Dual-Standard QMS — Design Plus | ISO 9001:2026 + ISO 13485:2016
Build an integrated documentation foundation with Dual-Standard QMS — Design Plus. This digital package supports work across ISO 9001:2026 and ISO 13485:2016.
Why A.P. Lyon documentation
Written by Aaron Lyon, former Senior Director of Regulatory Affairs, from 30+ years in medical device design and manufacturing
Current to FDA QMSR (effective February 2, 2026) and ISO 9001:2026
Preview before you buy: the gallery shows the actual content-list pages for this package
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
“We aligned the system to our organization and devices. A P Lyon's procedures were very handy and easy to implement in a couple of months.” — Bal G.
Who this package suits
A broader design-oriented package when development work also needs software lifecycle, software clinical evaluation, supplier, complaint and corrective-action procedures.
What is included
49 editable -C procedures.
QMSM-C Quality Management System Manual and ORG-001-M-C editable organization chart.
Package-specific LIST 0001-C content list.
LIST 0002-C External Standards List.
New for ISO 9001:2026: SOP 5-003-C QMS Context and Planning Procedure and SOP 8-015-C Customer Satisfaction Monitoring Procedure, with FORM 0035-C to FORM 0038-C.
25 editable form templates.
Delivered as one digital ZIP. Review the product gallery’s actual 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. A typical approach is to 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.
Before release, change wet-signature blocks and paper-record wording to match how your system applies electronic signatures and keeps records, and align each procedure’s approval steps with the system’s workflow. Validating the eQMS software for its intended use is your responsibility under ISO 13485:2016 clause 4.1.6 and, for U.S. devices, FDA’s QMSR (21 CFR Part 820), including 21 CFR Part 11 where it applies. The SOP 7-033-C Software Validation Procedure is included in this package and can support that work. The package supplies documentation; it does not configure or validate your software.
For a step-by-step walkthrough, read Using A.P. Lyon Procedures in an eQMS: Import, Adapt and Validate.
How it differs from Dual-Standard QMS — Design & Development
This package contains 16 additional procedures compared with that set. Examples include:
Compare the six Dual-Standard systems
Dual-Standard QMS — Base — 27 procedures; 25 editable form templates.
Dual-Standard QMS — Base Plus — 42 procedures; 26 editable form templates.
Dual-Standard QMS — Design & Development — 33 procedures; 15 editable form templates.
Dual-Standard QMS — Design Plus — 49 procedures; 25 editable form templates.
Dual-Standard QMS — Manufacturing — 62 procedures; 27 editable form templates.
Dual-Standard QMS — Manufacturing Plus — 75 procedures; 27 editable form templates.
Packages differ in scope, not just document count. Review each package-specific LIST 0001-C in the product gallery. Other system packages are separate purchases; compare contents to avoid duplicates.
Select documents according to your organization’s actual processes and responsibilities. Adapt, review and approve them before implementation, and retain evidence that the processes are performed. Purchasing this package does not certify an organization or establish device conformity.
