Pamukkale / Denizli EN | TR

Our Quality Policy

International standards at every stage of production.

Our Policy

Quality at Every Step

At Temaş, we have made it our principle to implement international standards at the highest level in the production of medical textile products, from raw material selection to final product packaging.

Our Quality Management System is built on fully meeting customer requirements, continuously improving product safety and efficacy, producing in an environmentally sensitive manner and being a reliable business partner to all our stakeholders.

Our company, which has held the CE production quality assurance system since 2002, keeps its certifications up to date through regular audits and process improvements.

✓ ISO 9001:2015 ✓ ISO 13485:2016 ✓ CE (2002) ✓ TSE
Quality Control
Our Certificates

Quality Certificates

ISO / IEC

ISO 9001:2015

Our ISO 9001:2015 certificate covering the general quality management system encompasses the principles of customer focus, leadership, process approach and continuous improvement.

Valid since 2008
ISO / IEC

EN ISO 13485:2016

EN ISO 13485:2016, the quality management system standard specific to medical devices, includes risk management, verification and validation activities.

Valid since 2016
EU Directive

CE Certificate

The CE certificate, active since 2002 under the European Union Medical Devices Directive, is the fundamental assurance for exporting to the EU market.

Valid since 2002
T.C. Sağlık Bakanlığı

Turkish Ministry of Health

With the production permits and compliance certificates issued by the Ministry of Health of the Republic of Turkey, the compliance of our products with domestic and international health legislation is ensured.

Valid since 1983
TSE

TSE

With Turkish Standards Institution compliance certificates, the conformity of our products to Turkish Standards has been tested and verified.

Valid since 1990
WHO/FDA

GMP – Good Manufacturing Practices

All our production processes are conducted in accordance with Good Manufacturing Practices (GMP) principles, from raw material acceptance to final product shipment.

Valid since 2010
Production

Production Quality Process

5-stage quality assurance from raw material to finished product.

01

Raw Material Control

Acceptance of test-approved cotton and chemical inputs.

02

Production

Gauze and bandage production under ISO conditions.

03

Quality Testing

Laboratory durability, elasticity and sterility tests.

04

Packaging

GMP-compliant sterile/non-sterile packaging.

05

Shipment

Perfect delivery with customer-approved lot tracking.

Would You Like to See Our Quality Certificates?

Contact us for certificate copies and technical documents.

Contact Us Get a Quote