The Quality Edge

Third Revision of ISO 2859-1

jvdbd@hotmail.com (John Vandenbemden) — Fri, 10 Apr 2026 00:00:00 -0400

The final draft of ISO 2859-1 was approved in December 2025.

Why Process Variation Control Matters for ISO 9001 and Quality

jvdbd@hotmail.com (John Vandenbemden) — Mon, 09 Feb 2026 00:00:00 -0500

Previously, I discussed my concerns about organizations not properly managing corrective actions or process variation. While corrective actions were covered before, this piece focuses on variation.

Why Is Corrective Action So Hard?

jvdbd@hotmail.com (John Vandenbemden) — Sat, 10 Jan 2026 00:00:00 -0500

In the early 1980s, my Quality career emphasized variation and corrective action. Although I’ve attended various solution-branded workshops, many organizations still struggle with understanding variation and effectively implementing corrective actions.

Configuration Management: Consistency in Product Performance and Design Throughout Its Lifecycle

jvdbd@hotmail.com (John Vandenbemden) — Fri, 10 Oct 2025 00:00:00 -0400

The upcoming revision of ISO 10017: 2017 focuses on "Quality management — Guidelines for configuration management," aimed at maintaining consistency in a product’s functionality and characteristics throughout its lifecycle. The configuration management process includes five steps.

Standards Update: Draft of Report Currently Being Circulated to Tag69 Members for Comments

jvdbd@hotmail.com (John Vandenbemden) — Sun, 14 Sep 2025 00:00:00 -0400

After three years and many meetings, ISO 10012: 2025 Measurement Management Systems has reached the status of Final Draft International Standard, also referred to as FDIS.

Manufacturers Must Verify Products are Fit Through Analysis and Testing

jvdbd@hotmail.com (John Vandenbemden) — Wed, 16 Jul 2025 00:00:00 -0400

This article highlights some key points of product hazard analysis.

The Forgotten Methodology

jvdbd@hotmail.com (John Vandenbemden) — Mon, 14 Apr 2025 00:00:00 -0400

TRIZ reduces the risk of unpredictable outcomes common in brainstorming by identifying that 90-95% of engineers' root problems have already been solved, often in different industries using different technologies.

Do You Need to Implement ISO27001?

jvdbd@hotmail.com (John Vandenbemden) — Mon, 17 Feb 2025 00:00:00 -0500

Evaluating your organization’s vulnerability to cyberattacks is essential, especially regarding ISO27001 requirements. Many overlook IT security, which can lead to serious issues; I’ve witnessed two organizations attacked, one during a renewal audit, emphasizing the need for strong cybersecurity.

EPA’s Oil Spill Prevention, Control, Countermeasure Program

jvdbd@hotmail.com (John Vandenbemden) — Mon, 23 Dec 2024 00:00:00 -0500

I discuss the EPA's Spill Prevention, Control, and Countermeasure (SPCC) regulation from 1973, highlighting the significance of SPCC Plans in preventing oil spills, which incorporate emergency response strategies and training to ensure compliance with regulations.

ISO 10012 Update

jvdbd@hotmail.com (John Vandenbemden) — Mon, 11 Nov 2024 15:00:00 -0500

I have provided updates of the progress and development of ISO 10012 over the past three years. I am happy to say that after three years and numerous meetings the Draft International Standard (DIS) ISO10012 Quality management – Requirements for measurement management system has been released for review, approval, and comments.

ITAF Rule 6 Changes

jvdbd@hotmail.com (John Vandenbemden) — Mon, 14 Oct 2024 00:00:00 -0400

The sixth edition of the IATF Rules, released on March 31, 2024, introduces significant changes to certification requirements, including a shift to performance and risk-based audits. These updates, aimed at improving audit efficiency and certifiability, must be adopted by January 1, 2025.

ISO45001 and the OSHA Regulations

jvdbd@hotmail.com (John Vandenbemden) — Sun, 29 Sep 2024 00:00:00 -0400

Safety is paramount in manufacturing and distribution, with ISO 45001 (2018) guiding Health and Safety programs under federal regulations. However, there's less focus on OSHA's requirements in 29 CFR 1910.

The AIAG Control Plan Manual

jvdbd@hotmail.com (John Vandenbemden) — Fri, 02 Aug 2024 00:00:00 -0400

Starting March 1, 2024, a standalone Control Plan Reference Manual will maintain linkages between core tools under APQP, providing more guidance for creating and using control plans.

Brief History of ANSI/ASQ Z1.4

jvdbd@hotmail.com (John Vandenbemden) — Wed, 03 Jul 2024 00:00:00 -0400

The ANSI/ASQ Z1.4 standard is similar in format to MIL-STD-105E and ASTM E2234-09 but differs in its definition of a rejectable item. It uses definitions and terminology in line with ANSI/ISO/ASQ 3534-2:2006. Two definitions are particularly important in applying the standard.

Organizational Knowledge: So, where do we begin?

jvdbd@hotmail.com (John Vandenbemden) — Thu, 27 Jun 2024 00:00:00 -0400

What is the purpose of the requirement in ISO9001: 2015 for organizational knowledge? This particular requirement is part of a set of six requirements categorized under resources. Allow me to outline the specific details of this requirement.

Climate Change and Management Standards

jvdbd@hotmail.com (John Vandenbemden) — Tue, 09 Apr 2024 00:00:00 -0400

The ISO has added new statements to management standards in support of the ISO London Declaration on Climate Change. The change addresses the impact of climate change on management system effectiveness.

Is Customer Satisfaction Dead?

jvdbd@hotmail.com (John Vandenbemden) — Thu, 28 Mar 2024 00:00:00 -0400

Blaming technology for lower customer satisfaction due to reduced personal interaction, while emphasizing the importance of face-to-face meetings for happiness and increased effectiveness, highlights the need for strategies like limiting electronics during meals and following established standards.

The Standard Explained: What is ISO 17025: 2017?

jvdbd@hotmail.com (John Vandenbemden) — Mon, 11 Mar 2024 00:00:00 -0400

The official document is titled ISO/IEC 17025: 2017, General requirements for the competence of testing and calibration laboratories. It is the international reference for laboratories performing calibration and testing activities.

An Effective Management System and Lean Enterprise Require a Cultural Change

jvdbd@hotmail.com (John Vandenbemden) — Mon, 18 Dec 2023 00:00:00 -0500

A management system such as ISO9001, when implemented and deployed properly, provides the organization with predictable and consistent processes. This is also a critical component for the success of lean enterprise.

Performance Measures Not Always What They Appear

jvdbd@hotmail.com (John Vandenbemden) — Thu, 23 Nov 2023 00:00:00 -0500

At times, performance measures reveal a hidden story that can only be found by peeling back the onion. Let’s pursue this concept with an example.

Manufacturing Organizations Find the Following Sampling Strategies Useful

jvdbd@hotmail.com (John Vandenbemden) — Wed, 25 Oct 2023 00:00:00 -0400

The sampling strategy is an important part of statistical sampling. Manufacturing organizations find the following sampling strategies to be useful.

Volunteers Needed for TAG 69

jvdbd@hotmail.com (John Vandenbemden) — Mon, 18 Sep 2023 00:00:00 -0400

First let’s address the first part of what TAG is. The Technical Advisory Group"s primary purpose is to develop and transmit the U.S. position on activities or draft standards of the appropriate ISO or IEC technical committees.