Device History Record Procedure | ISO 9001:2026 + ISO 13485:2016
Create, review and retain Device History Records documenting conformity and traceability before finished-device or batch release. This editable device history record procedure is part of the A.P. Lyon Dual-Standard QMS family for ISO 9001:2026 and ISO 13485:2016.
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Scope and intended use
Create a DHR for each finished medical device or batch manufactured by the company and for critical components where required by the approved production plan. The DHR demonstrates conformity to applicable controlled specifications and records the identity, acceptance and traceability of product.
What you receive
One digital ZIP containing the editable SOP 7-019-C Word procedure and a PDF copy. The gallery shows representative pages from the document.
Additional editable files included in this ZIP:
FORM 0016-C.docx
FORM 0017-C.docx
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.
Related procedures
These procedures address connected work and are sold separately:
Systems containing this procedure
A system package includes this procedure with other documents. Review its content list before purchasing both.
Before implementation
Adapt responsibilities, process steps, acceptance criteria and records to your organization, device and intended markets. Confirm the applicable standards and regulatory requirements before approval and use. This download supplies documentation, not executed testing, regulatory authorization or certification.
