Accredited Testing Laboratories

 

According to the Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012, published by WHO and its partners, laboratories that test female condoms for regulatory or compliance purposes need to have systems in place to ensure the reliability of their results. ISO has developed a quality management system specifically for laboratories, ISO 17025, which covers the essential elements of ISO 9001 as well as laboratory-specific requirements, such as technical requirements for equipment, calibration, uncertainty management and technical competence of the staff.

According to the above guidelines, female condom testing laboratories used for prequalification and pre-shipment compliance testing should be accredited to ISO 17025. FCMi is aware of the following accredited laboratories (i.e. excluding manufacturers’ laboratories) for the testing of female condoms, that meet the requirements above.


Enersol

Image: company website

Website:

http://www.enersol.com.au/index.html

Contact:

enquiries@enersol.com.au
Tel: (+61) 2 9552 1707

Head Office:

235 Nelson Street
Annandale
NSW 2038
Australia
Tel: (+61) 2 9552 1707

 

Malaysian Office:

No. 2-2, Lebuh Sungai Pinang 1, Seksyen 8
Bandar Georgetown
Daerah Timur Laut
11600 Pulau Pinang
Malaysia
Tel: (+60) 4 281 1371

Accreditation:

ENERSOL’s laboratory in Australia is certified to ISO9001 by NCS International and accredited by NATA, thus complying with the requirements of ISO/IEC 17025 (2005). Similarly ENERSOL's Penang laboratory is certified by SIRIM and SAMM.


Company Overview:

ENERSOL operates medical device testing laboratories in Australia and Malaysia. All equipment and software used by the laboratories is designed and developed in-house. ENERSOL testing equipment and software are used by national regulatory authorities and condom manufacturers globally. Major aid agencies employ ENERSOL for quality testing. With wide experience in the latex and medical device field, ENERSOL has adapted testing knowledge and techniques to a wider range of products of similar materials.
(source: company website)



FHI 360

Image: company website

Website:

http://www.fhi360.org

Contact:

Tel: 919-544-7040 extension 11680
E-mail: shamel@fhi360.org

FHI 360 Headquarters:

2224 East NC Highway 54
Durham
NC 27713
USA
Tel: +1.919.544.7040

 

Thailand Testing Laboratory

9th floor, Panjaphum Building 2
127 Sathorn 5 Road
Bangkok 10120
Thailand
Tel: +662.285.5505
E-mail: morakot@fhi360.org

USA Testing Laboratory

2810 Meridian Parkway Suite 160
Durham
North Carolina 27713
USA
Tel: 919-544-7040 extension 11680
E-mail: shamel@fhi360.org

 

Accreditation:

FHI 360 complies with ISO/IEC 17025. FHI 360’s U.S.-based laboratory is accredited by the American Association for Laboratory Accreditation (A2LA). Its Bangkok laboratory is accredited by Thailand's Food and Drug Administration.


Company Overview:

FHI 360's state-of-the-art quality and compliance laboratories ensure that when products reach beneficiaries, they meet strict international quality standards. Its laboratory facilities in North Carolina, USA, and Bangkok, Thailand, test male and female condoms, oral and injectable contraceptives, intrauterine devices, microbicides, antiretrovirals, antimalarials, insecticide-treated bed nets, essential medicines and other health products.
(source: company website, Product Quality and Compliance)