Insights
Implementation questions answered with technical judgment rather than a sales pitch — audit readiness, internal auditing, documentation, and choosing between schemes.
12 articles
ISO 13485 does real work toward EU MDR and none of the work on the parts that take longest — here is what transfers, what has no 13485 equivalent, and the three misunderstandings that cost medical device manufacturers time they do not have.
TIA is writing a new quality management standard for data centre power, cooling and mechanical infrastructure, chaired by Google, with Modine, Johnson Controls, Trane and Omnex leading the drafting teams. Release 1.0 lands Q1 2027. Nothing is certifiable yet — but one piece of preparation has a real lead time.
Researchers in Brazil found Escherichia albertii and Kosakonia cowanii on Rangpur limes while studying something else. No outbreak, no immediate threat — but it exposes a question most hazard analyses assume away: what is your process for the hazards you do not know about?
FDA is taking comments on Listeria monocytogenes prevention until 2 November 2026, after a two-day meeting where experts debated zero tolerance and pressed for environmental monitoring that genuinely looks for the organism. Three things worth understanding, whether or not you comment.
Most food manufacturers run two competent systems that never meet: HACCP and the GFSI scheme on one side, lean and six sigma on the other. Recurring nonconformities live in the gap. Four connections that close it.
ISO 9001:2026, ISO 14001:2026 and ISO 37001:2025 are all in transition on different clocks. ISO 37001 expires on 28 February 2027, more than two years before the others. Here are the dates, what actually changed, and why transitioning 9001 and 14001 together costs less.
AS9100 is being replaced by IA9100 — a single global aerospace quality standard aligned with the 2026 revision of ISO 9001. Here is what is expected to change, the likely timeline, and what aerospace and defense suppliers should do now.
Four GFSI-recognized food-safety schemes — and the right one usually comes down to your customers and the markets you sell into. A plain-English guide to choosing.
For most organizations, ISO certification takes about six to seven months. Here is what happens in each phase — and what makes it faster or slower.
Your first certification audit is less about heroics and more about being ready. Here is a calm, practical way to walk in prepared — and walk out certified.
A thick manual feels safe and reads like proof of effort. In practice, it is the thing most likely to fail you. Here is the case for keeping it lean.
If your internal audit turns into a scramble every cycle, the problem is not your team — it is the rhythm. Here is how to make audits routine and genuinely useful.
