Quality and compliance
How we control garment quality, and the certifications and standards that support every order, from India or for export.
Quality starts with the garment
A cleanroom garment fails at its weakest point: an open seam, a zip that lets particles through, a cuff that rides up. Our process checks those points on every garment, not on a sample.
- Fabric is inspected on arrival for weave defects, shade and finish.
- Cutting and stitching follow fixed patterns for each style and size, so a size L in March fits like a size L in October.
- Seams, zips and cuffs are inspected before packing.
- Batches are coded so any garment can be traced back to its fabric lot and production date.
Documents for your QA team
Certificates, test reports and data sheets are shared during supplier qualification, together with a certificate of conformity for each batch. Ask for the supplier qualification pack and we send it within one working day.
Four checks before anything ships
Fabric inspection
Incoming fabric checked for defects, shade and construction before cutting.
Construction checks
Seams, zips, cuffs and labels inspected on every garment.
Batch identification
Each batch is coded so it can be traced back to its fabric lot.
Clean packing
Garments are folded and sealed in pouches, ready for your sterilisationSupplied clean and packed so your site can sterilise it in its own validated autoclave cycle before use..
The standards behind every order
Our garments are made and shipped through a certified manufacturing and export network. Certificates and test reports are shared during supplier qualificationThe checks a buyer's QA team runs before approving a new supplier: documents, samples, audits and test reports..
Company registration
- GST registrationGoods and Services Tax registration
- Udyam (MSME) registrationMicro, Small and Medium Enterprise: a government of India registration (Udyam) for smaller manufacturers.Micro, small and medium enterprise registration
- Import Export Code (IEC)Importer Exporter Code: the 10-digit registration every Indian business needs to export goods.Required for exports from India
- Trademark registration for cleanwearWord mark and logo
Quality management
- ISO 9001:2015 quality management systemInternational standard for quality management systems, covering how an organisation controls processes, documents and improvement.Certification of our quality management system
- ISO 13485:2016 medical devices quality managementInternational standard for quality management systems for medical device organisations. Many pharma and device QA teams look for it when qualifying garment suppliers.Required if garments are supplied as medical devices
Cleanroom and sterilisation
- ISO 14644-1 classification of packing areaInternational standard that classifies cleanrooms by airborne particle concentration, from ISO 1 (cleanest) to ISO 9.Particle classification of our clean packing room
- Steam sterilisation validation (ISO 17665)For garments we supply pre-sterilised
Product testing
- Fabric particle shedding and filtration testingIEST-RP-CC003 and ASTM F51 methods
- Electrostatic properties testing (EN 1149-1 / EN 1149-5)European standard for protective clothing with electrostatic properties, used where a spark could ignite a flammable atmosphere. The fabric must meet a surface resistance or charge decay requirement.For antistatic carbon grid fabrics
- Garment life study across autoclave cyclesDurability of garments over repeated laundering and steam autoclaving
Export and market access
- REACH declaration for fabricsThe EU regulation on chemicals. EU buyers may ask for a statement on substances of very high concern in fabrics.Chemical compliance statement for EU buyers
Distribution
- Authorised distributor of St. Marys Rubbers (SMR)Medismart surgical and examination gloves
Tell us what your cleanroom needs
Share your ISO class, quantities and timelines. We reply with options, a quote and sample availability within one working day.