News Articles

Swissmedic has recently introduced key updates to its Technical Interpretation regarding the role of the "Responsible Person" under the Swiss Medical Devices Ordinance (MedDO). These new guidelines are essential for maintaining compliance in Switzerland’s medical device market. Is your organisation prepared to comply with these changes?

Here’s a quick breakdown of the key changes:

• Qualifications and Experience: The Responsible Person (RP) must have the appropriate educational background and relevant industry experience. Depending on the nature of your operations (GMP, GDP), this could range from 1 to 4 years of professional experience. For companies handling high-risk medical devices, it’s mandatory that the RP has specific experience in this area.

• Language Proficiency: Swissmedic now requires the Responsible Person to be fluent in one of Switzerland’s official languages: German, French, or Italian. This ensures effective communication with regulatory bodies and guarantees that the company can meet compliance requirements seamlessly.

• Operational Supervision: The Responsible Person is required to actively supervise the company’s operations. This includes dedicating at least 10% of full-time work hours to ensuring that all critical steps are compliant with Swiss regulations. This hands-on approach helps to prevent non-compliance and ensures continuous oversight of key operational processes.

• Absence Coverage: In the event of the Responsible Person’s absence (up to four months), a qualified deputy must be appointed to take over full responsibilities, ensuring compliance is maintained without interruption. If the absence exceeds four months, a new application for a Responsible Person is required to guarantee that the company remains compliant with Swissmedic’s guidelines.

Why This Matters:

Non-compliance with these requirements can lead to significant penalties, including market delays, product recalls, or suspension of market access in Switzerland.

Don’t risk market delays or penalties, contact us today for a compliance audit and keep your operations running smoothly.

📧 enquiry@ia-uk.com | 🌐 www.ia-uk.com

Author: m-coles

Published Date: October 1, 2024

Keeping up with Health and Safety (H&S) regulations is an essential part of running any business, nevertheless, it can also be time consuming and complex, particularly when you are managing multiple locations. Effective H&S practices go beyond compliant to protect your people, reputation and your bottom line. In fact, businesses with strong H&S practices are 50% less likely to experience workplace incidents, which results in fewer disruption and lower costs.

To address this challenges, International Associates has collaborated with Deep Fathom to introduce the H&S Digital Assessment, an easy-to-use digital solution designed to simplify and improve your H&S internal audits. This innovative solution pinpoints areas of improvement, supports smarter decision-making, and ultimately strengthen your compliance, ensuring your organisation remains align with regulatory requirements. It is built to save time, reduce risk, and make your audits more effective.

What is the H&S Digital Assessment?

The H&S Digital Assessment is a comprehensive online platform that assists organisations in evaluating their health and safety practices efficiently and accurately. It is specifically designed to simplify the auditing by offering valuable insights and recommendations that lead to apparent improvements.

Here’s how it works:

• Identify Gaps in H&S Compliance: The solution provides a thorough assessment of your current H&S practices, identifying compliance gaps that required addressed before they become significant issues. Early identification of these gaps allows for proactive management, lowering the risk of costly incidents.

• Data Driven Insights for Decision Making: Using the cutting-edge analytics and real-time data, the H&S Digital Assessments provides reports that help you make informed decisions. With these insights, you can strategically align your H&S efforts with your overall business goals, improving both compliance and efficiency.

• Accelerated Improvements: The assessment tool offers actionable guidance on how to close compliance gaps, allowing your team quickly move from analysis to action. This speeds up the process of putting improvements into practice, enabling you to maintain high standards of Health and Safety across your operations.

• Risk Reduction and Cost Savings: By understanding your organisation’s H&S maturity level, you can mitigate potential risks and improve your compliance posture. Additionally, the platform also allows you to conduct audits across multiple sites simultaneously, saving time and reducing the costs associated with manual, location-specific audits.

Key Benefits of the H&S Digital Assessment

The H&S Digital Assessment brings a range of advantages to businesses, particularly those that operate across multiple locations.

• Improved Efficiency: The platform simplifies the audit process, allowing you to complete your internal audits more quickly, without interrupting daily operations. It is designed to be intuitive, making it easy for teams to adapt and use.

• Consistent Compliance Across Locations: With the ability to assess multiple sites simultaneously, you can ensure that your entire organisation is compliant with H&S regulations, whether you operate in one location or across many.

• Cost-Effective Auditing: By streamlining the audit process and providing clear, actionable insights, the solution helps reduce the time and resources traditionally needed for manual auditing. This translates into lower costs for your business and fewer disruptions to your day-to-day operations.

• Customised Reports for Targeted Action: The H&S Digital Assessment offers custom reports that are tailored to your organisation’s specific needs. These detailed reports give you a full overview of your H&S performance, helping you focus on areas that need immediate attention.

enquiry@ia-uk.com | www.ia-uk.com

Author: m-coles

Published Date: October 1, 2024

Sedex has recently introduced SMETA 7.0, an enhanced version of the widely recognised Sedex Members Ethical Trade Audit (SMETA). At International Associates, we are ready to support your organisation through this transition and ensure compliance with the updated standards.

The updated SMETA 7.0 methodology introduces improvements aimed at helping businesses more effectively address the root causes of non-conformities while driving long-term sustainable improvement. In the absence of identified non-conformities, the new methodology provides a deeper evaluation of management systems to ensure continued alignment with ethical principles and standards.

One of the most impactful enhancements in SMETA 7.0 is the introduction of Workplace Requirements. These clear, actionable guidelines simplify the Ethical Trading Initiative (ETI) codebase and Sedex additions, making it easier for auditors to assess compliance. This update helps ensure that businesses meet both local laws and international standards, which ultimately means better protection for workers and stronger supply chain compliance.

We highly encourage our Sedex member clients to explore the Sedex E-Learning platform, which offers comprehensive resources to help you understand the updated framework and prepare effectively for future audits under SMETA 7.0.

Whether you are preparing for your first SMETA audit or seeking guidance on the new requirements, International Associates is here to assist you every step of the way. Our team of experienced professionals is dedicated to ensuring a smooth transition and providing tailored support to help your organization achieve full compliance.

Whether you are preparing for your first SMETA audit or seeking guidance on the new requirements, International Associates is here to assist you every step of the way. Our team of experienced professionals is dedicated to ensuring a smooth transition and providing tailored support to help your organization achieve full compliance.

For more information or to discuss how we can assist with your auditing needs, please get in touch with us.

enquiry@ia-uk.com

Author: m-coles

Published Date: October 1, 2024

Slave-Free Alliance (SFA) and International Associates (IA) are solidifying their relationship around the common goal of mitigating the risk of modern slavery and labour exploitation in global supply chains. With SFA’s Annual Conference coming up this November, there isn’t a better time to find out more about the organisation, and how to partner with SFA to work together towards a slave-free supply chain.

What is Slave-Free Alliance?

SFA is a social enterprise whose mission is to help organisations of all sizes mitigate the risk of modern slavery and labour exploitation within their own operations and supply chains. It was founded in 2018 by the global anti-trafficking charity Hope for Justice following Operation Fort, which unveiled the UK’s biggest modern slavery network and implicated multiple national businesses.

Since then, SFA has grown to a significant community of over 120 members across every industry, including 17 FTSE100 companies, and continues to donate all profits to Hope for Justice. International Associates has been a member of Slave-Free Alliance for 6 years, a longstanding collaboration that continues to evolve and highlight the numerous synergies between both organisations.

What does Slave-Free Alliance offer?

Modern slavery affects an estimated 50 million people worldwide; addressing this crime is a contemporary, urgent issue that is becoming business-critical. SFA acts as a critical friend to the organisations it engages with, helping them rise above baseline compliance by creating tailored and proportionate anti-modern slavery strategies that deliver real results.

Composed of a multidisciplinary team of experts from a wide variety of backgrounds, SFA works with its members to understand, identify, and mitigate potential and actual areas of risks; to build capability and strengthen their resilience to those risks; and to create collaborative spaces for them to learn and share best practice.

To do this, SFA has developed a suite of curated and impactful products. Among them are SFA’s pioneering membership programme designed for long-term support and strategic change, consultancy services (ranging from modern slavery statement reviews to escalation processes development), and varied training and technology solutions.

Get in touch with Slave-Free Alliance

If you think your organisation could benefit from SFA’s human rights expertise, get in touch with their friendly commercial team:

Slave-Free Alliance Annual Conference: A Global Forum for Change

IA clients are also warmly invited to discover Slave-Free Alliance and explore possibilities of collaboration at the SFA Annual Conference in Manchester on 21st November 2024.

A full day packed with insightful talks, organised around each step of the OECD Due Diligence Guidance for Responsible Business Conduct, it will be an unmissable event for sustainability professionals at all levels and across the entire ESG spectrum.

Speakers from the United Nations Global Compact Network UK, Tony’s Chocolonely, John Lewis Partnership, and more have been confirmed, and the whole SFA team would be delighted to welcome you to their annual celebration of human rights best practice.

For IA clients only, an exclusive discount code is available for a £50 reduction on the standard ticket price, which makes it all the more worth it: IACLIENTS2024.

Click here to learn more about this highly anticipated event, apply the code, and secure a spot.

SFA looks forward to IA clients joining these important conversations around human rights in supply chains and making a difference for workers worldwide.

Author: m-coles

Published Date: October 1, 2024

𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐯𝐞 𝐁𝐥𝐞𝐧𝐝𝐞𝐝 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐀𝐮𝐝𝐢𝐭𝐢𝐧𝐠 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞

Technology has always been a core part of International Associates’ business, our commitment to cutting-edge IT solutions is a key driver for our business.

Today, we are excited to announce our strategic collaboration with DeepFathom to introduce an innovative internal auditing software solution which allows your internal audits to be conducted using a blended approach all through a fully customisable portal, which can be embedded into your website or software.

What does this mean for you? This new solution can transform your auditing processes by combining the convenience of software with the thoroughness of face-to-face audits.

𝐖𝐡𝐲 𝐜𝐡𝐨𝐨𝐬𝐞 𝐃𝐞𝐞𝐩 𝐅𝐚𝐭𝐡𝐨𝐦’𝐬 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐯𝐞 𝐚𝐮𝐝𝐢𝐭𝐢𝐧𝐠 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧?

Deep Fathom’s internal auditing solution revolutionises face-to-face auditing methods with a blended approach, seamlessly integrating advanced technology with on-site verification, all combined within one seamless software package

𝐊𝐞𝐲 𝐁𝐞𝐧𝐞𝐟𝐢𝐭𝐬:

• More consistent results across your internal audit resource

• Reduced travelling, helping to reduce your carbon footprint

• Enhanced collaboration between remote and on-site teams

• Fully customisable to your requirements and easily integrated into your software solutions.

Experience the future of auditing with International Associates Ltd and Deep Fathom Ltd. Contact us today to learn how this innovative system can revolutionise your auditing process and elevate your business.

📧 enquiry@ia-uk.com | 🌐 www.ia-uk.com

#InternationalAssociates #Innovation #Digital #Audit #Software #Technology #Leaders #RiskManagement #Analytics #Training #Auditors #Business #Growth #Quality #QualityAssurance #QualityManagement

Author: m-coles

Published Date: July 24, 2024

Update on Battery Regulations!

In July 2023, a new EU battery regulation (Regulation 2023/1542) was approved by the EU. The aim of the regulation is to create a harmonised legislation for the sustainability and safety of batteries. Some provisions came into force on 18 February 2024, while others will become relevant over the next few years. This significant move marks a major step forward in promoting responsible production and recycling of batteries across the EU.

If you are importing batteries or if your product contains a battery, then this will apply to your product including medical devices. And you will need to appoint an Authorised Representative such as International Associates Limited and also update your technical file accordingly.

Here are some key highlights from the new regulation:

𝐑𝐞𝐜𝐲𝐜𝐥𝐞𝐝 𝐂𝐨𝐧𝐭𝐞𝐧𝐭 𝐌𝐚𝐧𝐝𝐚𝐭𝐞𝐬: From August 2028, industrial and electric vehicle batteries must contain specific minimum percentages of recycled materials. For instance, by 2036, these batteries must have at least 26% recycled cobalt and 85% recycled lead.

𝐂𝐚𝐫𝐛𝐨𝐧 𝐅𝐨𝐨𝐭𝐩𝐫𝐢𝐧𝐭 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬: Starting February 2025, electric vehicles and industrial batteries must include detailed carbon footprint declarations, highlighting the environmental impact of their production.

𝐄𝐧𝐡𝐚𝐧𝐜𝐞𝐝 𝐑𝐞𝐜𝐲𝐜𝐥𝐢𝐧𝐠 𝐓𝐚𝐫𝐠𝐞𝐭𝐬: By December 2030, the EU aims to achieve ambitious recycling efficiency targets, such as recycling 70% of lithium-based batteries and 95% of nickel.

𝐃𝐮𝐞 𝐃𝐢𝐥𝐢𝐠𝐞𝐧𝐜𝐞 𝐢𝐧 𝐑𝐚𝐰 𝐌𝐚𝐭𝐞𝐫𝐢𝐚𝐥 𝐒𝐨𝐮𝐫𝐜𝐢𝐧𝐠: Economic operators must now adopt robust due diligence policies to ensure responsible sourcing of raw materials, addressing both social and environmental risks associated with battery production.

𝐁𝐚𝐭𝐭𝐞𝐫𝐲 𝐏𝐚𝐬𝐬𝐩𝐨𝐫𝐭 𝐈𝐧𝐢𝐭𝐢𝐚𝐭𝐢𝐯𝐞: A new battery passport will provide detailed information on battery composition, carbon footprint, and responsible sourcing practices, ensuring transparency and traceability throughout the supply chain.

enquiry@ia-uk.com | www.ia-uk.com

#InternationalAssociates #EuropeanUnion #Batteries #Energy #Sustainability #Innovation #CircularEconomy #Safety #Production #Manufacturing #Recycling #MedicalDevices #ElectricVehicle #EV #Transportation #Sourcing #Environment #Transparency #Traceability #SupplyChain

Author: m-coles

Published Date: July 20, 2024