Terms of Service

Last updated: August 29, 2026

Welcome to GroundworkQualitySystems.com (the “Site”). The Site is operated as Groundwork Quality Systems (“Groundwork,” “we,” “our,” or “us”).

These Terms of Service (“Terms”) govern your access to the Site and your use or purchase of its articles, checklists, templates, downloads, and other resources. By accessing the Site or purchasing or downloading a resource, you agree to these Terms. If you do not agree, please do not use the Site.

1. Use of the Site

You may use the Site only for lawful purposes and in accordance with these Terms.

You agree not to:

• Interfere with the operation or security of the Site
• Attempt to gain unauthorized access to the Site or its systems
• Use the Site for fraudulent, unlawful, or harmful purposes
• Copy, distribute, publish, or commercially exploit Site content except as expressly permitted by these Terms
• Misrepresent Groundwork content as your own original work or as an official regulatory publication

We may restrict or discontinue access to the Site when reasonably necessary to protect the Site, its users, or Groundwork.

2. Educational Information

Groundwork provides general educational information and practical resources related to medical-device quality systems, operations, and organizational development.

The Site and its resources do not constitute legal, regulatory, certification, engineering, clinical, or other professional advice. They are not a substitute for advice from qualified professionals familiar with your organization, device, markets, risks, and regulatory responsibilities.

References to laws, regulations, standards, or industry practices are provided for general informational purposes. Requirements may change and may apply differently depending on the circumstances.

3. No Regulatory Guarantee

Using a Groundwork resource does not guarantee:

• Compliance with any law, regulation, or standard
• Certification under ISO 13485 or another standard
• FDA clearance, approval, authorization, or acceptance
• Successful completion of an audit or inspection
• Any particular business, quality, or regulatory outcome

You are responsible for determining which requirements apply and for reviewing, adapting, approving, implementing, and maintaining any documents or systems used by your organization.

Groundwork is not affiliated with, endorsed by, or acting on behalf of the U.S. Food and Drug Administration, the International Organization for Standardization, or any other regulatory or standards organization.

4. Digital Products and Downloads

Groundwork may offer free and paid digital resources, including checklists, templates, procedures, guides, workbooks, and other downloadable files.

Unless otherwise stated at the time of purchase, digital products are provided under a limited, nonexclusive, nontransferable license.

You may:

• Download and retain the purchased resource
• Modify an editable resource for your own use or your organization’s internal use
• Share the modified resource internally with employees and contractors who need it for that authorized purpose

You may not:

• Resell, sublicense, or redistribute the original resource
• Post the resource publicly or place it in a shared library available outside your organization
• Give copies to clients, unrelated companies, or other third parties
• Use the resource to create a competing product for sale or distribution
• Remove copyright, attribution, or ownership notices from an unmodified resource

Purchasing a resource does not transfer ownership of its underlying intellectual property.

5. Orders and Payment

Prices are shown in U.S. dollars unless otherwise stated. You agree to provide accurate and current billing and contact information when making a purchase.

Payments may be processed by Shopify or another third-party payment provider. Your use of those services may also be subject to the provider’s terms and privacy practices.

We may cancel or refuse an order when reasonably necessary, including in cases of suspected fraud, pricing errors, unauthorized transactions, or misuse of the Site.

6. Refunds

Because digital products are generally delivered or made accessible immediately, purchases of downloadable products are normally final and non-refundable.

If a file is defective, corrupted, materially different from its description, or cannot be accessed, contact us so we can attempt to provide a working replacement or another appropriate remedy.

Nothing in these Terms limits any refund, cancellation, or other right that cannot legally be waived.

7. Intellectual Property

The Site and its original content, branding, graphics, downloads, templates, and resource designs are owned by or licensed to Groundwork and are protected by applicable intellectual-property laws.

Except for the limited license provided with a resource, no right, title, or interest in Groundwork intellectual property is transferred to you.

Names and references belonging to third parties remain the property of their respective owners.

8. User Accounts

If the Site permits you to create an account, you are responsible for safeguarding your login credentials and for activity conducted through your account.

Please notify us promptly if you believe your account has been accessed without authorization. We may suspend or close an account when reasonably necessary to address security concerns, misuse, or violations of these Terms.

9. Third-Party Services and Links

The Site may contain links to or integrations with third-party websites, platforms, applications, products, or services.

Groundwork does not control and is not responsible for third-party content, availability, security, terms, or privacy practices. A link or reference does not necessarily constitute an endorsement. Your use of third-party services is at your own discretion and risk.

10. Site Availability and Changes

We may update, modify, suspend, or discontinue any part of the Site or its resources. We do not guarantee that the Site or any particular resource will always be available, uninterrupted, secure, or error-free.

We may also correct errors in descriptions, pricing, or other Site content.

11. Disclaimer of Warranties

To the fullest extent permitted by law, the Site and its resources are provided “as is” and “as available,” without warranties of any kind, either express or implied.

We do not warrant that a resource will satisfy every requirement applicable to your organization or be suitable for every device, market, quality system, or intended use.

Some jurisdictions do not allow certain warranty exclusions, so portions of this section may not apply to you.

12. Limitation of Liability

To the fullest extent permitted by law, Groundwork will not be liable for indirect, incidental, special, consequential, exemplary, or punitive damages arising from your access to or use of the Site or its resources.

You are responsible for decisions made, documents approved, and actions taken based on Site content. You should independently review and validate resources before implementing them.

Where liability cannot legally be excluded, Groundwork’s total liability relating to a paid digital product will not exceed the amount you paid for that product.

Nothing in these Terms excludes or limits liability that cannot legally be excluded or limited.

13. Privacy

Your use of the Site is also governed by our Privacy Policy. Please review that policy for information about how personal information is collected, used, and protected.

14. Changes to These Terms

We may update these Terms periodically. Changes will be posted on this page, and the “Last updated” date will be revised.

Your continued use of the Site after updated Terms take effect constitutes acceptance of those Terms.

15. Severability

If any provision of these Terms is determined to be invalid or unenforceable, the remaining provisions will remain in effect to the fullest extent permitted by law.

16. Contact

For questions about these Terms, contact:

Groundwork Quality Systems
support@groundworkqualitysystems.com