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Editable QMS Documents: ISO 13485, ISO 9001, Food Safety, HACCP, Cosmetics and Supplements

Complete systems or individual procedures for medical device, manufacturing, food, cosmetics and dietary supplement companies, written by a former Director of Quality Assurance and International Regulatory and used in FDA, notified-body and ISO 9001 certification audits in 58 countries. Use them on paper or import them into your eQMS.

Choose your industry

Medical Devices: ISO 13485 & FDA QMSR

Three complete packages from $1,195, 81 individual procedures, procedure bundles and validation protocols. Also certified to ISO 9001? Choose the Dual-Standard family.

Cosmetics: GMP & MoCRA

A cosmetic GMP and MoCRA quality system for $995, or the MoCRA Compliance Procedures pack for $345.

Manufacturing: ISO 9001:2026

Quality management systems for manufacturers and their suppliers in any industry. Three complete packages from $595 and 58 individual procedures.

HACCP Programs

HACCP programs for seafood (21 CFR 123), juice (21 CFR 120), meat and poultry (USDA 9 CFR 417) and restaurants, from $249.

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Food Safety: ISO 22000 & FSSC 22000

A food safety management system aligned to FDA 21 CFR 117: the Complete system for $1,295, a Starter set for $595 and 57 individual procedures.

Dietary Supplements: 21 CFR 111

A complete cGMP quality system for $1,195, or a Brand Owner Compliance Pack for $395.

Free quality tools

Practical tools for quality and regulatory teams, free to use.

Free Startup Quality Plan: see which QMS procedures your startup needs now
Free QMS Gap Check: score your quality system and find the procedures that close each gap
Inspection Ready: free AI mock FDA inspection with a readiness score and mock Form 483
Inspectle: free daily FDA inspection citation puzzle
Quality manager comparing A.P. Lyon QMS packages on a desktop monitor

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

Editing an A.P. Lyon standard operating procedure on a laptop beside the printed copy

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.

Quality manager and lab scientist reviewing and signing an A.P. Lyon quality form

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.

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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.

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