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Seminář „Vedení a kontext organizace ve smyslu požadavků ISO 9001:2015"

Co to je „kontext organizace“, jak určit „zainteresované strany“, jak řídit vztahy s těmito zájmovými a zúčastněnými stranami, jak analyzovat a vyhodnocovat výkonnost organizace a její zlepšování, to vše zazní na semináři  „Vedení a kontext organizace ve smyslu požadavků ISO 9001:2015" , na kerý jste zváni. Odkaz na stránky semináře ZDE.


Rozšíření rozsahu akreditace AKL o kalibraci měřičů zatmavení autoskel

Kalibrační laboratoř v rámci rozšiřování služeb nabízí akreditovanou kalibraci měřičů zatmavení skel. Kalibrace těchto měřičů je důležitá pro zjištění hodnoty propustnosti světla a to především u autoskel, kde nejnižší povolená hodnota propustnosti světla čelního skla a bočních skel je 70%. Služba je vhodná především pro autoservisy a firmy, provádějící instalaci a kontroly tónovaných skel či zatmavovacích fólií.  
Odkaz na akreditaci zde.
Odkaz na kalibrační laboratoř zde.


ČSN EN ISO 9000:2016 v české verzi

V souvislosti s normou ISO 9001:2015 byla nově vydána také ISO 9000:2015 Systémy managementu kvality - Základní principy a slovník. Česká verze této normy je dostupná od 02/2016 jako ČSN EN ISO 9000:2016.


ČSN EN ISO 9001:2016 a ČSN EN ISO 14001:2016 na ČSN online

Registrovaní uživatelé mohou od 19.1.2016 na stránkách https://csnonline.unmz.cz/ stahovat českou verzi revidovaných norem ISO 9001 a ISO 14001.


Ukončení smluvní spolupráce se společností Sastek, Turecko

Ke dni 31. 8. 2015 byla ukončena smluvní spolupráce s tureckým obchodním zástupcem ITC, firmou „Sastek Conformity Assessment Services Industry and Trade Inc“.


MD legislation

VOLNĚ PŘÍSTUPNÁ SEKCE 


OBSAH VOLNĚ PŘÍSTUPNÉ SEKCE:

FORMULÁŘE PRO KLIENTY

  SOUBOR Verze

Předběžný dotazník
 
2014-05-08

GFA CZ
 
2016-05-22

Žádost o posouzení shody MDD
 
2016-05-23

Žádost o posouzení shody IVDD
 
2015-04-01

Žádost o posouzení shody AIMD
 
2015-04-01

Příručka pro klienty MD
 
2015-06-22

Příručka pro klienty IVDD
 
2015-06-22

Příručka pro klienty AIMD (english version only)
 
1304

COMPETENCE NB 1023

  www link FILE

Notification MDD - Nando
http://ec.europa.eu/enterprise/newapproach/nando/in dex.cfm? fuseaction=notification.pdf&dir_id=13&ntf_id=191 281  

Notification IVDD - Nando
http://ec.europa.eu/enterprise/newapproa ch/nando/index.cfm? fuseaction=notification.pdf&dir_id=20&ntf_id=187 921  

Notification AIMD - Nando
http://ec.europa.eu/enterprise/newapproa ch/nando/index.cfm? fuseaction=notification.pdf&dir_id=8&ntf_id=1915 61  

USEFUL LINKS

  www link

EURLEX
http://eur- lex.europa.eu/en/index.htm

NANDO
http://ec.europa.eu/enterprise/newapproa ch/nando/

European Commision – Medical Devices
http://ec.europa.eu/health/medical- devices/documents/guidelines/index_en.htm

European Medical Device Regulations
http://www.emergogroup.com/resources/reg ulations-europe

CEN (European Committee for Standardization ) - Healthcare
http://www.cen.eu/CEN/sectors/sectors/he althcare/Pages/default.aspx

Central Management Committee  (CMC) on Medical Devices
http://www.cmc-md.eu/

Notified Body Operations Group (NBOG) NBOG’s Best Practice Guide
http://www.nbog.eu/2.html

TEAM NB - The European Association for Medical devices of Notified Bodies
http://www.team-nb.org/

International Medical Device Regulators Forum
http://www.imdrf.org

DIRECTIVES - Main legislation
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

    FILE

MDD 93/42/EEC
 
concerning medical devices
 
List of harmonised standards under the Directive

 

AIMD 90/385/EEC
 
on the approximation of the laws of the Member States relating to active implantable medical devices
 
List of harmonised standards under the Directive
 


IVDD 98/79/EC

Directive of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
 
List of harmonised standards under the Directive

 

DIRECTIVES – Classification
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Directive 2005/50/EC Reclassification of hip, knee and shoulder joint replacements

Directive 2003/12/EC Reclassification of breast implants

REGULATION - Electronic instructions for use of MD
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Regulation (EU) No 207/2012


Prováděcí nařízení Komise (EU) č. 920/2013 o jmenování oznámených subjektů

Commission Regulation (EU) No 920/2013 on the designation and the supervision of notified bodies




Doporučení Komise 2013/473/EU o auditech a posouzeních prováděných oznámenými subjekty v oblasti zdravotnických prostředků

Commission Recommendation 2013/473/EU on the audits and assessments performed by notified bodies in the field of medical devices



DIRECTIVES - MD manufactured utilising tissues of animal origin
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Regulation (EU) No 722/2012

DIRECTIVES - Variant Creutzfeld-Jakob Disease assai
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Directive 2011/100/EU

DECISIONS - Common Technical Specification on IVD
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Decision 2011/869/EU

Commission Decision 2002/364/EC

Commission Decision 2009/886/EC

Corrigendum to Commission Decision 2009/886/EC

DECISION - Eudamed - European Databank on Medical Devices
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Decision 2010/227/EU

MEDDEV - Guidelines relating to medical device Directives
(Compiled from the accessible information at the Web: http://ec.europa.eu/health

    FILE Version
2.1 - Scope, field of application, definition    

MEDDEV 2.1/1
Definitions of "medical devices", "accessory" and "manufacturer" April 1994

MEDDEV 2.1/2 rev.2
Field of application of directive "active implantable medical devices" April 1994

MEDDEV 2.1/2.1
Field of application of directive "active implantable medical devices February 1998

MEDDEV 2.1/3 rev.3
Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative December 2009

MEDDEV 2.1/4
Interface with other directives - Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective  equipment March 1994
 
For the relation between the MDD and directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009
August 2009

MEDDEV 2.1/5
Medical devices with a measuring function June 1998

MEDDEV 2.1/6
Qualification and Classification of stand alone software January 2012

2.2 - Essential requirements
   

MEDDEV 2.2/1 rev.1
EMC requirements February 1998

MEDDEV 2.2/3 rev.3
"Use by" - date June 1998

MEDDEV 2.2/4
Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products January 2012

2.4 - Classification of MD
   

MEDDEV 2.4/1 rev.9
Classification of medical devices June 2010

2.5 – Conformity assessment procedure - General rules
   

MEDDEV 2.5/3 rev.2
Subcontracting quality systems related June 1998

MEDDEV 2.5/5 rev.3
Translation procedure February 1998

MEDDEV 2.5/6 rev.1
Homogenous batches (verification of manufacturers' products) February 1998

2.5 – Conformity assessment procedure - Conformity assessment for particular groups of products
   

MEDDEV 2.5/7 rev.1
Conformity assessment of breast implants July 1998
 
Evaluation of medical devices incorporating products of animal origin.
(See MEDDEV 2.11/1 rev.2)
   

MEDDEV 2.5/9 rev.1
Evaluation of medical devices incorporating products containing natural rubber latex February 2004

MEDDEV 2.5/10
Guideline for Authorised Representatives January 2012

2.7 - Clinical investigation, clinical evaluation
   

MEDDEV 2.7/1 rev.3
Clinical evaluation: Guide for manufacturers and notified bodies    December 2009 December 2009
  Appendix 1: Clinical evaluation on coronary stents December 2008

MEDDEV 2.7/2
Guide for Competent Authorities in making an assessment of clinical investigation; notification December 2008

MEDDEV 2.7/3
Clinical investigations: serious adverse event reporting December 2010
  SAE reporting form XLS  

EDDEV 2.7/4
Guidelines on Clinical investigations: a guide for manufacturers and notified bodies December 2010

2.10 - Notified bodies
   

MEDDEV 2.10/2 rev.1
Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices April 2001
 
Annex 1
 
 
Annex 2
 
 
Annex 3
 
 
Annex 4
 

2.11 - Products using materials of biological origin
   


MEDDEV 2.11/1 rev.2
 
Application of Council Directive 93/42/EEC taking into account the Commission Directive 2003/32/EC for Medical Devices utilising tissues or derivatives originating from animals for which a TSE risk is suspected January 2008
  Annex 1  

2.12 - Market surveillance
   

MEDDEV 2.12/1 rev.8
Medical Devices Vigilance System    January 2013
 
Manufacturer Incident Report
 
 
How to use the MIR
 
 
Field Safety Corrective Action
 
 
Trend Report
 
 
Periodic Summary Report
   
 
MIR and FSCA xml files
   
 
List of contact points
   

MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies January 2012

2.13 - Transitional period
   

MEDDEV 2.13 rev.1
Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) August 1998
 
As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009
June 2009

2.14 - IVD
   

MEDDEV 2.14/1 rev.2
Borderline and Classification issues. A guide for manufacturers and notified bodies January 2012

MEDDEV 2.14/2 rev.1
Research Use Only products February 2004

MEDDEV 2.14/3 rev.1
Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices January 2007
 
Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10
January 2007

MEDDEV 2.14/4
CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP January 2012

2.15 - Other guidances
   

MEDDEV 2.15 rev.3
Committees/Working Groups contributing to the implementation of the Medical Device Directives December 2008

NBOG - Documents provide guidance on specific aspects related to the activities of NB
(Compiled from the accessible information at the Web: http://www.nbog.eu)

    FILE Version

NBOG BPG 2014-1
Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general Nov 2014

NBOG BPG 2014-2
Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assess-ment Activities Nov 2014

NBOG BPG 2014-3
Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System Nov 2014

NBOG BPG 2006-1
Change of Notified Body Nov 2008

NBOG BPG 2009-1
Guidance on Design-Dossier Examination and Report Content Mar 2009

NBOG BPG 2009-2
Role of Notified Bodies in the Medical Device Vigilance System Mar 2009

NBOG BPG 2009-3
Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment Mar 2009

NBOG BPG 2009-4
Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative Basis Jul 2009

NBOG BPG 2010-1
Guidance for Notified Bodies auditing suppliers to medical device manufacturers Mar 2010

NBOG BPG 2010-2
Guidance on Audit Report Content Mar 2010

NBOG BPG 2010-3
Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EEC Mar 2010

NBOG Checklists
   

NBOG CL 2010-1
Checklist for audit of Notified Body’s review of Clinical Data/Clinical Evaluation Mar 2010

NBOG Forms
   

NB OG F 2014-1
Application form to be submitted when applying for designation as a notified body Nov 2014

NB OG F 2014-2
Qualification of personnel (see NBOG BPG 2014-2) Nov 2014

NB OG F 2012-1
Notification form – Directive 93/42/EEC Jan 2013

NB OG F 2012-2
Notification form – Directive 90/385/EEC Jan 2013

NB OG F 2012-3
Notification form – Directive 98/79/EC Jan 2013

NB OG F 2010-1
Certificate Notification to the Commission and other Member States Mar 2010
       

VIGILANCE
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

    FILE Version

MEDDEV 2.12/1 rev.8
Medical Devices Vigilance System January 2013
 
Manufacturer Incident Report
 
 
How to use the MIR
 
 
Field Safety Corrective Action
 
 
Trend Report
 
 
Periodic Summary Report
 
 
MIR and FSCA xml files
   
 
List of contact points
   

MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies January 2012

GHTF Study Group 5 Documents  - Clinical Safety/Performance
(Compiled from the accessible information at the Web: http://www.imdrf.org/documents/doc-ghtf-sg5.asp)

    FILE Version
GHTF-SG5-N2R8:2007
Clinical Evaluation
May 2007
GHTF-SG5-N3:2010
Clinical Investigations
February 2010
GHTF-SG5-N4:2010
Post-Market Clinical Follow-Up Studies
February 2010

 

Aktualizováno: 26. května 2016
 
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