ISO 13485

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

REIВ Consultant can give your organization the best service for set-up and or training for ISO 13485 Medical Device

Head Office

Legenda Wisata Ruko Newton Square
Blok U17 No. 11, Jl. Alternatif Cibubur, 16830 - Indonesia
Tlp./Fax. 021-292 19412
Hp. 081.380.602.166
WhatsApp/Line: 081.380.602.166
Email1: edyskoto[at]yahoo.com
Email2: info[at]reisistem.com Email3: reisistem.jkt[at]gmail.com
Email4 : rei.services.indonesia[at]gmail.com
Email5 : edyskoto[at]reisistem.com

Branch office

Surabaya, Sidoarjo & Indonesia Timur
Ruko Citra Harmoni, Chi Walk, Marina 3, Taman-Sidoarjo, Jawa Timur
Tlp./Fax. 031- 997 84103
Hp. 081.380.602.166
WhatsApp/Line: 081.380.602.166В / 081.235.902.215
Email1: edyskoto[at]yahoo.com
Email2: reisistem.sby[at]gmail.com
EMail3 : rei.services.indonesia[at]gmail.com
EMail4 : edyskoto[at]reisistem.com

Branch Office

Medan & Indonesia Barat
Jl.Sipirok No.26. P.Siantar
Tlp.В 0622-7356227
Hp. В 081.380.602.166
WhatsApp/Line: 081.380.602.166 / 082.276.502.448
Email1: edyskoto[at]yahoo.com
Email2: rei.services.indonesia[at]gmail.com
Email3: edyskoto[at]reisistem.com

Consultation/Training Register

В