ISO 9001 serves as the foundational quality management system (QMS) standard for organizations across industries, setting a global benchmark for delivering consistent and reliable products and services. However, in high-stakes sectors like aerospace, aviation, and defense, ISO 9001 alone does not meet the rigorous requirements for safety and precision. To address these unique … [Read more...] about The Evolution of Quality Standards: From ISO 9001 to the 9100 for Aerospace
Quality-ISO 9001
Fun List of Ways ISO 9001 Doesn’t Comply with ISO’s Directives on Standards Development
One scathing and detailed critique of ISO 9001 shows how ISO 9001:2015 and the forthcoming 2026 revision, fails to comply with the very rules ISO sets for developing standards. These rules are laid out in the ISO/IEC Directives Parts 1 and 2, which govern everything from language clarity to requirement verifiability. According to Christopher Paris, ISO 9001 violates several of … [Read more...] about Fun List of Ways ISO 9001 Doesn’t Comply with ISO’s Directives on Standards Development
ISO 9001 and Lean’s Continuous Improvement
This podcast explores the synergy between ISO 9001 and Lean methodologies, emphasizing how they complement one another in improving quality management and operational efficiency. While ISO 9001 provides a structured framework for quality assurance, Lean principles focus on waste reduction and continuous improvement. Organizations that integrate both approaches can create more … [Read more...] about ISO 9001 and Lean’s Continuous Improvement
Responding to ISO 9001 Compliance Audits
This forum discussion revolved around an ISO 9001 pre-recertification/certification audit report that highlighted multiple nonconformities related to stock control, documentation, and process adherence under ISO 9001. Internal audits play a critical role in quality management systems by identifying areas for improvement and ensuring compliance with ISO 9001. However, audits can … [Read more...] about Responding to ISO 9001 Compliance Audits
An approach to integrate Artificial Intelligence in ISO 9001-based quality management systems
The article explores a structured approach to integrating Artificial Intelligence (AI) into ISO 9001-based quality management systems (QMS), emphasizing the importance of aligning three key frameworks: Annex SL, ISO 9001, and ISO/IEC 42001. With the publication of ISO/IEC 42001:2023, organizations now have a dedicated standard for AI management systems, providing structured … [Read more...] about An approach to integrate Artificial Intelligence in ISO 9001-based quality management systems
ISO 9001:2025 Revision – What you need to know
The upcoming ISO 9001:2026 revision is a crucial update for quality management professionals, aiming to reflect significant changes in business, technology, and global challenges since the last major update in 2015. The revision process is currently in progress, with Working Group 29 reviewing feedback on the first Committee Draft (CD) and preparing for the Draft International … [Read more...] about ISO 9001:2025 Revision – What you need to know
The ISO 9001:2015 Quality Management System Standard: Companies’ Drivers, Benefits and Barriers to Its Implementation
A survey of 493 ISO 9001-certified Italian companies reveals that the standard is widely recognized, especially in northern Italy, where economic development is highest. The study finds that most businesses have been certified for over seven years, indicating a long-standing quality culture. Companies transitioning from ISO 9001:2008 to the 2015 version acknowledge its emphasis … [Read more...] about The ISO 9001:2015 Quality Management System Standard: Companies’ Drivers, Benefits and Barriers to Its Implementation
An In-Depth Look at Committee Draft 2 (CD2) of ISO 9001:2026
The Committee Draft 2 of ISO 9001:2026 retains much of the structure and content from the 2015 version, with few significant changes. Key updates include additional guidance in the annexes, some of which critics argue are unhelpful or contradictory. The annexes include suggestions, such as conducting SWOT analyses, but these optional elements could lead to confusion if … [Read more...] about An In-Depth Look at Committee Draft 2 (CD2) of ISO 9001:2026
Sustainability and Technology are Shaping the Next ISO 9001 Update
The 2026 ISO 9001 revision signals a transformative shift in quality management by integrating Industry 4.0 technologies, such as AI and IoT, into standard practices. This update reflects the growing importance of digital transformation and aims to modernize quality systems to enhance efficiency and responsiveness. Concurrently, sustainability has moved from an optional … [Read more...] about Sustainability and Technology are Shaping the Next ISO 9001 Update
Mastering Leadership in Quality Management: ISO 9001 Clause 5
ISO 9001 Clause 5 serves as a cornerstone for quality management, highlighting the importance of leadership in driving the success of a QMS. Leaders are tasked with actively participating in developing and maintaining the QMS, establishing clear quality policies and objectives, and ensuring sufficient resources are allocated to meet these goals. By aligning the QMS with the … [Read more...] about Mastering Leadership in Quality Management: ISO 9001 Clause 5
What Does the 2023 ISO Survey Tell Us About ISO 9001, ISO 14001 and ISO 45001 Certifications?
The 2023 ISO Survey of Certifications revealed shifts in the number of valid certificates and sites across various ISO management system standards. This year, the absence of data from China's accreditation body significantly impacted the reported numbers, particularly for ISO 9001 and ISO 14001, traditionally dominated by China. Despite this, countries like Italy, Korea, and … [Read more...] about What Does the 2023 ISO Survey Tell Us About ISO 9001, ISO 14001 and ISO 45001 Certifications?
How To Address Risk in ISO 9001
In ISO 9001:2015, risk-based thinking has become central, urging companies to systematically identify and address risks and opportunities. The approach involves four key steps: identifying risks and opportunities, planning responses, integrating these plans into the Quality Management System (QMS), and evaluating effectiveness. Initially, companies assess both internal and … [Read more...] about How To Address Risk in ISO 9001
ISO 9001 Auditing Practices Group Guidance on Auditing Climate Change Issues in ISO 9001
The International Organization for Standardization (ISO) has introduced a climate change amendment to ISO 9001, aimed at incorporating climate-related considerations within Quality Management Systems (QMS). This update, part of ISO’s commitment to climate action under the London Declaration, requires organizations to assess if climate change is relevant to their QMS goals. This … [Read more...] about ISO 9001 Auditing Practices Group Guidance on Auditing Climate Change Issues in ISO 9001
CMMI and ISO 9001 Comparison: What’s the Difference?
ISO 9001 and CMMI are two widely recognized frameworks in quality management, each offering unique approaches to enhancing organizational performance. ISO 9001 is an international standard for establishing and maintaining a Quality Management System (QMS), providing a structure for organizations to improve processes and prioritize customer satisfaction. It applies to any … [Read more...] about CMMI and ISO 9001 Comparison: What’s the Difference?
Checklist of Mandatory Documentation Required by ISO 9001:2015
Documentation for ISO 9001:2015 certification includes both mandatory and optional documents. ISO 9001:2015 is more flexible than its predecessor, reducing the number of mandatory procedures but still requiring specific documents and records, including those related to the scope of the QMS, quality policies, and calibration of measuring equipment. Additionally, mandatory … [Read more...] about Checklist of Mandatory Documentation Required by ISO 9001:2015
Guide to Clause 4.4: ISO 9001 Quality Management System and its Processes
Clause 4.4 of ISO 9001 is crucial for developing a robust Quality Management System (QMS), yet many organizations struggle to grasp its requirements fully. This clause emphasizes a process-based approach to ensure all activities within a company contribute effectively to meeting customer and regulatory requirements. A well-executed QMS, grounded in this clause, helps meet … [Read more...] about Guide to Clause 4.4: ISO 9001 Quality Management System and its Processes
The 7 Most Important ISO 9001:2015 Audit Questions
When preparing for an ISO 9001:2015 audit, auditors must focus on several critical areas to comprehensively evaluate an organization’s Quality Management System (QMS). One key question concerns the "context of the organization," which involves understanding internal and external factors influencing the company’s strategy and goals. This context and identifying interested … [Read more...] about The 7 Most Important ISO 9001:2015 Audit Questions
Working With an ISO 9001 Certified Logistics Company
Collaborating with an ISO 9001-certified logistics company ensures adherence to high-quality assurance standards, customer satisfaction, and continuous improvement. ISO 9001 certification emphasizes robust quality management systems, regular audits for compliance, and a commitment to process enhancement. This certification showcases a company's dedication to providing reliable … [Read more...] about Working With an ISO 9001 Certified Logistics Company
Book Excerpt: ISO 9001:2015 Internal Audits Made Easy
ISO 9001:2015 Internal audits are crucial for verifying compliance, enhancing process effectiveness, and driving continuous organizational improvement. These audits help identify nonconformities and areas for improvement, ensuring the quality management system (QMS) is effective and aligned with the organization's goals. Internal audits should not merely mimic external … [Read more...] about Book Excerpt: ISO 9001:2015 Internal Audits Made Easy
ISO 9001 Clause 8.4 Control of externally provided processes, products and services
ISO 9001 Clause 8.4 covers the requirements for controlling externally provided processes, products, and services. The clause starts with subclause 8.4.1, which mandates that organizations ensure all externally provided processes conform to specified requirements. Businesses must determine the necessary controls when external products and services are intended for incorporation … [Read more...] about ISO 9001 Clause 8.4 Control of externally provided processes, products and services