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A.P. Lyon
ISO 13485 Process Validation Procedure Bundle — editable documents cover

ISO 13485 Process Validation Procedure Bundle

$399.00Price

The ISO 13485:2016 Process Validation Procedure Bundle includes 4 procedures related to the validation of medical device processes. The process validation procedures are ISO 13485:2016 and FDA QMSR aligned.

  • ISO 13485:2016 aligned

  • FDA QMSR aligned

  • MS Word Format

  • Includes Related Form(s)

  • Digital Content - Instant Download

The Process Validation Procedure Bundle includes four (4) ISO 13485:2016 aligned procedures related to medical device process validation.

Process Validation Procedure Bundle - Overview

  • 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 Procedure Bundle - Compliance

The Process Validation Procedure Bundle content is ISO 13485:2016 and FDA QMSR aligned.

To learn more about our ISO 13485:2016 Process Validation Procedure Bundle contact us at [email protected]

Process Validation Procedure Bundle Content

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.

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