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- PRINCIPLE OF CERTIFICATION ACCORDING TO ISO
13485:2003
The certificate issued by an independent accredited
certification body guarantees that the quality management system of a
supplier and manufacturer of medical devices has been established, documented, used
and maintained in accordance with the requirements of ISO 13485:2003 standard.
 As more stringent quality management system demands
are placed on suppliers and manufacturers of medical devices, ISO 13485/13488:2001
standard has been developed, extending the requirements of ISO 9001 standard (sterilization,
technical documentation requirements, traceability, etc.).
In 2003, ISO 13485:2003 standard was published as a revised standard, with structure
corresponding to ISO 9001:2000 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.
- BENEFITS OF CERTIFICATION
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Guarantee of production process stability and thus steady and
high quality of services and products supplied to customers;
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Simplifying the process of attestation of conformity to requirements
of EU directives and corresponding Government Orders;
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Attestation of efficiency and effectiveness of the established
quality management system by an independent third party;
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Optimization of costs " reduction of operating costs, reduction
of nonconforming products costs, raw materials, energy and other resources savings,
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Enhancing trust of public and public monitoring bodies in respect
of the medical devices manufacturer.
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The certification process consists of 3 basic stages:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice are
individual (it usually takes several months).
Certification by the accredited certification
body No. 3002
- Assessment and registration of the client"s application for certification;
- Signing an agreement for conducting a certification audit (Note:
the certification audit is conducted in two stages);
- Appointing a team of auditors;
- Preparing an audit plan;
- Verification of facts in the following stages
a) examination of the client"s documentation
b) checking facts on site;
- Elaboration of the Certification Audit Report;
- Assessment of the Audit Report by the Certification Body;
- Issuing the Certificate.
During the three year validity period of the certificate, a
surveillance audit takes place once a year. One of the following is
issued depending on the surveillance findings
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Decision on confirmation of the certificate validity until the next surveillance;
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Decision on suspension of the certificate;
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Decision on withdrawal of the certificate in case of fundamental deviations from
requirements of standards.
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Certification of Quality Management System ( ISO
9001)
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Certification of Environmental Management System ( ISO
14001)
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Certification of food safety management system ( ISO
22000)
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Certification of quality management systems in manufacturers of medical devices
( ISO 13485)
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Certification of occupational health and safety management system ( OHSAS
18001)
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Assessment of conformity of products to the requirements of European directives
(CE marking of products)
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Testing of products, ATEST ITC
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Technical standardization
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- FIELDS COVERED BY ACCREDITATION
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Manufacture of chemical substances, preparations and man-made
fibres
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Manufacture of rubber and plastic products
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Manufacture and repairs of other machines and equipment
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Production of electrical and optical devices and equipment
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