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Global Operations, Local Commitment!

At International Associates, we are excited to amplify our global operations with a keen focus on local excellence, particularly in China. We are dedicated to providing specialised services such as SMETA, SLCP, FEM, and ESEP, ensuring tailored and effective solutions that uphold the highest standards in China. This year, we are enhancing our capabilities in China by strengthening our team, pursuing WRAP China’s regional qualifications, as well as other exciting projects designed to maximise our local impact. Reach out to f.yinn@cn.ia-net.com to discover how our blend of global expertise and local knowledge drive business growth!

#InternationalAssociates #China #Audit #Certification #QualityAssurance #Compliance #Business #Growth #Future #ContinuousImprovement

Author: m-coles

Published Date: June 5, 2024

International Associates in Pakistan is now proudly approved to conduct the Social & Labor Convergence Program scheme! 🌟

𝐖𝐡𝐲 𝐢𝐬 𝐭𝐡𝐢𝐬 𝐚 𝐠𝐚𝐦𝐞-𝐜𝐡𝐚𝐧𝐠𝐞𝐫 𝐟𝐨𝐫 𝐲𝐨𝐮𝐫 𝐛𝐮𝐬𝐢𝐧𝐞𝐬𝐬?

🔍 𝐂𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭𝐬: Gain a clear, unified view of your social and labour practices.

🌟 𝐁𝐨𝐨𝐬𝐭 𝐂𝐫𝐞𝐝𝐢𝐛𝐢𝐥𝐢𝐭𝐲: Strengthen your reputation with internationally recognised audits.

📈 𝐃𝐫𝐢𝐯𝐞 𝐈𝐦𝐩𝐫𝐨𝐯𝐞𝐦𝐞𝐧𝐭: Identify areas for enhancement and ensure continuous progress.

💡 𝐒𝐢𝐦𝐩𝐥𝐢𝐟𝐲 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Streamline your compliance with global standards, saving time and resources.

𝐖𝐡𝐲 𝐂𝐡𝐨𝐨𝐬𝐞 𝐔𝐬?

𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞 𝐘𝐨𝐮 𝐂𝐚𝐧 𝐓𝐫𝐮𝐬𝐭: Backed by our experienced team and global standards.

𝐓𝐚𝐢𝐥𝐨𝐫𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: Customised to meet your specific needs and challenges.

𝐂𝐨𝐦𝐦𝐢𝐭𝐦𝐞𝐧𝐭 𝐭𝐨 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞: Dedicated to helping you achieve and maintain top-tier ethical practices.

𝐖𝐞’𝐯𝐞 𝐠𝐨𝐭 𝐲𝐨𝐮 𝐜𝐨𝐯𝐞𝐫𝐞𝐝! Our SLCP approval means we can now offer you top-tier, reliable assessments that bring clarity and confidence to your operations.

Ready to elevate your social responsibility game? Contact us at enquiry@ia-uk.com today to learn how we can help!

#InternationalAssociates #Pakistan #SLCP #Audit #Social #Compliance #Business #Growth #BusinessGrowth #Innovation #Sustainability

Author: m-coles

Published Date: June 3, 2024

Since MDR came into force, a lot has changed in Europe, especially in regulating previously overlooked areas. For example, Advertising for medical devices must now accurately reflect their intended use as stated in the Technical Documentation. Article 7 of MDR prohibits misleading advertising and off-label promotion, emphasizing the need for accurate and truthful communication across all platforms.

We have seen many cases of people just ignoring this clause.

Manufacturers, how are you ensuring your distributors and importers comply with these stringent requirements? How do you monitor their adherence to the regulation, especially regarding accurate advertising and the prohibition of off-label promotion? Are there specific systems or audits in place to ensure compliance? How do you handle non-compliance when it occurs?

Interested to know your thoughts on this.

Author: m-coles

Published Date: May 27, 2024

𝐒𝐭𝐫𝐮𝐠𝐠𝐥𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐂𝐄 𝐌𝐚𝐫𝐤𝐢𝐧𝐠 𝐨𝐧 𝐀𝐦𝐚𝐳𝐨𝐧? 𝐖𝐞’𝐫𝐞 𝐇𝐞𝐫𝐞 𝐭𝐨 𝐇𝐞𝐥𝐩! Navigating the complexities of CE marking for Amazon sales in the EU can be daunting. That’s where International Associates comes in! Our authorized representative service is designed to act on your behalf, ensuring full compliance with EU regulations, thus preventing any disruptions in your sales.

𝐖𝐡𝐚𝐭 𝐖𝐞 𝐎𝐟𝐟𝐞𝐫:

• Full compliance checks and product assessments

• Documentation support and lab testing facilitation

• Authorized representation for non-EU based sellers

𝐃𝐨𝐧’𝐭 𝐥𝐞𝐭 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐢𝐬𝐬𝐮𝐞𝐬 𝐡𝐨𝐥𝐝 𝐲𝐨𝐮 𝐛𝐚𝐜𝐤!

Reach out at enquiry@ia-uk.com or visit https://www.ia-uk.com today for expert assistance and keep your business on the right track.

Learn More About CE Marking Requirements: https://lnkd.in/eNRN3ZsS

#InternationalAssociates #AuthorisedRepresentative #QualityAssurance #Audit #Compliance #Amazon #eCommerce #Business #Health #Safety #HealthandSafety #Environment

Author: m-coles

Published Date: May 21, 2024

𝐒𝐭𝐫𝐮𝐠𝐠𝐥𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐂𝐄 𝐌𝐚𝐫𝐤𝐢𝐧𝐠 𝐨𝐧 𝐀𝐦𝐚𝐳𝐨𝐧? 𝐖𝐞’𝐫𝐞 𝐇𝐞𝐫𝐞 𝐭𝐨 𝐇𝐞𝐥𝐩! Strengthen Your Defences Against Bribery with ISO 37001:2016 Certification

𝐃𝐢𝐝 𝐘𝐨𝐮 𝐊𝐧𝐨𝐰?

The UK has hit its lowest ever on Transparency International’s Corruption Perceptions Index. This signals a crucial time for businesses to step up their anti-bribery measures. ISO 37001:2016 isn’t just a certification; it’s a declaration of your commitment to ethical operations. Recognised globally among the top ten ISO standards, it’s essential for safeguarding your business’s integrity.

𝐖𝐡𝐲 𝐈𝐭 𝐌𝐚𝐭𝐭𝐞𝐫𝐬:

In a world where trust is your most valuable asset, ensuring your business operations are clean and transparent can significantly set you apart from the competition.

𝐇𝐨𝐰 𝐖𝐞 𝐇𝐞𝐥𝐩:

International Associates provides a full range of services to support your journey towards ISO 37001:2016 certification, including:

• 𝐓𝐫𝐚𝐢𝐧𝐢𝐧𝐠 𝐏𝐫𝐨𝐠𝐫𝐚𝐦𝐬: Our expert-led training sessions equip your team with the knowledge and skills to implement and maintain an effective anti-bribery management system.

• 𝐆𝐚𝐩 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬: We conduct an in-depth assessment to identify areas where your current practices do not meet ISO 37001:2016 requirements and provide actionable recommendations.

• 𝐂𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐀𝐮𝐝𝐢𝐭𝐬: Our experienced auditors perform rigorous assessments to verify that your anti-bribery management system complies with ISO 37001:2016 standards.

𝐖𝐞 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐇𝐞𝐚𝐫 𝐅𝐫𝐨𝐦 𝐘𝐨𝐮:

What steps has your company taken towards anti-bribery compliance? Are there specific challenges you’ve encountered? Share your story in the comments or direct message us for a personalised consultation on how ISO 37001:2016 can benefit your organisation.

𝐓𝐚𝐤𝐞 𝐭𝐡𝐞 𝐋𝐞𝐚𝐝 𝐢𝐧 𝐓𝐫𝐚𝐧𝐬𝐩𝐚𝐫𝐞𝐧𝐜𝐲!

Don’t wait—elevate your business above the rest by achieving ISO 37001:2016 certification now! Position your company at the forefront of integrity and gain a competitive edge by demonstrating your unwavering commitment to anti-bribery practices. Contact us today to discover how we can transform your operations and help you lead your industry in trust and compliance. Click the link below or email us directly to start securing your business’s future.

https://lnkd.in/dh_w4JJZ

enquiry@ia-uk.com

#InternationalAssociates #ISO37001 #AntiBribery #Management #EthicalBusiness #CorporateGovernance #RiskManagement #Trust #Ethics #Business #Regulatory #Legal #Certification

Author: m-coles

Published Date: May 15, 2024

𝐒𝐭𝐫𝐮𝐠𝐠𝐥𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐂𝐄 𝐌𝐚𝐫𝐤𝐢𝐧𝐠 𝐨𝐧 𝐀𝐦𝐚𝐳𝐨𝐧? 𝐖𝐞’𝐫𝐞 𝐇𝐞𝐫𝐞 𝐭𝐨 𝐇𝐞𝐥𝐩! 𝐄𝐧𝐬𝐮𝐫𝐢𝐧𝐠 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: 𝐓𝐡𝐞 𝐑𝐨𝐥𝐞 𝐨𝐟 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦𝐬 𝐢𝐧 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 – 𝐈𝐒𝐎 13485 𝐚𝐧𝐝 𝐀𝐥𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐯𝐞𝐬

The evolving landscape of medical device regulations highlights the critical role of Quality Management Systems (QMS). At the core of every successful medical device manufacturer lies a well-crafted QMS, ensuring product quality, safety, and regulatory compliance.

One critical aspect often underlined in discussions within the industry pertains to the flexibility afforded to manufacturers in choosing their preferred quality system framework. Contrary to popular belief, regulatory authorities 𝐝̲𝐨̲ ̲𝐧̲𝐨̲𝐭̲ ̲𝐦̲𝐚̲𝐧̲𝐝̲𝐚̲𝐭̲𝐞̲ ̲𝐚̲ ̲𝐬̲𝐩̲𝐞̲𝐜̲𝐢̲𝐟̲𝐢̲𝐜̲ ̲𝐐̲𝐌̲𝐒̲ ̲𝐟̲𝐨̲𝐫̲ ̲𝐦̲𝐞̲𝐝̲𝐢̲𝐜̲𝐚̲𝐥̲ ̲𝐝̲𝐞̲𝐯̲𝐢̲𝐜̲𝐞̲ ̲𝐦̲𝐚̲𝐧̲𝐮̲𝐟̲𝐚̲𝐜̲𝐭̲𝐮̲𝐫̲𝐞̲𝐫̲𝐬̲. While this might seem liberating at first glance, it’s essential to recognize the nuanced implications associated with this freedom of choice.

Underpinning this discussion is the distinction between adopting the harmonized standard ISO 13485 and other quality system frameworks. ISO 13485 is globally recognized and tailored to the specific needs of medical device production, offering a presumption of conformity with regulatory standards. Choosing an alternative to ISO 13485 means manufacturers must rigorously demonstrate their system’s compliance with regulations. This requires detailed documentation and robust processes to show alignment with regulatory requirements.

The flexibility in choosing a QMS allows customization to meet specific needs but demands a deep understanding of regulatory expectations and a proactive compliance strategy. Regular audits and continuous improvement are crucial to navigate the dynamic regulatory environment and maintain market access.

The decision on a QMS should be made with care, understanding that opting out of ISO 13485 can complicate compliance efforts. For manufacturers of lower-risk devices, the costs of an ISO 13485 certified QMS are comparable to those of an ISO 9001 certificate.

𝐂𝐨𝐧𝐭𝐚𝐜𝐭 𝐮𝐬 𝐚𝐭 𝐞𝐧𝐪𝐮𝐢𝐫𝐲@𝐢𝐚-𝐮𝐤.𝐜𝐨𝐦 𝐢𝐟 𝐲𝐨𝐮 𝐰𝐨𝐮𝐥𝐝 𝐥𝐢𝐤𝐞 𝐭𝐨 𝐝𝐢𝐬𝐜𝐮𝐬𝐬 𝐲𝐨𝐮𝐫 𝐨𝐩𝐭𝐢𝐨𝐧𝐬.

#InternationalAssociates #Healthcare #MedicalDevices #Technology #Manufacturing #QualityManagement #RegulatoryCompliance #ISO13485 #ManufacturingExcellence #PatientSafety #QualityAssurance #MedicalTechnology

Author: m-coles

Published Date: May 8, 2024