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?
Quality-ISO 9001
ISO 9001 Clause 7.5.3. What are the Required Work Instructions?
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?
Who’s interpretation of ISO standards matters?
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?
Forum Discussion: What are the Requirements for Products and Services in ISO 9001?
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?
What should be changed in the next edition of 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?
What if ISO had to explain its changes?
What if ISO had to explain changes to its standards? Should ISO require official documentation explaining the specific value of certain changes to users? This blog post from a quality management expert answers this and similar questions. The author posits whether ISO should require public reasons to the full clauses of its standards and whether ISO should go further in … [Read more...] about What if ISO had to explain its changes?
Risk-Based Thinking and the IATF 16949 Requirements Related to Risk
Risk-based thinking is one of the more significant additions to ISO 9001:2015's list of quality management principles. Risk-based thinking involves incorporating risk analysis in an organizational quality management system, including certain risks' opportunities, probability, and consequences. The goal is to prevent identifiable problems before they happen, evaluating risks … [Read more...] about Risk-Based Thinking and the IATF 16949 Requirements Related to Risk
ISO to Develop Design Specification for New Version of ISO 9001
The ISO technical committee, who develops, manages, and updates ISO 9000, is now developing a similar set of design standards for a potential future revision of ISO 9001. TG5 has been assigned to develop these design standards by the ISO/TC 176/SC2 Strategic Planning and Operations Task Group (SPOTG). In April, SPOTG met to review a report from ISO/TC 176/SC2/TG 5 where they … [Read more...] about ISO to Develop Design Specification for New Version of ISO 9001
ISO Certification and Risk Management Practices
ISO Certification Standard is an essential Certification for all major industry sectors and companies of any size and nature of work. There are numerous business benefits from getting an ISO Certification for an organization.Depending on the area of operation, the organization can choose from a wide variety of ISO Certification Standards for them to transform their business … [Read more...] about ISO Certification and Risk Management Practices
What does “external documents control” mean in ISO 9001?
Can you imagine the possible consequences of selling a product or service that no longer complies with legislation because the seller was not aware of legislative changes? Can you imagine receiving a complaint from a customer because he claims that the product received no longer meets the last version of an ISO standard that your company mentions in the product specification … [Read more...] about What does “external documents control” mean in ISO 9001?
Beyond Compliance: Meaningful Benefits of ISO 9001 for Small Businesses
Increasingly, business owners recognize the benefits of ISO 9001 for small businesses. In a 2020 ISO 9001 user survey, 38% of companies implementing ISO 9001 had fewer than 50 employees.ISO 9001 can have a transformational impact – especially for a small business – when combined with a digital quality management system (QMS).Increased adoption of ISO 9001 by SMEsAccording … [Read more...] about Beyond Compliance: Meaningful Benefits of ISO 9001 for Small Businesses