QMS implementation solutions
QMS implementation solutions for ISO 9001, AS9100D, and ISO 13485.
Choose the right implementation scope for the customer: guided configuration, roadmap assessment, certification-readiness review, full implementation, consulting, or fractional support.
QMS implementation solutions
Implementation services for the QMS model your customer actually needs.
Choose guided configuration, gap assessment, certification-readiness review, full implementation, consulting, or fractional support as scoped professional services.
Implementation pricing
CSV pricing for QMS implementation services.
Rates below reflect the supplied CSV. Carry the selected scope, exclusions, and billing basis into the proposal or statement of work.
| Feature | Offering | Introductory Price | Standard Low | Standard High | Billing Basis | What Is Included | Key Exclusions / Conditions | Customer-Facing Price |
|---|---|---|---|---|---|---|---|---|
| ISO 9001 guided configuration | $1,500 | $1,500 | per engagement | Guided scope, roles, tokens, retention and document configuration | Digital package sold separately unless included in proposal | $1,500 per engagement | ||
| AS9100D guided configuration | $2,250 | $2,250 | per engagement | Core configuration plus aerospace, contract and operational controls | Digital package sold separately unless included in proposal | $2,250 per engagement | ||
| ISO 13485 guided configuration | $3,000 | $3,000 | per engagement | Core configuration plus device and regulatory-profile controls | Digital package sold separately unless included in proposal | $3,000 per engagement | ||
| ISO 9001 gap assessment and roadmap | $1,500 | $1,500 | per assessment | Interviews, document review, gap summary and prioritized roadmap | Scope assumes a small, single-site organization | $1,500 per assessment | ||
| AS9100D gap assessment and roadmap | $2,500 | $2,500 | per assessment | Includes aerospace-specific control assessment | Scope assumes a small, single-site organization | $2,500 per assessment | ||
| ISO 13485 gap assessment and roadmap | $3,000 | $3,000 | per assessment | Includes device, regulatory, validation and post-market assessment | Jurisdiction and device complexity may change the scope | $3,000 per assessment | ||
| ISO 9001 certification-readiness review | $2,000 | $2,000 | per review | Evidence sampling, findings and readiness report | Not a certification audit or certification guarantee | $2,000 per review | ||
| AS9100D certification-readiness review | $3,000 | $3,000 | per review | Aerospace-focused evidence and readiness review | Not a certification audit or certification guarantee | $3,000 per review | ||
| ISO 13485 certification-readiness review | $4,000 | $4,000 | per review | Medical-device QMS evidence and readiness review | Not a regulatory inspection, submission or approval | $4,000 per review | ||
| ISO 9001 full implementation | $7,500 | $15,000 | project range | Package, configuration, training, implementation guidance and readiness support | Registrar, travel, standards, software and certification fees excluded | $7,500-$15,000 project range | ||
| AS9100D full implementation | $12,500 | $25,000 | project range | Core and aerospace implementation support | Registrar, travel, standards, software and certification fees excluded | $12,500-$25,000 project range | ||
| ISO 13485 full implementation | $15,000 | $35,000 | project range | Core, medical-device and regulatory-profile implementation support | Regulatory submissions, testing, software and certification fees excluded | $15,000-$35,000 project range | ||
| QMS consulting and coaching | $195 | $195 | per hour | Defined advisory, review or coaching work | Travel and third-party expenses excluded | $195 per hour | ||
| Ten-hour consulting block | $1,750 | $1,750 | ten prepaid hours | Prepaid QMS support at a discounted hourly rate | Unused hours and expiration terms must be stated in the proposal | $1,750 ten prepaid hours | ||
| Fractional QMS support | $2,500 | $5,000 | per month | Recurring document, CAPA, audit, management-review and QMS support | Monthly scope, response time and included hours require an agreement | $2,500-$5,000 per month |
Readiness note
Readiness reviews help, but they are not certification guarantees.
Gap assessments and certification-readiness reviews can expose missing evidence, weak controls, and scope issues, but a successful audit still depends on the organization actually doing what the QMS requires.
Need a proposal for this scope?
Request a scoped quote for QMS implementation work, or pair the service with the digital package that matches the standard.