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5 days ago · What are ISO standards 9001 and 13485, and what do they cover? This article aims to answer those questions and to highlight the key differences between the two.
5 days ago · Understanding the Importance of ISO-13485 in Medical Device Quality Management Medical devices play a crucial role in the healthcare industry, providing essential tools for diagnosis, treatment, and patient care. Ensuring the quality, safety, and effectiveness of these devices is paramount to protect patient health and well-being.
4 days ago · Step 2: Prepare Checklists and Schedule the Audit. Checklists guide auditors during the factory audit process and ensure no information is overlooked. A manufacturing audit checklist specifies the areas to be inspected, the standards or regulations to be verified, and what information needs to be gathered.
5 days ago · Download and use this free compliance risk assessment template to systematically evaluate potential risks associated with regulatory compliance within your organization. This template provides a structured framework for identifying, analyzing, and mitigating compliance-related risks across various operational areas.
4 days ago · Good morning, My company is ISO 13485 certified but is looking to adopt the AS9102 for our first articles. I was wondering if anyone has a copy they can share of Rev C? I have AS9102 Rev B from my previous life but do not have the current standard revision and I am wanting to review and bring it forward to my company's president to see if this ...
3 days ago · Compliance Audit Checklist: Regulatory Context: Identify and assess relevant regulations for your business. Policies and Procedures: Review and ensure compliance policies are followed by employees. Risk Management: Prioritize and address critical regulatory risks. Data and Network Security: Audit cybersecurity measures and verify network ...
5 days ago · Building a detailed audit checklist that covers all areas and aspects of cleaning within the facility will ensure that nothing is overlooked. It will serve as a road map for the audit, guiding the team systematically through each area of inspection.
