01
Day 0
Service agreement
The process starts when you sign the service agreement with Lisora and a dedicated project team is assigned.
ISO certification · Regulatory affairs
ISO certification & global approvals, done vigorously.
Lead auditors and regulatory specialists who take you from gap analysis to certificate — ISO 9001, 13485, 27001 and 15+ standards, plus FDA, EU MDR, MDSAP, TGA and MHRA market access.
- ISO & sector standards
- 15+
- ISO & sector standards
- Regulatory markets
- 6
- Regulatory markets
- Days to certificate
- 30–90
- Days to certificate
ISO 9001:2015ISO 14001:2015ISO 45001:2018ISO 22000:2018ISO 13485:2016ISO/IEC 27001:2022ISO 21001:2018ISO/IEC 42001:2023ISO 15189:2022ISO/IEC 17025:2017BA 9000:2016AS9100DGMPcGMPHACCPFDAMDRMDSAPTGAPRRCMHRA
What we do
Everything between you and your certificate.
One accountable team for documentation, implementation, audits and regulatory submissions — so nothing falls between consultants.
ISO & management systems
15 standards. One method.
Quality, environment, safety, information security, AI, medical devices, laboratories, food and aerospace — documentation to accredited certificate.
- ISO 9001
- ISO 14001
- ISO 45001
- ISO 22000
- ISO 13485
- ISO 27001
- ISO 21001
- ISO 42001
- ISO 15189
- ISO 17025
- BA 9000
- AS 9100D
- GMP
- cGMP
- HACCP
Regulatory affairs
Market access for medical devices in six jurisdictions.
- FDA
- MDR
- MDSAP
- TGA
- PRRC
- MHRA
Quality documents
Clear, lean documentation that meets ISO requirements and supports a lasting management system.
Internal & external audits
Gap reviews and internal audits that close nonconformities before the certification body arrives.
Accredited certification
We coordinate your Stage 1 & 2 audits with reputable, accredited certification bodies.
How it works
Five steps from agreement to certificate.
Scroll to follow the journey
02
Week 1
Gap analysis
Your project team reviews current practice against the standard and prepares a precise plan of action.
03
Weeks 2–6
Documentation
A documentation plan helps you generate the procedures and records the certification audit will sample.
04
Weeks 6–10
Internal audit
An internal audit tests the implemented system and confirms compliance — so there are no surprises later.
05
Day 30–90
Final certificate
An accredited certification body audits and issues your verifiable certificate.
Standards we certify
The right standard, implemented properly.
Every engagement follows the same proven path — documentation, implementation, internal audit and an accredited certification audit.
- ISO 9001HotQuality Management SystemThe world’s most recognised quality management standard — proof you deliver consistently.
- ISO 14001HotEnvironmental Management SystemA systematic framework to control environmental impact and prove it to stakeholders.
- ISO 45001HotOccupational Health & SafetyReduce incidents and protect your people with the global OH&S benchmark.
- ISO 22000HotFood Safety Management SystemA farm-to-fork food safety system that customers and retailers trust.
- ISO 13485HotMedical Devices QMSThe medical-device QMS regulators worldwide build on — FDA, MDR, MDSAP.
- ISO 27001HotInformation Security ManagementProve your information security to customers, partners and regulators.
- ISO 21001Educational Organisations ManagementA learner-centred management system for schools and training providers.
- ISO 42001NewAI Management SystemThe first international standard for governing AI responsibly.
- ISO 15189Medical LaboratoriesQuality and technical competence for clinical and pathology laboratories.
- ISO 17025NewTesting & Calibration LaboratoriesProve your lab’s competence, impartiality and reliable results worldwide.
- BA 9000Body Armor Quality ManagementThe NIJ-aligned quality standard for ballistic-resistant body armor.
- AS 9100DAerospace Quality ManagementThe IAQG quality standard for aviation, space and defense suppliers.
- GMPGood Manufacturing PracticeConsistent, controlled manufacturing for pharma, cosmetics and food.
- cGMPCurrent Good Manufacturing PracticeFDA-grade manufacturing controls for pharma and biotech startups.
- HACCPHazard Analysis Critical Control PointA preventive, cost-effective system for controlling food safety hazards.
Regulatory affairs
One partner. Six markets.
From FDA 510(k) to EU MDR technical files, MDSAP, TGA and MHRA registration — plus PRRC and UK Responsible Person services so you stay compliant after approval.
Build the momentum
The power of good advice may change your perspective indefinitely.
Better decisions compound. We bring the clarity of lead auditors to every step, so your certification builds momentum instead of paperwork.
Luqman Ali
Chief Executive Officer, Lisora LLC
“
We remove complexity from ISO certification so businesses grow with confidence.
Why Lisora
Vigorous is our word — and our standard.
Lisora was founded in 2022 to bring a streamlined, modern approach to regulatory processes that meet ISO standards. We deliver ISO certification and global regulatory frameworks — MDSAP, MDR, FDA, TGA and MHRA — with PRRC and UKRP services that keep you compliant in Europe and the UK.
01
Expert ISO team
Qualified specialists, lead auditors and assessors with cross-industry experience.
02
End-to-end ownership
Gap analysis to final certificate, handled under one accountable team.
03
Global reach
Clients across industries worldwide, with RA coverage in six jurisdictions.
04
Practical systems
Lean documentation that people actually use — built to survive the audit and the years after.
- 2022
- Established
- 24h
- Response time
- 3 yrs
- Certificate cycle
FAQ
Questions, answered.
01What does Lisora do?
Lisora is an ISO certification and regulatory affairs consultancy. We prepare organisations for ISO certification (ISO 9001, 14001, 45001, 22000, 27001, 13485, 42001 and more) and secure medical device market access through FDA, EU MDR, MDSAP, TGA and MHRA — including PRRC and UK Responsible Person services.
02How long does ISO certification take?
With our fast-track approach most organisations are certified in 30–90 days. The timeline depends on company size, number of sites, the standard and how much of your management system already exists.
03Does Lisora issue the ISO certificate?
No. We prepare you and coordinate the audit with an independent, accredited certification body, which issues a verifiable certificate. Keeping consulting and certification separate is what makes your certificate credible.
04Do you work with companies outside the United States?
Yes. Lisora is headquartered in Lansing, Michigan and supports clients worldwide through remote and on-site delivery, with regulatory coverage across the US, EU, UK, Canada, Australia, Brazil and Japan.
05How much does ISO certification cost?
Cost depends on the standard, number of employees and sites, and the package you choose — from documentation only to a full package. Use our quote builder and a lead auditor will send a fixed, itemised quote within 24 hours.