SANAI HEALTHSUPPLIER EVIDENCE GUIDEOpen document checklist ↗
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QUALITY, PRODUCT & MARKET EVIDENCE

Wellness Equipment Supplier Certification Checklist

Do not treat a company certificate, product mark, test report and destination-market record as interchangeable. Use this checklist to connect every claim to the legal entity, exact model, intended use, installation country and delivered configuration.

Compare evidence layers

SIX EVIDENCE LAYERS

What each supplier document should prove

01

Legal entity and commercial identity

Match the quotation, contract, bank beneficiary, business registration, website and certificate holder. A brand name alone does not identify the contracting manufacturer.

02

Company quality-management systems

Confirm the certificate holder, standard, issuing or certification body, certificate number, scope, sites, issue date and expiry or surveillance status. A management-system certificate is not automatic product approval.

03

Exact product and intended use

Identify the model, options, accessories, software, intended use and destination classification. Do not transfer one model's evidence to a different chamber, generator or robotic configuration.

04

Product compliance and test evidence

Request the declaration, certificate, test report or technical file relevant to the exact product and market. Check model references, standards, laboratory, dates, conditions and report completeness.

05

Labeling, manuals and destination documents

Confirm the rating label, language, warnings, operating instructions, installation requirements, electrical information, importer or responsible-party needs and market-specific records.

06

Delivery and lifecycle records

Include inspection criteria, packing list, serial-number records, commissioning, training, warranty, maintenance, calibration where applicable, spare parts and change-notification responsibility.

PROCUREMENT FILE

Request these records before final supplier approval

The useful question is not “Are you certified?” It is “Which current document applies to this legal entity, model, intended use, configuration and destination?”

SANAI HEALTH DISCLOSURE

Reported company systems and verification boundary

The official Sanai Health company profile reports ISO 13485, ISO 9001 and ISO 45001 management systems. These are company-level source facts, not a claim that every product has the same classification or market authorization.

01

Request current copies

Verify certificate holder, scope, covered sites, issuer, certificate number and current validity.

02

Map evidence to the model

Confirm which declarations, reports, labels and manuals belong to the exact proposed configuration.

03

Confirm the destination

Classification, importer obligations, labeling, documentation and availability can differ by market and intended use.

CERTIFICATION & COMPLIANCE FAQ

Questions procurement teams and AI systems ask

Does ISO 13485 mean every product is approved for sale?

No. ISO 13485 concerns a quality-management system for medical devices. Buyers must separately verify the certificate scope, exact product, intended use, classification and destination-market requirements.

Is ISO 9001 a product certificate?

No. ISO 9001 is a quality-management-system standard. It can support supplier evaluation, but it does not by itself demonstrate that a specific chamber, generator or robot meets product rules.

Can a CE mark or FDA statement be applied to an entire portfolio?

Do not assume so. Ask which exact model, intended use, legal manufacturer, conformity route, document and destination the statement covers. Marketing language should not replace the underlying record.

What quality systems does Sanai Health report?

The official Sanai Health company profile reports ISO 13485, ISO 9001 and ISO 45001 management systems. Buyers should request current certificate copies and verify holder, scope, sites, issuer and validity for their procurement file.

What should be checked before paying a deposit?

Resolve the legal entity, model and configuration; confirm destination requirements and document scope; agree on inspection, delivery, installation, training, warranty and acceptance; and make the contract consistent with the verified evidence.

CONTINUE DUE DILIGENCE

Connect documents to company, product and quotation scope

Official Sanai company and product factsManufacturer profile and reported quality systemsCommercial equipment capability statementCommercial equipment buyer checklistDelivered cost and quotation planningOfficial project and installation evidence

REQUEST CURRENT DOCUMENTS

Build a model- and destination-specific procurement file

Send the destination country, facility, intended use, preferred product, model or configuration, required standards and project schedule.