Frequently Asked Questions
Which system is right for my company?
Medical device makers start with ISO 13485 & FDA QMSR, or Dual-Standard if they are also certified to ISO 9001. Manufacturers outside the device industry use ISO 9001:2026. Food manufacturers and their suppliers use the Food Safety Management System. The Compare page shows the scope and price of every package.
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Are the ISO 9001 documents suitable outside the medical device industry?
Yes. The ISO 9001:2026 family is written for manufacturers and their suppliers in any industry. Device-specific requirements are in the ISO 13485 and Dual-Standard families.
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Do the food safety documents cover FSMA preventive controls and the PCQI?
Yes. The system is written to ISO 22000:2018 and the FSSC 22000 additional requirements, with FDA 21 CFR 117 requirements built in, including the written food safety plan, preventive controls and the designation of a Preventive Controls Qualified Individual (PCQI).
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Can I use the food safety system for FSSC 22000 certification?
The documents cover the FSSC 22000 additional requirements and give you a starting point. Certification depends on how your site adapts, implements and audits the system.
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What is included with a QMS system or individual procedure?
QMS system packages contain the documents identified in their individual content lists, which may include a quality system manual, procedures and related forms. An individual procedure contains the document and any included forms shown on its product page. Files are supplied as editable digital downloads; check the product description and content list for the exact scope.
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Can I use the procedures with an electronic QMS?
Yes. Every procedure, manual, list and form is an editable Word or Excel file, so you can import it into any eQMS that manages Office documents or use it on paper. Before release, adapt signature blocks, approval steps and record references to match your system's workflow. Validating the eQMS software for its intended use remains your responsibility under the standards and regulations that apply to you, for example ISO 13485 clause 4.1.6 and 21 CFR Part 11 for medical device companies. Read our step-by-step eQMS guide.
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Is the package ready to use without changes?
It provides a starting point. Your organization should adapt responsibilities, workflows and forms to its products and markets, identify any additional documentation needed, approve the procedures and train personnel.
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Does buying the package establish regulatory compliance or certification?
No. Compliance and certification depend on how your organization adapts and implements its system. The relevant framework is shown on each product: FDA QMSR and ISO 13485 for medical devices, ISO 9001:2026 for quality management, and ISO 22000, FSSC 22000 and FDA 21 CFR 117 for food safety.
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Is implementation support available?
A.P. Lyon offers assistance with installation and post-installation quality-system audits. Contact A.P. Lyon to discuss scope; timing depends on the organization, customization and available resources.
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Can I use the documents at more than one site?
Each purchase licenses the documents for use at a single site. If your organization will use them at additional sites, purchase a separate license for each site. Consultants can choose the Consultant license on any package page. It costs three times the single-site price and lets you adapt the documents and pass them on to your clients for use in their own systems.
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Can I get a refund?
No. Because the documents are delivered as digital downloads, all sales are final and refunds are not offered. Review the product description, content list and preview pages before purchasing.
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Do I receive updates?
Yes. Free updates to the documents you purchased are provided for one year from the date of purchase.
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How can I pay?
All orders are placed through the website checkout, using a credit card or another payment method offered at checkout. Purchase orders and invoicing are not available.​
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I already bought individual procedures. Can I upgrade to a package?
Yes. What you paid for individual procedures in the last 60 days is credited toward a complete package in the same family. Contact us before you order and we will apply the credit.