Compliance and certifications
Our registrations, certifications and testing, and their current status.
Last updated: 8 October 2026
We publish the status of every registration, certification and test programme we are working on. An item marked In progress is being worked on and is not yet held. We never describe a certification as held until the certificate is issued.
Copies of certificates and test reports are available to customers on request at info@cleanwear.in.
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