ISO 13485 QMS — Manufacturing Plus | ISO 13485 & FDA QMSR
MANUFACTURING PLUS is A.P. Lyon's broadest QMS package in this range, developed for organizations engaged in medical device research, development and manufacturing. It brings together documentation for design, production and post-commercialization activities in one system.
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 13485:2016
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.
Experience behind the documentation
A.P. Lyon’s quality-system procedure portfolio is in use by organizations in over 45 countries and has been reviewed during FDA, notified-body, and other third-party audits. Each buyer must adapt, approve, and implement the documents for its own activities.
What is included
Quality Management System Manual
73 procedures and related forms, as detailed in the content list
Editable Microsoft Word and Excel content
Digital download
Selected topics described in the package documentation include:
Document control, retention, external standards and documentation practices
Management responsibilities, training and work-environment controls
Design control, design reviews, risk management and verification/validation
Supplier management, purchasing, receiving and finished-goods shipment
Manufacturing controls, inspection, calibration and device history records
Process validation, sterilization validation and cleanroom design
Clinical evaluation, clinical investigation, human factors and software development
Complaint handling, recalls, vigilance, post-market surveillance and failure investigation
Putting the documentation to work
The package provides a starting point for introducing procedures, training personnel and organizing quality-system activities. Using existing documentation allows your team to focus on implementation and the needs of your business.
Adapt responsibilities, workflows and forms to your organization, products and markets. Review the content against your activities, identify additional documentation needs, approve the procedures and train the people who will use them.
Selling in Canada, Australia, Brazil or Japan?
Health Canada requires certification under the Medical Device Single Audit Program (MDSAP) for Class II to IV device licences, and the regulators in the United States, Australia, Brazil and Japan also rely on MDSAP audits. This system is available MDSAP-ready:
MDSAP-Ready ISO 13485 QMS — Manufacturing Plus ($3,860): this complete system with the requirements of all five MDSAP jurisdictions already built in. Choose it instead of this package if you need MDSAP.
MDSAP Upgrade Kit — ISO 13485 Edition ($1,495): already own this system? Add MDSAP with 11 new documents and 33 updated procedures.
Can it be used with an electronic QMS?
Yes. The manual, procedures 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 documents.
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 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.
Implementation support
A.P. Lyon offers assistance with installation and post-installation quality-system audits. Contact us to discuss the support your organization requires. Implementation timing depends on your organization, the customization needed and the resources available.
For a smaller design-focused package, compare the 45-procedure DESIGN PLUS system. Review the two content lists to see which procedures your activities require.
Choosing the right package
Review the package scope against your responsibilities before purchase. Procedure counts describe procedures with related forms, not the total number of files.
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
Compare Quality System Packages or contact A.P. Lyon about this package.
FDA QMSR & ISO 13485 Resource Center
Practical guide
Read How to Choose a Medical Device Quality Management System for workflow guidance, a checklist and common mistakes.
Upgrade credit: already bought individual procedures from this family? What you paid for them in the last 60 days is credited toward this package. Contact us before you order and we will apply the credit.
License: Single site covers one organization at one site. Consultant, at three times the single-site price, lets a consultant adapt the documents and pass them on to their clients for use in the clients' own systems. See the license terms.
