Procedure Review: Up to 5 Procedures | ISO 13485, FDA QMSR & ISO 9001
Drafted a procedure with AI, in an eQMS or in-house? Have it reviewed against ISO 13485, FDA QMSR and ISO 9001 by the team behind working QMS documents installed in companies in more than 45 countries, before your auditor sees it.
Covers up to five procedures, including the interfaces between them, such as complaint handling and CAPA or purchasing and supplier management.
What you receive
Written findings report: gaps, potential nonconformities and improvement points, each tied to the requirement it relates to
Redlined Word documents with tracked changes you can accept or reject
Clause traceability table mapping each section to the ISO 13485 / FDA QMSR or ISO 9001 requirement it addresses
One re-review of your revised version, sent back within 60 days
Turnaround
5 business days, counted from receipt of your complete documents.
How it works
Purchase the review and download the intake guide.
Email your documents and order number to info@aplyon.com, with the standards, markets and any audit date you are working toward.
Receive your findings report, redlines and traceability table.
Revise and send it back once for re-review.
Why A.P. Lyon
Reviews are performed by Aaron Lyon, a former Senior Director of Regulatory Affairs whose documents have been used in FDA, notified-body and ISO 9001 certification audits in 45 countries. You get the perspective of someone who has written, implemented and defended these procedures, not a generic checklist.
Confidentiality and scope
Your documents are used only for your review. A non-disclosure agreement is available on request before you send anything. The review assesses your documents against the applicable requirements; it does not certify your QMS or guarantee an audit outcome, and it is not legal advice.
