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E-waste management

I find in the internet some discrepancies in the information about e-waste. Some sources say that it is becoming more dense, less volume. Other sources, like the European Parliament, say something like “E-waste is the fastest growing waste stream in the EU and less than 40% is recycled.” Some sources see a great problem, others see a great opportunity for recycling rare metals.

Concerning ISO 14001, please consider this ISO 14001 document template: Guideline for Electronic Waste Management - https://advisera.com/14001academy/documentation/guideline-for-electronic-waste-management/ - Consider also this article - Using ISO 14001 to manage and reduce waste in the electronics industry - https://advisera.com/14001academy/blog/2017/02/13/using-iso-14001-to-manage-and-reduce-waste-in-the-electronics-industry/

ISO 45001 - identifying internal and external issues

If your organization uses the SWOT analysis already, then the strengths and weaknesses of the SWOT analysis are applicable tot eh internal and external issues in ISO 45001 clause 4.1. Likewise, the issues causing the threats and opportunities would also be external issues, and the threats and opportunities would be applicable in clause 6.1.

It is however important to note that a SWOT analysis is not a mandatory requirements of ISO 45001, and is only one way to identify this information.

You can learn a bit more of how SOWT works in the OHSMS in the article: Benefits of SWOT analysis in ISO 45001, https://advisera.com/45001academy/blog/2019/05/27/iso-45001-swot-analysis-what-are-the-benefits/

OHSAS 18001 vs ISO 45001

OHSAS18001 was the designation for the previous standard from BSI for creating an OHSMS, or Occupational Health & Safety Management System, which is the collection of all the rules, policies, procedures and processes you put in place to manage OH&S performance in your organization. ISO 45001 is the new OHSMS standard which is released by the International Organization for Standardization, making it a more internationally accepted and applicable document.

Both OHSAS 18001 and ISO 45001 are documents that provide requirements on how to create an OHSMS, with OHSAS 18001 becoming obsolete in the near future as ISO 45001 becomes the new international standard. Organizations have a certain time to transition before the OHSAS 1`8001 standard is made obsolete and certification to this older standard is stopped.

You can learn more on the changes from OHSAS 18001 to ISO 45001 in the recorded webinar: ISO 45001 vs OHSAS 18001 the main changes, https://advisera.com/45001academy/webinar/iso-45001-2017-vs-ohsas-18001-2007-the-main-changes-on-demand/

Process turtle for Customer Specific Requirements

Many companies use turtle diagrams when defining processes. This form of identification is not mandatory for IATF 16949 but is preferred because it is an easy identification method. If you want to define a process such as reviewing customer-specific requirements in your QMS structure, you can use this type of process definition map.

For more information, see this article: 

• How to satisfy customer-specific requirements when implementing IATF 16949 https://advisera.com/16949academy/blog/2019/07/02/iatf-16949-customer-specific-requirements-how-to-meet-them/

• Are Cardiovascular Stent covered in ISO 13485?

  Cardiovascular stents are medical devices. ISO 13485:2016 is a standard that is applicable for manufacturers of all types of medical devices, therefore, it's applicable for cardiovascular stents.

  For more information on what is ISO 13485, please see the following links:

  • >What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
  • Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
  • ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/
  • Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

  • Assessing risks and opportunities

    While there is no mandatory timeline in ISO 45001 for risk and opportunity assessment, it is common to have this done as part of management review on a cycle or 3, 4 or 12 months. The important thing to consider for your company is how often do the risks and opportunities in your industry and location change. If there are highly changing risks and opportunities in your industry, then more frequent review is a wise decision. In many cases a 4 month review cycle is likely adequate.

    You can read a bit more on risk and opportunity in the OHSMS in the article: What are the new requirements for risks and opportunities according to ISO 45001?, https://advisera.com/45001academy/blog/2018/04/25/what-are-the-new-requirements-for-risks-and-opportunities-according-to-iso-45001/

  • Strategic intent

    ISO 9001:2015 only mention “strategic direction” in clauses:

    • 4.1 – organizations must determine internal and external issues that are relevant to their strategic direction. Different strategies make some issues relevant or not and positive or negative. For example, an organization that serve premium segment customers sees a downturn in the economy differently than an organization in the same economic sector but serving low-price customers
    • 5.1.1 and 5.2.1 – the quality policy must be aligned with the strategic orientation. For example, an organization that competes on price has different priorities and concerns than an organization that competes on product innovation
    • 9.3.1 – management review must evaluate if the system is aligned with the strategic direction

    Neither ISO 9001:2015 nor ISO 9000:2015 define what is strategic direction. Also, it is not mandatory, according to ISO 9001:2015, to have a document about the strategic direction. Please check this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ - where you can see the mandatory documents and records according to ISO 9001:2015.

    According to ISO 9001:2015, one can draw a model of how an organization works based on the process approach. For example:

    

    If an organization competes on cost, this may be the critical processes:

    

    If an organization competes on customization/service, this may be the critical processes:

    

    If an organization competes on innovation, this may be the critical processes:

    

    Different strategies, different priorities, different motivations, different indicators.

    As an auditor, I do not expect to see a document, but I expect some consistency between priorities in the quality policy and what top management considers its strategic direction.

     

  • Risk based thinking in ISO 9001-2015

    I always recommend following three ways to determine risks:

    • Risks deriving from context and interested parties (see clause 6.1.1 of ISO 9001:2015)
    • Risks deriving from products and services (see clause 5.1.2 b) of ISO 9001:2015)
    • Risks deriving from processes (see clause 4.4.1 f) of ISO 9001:2015)  

    In this free webinar on-demand - ISO 9001:2015 clause 4 - Context of the organization, interested parties, and scope - https://advisera.com/9001academy/webinar/iso-90012015-clause-4-context-of-the-organization-interested-parties-and-scope-free-webinar-on-demand/ - I show examples of risks and opportunities derived from context and interested parties.

    ISO 9001:2015 promotes the process approach and in this free webinar on-demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/ I show how to relate processes, risks, training, documentation, and control.

    In this free webinar on-demand - How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/ - I show some examples of determining risks and then acting on them.

    You can find more information below about risks.

    • How to address risks and opportunities in ISO 9001: https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
    • How to identify risk significance in ISO 9001:2015 - https://advisera.com/9001academy/blog/2019/01/14/how-to-identify-risk-significance-in-iso-90012015/
    • For a free preview of an example of the Registry of Key Risks and Opportunities - https://advisera.com/9001academy/documentation/registry-of-key-risks-and-opportunities/
    • Enroll for a free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
    • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ (I use a lot of examples based on the risk-based approach)

  • Collecting email addresses

    First of all, if the email collected are composed like info@company.com these are not considered as personal data under GDPR, so the answer is yes.On the contrary, if you are planning to collect email like name.surname@company.com these email addresses are considered as personal data under GDPR. You can process personal data using the legitimate interest as legal ground only to introduce your company to a potential client with the so-called cold email. 

    There must be relevance between the sender and the recipient of the email. For example, I can send a cold email to introduce a company that offers a selection of employees to an HR Manager, but I cannot do the same to the Head of Logistics. The reason is that once the email address is published on the company website, the owner consent to be contacted for reasons connected to the role in the company.Of course, in the cold email, you can add a button to subscribe to a newsletter and receive information on products, offers, and so on.

    To know how to ensure email marketing compliance you can read this article:

    • Email marketing in the era of GDPR – How to ensure compliance? https://advisera.com/eugdpracademy/blog/2019/05/27/gdpr-and-email-marketing-rules-for-compliant-campaigns/

    If you need to understand how to manage email addresses under GDPR, you can consider enrolling in our free online training EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

  • ISO 9001 Continuous Improvement Process

    I can give you my experience. I answer your question in three layers:

    • The performance layer. The three most common errors in presenting performance data are: using tables instead of graphics, showing just the last result, and presenting no performance benchmark or target. So, I leave the tables with numbers for annexes, and I use graphics. Not graphics simulating car dashboards, but what is called sparklines or micro charts, where you can see the trend and compare with the target. One last warning. You have to present all the graphics in one page or in one screen. The first commandment of a good dashboard is to present all indicators in a way that you can see them all at the same time. This picture presents an example and also includes another kind of graphic, the bullet chart useful to compare current performance with target or benchmark. You can find this picture in our free webinar on-demand - Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/
    • The context layer. Add to the previous layer a picture of the model of how the organization works, based on the process approach, and coloring each process with the semaphore colors (Since 10% of men and 1% of women have color identification issues, the semaphore colors may be shades of a color. For example, if OK no color, if with concerns rose if bad red). You can find this picture in our free webinar on-demand - The Process Approach - What it is, why it is important, and how to do it - https://advisera.com/9001academy/webinar/iso-9001-process-approach-free-webinar-on-demand/ - the advantage of this approach helps people realize how they can influence or contribute to performance because they can situate themselves in the processes and their interaction. Everybody is an internal supplier and customer.
    • The strategic layer. Even better than the previous one is to present the same technique but over a strategy map of the organization