Editable QMS Documents: ISO 13485, ISO 9001 and ISO 22000 Food Safety
Complete systems or individual procedures for medical device, manufacturing and food companies, written by a former Senior Director of Regulatory Affairs and used in FDA, notified-body and ISO 9001 certification audits in 45 countries. Choose medical device, dual-standard, ISO 9001 or food safety systems, and use them on paper or import them into your eQMS.
Choose your industry
1. Choose Your Scope
Compare a complete quality system, individual procedures, or validation protocols. Check each listing for its document scope and included files.
From Download to Working Document
2. Tailor Your Documents
Use the editable documents as a starting point. Add your organization’s details, responsibilities, process requirements, and study-specific acceptance criteria.
3. Review and Implement
Review and approve documents through your own quality system. Need help with implementation or a technical question? Contact A.P. Lyon about consulting support.
Support for Your Next Quality or Validation Project
Consulting Services
- ISO 13485 & FDA QMSR Implementation
- FDA QMSR Inspection Readiness
- FDA Submissions & Regulatory Strategy
- ISO 9001 Certification Support
- Food Safety System Implementation (ISO 22000 / FSSC 22000)
- Process & Equipment Validation
- Gap Analysis & Audit Preparation
About A.P. Lyon
A.P. Lyon provides editable quality and food safety management system documents for medical device, manufacturing and food companies, with quality and regulatory consulting and FDA U.S. Agent services for medical device companies.
Whether you need a coordinated system or support for a specific project, start with the relevant documents and tailor them to your intended use. Our consulting services can help you identify gaps and plan the next steps.
Editable documents. Practical guidance. Support for your next step.