The Quality Hub

• Episode 7 - S3- ISO 9001 vs other QMSs What's the Difference? Part 1

  In this episode of the Quality Hub: Chatting with ISO Experts, host Xavier Francis discusses ISO 9001 vs other Quality Management Systems - What's the Difference (Part 1) with Suzanne Weber-Smatko and Murphy Shaw from Core Business Solutions. They explore ISO 9001’s role in standardizing processes for consistency and improvement, comparing it to industry-specific standards like ISO 13485 for medical devices, AS 9100 for aerospace, and 21 CFR Part 820, an FDA regulation. The discussion also covers Six Sigma, a data-driven methodology for reducing defects, highlighting its individual certification structure versus ISO 9001’s organizational certification. The episode emphasizes how businesses can integrate multiple quality systems for better efficiency and compliance, setting the stage for Part 2.   Helpful Resources:   What is a Mature QMS?:  https://www.thecoresolution.com/quality-management-system-maturity Compliance vs. Certification:  https://www.thecoresolution.com/iso-compliance-vs-certification For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at [email protected] A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting  

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• Episode 6 - S3 - Understanding the PDCA Cycle in ISO9001

  In this episode of The Quality Hub, Chatting with ISO Experts, host Xavier Francis welcomes back Suzanne Strasser, VP of Consulting and Development, to explore the PDCA Cycle (Plan-Do-Check-Act) and its vital role in ISO 9001. They discuss how this structured, iterative method drives continuous improvement by aligning with key ISO 9001 clauses. From setting goals and testing solutions to analyzing outcomes and implementing changes, PDCA helps businesses enhance efficiency, mitigate risks, and meet customer expectations. They also emphasize the importance of focusing on real outcomes rather than rigidly following methodologies. Tune in to learn how applying PDCA within ISO 9001 can strengthen your quality management system and drive meaningful improvements in your organization! Helpful Resources: Compliance vs. Certification:  https://www.thecoresolution.com/iso-compliance-vs-certification   For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015   Contact us at 866.354.0300 or email us at [email protected]   A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources   ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting      

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• Episode 5 - S3 - ISO 9001 Clause 7.1.5 Calibration in Your QMS Part 2

  On this episode of the Quality Hub Podcast hosted by Xavier Francis, guests Brian Smith and Joe Hill discuss ISO 9001, Clause 7.1.5. They explore how calibration frequency should be determined based on risk levels, such as manufacturer's guidelines, regulatory requirements, and other factors. They stress the need for frequent calibration in high-risk scenarios and discuss the importance of using accredited services for calibration. The episode emphasizes the consequences of neglecting proper calibration and highlights the difference between verification and certification of equipment. Helpful Resources: ISO 9001 Clause 7.1.5:  https://www.thecoresolution.com/clause-7-1-5-iso-9001-explained   ISO 9001 Clause 7:  https://www.thecoresolution.com/iso-9001-clause-7   For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015   Contact us at 866.354.0300 or email us at [email protected]   A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources   ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting

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• Episode 5 - S3 - ISO 9001 Clause 7.1.5 Calibration in Your QMS Part 1

  On this episode of the Quality Hub Podcast hosted by Xavier Francis, guests Brian Smith and Joe Hill discuss ISO 9001 Clause 7.1.5 on calibration within a Quality Management System (QMS). They elaborate on the importance of calibration in ensuring the accuracy of tools and equipment used in monitoring and measuring product quality. They discuss the specifics of the clause, including requirements for monitoring resources, measurement traceability, and the responsibilities organizations have towards calibration. They also cover how organizations should handle equipment that is out of calibration, and the proper management and retention of calibration records. The episode aims to clarify the clause's provisions and offer practical advice on maintaining compliance and ensuring measurement reliability within a QMS. Helpful Resources:   ISO 9001 Clause 7.1.5:  https://www.thecoresolution.com/clause-7-1-5-iso-9001-explained   ISO 9001 Clause 7:  https://www.thecoresolution.com/iso-9001-clause-7   For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015   Contact us at 866.354.0300 or email us at [email protected]   A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources   ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting  

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• Episode 4 - S3 - ISO 27001 What's new in Version 2022

  In this episode of the Quality Hub podcast, Xavier Francis speaks with Suzanne Strausser, and Brian Reich as they discuss the key updates and implications of the 2022 version of ISO 27001. They focus on key changes such as better alignment with other ISO standards, a reduction in Annex A controls, the addition of new controls, and more. They speak to the new updates emphasizing a streamlined, risk-based approach, making the standard more accessible to smaller organizations with simpler IT environments. The speakers highlight challenges in transitioning to the new version of the standard, including reassessing existing controls and addressing gaps, and how the updated version enhances cybersecurity by focusing on proactive monitoring and secure practices.   Helpful Resources:   https://www.thecoresolution.com/iso-27001   https://www.thecoresolution.com/who-needs-iso-27001-certification   For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015   Contact us at 866.354.0300 or email us at [email protected]   A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources   ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting    

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