Remote ISO Consulting: ISO 9001:2026 and ISO 13485
By Ishan Maharaj, Founder and Principal Consultant. Last reviewed 26 October 2026.
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.
Most consulting engagements for ISO start with the standard and end with a folder.
Proof: two systems built from the inside
The founder is an industrial engineer (BSc Eng Hons, MSc Engineering Management) who has designed, built and run an ISO 13485:2016 QMS that has held certification for six years and passed an accredited certification-body transfer audit in 2026, and an ISO 9001 system for a freight and warehousing company now transitioning to ISO 9001:2026. Both are documented, with video walk-throughs:
- ISO 13485 case study: a SharePoint QMS certified for six years
- ISO 9001 case study: a logistics QMS built in five months, transitioning to 2026
Processes first, standard second
Most ISO implementations start with the clause list and work backwards into the business. The result is procedures nobody reads and a certificate that changes nothing. Every engagement here starts the other way round: your processes are studied and optimised first, the management system is built around the improved process on the Microsoft 365 or Google Workspace platform you already pay for, and the standard is mapped on last. Systems are not built to the standard; they are built around procedures that actually work in your business, and the standard is then satisfied by them.
Industrial engineering services are available on their own; you do not need to be pursuing a certificate.
- Process optimisation: current-state mapping of a process as it really runs, identification of rework, waiting, duplication and hand-off failures, and a redesigned future-state process with owners, controls and measures. Typical targets: order-to-dispatch, receiving and inspection, complaint handling, supplier onboarding, change control, batch release.
- Operations management improvement: capacity and workload analysis, roles and RACI, KPI design, and management-review and reporting cadences that give leadership real numbers monthly rather than reconstructed figures before an audit.
- Efficiency improvements: lean waste analysis, layout and material flow in warehouses and production areas, inventory and traceability controls, and automation of record-keeping through forms, workflows and registers so that records are a by-product of working rather than an extra job.
- Tailored procedures, not templates dropped in: every procedure is written for your process after it has been improved. Templates from this site are a starting point for speed, never the finished article.
- Cloud QMS build: site architecture, read-only publishing, library segregation, role-based permissions, forms-to-register automation, and migration of an existing QMS from shared drives, Google Sites or paper onto one controlled platform without losing history.
Turnkey eQMS builds
On this page we explain the part of ISO Cloud Consulting that most people do not expect from a quality consultancy.
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, certification-body transfers and A11:2021 upgrades, 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 and pre-audit readiness reviews: single-process, multi-process or full-system audits by video, with a written report and graded findings, or a records-based readiness walk-through three to six weeks before a certification, transfer or surveillance audit. 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
People are often surprised that we deliver ISO consulting remotely by default.
- Enquiry. Use the form at the bottom of this page. We reply by email within 2 business days.
- 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 |
| Process diagnostic (one core process: current state, waste analysis, future-state design, implementation plan) | from $1,950 |
| 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. Self-paced ISO 9001:2026 and ISO 13485 courses are available for teams who want to build the capability in-house.
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.