Remote ISO Consulting: ISO 9001:2026 and ISO 13485
Short answer: ISO Cloud Consulting offers remote consulting for companies building, fixing or transitioning a quality management system: ISO 9001:2026 transitions, ISO 13485 and ISO 14971 for medical devices, and quality systems run in SharePoint or Microsoft 365. All work is done remotely by video call and shared documents. You can book fixed-scope packages or pay a single senior rate of $125 per hour.
What we help with
- ISO 9001:2026 transition: a remote gap assessment, a transition plan, updated documents for the new requirements, and an internal audit against the 2026 edition before your certification body visits.
- ISO 13485 quality systems: QMS frameworks, implementation support, and readiness for certification or surveillance audits.
- Audit findings and CAPA: root cause, corrective action and effectiveness evidence that holds up at the follow-up audit. See audit findings recovery and CAPA system repair.
- ISO 14971 risk management: risk management plans, hazard analysis structure and residual risk justification. See risk file remediation.
- Design controls and process validation: DHF structure, traceability, and IQ, OQ and PQ evidence. See design controls completion and process validation remediation.
- Remote internal audits: single-process, multi-process or full-system audits by video, with a written report and graded findings. See internal audit programme setup.
- SharePoint and Microsoft 365 QMS: document libraries, metadata, permissions and approval workflows. See the SharePoint QMS guides.
How remote consulting works
- Enquiry. Use the form at the bottom of this page. We reply by email within one business day.
- Free 30-minute scoping call by video: your standard, certification status, audit dates, open findings and where your documents live.
- Written proposal with a fixed scope, deliverables, exclusions, dates and price.
- Delivery through scheduled video sessions and document review in your own SharePoint, Google Drive or a shared folder. Sessions are arranged to overlap with your working day, including US Eastern mornings.
- Handover of editable Word and Excel deliverables that your team maintains after the engagement.
Rates and packages (USD)
All work is done by a senior consultant. Prices exclude taxes and are confirmed in the written proposal. Payment is 50% on acceptance and 50% on delivery.
| Service | Price |
|---|---|
| Advisory hours (remote, minimum 2 hours) | $125 per hour |
| Remote day rate | $900 per day |
| ISO 9001:2026 remote gap assessment | from $1,250 |
| ISO 9001:2026 transition internal audit | from $1,950 |
| ISO 9001:2026 done-with-you transition | from $4,500 |
| Remote internal audit, single process (ISO 13485) | from $1,250 |
| Remote internal audit, several linked processes | from $2,250 |
| Remote full-system internal audit | from $4,500 |
| Supplier controls support | from $1,500 |
| CAPA and audit findings response sprint | from $2,500 |
| ISO 14971 risk management support | from $2,500 |
| QMS simplification and workflow review | from $3,500 |
| Design controls and DHF support | from $4,500 |
| Audit readiness sprint | from $4,500 |
| ISO 13485 framework development | from $6,500 |
| ISO 13485 framework and implementation | from $12,500 |
| ISO 13485 full build and audit readiness | from $22,000 |
| Monthly retainers: Essential, Growth, Fractional QA/RA, Enterprise | $1,500, $3,000, $5,500, $8,500 per month |
Templates or consulting?
If someone on your team has time and quality management experience, our editable ISO 9001:2026 templates and ISO 13485 kits usually cover most of the documentation work for a fraction of the cost. Consulting is the better choice when an audit date is close, findings are open, nobody owns the quality system, or you want an independent internal audit. Many clients start with the templates and book a few advisory hours for review.
What we do not do
- We are not a certification body and do not issue certificates. No consultant can guarantee certification or an audit outcome.
- We do not work on site. Everything is delivered remotely.
- We do not supply copies of ISO standards. You need your own licensed copy of each standard you work to.
Frequently asked questions
Do you offer on-site consulting?
No. All consulting is delivered remotely by video call and shared documents, including internal audits. Remote delivery keeps costs down and works well for document review, interviews, gap assessments and audit preparation. Sessions are scheduled to overlap with your working day.
How much does ISO consulting cost?
Advisory work is $125 per hour with a 2-hour minimum, or $900 per day. Fixed-scope packages start at $1,250 for a remote gap assessment or single-process internal audit, and ISO 13485 framework builds start at $6,500. Every engagement is confirmed in a written proposal after a free scoping call.
Are you a certification body?
No. We help you prepare, but certification audits are carried out by an accredited certification body, which makes the certification decision. No consultant can guarantee certification or a particular audit outcome.
Can you work inside our SharePoint, Google Drive or eQMS?
Yes. We can review and edit documents in your own SharePoint, Microsoft 365 or Google Drive with guest access, or work from a shared folder you control. We can also help structure a SharePoint or Microsoft 365 QMS.
Should we buy templates or hire a consultant?
If someone on your team has time and quality experience, templates usually cover most of the documentation at a fraction of the cost. A consultant adds most value when an audit is close, findings are open, or you want an independent internal audit. Many clients combine both.
Tell us what you need
Send a short description of your situation. We reply by email within one business day and suggest a time for a free 30-minute scoping call.