QUALITY ASSURANCE POLICIES AND STANDARDS

Röth Medical Components (Pty) Ltd is committed to a policy of total Quality Assurance and product conformity and the company endeavours to ensure that this policy is understood, accepted, implemented and maintained throughout the company, in accordance with:

1. ISO 9001:2000
2. ISO 13485:2003
3. ISO 14971
4. MDD 93/42/EEC (CE Mark)
5. Good manufacturing practice (GMP) certificate (issued by R.S.A. Dept.
    of Health)
6. Certificate of Free Sale
7. “Proudly South African” founder membership
8. “Cape Town Regional Chamber of Commerce and Industry” Founder
     Membership

The company Quality Management system is designed to ensure a culture of product quality, customer focus, and service excellence, in order to underpin the constant commitment to the company slogan:

“QUALITY WITHOUT COMPROMISE”.