ISO Consulting: ISO 9001:2026, ISO 13485 and Process Optimisation
By Ishan Maharaj, Founder and Principal Consultant. Last reviewed 6 November 2026.
Short answer: ISO Cloud Consulting helps companies build, fix and transition quality management systems: ISO 9001:2026, ISO 13485 and ISO 14971 for medical devices, and quality systems run in Microsoft 365, SharePoint or Google Workspace. The work is led by founder and principal consultant Ishan Maharaj, with associate consultant Jacques Fauré, founder of Fauré Enterprise Engineering; we optimise your processes first and build the system around them. Our most requested services have fixed prices, starting with a $349 document review and a $1,950 gap assessment. Everything else is scoped and fixed in a written proposal after a free 30-minute call.
Led by Ishan Maharaj, founder, with associate consultant Jacques Fauré, also founder of Fauré Enterprise Engineering. Meet the consultants
Fixed-price services
Prices in US dollars for an organisation of up to 50 people on one site. Larger or multi-site organisations are quoted after the scoping call.
Document review
Drafted your documents with AI, or adapted our templates? Send up to 5. You get clause-referenced comments, a ranked summary of what an auditor is likely to raise, and one re-review.
Remote internal audit day
ISO 9001 or ISO 13485, led by an LRQA-trained ISO 13485:2016 internal auditor. Audit plan, opening and closing meetings, one full audit day by video covering up to 6 processes, and a written report with graded findings, evidence for management review and the auditor qualification record.
ISO 9001:2026 transition gap assessment
For ISO 9001:2015 certified companies. Every changed requirement checked against your documents and people, a scored gap report, prioritised actions and a dated transition plan.
ISO 9001:2026 gap assessment, first certification
Clauses 4 to 10 against how your business really runs, a process map, a scored gap report and a roadmap to certification with effort estimates.
ISO 13485:2016 gap assessment
Clauses 4 to 8 including ISO 14971 interfaces, design controls, purchasing, production and post-market processes, with prioritised actions and a certification roadmap.
Free scoping call
30 minutes by video: your standard, certification status, audit dates, open findings and where your documents live. You get a written recommendation, even when it is “use the templates”.
Every gap assessment ends with a 60-minute readout call. If you go on to an implementation package within 60 days, half the gap assessment fee is credited against it.
Implementation and system builds
Every implementation and build is a fixed price, quoted in writing after the free scoping call and sized to your scope, sites and platform, so it does not grow with the hours.
| Package | What it covers | Typical duration | Pricing |
|---|---|---|---|
| ISO 9001:2026 done-with-you transition | Gap assessment, transition plan, guided document updates, staff awareness, transition internal audit and management review preparation. Transition Toolkit included. | 6–10 weeks | Fixed quote after a free scoping call |
| ISO 9001:2026 implementation | Core processes mapped and redesigned, procedures written for how you work, records, training, internal audit, management review and support through certification. | 12–16 weeks | Fixed quote after a free scoping call |
| ISO 13485:2016 QMS implementation | All of the above plus ISO 14971 risk management, design controls and DHF, supplier controls, process validation planning, traceability, complaints, CAPA and post-market surveillance. | 16–26 weeks | Fixed quote after a free scoping call |
| Digital QMS build (eQMS) | A controlled QMS on Microsoft 365, SharePoint or Google Workspace: architecture, read-only publishing, permissions, approval workflows, forms-to-register automation and migration with history kept. | 4–8 weeks | Fixed quote after a free scoping call |
| Process optimisation sprint | One core value stream mapped, measured and redesigned with owners, controls and KPIs, plus rewritten procedures and an implementation plan. | 3–4 weeks | Fixed quote after a free scoping call |
Need something else, such as audit findings and CAPA, an ISO 14971 risk file, design controls, process validation, supplier controls, a mock certification audit or a monthly retainer? These are scoped individually. Ask for our full rate card in the form below and we will send it with our reply.
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. We start the other way round: your processes are studied and optimised first, the management system is built around the improved process on the platform you already pay for, and the standard is mapped on last. 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 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 modelling, roles and RACI, KPI design, and management-review cadences that give leadership real numbers every month.
- Efficiency improvements: lean waste analysis, layout and material flow in warehouses and production areas, inventory and traceability controls, and automated record-keeping so records are a by-product of working.
- Tailored procedures, not templates dropped in: every procedure is written for your process after it has been improved. Our templates speed things up; they are never the finished article.
- Cloud QMS build: site architecture, read-only publishing, library segregation, role-based permissions, forms-to-register automation, and migration from shared drives or paper onto one controlled platform without losing history.
Proof
The founder designed, built and ran an ISO 13485:2016 QMS that has held certification for six years and passed an accredited certification-body transfer audit in 2026, and built an ISO 9001 system for a freight and warehousing company that is now transitioning to ISO 9001:2026. The associate consultant, who founded his own industrial engineering practice, Fauré Enterprise Engineering, has more than a decade of operations design behind him, including a four-distribution-centre consolidation covering about 100,000 SKUs that lifted picker productivity by 16%.
- 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
- Consultant profiles: experience, recognition and who does what
What else we help with
- 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.
- Internal audit programmes and pre-audit readiness reviews: see internal audit programme setup.
- Fractional quality support: monthly retainers for companies that need a quality function without a full-time hire.
How an engagement works
- Enquiry. Use the form below. We reply by email within one business day.
- Free 30-minute scoping call by video with both consultants where useful.
- Written proposal with fixed scope, deliverables, exclusions, dates and price. Payment is 50% on acceptance and 50% on delivery.
- Delivery through scheduled video sessions and work in your own SharePoint, Google Drive or a shared folder, with weekly progress notes. Sessions overlap with your working day, including US Eastern mornings.
- Handover of editable Word, Excel and platform files that your team owns.
On-site support: work is remote by default. For larger engagements we can arrange a short on-site visit, such as an audit week, a process walk-through or an implementation workshop, between remote preparation and follow-up.
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 for a fraction of the cost, and a $349 document review checks the result. Consulting is the better choice when an audit date is close, findings are open, processes need redesign, nobody owns the quality system, or you want an independent internal audit. 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.
- Whoever designed or implemented a process for you does not carry out its internal audit.
- We do not supply copies of ISO standards. You need your own licensed copy of each standard you work to.
Book a free scoping call or request the full rate card
Watch: how this works in practice (3 short videos)
Most consulting engagements for ISO start with the standard and end with a folder.
Turnkey eQMS builds
On this page we explain the part of ISO Cloud Consulting that most people do not expect from a quality consultancy.
How a remote engagement runs
People are often surprised that we deliver ISO consulting remotely by default.
Frequently asked questions
How much does ISO consulting cost?
Our most requested services have fixed prices: document review $349, ISO 9001:2026 transition gap assessment $1,950, ISO 9001 gap assessment for first certification $2,750, ISO 13485 gap assessment $3,950 and a remote internal audit day $2,250. Implementation and system builds start at $4,950 to $24,500 and are fixed in a written proposal after a free scoping call. Our full rate card is available on request.
Why don't you publish hourly rates?
Because most clients are better served by a fixed price for a defined result than by an open hourly meter. Every engagement is scoped and priced individually. Hourly and day rates are on our full rate card, which we send on request.
Who does the work?
Ishan Maharaj, Founder and Principal Consultant, leads ISO 9001, ISO 13485 and ISO 14971 and reviews every deliverable. Jacques Fauré, Associate Consultant, leads process design and carries most of the delivery work. Ishan founded ISO Cloud Consulting; Jacques is an associate consultant, not a founder or owner.
Do you offer on-site consulting?
Work is remote by default, by video and shared documents in your own systems. On-site support is available by arrangement for larger engagements, usually as a short concentrated visit between remote preparation and follow-up.
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.
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. Consulting adds most value when an audit is close, findings are open, processes need redesign, 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.