NEWS
January 30th, 2012
Transition from ISO 19011:2002 to a new version ISO 19011:2011
ISO 19011 has been revised to provide persons, involved in management system
auditing with good audit practice, guidance relevant to today's environment where many
organisations operate a management system covering multiple disciplines, for example
quality, environment, occupational health and safety and information security etc.
Regarding the new issue/revision of international standard ISO 19011:2011 we would like to provide you the brief summary and review of changes in this new revision.
Here you can download document: Summary of the changes within ISO 19011:2011.
August 2nd, 2011
On August 2nd, 2011 our company has been awarded a new Decree on Authorization, with the enlarged scope of the authorization.
Slovak office of Standards, Metrology and Testing (ÚNMS SR) issued o August 2nd, 2011 new Decree on Authorization for our company, as Authorized Body No. SKTC-113 for the Slovak Republic Decree No. 569/2001 Law Digest amended No. 610/2008 Law Digest and No. 582/2008 Law Digest, for the directives:
- Council Directive 93/42/EHS concerning to medical devices,
- Directive 98/79/ES of the European Parliament and of the Council on diagnostic medical devices in vitro.
This Decree enters into force on September 1st, 2011 and replaces the old Decree A1/2010/800/003829/01737 from July 20th, 2010.
Based on this Decree, 3EC International a.s. expanded the scope of the authorization for diagnostic medical devices in vitro according to the Annex. 2 for the Slovak Republic Decree No. 569/2001 Law Digest amended No. 610/2008 Law Digest as follows:
- conformity assessment procedure for self-inquiry medical devices was extended of EC declaration of conformity according to Annex. 3, point 6 of the Government Regulation.
This Decree authorizes 3EC International a.s. to perform the conformity assessment of medical devices in accordance with the directives and in the new range.
June 30th, 2011
Our company has successfully passed reaccreditation audit as per ISO/IEC 17021: 2006 standard.
In April 2011, took place in our company reaccreditation audit in the area of certification of:
- Quality management system as per ISO 9001: 2008,
- Quality management system for medical devices as per ISO 13485: 2003,
- Environmental management system as per ISO 14001: 2004,
- Occupational health & safety management system as per OHSAS 18001: 2007,
- Food safety management system as per ISO 22000: 2005, including the principles of HACCP.
As the Slovak National Accreditation Service in the performance of accreditation acts in our company found that all the legal requirements for reaccreditation have been met, on July 30th, 2011 accreditation certificate for each of the above mentioned management systems has been granted to 3EC International a.s.
The scope of our accreditation can be found on SNAS (Slovak National Accreditation Service) webpage, section Accredited Organizations http://www.snas.sk/e/index.php?page=4.
March 23rd, 2011
We have obtained accreditation as per EN 45011: 1998.
Based on the successful completion of certification audit in the field of medical devices and diagnostic medical devices in vitro, on March 23rd, 2011, we have been granted by Slovak National Accreditation Service the Certificate of accreditation No. P-043 as per EN 45011: 1998.
This certificate is located in the section Certificates. Certificates.
Accreditation was awarded from March 23rd, 2011 to March 23rd, 2014.
According to the Certificate, 3EC International a.s. is eligible to carry out certification of medical devices and diagnostic medical devices in vitro to the extent specified in the Annex to this Certificate. |
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December 7th, 2010
Our Head of the Certification Body, Dr. Katarina Srdošová, was awarded the prize „Top Quality Manager in 2010“ within the A) category, a private sector.
On 7th December, 2010 a ceremony of the competition results the Top Quality Managers in 2010 took place. It was organized by the Slovak office of Standards, Metrology and Testing (ÚNMS SR). Within the competitive category A) a private sector has been as well awarded Head of our Certification Body - Dr. Katarína Srdošová.
Slovak office of Standards, Metrology and Testing being a coordinator of the state quality policy declared the 7th competition range in the 3rd quarter of 2010, while it continued in a tradition to award the outstanding representatives of quality management within the Slovak Republic. The competition and its criteria followed from the competition „European Quality Manager“, which is being declared each year by the European Organization for Quality (EOQ).
Organizations of private and public sector had opportunity to nominate their Quality Managers, Quality Representatives, Quality Specialists, Methodologists of EFQM exceptionality model, guaranteed Methodologists of CAF model and persons being directly linked to quality management in two competitive categories – A) category a private sector and B) category public sector. In both categories the prize was awarded to three from all nominated, who had to meet demanding competition criteria.
November 15th, 2010
Starting the November 15th, 2010 our company has become a Notified Body with an assigned number 2265 for Conformity Assessment of the Medical Devices.
On November 15th, 2010 the Slovak office of Standards, Metrology and Testing (ÚNMS SR) issued an Confirmation of Notification for our company being the Authorized Body No. SKTC-113 for the Slovak Republic Decree No. 569/2001 Law Digest amended No. 610/2008 Law Digest and No. 582/2008 Law Digest for the directives:
- Council Directive 93/42/EEC concerning to medical devices
- Directive 98/79/ES of the European Parliament and of the Council on in vitro diagnostic medical devices
Such confirmation authorize 3EC International a.s. to perform the Conformity Assessment of Medical Devices in accordance with the mentioned directives and for the scope of activities , being specified on the website http://ec.europa.eu/enterprise/newapproach/nando/.
In the case of interest for Conformity Assessment of Medical Device it is sufficient to complete the application form, which you may find in the part SERVICES.
NOTE: NANDO (New Approach Notified and Designated Organisations) is an information system of the European Commission Enterprise and Industry DG located in Brussels.
