Certification of quality systems for manufacturers of medical devices is based onEN ISO 13485:2016, which has been declared as a harmonized standard to the European Directives 93/42/ EEC, 90/385/EEC and 98/79/ EC in the Official Journal of European Union, which enables it to be used to demonstrate compliance with the requirements of these European directives.. This standard is applied in conformity assessment processes.
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PRINCIPLES OF THE CERTIFICATION ACCORDING TO ISO 13485
Due to the growing demands on the quality management system of suppliers and manufacturers of medical devices, ISO 13485:2016 has been developed. The standard includes criteria for the full range of quality management system for medical devices. A certificate issued by an independent accredited certification body ensures that the quality management system of the supplier and the manufacturer of medical devices is implemented, documented and used in accordance with the requirements of ISO 13485.
BENEFITS OF CERTIFICATION
- it guarantees the constancy of the manufacturing process, resulting in a stable and high quality of the services and products provided
- it simplifies the process to demonstrate conformity with the requirements of EU regulations and applicable government decrees
- it proves the effectiveness of the quality management systems by an independent third party
- cost optimisation – lower operational costs, reduction of the costs of non-conforming products, savings in raw materials, energy and other resources
- increased confidence of the public and state authorities for the manufacturers of medical devices
- The certification procedure consists of the following basic phases:
- processing of documentation
- implementation of a management system into practice
certification by an accredited certification body
- assessment and registration of client's application for certification
- contract for the certification audit (the initial certification audit takes place in two stages)
- forming the team of auditors
- preparing the audit plan
- verification of facts in stages:
a) review of client’s documentation
b) verification of facts on site
- report of the results of the audit
- assessment of the audit report by a certification body
- issuance of certificate
an annual surveillance audit shall conducted during the three year validity of the certificate. Depending on the results, a decision confirming (or suspending) the validity of the certificate until the next surveillance audit is issued. In the event of significant deviations from the standard, and as an extreme measure, the certificate may be revoked.
In order to ensure the continuity of the validity of the certificate, and according to the decision of the holder, a recertification audit should be conducted in the third year, before the expiration of the certificate.
IQNET – international certificate
Institute for Testing and Certification is a member of the 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 according to other system and industry standards (ISO 9001, ISO 14001, ISO 50001, OHSMS – ISO 45001)
- 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
Ing. Jaroslav Rapant
head of management system certification department
Institute for testing and certification
management system certification department
trida Tomase Bati 5264, 760 01 Zlin
The person responsible for accuracy of data: Jaroslav Rapant