Medical Device Quality Management System | MANUFACTURING
MANUFACTURING is a quality management system for organizations engaged in both research and development and medical device manufacturing. It provides documentation covering design activities, production and post-commercialization processes.
What is included
Quality Management System Manual
60 procedures and related forms, as listed on the product overview
Editable Microsoft Word and Excel content
Digital download
Areas covered
Selected topics described in the package documentation include:
Document control, management responsibilities and training
Design controls, risk management and product specifications
Purchasing, suppliers, receiving and identification
Manufacturing controls, calibration, inspection and device history records
Process validation, software validation and sterilization
Labeling, shelf life, biocompatibility and UDI
Complaint handling, recalls, internal audits and post-market surveillance
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.
Can it be used with an electronic QMS?
The procedures can be adapted to establish or supplement eQMS content and aligned with your work instructions, workflows and forms. The package supplies documentation; your team will need to configure and implement it within the system you use.
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.
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.
Compare Quality System Packages or contact A.P. Lyon about this package.
Regulatory framework
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.
