Introducing the ISO 9001 QMS: Editable ISO 9001:2026 Documents for Manufacturers

A.P. Lyon documents have been used by medical device companies in FDA and notified-body audits in 45 countries. Their suppliers, and manufacturers outside the medical device field, have asked for the same practical documents without the regulatory content they don't need. The new ISO 9001 QMS is that system.

What's in the ISO 9001 QMS

• Built on ISO 9001:2026. A Quality Manual organized by ISO 9001 clauses 4 to 10, with procedures, forms and master lists that reference each other.

• Written for manufacturers and their suppliers. ISO 13485, FDA QMSR and EU MDR requirements are removed. The operational controls auditors look for remain.

• Editable files. Every document is a Word or Excel file you can run on paper or import into your eQMS.

Three complete systems

• Base, 20 procedures, $595. Document control, management review, training, purchasing, supplier management, receiving and lot inspection, calibration, complaints, CAPA, internal audit, nonconforming material and customer satisfaction.

• Standard, 38 procedures, $995. Adds design control, risk management, production records, first article inspection, line clearance, statistical techniques and failure investigation.

• Complete, 54 procedures, $1,295. Adds process validation, environmental controls, installation qualification, software validation, shelf life, labeling review, injection mold validation and recall.

Each package includes the Quality Manual, the master list of documents, the external standards list and every form the procedures use. Compare the packages or browse the ISO 9001 QMS.

Or build your own

Every procedure is also sold on its own. In Build Your QMS, choose ISO 9001 QMS, pick the procedures you need and mark the ones you already have. Volume discounts apply automatically: 20% off 5 to 9 procedures, 35% off 10 to 19, 50% off 20 to 39 and 60% off 40 or more.

Which family fits your organization?

• ISO 9001 QMS: manufacturers and suppliers working toward ISO 9001:2026 certification.

• ISO 13485 QMS: medical device companies working to ISO 13485 and FDA QMSR.

• Dual-Standard QMS: organizations certified to both ISO 9001 and ISO 13485 that want one integrated set of documents.

Not sure which one you need? Contact us and we'll help you choose the scope.