Dual-Standard Quality Management System Manual | ISO 9001:2026 + ISO 13485:2016

An editable Word quality management system manual for organizations integrating ISO 9001:2026 and ISO 13485:2016, with applicable FDA QMSR and EU MDR references.

Document ID: QMSM-C. Includes one editable Word manual. The preview images show actual pages from this manual, including its integrated scope, standards references, organizational context and process requirements.

Updated October 2026 with a QMS scope statement template, process interaction tables and references to the new SOP 5-003-C QMS Context and Planning and SOP 8-015-C Customer Satisfaction Monitoring procedures.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Tailor the scope, company details, policies, responsibilities and process references to your organization. This manual is a documentation starting point; implementation and applicability review remain the organization's responsibility.

This is the Dual-Standard manual. Choose QMSM for the separate ISO 13485 manual.