ISO 13485 Process Validation Procedure Bundle
Use four editable procedures to plan medical device process validation, structure IQ/OQ/PQ/PPQ protocols and reports, qualify equipment installation, and apply statistical techniques to sampling and validation data. The documents support an ISO 13485:2016 and FDA QMSR aligned quality system and require adaptation to your processes.
Supplied as five editable Microsoft Word documents in a digital download.
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.
Process Validation Procedure - The Process Validation Procedure provides instruction for determining when process validation is required, validation pre-requisites, and overall strategy. The procedure also includes information on worst case product selection, validation lots, test methods and acceptance criteria.
Validation Protocols and Reports Procedure - The Validation Protocol and Report Procedure instructs on the development of Installation Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols, Performance Qualification (PQ) Protocols and Product Performance Qualification (PPQ) Protocols.
Installation Qualification Procedure - The Installation Qualification Procedure applies to the installation of new equipment, moving or relocating equipment, or after equipment modifications. The Installation Qualification (IQ) Procedure provides instruction on the requirements of conducting Installation Qualifications (IQ's).
Statistical Techniques Procedure - The Statistical Techniques Procedure provides guidance on statistical analysis methods used to support medical device sampling plans, failure analysis and validation data analysis.
Process validation and revalidation workflow
Protocol and report structure for qualification activities
Training, numbering and retention of validation evidence
Standards and frameworks addressed: ISO 13485:2016; FDA QMSR.
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.
Individual documents in this bundle
Validation Protocol and Report Procedure | ISO 13485 | FDA QMSR
Installation Qualification IQ Procedure | ISO 13485 | FDA QMSR
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.
Practical guide
Read Medical Device Process Validation: Protocols, Statistics and Mold Processes for workflow guidance, a checklist and common mistakes.
Process Validation Procedure vs Bundle vs Qualification Protocol
