Česky | English | Deutsch | Polski | По-русски | 中文 | 한국어 | Hrvatski | Türkie | ไทย |
ITC
new liquid chromatograph with tandem mass spectrometry Shimadzu LC-MS/MS 8045

At the beginning of 2018 department of analytical chemistry purchased brand new liquid chromatograph with tandem mass spectrometry Shimadzu LC-MS/MS 8045, which is used for trace analysis of organic substances. Spectrometer has superior sensitivity for organic substances in orders of nano-grams per litre of sample. In June first analytical procedures successfully passed accreditation after the validation. Contact for such a special analytical techniques – RNDr. Lukas Rozsypal, tel: +420 577 601 452, e-mail: lrozsypal@itczlin.cz


Conformity assessment of personal protective equipment

Institute for Testing and Certification is newly included in the NANDO database as the Notified Body for the Conformity Assessment of Personal Protective Equipment in accordance with Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016.

Detailed information HERE


Regulation (EU) 2016/425 on personal protective equipment - Guidance document on the implementation of Article 47

Good day.
Regulation (EU) 2016/425 on personal protective equipment - Guidance document on the implementation of Article 47 on transitional provisions. Awailable on web page HERE.


Testing of hydraulic brake hose assemblies by Standard SAE J1401

Institute for testing and certification offers a new service in a field of automotivetesting of Hydraulic Brake Hose Assemblies by Standard SAE J1401. For detailed informations please contact our expert from Physical Testing Laboratory mr. Radek Matejka rmatejka@itczlin.cz.


New method for determination of organometallic complexes

Our analytical laboratory has implemented new method for determination of organometallic complexes (i.e. alkyl mercury) by cation chromatography, coupled to ICP-MS detection. This group of substances is represented for example by Trimerosal, used as fungicide or fungistatic agent. Such a substances can be limited for example in vaccines or contact lens solutions. Contact: Laboratory of Analytical Chemistry, fpuype@itczlin.cz, analyt@itczlin.cz


ISO 13485

Management systems certification » Certification of management system

Certification of quality systems for manufacturers of medical devices according to EN ISO 13485. This standard is applied in conformity assessment processes.

 

Application
  Obligatory Business Conditions
 
Searching the database of certificates   Client's Handbook
 
      Rules for Use Certificate  

PRINCIPLES OF THE CERTIFICATION ACCORDING TO ISO 13485

ISO 13485:2001 was established in 2001, as a response to the growing demands on the quality management system of suppliers and manufacturers of medical devices, broadening the requirements of ISO 9001:1995 with regards to sterilisation, technical documentation, traceability, etc. Revisions were issued in 2003 and 2016.

REVISION OF ISO 13845

The International Organization for Standardization (ISO) has completed the revision of ISO 13485. The new version, ISO 13485:2016, was published on 1/3/2016, and a transitional period of three years till 31.3.2019 was established for its implementation at companies. The translation in Czech was completed and issued in December 2016 as ČSN EN ISO 13485:2016 ed. 2. The standard is in effect as of 1/1/2017.

Currently, it is possible to certify the quality management systems of medical devices according to ČSN EN ISO 13485:2012 or ISO 13485:2003 or ISO 13485:2016 or ČSN EN ISO 13485:2016 ed. 2. The certificate applies to the entire management system of an organisation that manufactures or supplies medical devices and related services. The certificate, issued by an independent, accredited certification body, guarantees that suppliers and manufacturers of medical devices implement, document, apply and maintain quality management systems pursuant to ČSN EN ISO 13485:2012 (or ISO 13485:2003). The certification and recertification of management systems according to ISO 13485:2003 shall be conducted no later than 31/12/2017. Given that ISO 13485:2003 is valid until 31/1/2019, we recommend all interested parties to conduct their audits already according to ISO 13485:2016 /ČSN EN ISO 13485:2016 ed.2.

IMPORTANT CHANGES IN THE REVISION OF ISO 13485

  • The standard places emphasis on an approach based on risk management during the realisation of a product. It covers the entire life cycle of the device, from design and development, through manufacturing, storage and distribution, installation; to provision of services, including decommissioning and liquidation, as well as related activities.
  • It brings increased demands on compliance with legal regulations. A completely new section refers to the requirement to report to regulatory authorities
  • Greater emphasis has been placed on the management and control of outsourced processes,as well as the requirements for an appropriate infrastructure and the qualification thereof, in particular for the production of sterile devices.
  • Greater attention has also been paid to feedback mechanisms, which should serve as potential inputs to risk management and to the compliance with the requirements for product realisation or improvement processes.
  • The demands on complaint management have also been increased.
     

The structure of the main chapters has remained identical to the previous version’s (8 chapters). The current format of the standards is an inconvenience for companies with parallel certification of ISO 9001 and ISO 13485, as the former is based on the Annex SL (a 10 chapter structure).

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

CERTIFICATION PROCESS

  • The certification process consists of the following basic phases:
  • processing of documentation
  • implementation of a QMS
  • 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
  • surveillance audit
    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.
  • recertification audit
    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 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.

IQNet CQS

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 critical control points system in food processing industry (HACCP)
  • 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

CONTACTS

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


Post address:
Institute for testing and certification
management system certification department
trida Tomase Bati 299, Louky, 763 02 Zlin
Czech Republic

The person responsible for accuracy of data: Jaroslav Rapant

Updated: 3.1.2018
 
Webdesign studio
We use cookies that make this site work. By using our services you agree to use them. More about cookies I AGREE