ISO 9001 QMS — Complete | ISO 9001:2026
Set up a quality management system that meets ISO 9001:2026 with ISO 9001 QMS — Complete. Editable Word and Excel documents written for manufacturers and their suppliers, built on the procedures A.P. Lyon developed for regulated medical device manufacturing.
Why A.P. Lyon documentation
Written by Aaron Lyon, former Senior Director of Regulatory Affairs, from 30+ years in design and manufacturing
Current to ISO 9001:2026, including context, interested parties, climate change, quality culture and ethical behaviour
Preview before you buy: the gallery shows the package's content list
What customers say
“I have purchased several of your products and I have always been happy with the quality of your work. Thanks for providing a great product.” — A.P. Lyon customer
Who this package suits
Manufacturers that want the full set. Adds process validation, installation qualification, protocols and reports, environmental controls, software validation, technology transfer, returned goods, shelf life, labeling, design and process risk analysis, injection mold validation, customer requirements validation, recall and third-party inspections to the Standard set.
What is included
54 editable -Q procedures.
QMSM-Q Quality Management System Manual, structured on ISO 9001:2026 clauses 4 to 10, and ORG-001-M-Q editable organization chart.
LIST 0001-Q master list with an ISO 9001:2026 clause cross-reference, and LIST 0002-Q External Standards List.
31 editable form templates.
A PDF copy of every Word document.
Delivered as one digital ZIP. Review the product gallery's content-list pages for the document scope before purchase.
Can it be used with an electronic QMS?
Yes. The manual, procedures, lists and forms are editable Microsoft Word and Excel files, so you can import them into any eQMS that manages Office documents or run them as a paper-based system. Load the documents into the system's document control, route them through its review and approval workflow, and either rebuild the forms as electronic forms or attach them as templates. Validate the eQMS software for its intended use under your QMS; the included SOP 7-033-Q Software Validation Procedure supports that work.
For a step-by-step walkthrough, read Using A.P. Lyon Procedures in an eQMS: Import, Adapt and Validate.
Before implementation
Adapt responsibilities, process steps, acceptance criteria and records to your organization, products and customers. Confirm the applicable statutory and regulatory requirements before approval and use. Purchasing templates does not certify an organization.
