Quality-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

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

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?

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

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

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

 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

 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 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

Many organizations pursue ISO 9001 certification primarily due to regulatory or customer pressure, resulting in a certification that serves more as a checkbox than a tool for genuine quality improvement. This approach often leads to management viewing ISO 9001 as a costly and complicated requirement rather than a beneficial framework. Typically, the quality management system … [Read more...] about Is your ISO 9001 certification just for the wall?

The forum discussion revolves around the necessity and interpretation of Clause 7.5.3 regarding required work instructions (WIs) in quality management systems. A key point raised is that while Clause 7.5.3 discusses the need for documented information, Clause 7.5.1 provides flexibility. This clause states that the organization’s quality management system should include only the … [Read more...] about ISO 9001 Clause 7.5.3. What are the Required Work Instructions?

One interpretation of AS/ISO standards revolves around understanding who holds the authority to interpret these standards within organizations and the implications of such interpretations. This recent forum discussion begins by questioning how different interpretations of standards, particularly concerning competency, are handled within organizations and the role of quality … [Read more...] about Who’s interpretation of ISO standards matters?

The discussion in the Elsmar Cove Quality Forum revolves around a member's struggle with clauses 8.2.2 and 8.2.3 of a quality management standard following a major issue raised by an auditor. The primary concern was the need for more objective evidence of contract review within the organization. Participants in the forum shared insights and suggestions on addressing this issue, … [Read more...] about Forum Discussion: What are the Requirements for Products and Services in ISO 9001?

This forum discussion centered around the revision of ISO 9001, following the SC2 plenary meeting in October 2023 and the first meeting of Work Group 29 in December 2023. The forum participants reflect a mix of anticipation and skepticism about the upcoming changes to ISO 9001 and raise questions about the future direction of quality management standards.The design … [Read more...] about What should be changed in the next edition of ISO 9001?