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  • Sampling in coal mine

    ISO 17025 provides general requirements for Sampling from the management system perspective if a laboratory is performing the sample. The objective is to obtain the required item for testing and retain necessary records. The laboratory needs a sampling method that documents the selection of sites and or samples or sites, a plan, and the preparation and treatment of a sample for the laboratory. In the case of coal sampling, it is not likely the laboratory would be responsible for sampling.  Coal sampling is very complex and is and the samples seldom truly represent the whole amount. For this reason, there are standards (international and national) that provide guidelines under different conditions.        

    Depending on where you are based, I suggest you look at the national bodies for that sector. There are some published guidelines, along with ISO standards which fall under the ISO catalog ICS (International Classification for Standards) 73.040 Coals Including lignites. For Example, standard ISO/DIS 13909-1 Coal and coke Mechanical sampling

    To assist you in meeting the ISO 17025 QMS requirements, in conjunction with the ISO standards on coal sampling, have a look at the toolkit https://advisera.co/ISO17025Toolkit where there are there is a procedure to guide you (Sampling procedure) and forms for a  sampling plan and sampling report. Also, have a look at the Clause-by-clause explanation of ISO 17025:2017 https://advisera.co/17025ClauseByClause

  • Sustainability and Environmental Management

    I would be more comfortable answering if I knew the company's target customers and the strategy to seduce them. Still, I have come up with some suggestions:

      1. Risk Mitigation: Highlight how environmental risks, such as climate change, resource scarcity, and regulatory changes, could impact the business. Emphasize that integrating sustainability measures can mitigate future risks, ensuring the company's longevity and resilience.

      2. Market Demands: Today's consumers and investors increasingly prioritize sustainable practices. For example, check how European banks will include the sustainability factor in the future. Show how embracing sustainability can enhance brand reputation, attract environmentally conscious customers, and secure investments from funds prioritizing ESG (Environmental, Social, and Governance) factors.

      3. Cost Savings: Sustainable practices often lead to cost efficiencies in the long run. For instance, energy-efficient operations, waste reduction, and eco-friendly operational supply chains can lower costs and increase profitability over time.

      4. Regulatory Compliance: Highlight how governments worldwide are imposing stricter environmental regulations. Being proactive in sustainability can ensure compliance with evolving laws, avoiding future fines and legal issues.

      5. Innovation and Competitiveness: Explain that investing in sustainability fosters innovation. It can drive the development of new technologies, products, and services that meet evolving consumer preferences, giving the company a competitive edge in the market.

      6. Reputation and Brand Value: Consumers increasingly favor environmentally responsible businesses. Show how a commitment to sustainability can enhance the company's brand image, attract conscientious customers, and strengthen brand loyalty, leading to increased market share and profitability.

    Suggestions 1, 3, and 4 have more power if your company's strategy is around low cost.

    Suggestions 2, 5, and 6 have more power if your company's strategy is around innovation.

  • Residual Risk Calculations

    Thank you for your question.

    We answered it through Experta - you can find the answer here:

    1. https://experta.com/shared-post/7210f1ed-cd97-4aec-9c6f-19f873423b02
    2. https://experta.com/shared-post/1bb10439-8dab-4de6-98f5-152abb676119

  • SoA Tasks

    Thank you for your question.

    We answered it through Experta - you can find the answer here: https://experta.com/shared-post/5d32fe75-90e9-489c-be5f-67f139e2b3a7

  • ITSM: Policies for Process Areas

    What should be policies for all process areas under ITSM?

  • ISO 45001 resistance from company management and employees

    Making change in an organization can be difficult with resistance, especially from management and supervisors. The only real way to deal with this is to focus on the benefits that the management system will give you. I would suggest not talking about the certification, as many people don’t understand this, but rather on the benefits of having a systematic system in place for managing OH&S and improving workplace safety to prevent injury and ill health.

    Another thing to consider is finding those who are in favor of the change, after explaining the benefits, and working with them to help convince others.

     

    You can read more on the benefits in this article, 4 key benefits of ISO 45001 for your business, https://advisera.com/45001academy/blog/2015/09/30/4-key-benefits-of-iso-45001-for-your-business/

  • MDR Deadline

    For class I, you do not need the Notified body. What you need is to implement ISO 13485:2016, and then certification body will audit your Quality Management System according to ISO 13485. 


    For medical device class Ir, you need to certify it under the MDR by May 2024. There is no postponement for these device classes. 

  • Identifying gaps between ISO 13485 and ISO 9001

    We do not have as part of our documentation toolkit any GAP analysis template. But you can look at this article for details:

    Also, you can check the Annexes in ISO 13485:2016, where you have a cross-reference table between ISO 9001:2015 and ISO 13485:2016.

  • Specific pharma industry question

    Here are four detailed examples of risk management practices:

    Microbiological Contamination Control risk:

    • Management Approach: Implementing environmental monitoring programs, aseptic processing techniques, and robust sanitation practices to prevent microbial contamination. Conduct risk assessments to identify critical control points, establish microbial limits, and implement effective disinfection procedures, air filtration systems, and personnel training to mitigate the risk of microbial contamination during manufacturing.

    Raw Material Quality Control risk:

    • Management Approach: Implementing supplier qualification programs, quality agreements, and rigorous testing protocols to ensure the quality, purity, and identity of raw materials. Conduct risk assessments to evaluate the impact of raw material variability on the final product and establish appropriate specifications and controls to mitigate risks associated with raw material quality variations.

    Process Robustness and Variability risk:

    • Management Approach: Employing Quality by Design principles to design and optimize manufacturing processes, identifying critical process parameters, establishing control strategies, conducting risk assessments to understand and mitigate potential process variability, and implementing Process Analytical Technology (PAT) tools and continuous process monitoring to ensure consistency and robustness in manufacturing operations.

    Packaging Integrity and Stability risk:

    • Management Approach: Implement comprehensive packaging material qualification, stability testing, and integrity checks to ensure the packaging system maintains product integrity throughout its shelf-life. Conduct risk assessments to identify vulnerabilities in packaging processes and implement protective packaging, barrier systems, and appropriate storage conditions to mitigate packaging integrity and stability risks.

  • BIA Questionaire Assistance

    Included in your toolkit, you have access to a video tutorial that will guide you, providing real examples of how to fill in the BIA Questionnaire.

    The information about how to access the tutorial is included in the e-mail you received when you bought the toolkit. 

    For further information, see:
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