This Week in Compliance - November 2024

• ISO 9001 is evolving to meet modern challenges! The upcoming 2025 revision introduces deeper risk integration, digital transformation, sustainability, and enhanced customer focus. Expect updates in supply chain management, climate change considerations, and streamlined integration with other ISO standards. Also, don’t forget to sign up for the Quality Culture webinar.

Webinar: Developing a Culture of Quality

Title: Developing a Quality Culture that Drives Compliance & Business Success.

• This engaging session is designed to help you foster a culture of quality within your organization and connect quality outcomes with business success.

• Join us for an informative presentation and an interactive Q&A session with industry experts. Learn best practices for engaging employees in continuous improvement and applying these learnings in real-world scenarios.

  Webinar Details:

  • Date: December 17th, 2024

  • Time: 1:00 pm, Eastern Time EST

  • Duration: 40 minutes

  Register Here

• Secure your spot today and take the first step towards cultivating a quality-driven culture in your organization. The dynamic Cassandra Harbour will be presenting this session. We look forward to seeing you at the webinar.

Featured Article:

The globally trusted ISO 9001 standard for Quality Management Systems is undergoing a significant revision, set to release in 2025. This update addresses the evolving challenges and opportunities faced by organizations in today’s dynamic landscape. Here's a sneak peek at what to expect:

• Deeper Risk Integration: Strengthened risk-based thinking to identify and mitigate risks while fostering resilience proactively.

• Digital Transformation: Emphasis on leveraging digital tools for quality management and ensuring data security.

• Sustainability Focus: Aligning QMS practices with global sustainability goals and environmentally responsible practices.

• Enhanced Customer Centricity: New strategies to gather and act on customer feedback for continual improvement.

• Supply Chain Management: Addressing supply chain resilience and supplier quality assurance.

• Climate Change Considerations: Preparing organizations for climate-related challenges and integrating these into QMS strategies.

• Streamlined Integration: A high-level structure for easier alignment with other ISO standards.

These updates ensure ISO 9001 remains a robust framework for quality excellence, adaptability, and global competitiveness.

eBrief:

Title: Comprehensive Guide to ISO 14971: Risk Management for Medical Devices

• Summary: ISO 14971 is the global standard for risk management in the medical device industry. eLeaP provides an in-depth guide to understanding and implementing the risk management process, from identifying hazards to post-market monitoring.

• View Video: https://youtu.be/oOEhJig2Tww?si=YaWmQAc5Ebx-YNQA

Resources:

Title: Access and download resources from our site

• Computer System Validation – FDA Warning Letters Case Studies – Lessons Learned

• The GAMP Approach to 21 CFR Part 11 Compliance

• SOP Templates

About us:

eLeaP is a trusted platform specializing in learning, compliance, and performance management for highly regulated industries such as life sciences, aviation, manufacturing, finance, and technology. Our platforms help organizations meet rigorous regulatory requirements like 21 CFR and 14 CFR, develop high-performing teams, and achieve exceptional results. Learn more at www.eleapsoftware.com