ISO 9001

ISO 9001:2026 does not require a quality manual or a fixed set of procedures. Here is the documented information it does require, clause by clause, and what is optional but worth having.

A practical guide to ISO 9001:2026 for quality managers at manufacturers and suppliers. What changed from the 2015 edition, how the transition works, what documented information you need and how to choose a document package.

ISO 9001 and ISO 13485 share a common core but serve different purposes. Here is how to decide which standard fits your organization, and when it makes sense to run both.

A.P. Lyon now offers an ISO 9001:2026 quality management system for manufacturers and their suppliers: three complete packages and 58 individual procedures, all editable Word and Excel files.

ISO 9001:2026 is out. See what changed from 2015, the transition timeline, and which QMS procedures dual-certified medical device teams should review first.