This forum discussion from late November 2023 focused on the requirement of work instructions in Clause 7.5.3 Required Work Instructions in ISO 9001, particularly under controlled conditions as per clause 8.5.1. One user pointed out a potential misinterpretation of the clause, suggesting that the necessity for documented information should be determined based on its … [Read more...] about Forum Discussion: Clause 7.5.3 and Required Work Instructions in ISO 9001
ISO 9001
ISO 9001 Clause 7.5.3 Control of Documented Information, Explained
Clause 7.5.3 of ISO 9001, titled "Control of Documented Information," is critical to implementing and maintaining a quality management system (QMS) compliant with ISO 9001:2015 standards. This clause necessitates the organization to systematically organize and collect essential information pertinent to various processes and develop simplified, user-friendly materials suitable … [Read more...] about ISO 9001 Clause 7.5.3 Control of Documented Information, Explained
“Does ISO 9001 really require THAT?”
A common issue faced by professionals working with the ISO 9001 standard involves dealing with individuals who misinterpret the standard's requirements in extreme ways. The article describes scenarios where people, sometimes even auditors, assert that ISO 9001 requires absurd or overly specific practices, such as documenting paper clip usage or placing clear labels on items. … [Read more...] about “Does ISO 9001 really require THAT?”
Management Reviews Under ISO 9001: How Frequently Should They Be Held?
This forum thread delves into setting intervals for Management Reviews as per ISO 9001:2015. The discussion was initiated by a user who faced an audit issue due to not holding Management Review Meetings (MRM) quarterly, as stated in their procedures manual. The user expressed the challenges of having these meetings due to time constraints and sought advice on whether it's … [Read more...] about Management Reviews Under ISO 9001: How Frequently Should They Be Held?
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