Application			Obligatory Business Conditions
	Searching the database of certificates			Manual for ITC clients

PRINCIPLE OF CERTIFICATION ACCORDING TO ISO 13485:2003

As more stringent quality management system demands are placed on suppliers and manufacturers of medical devices, ISO 13485:2001 standard was developed in 2001, extending the requirements of ISO 9001:1995 standard (sterilization, technical documentation requirements, traceability, etc.). In 2003, ISO 13485:2003 standard was published as a revised standard, with its structure corresponding to ISO 9001:2001 and containing criteria for the whole range of the quality management system for medical devices. The certificate according to ISO 13485:2003 standard applies to the whole management system of an organization manufacturing or supplying medical devices and related services. The certificate issued by an independent accredited certification body guarantees that  the quality management system of the supplier and manufacturer of medical devices has been established, documented, used and maintained in compliance with the requirements of ČSN EN ISO 13485:2003 standard.

BENEFITS OF CERTIFICATION

• Guarantee of production process stability and thus steady and high quality of services and products supplied to customers;
• Simplifying the process of attestation of conformity to requirements of EU directives and corresponding Government Orders;
• Attestation of efficiency and effectiveness of the established quality management system by an independent third party;
• Optimization of costs – reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources savings,
• Enhancing trust of public and public monitoring bodies in respect of the medical devices manufacturer.

IQNET – international certificate

Institute for Testing and Certification is a member of the Association for Quality System Certification CQS, which is a member of the international network IQNet. Through this co-operation, it is possible to issue upon request both the ITC certificate and the CQS certificate and the internationally recognized IQNet certificate within the framework of a single certification process.

CERTIFICATION PROCESS

The certification process consists of 3 basic stages:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body
4) Surveillance audit
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

• Decision on withdrawal of the certificate in case of fundamental deviations from requirements of standards.

RELATED SERVICES

• Certification of Quality Management System (ISO 9001)
• Certification of quality management systems in manufacturers of medical devices (ISO 13485)
• Certification of Environmental Management System (ISO 14001)
• Certification of occupational health and safety management system (OHSAS 18001)
• Certification of food safety management system (ISO 22000)
• Assessment of conformity of products to the requirements of European directives (CE marking of products)
• Testing of products, ATEST ITC
• Calibration, verification of standards and measuring instruments
  
• Voluntary certification – “ITC – certified quality“ mark
• Technical standardization

FIELDS COVERED BY ACCREDITATION

• Manufacture of chemical substances, preparations and man-made fibres
• Manufacture of rubber and plastic products
• Manufacture and repairs of other machines and equipment
• Production of electrical and optical devices and equipment

CONTACTS

Person	Phone	fax	e-mail
Jaroslav Rapant	+420 577 601 299	+420 577 104 855	qscertitczlin.cz

Post address:
Intitute for testing and certification
management system certification department
street T. Bati 299
764 21 Zlin
Czech Republic

The person responsible for accuracy of data: Jaroslav Rapant