Normen CE-markering

Nieuws op het gebied van CE-markering richtlijnen en normen

 

Normalisatie is een continu proces waarbij het doel is dat de 'state of art' van de technologie wordt bijgehouden. Als gevolg hiervan worden normen in toenemende mate aangepast of vervangen. Het bijhouden van normen en richtlijnen is een tijdrovende zaak. De medewerkers van Kiwa Dare houden deze wijzigingen bij en rapporteren hun bevindingen in de onderliggende pagina's. In dit actieve gedeelte van onze site streven we ernaar u zoveel mogelijk van wijzigingen en/of voorgenomen wijzigingen op de hoogte te houden.

Laatste update: Q3 2024                                                                                                                                                                                                        

De onderliggende pagina's zijn in het Engels aangezien deze ook op onze internationale site www.dare.eu worden gebruikt

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De normen en richtlijnen zijn per categorie gerangschikt:

 

bekijk de tabel General Quality Assurance

Quality assurance

General Quality Assurance

Legenda:

In the column 'Status' the following codes are used:
  • A: Amendment
  • B: Basic standard
  • C: Correction
  • G: Generic standard
  • H: Harmonised standard
  • P: Product standard
  • D: Directive
  • R: Regulation
  • TR: Technical Reference
  • M: Manufacturer specific requirements

The validity of the standards/directives etc. is color coded:
  • Green: Valid
  • Orange: Will be changed or replaced soon
  • Red: No longer valid
  • Blue: Transition period
  • Yellow: Can be used as technical reference document
Identification Description Status Version Date of issue Remarks
Code of Conduct (CoC)

Code of Conduct for Notified Bodies under Directives 90/385/EEC, 93/42/EEC,98/79/EC, EU 2017/745 and EU 2017/746

TR 5.0 2024-09-16 --
EA-2/17

EA Guidance on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes

rev. 04 2020-04-17 Mandatory
EA-4/02

Expression of the uncertainty of measurement in calibration

rev. 03 2022-04-04 Mandatory
EA-4/16

EA guidelines on the expression of uncertainty in quantitative testing

rev. 00 2003-12-01 Withdrawn
FCC Technical Assessment Checklist (Publication nr: 853844) This checklist is intended to serve as a guide and provide a minimum list of items to be included in the technical evaluation of the test laboratory, as part of the complete ISO/IEC 17025 assessment for an accredited testing laboratory. v02r01 2018-03-02 --
IAF GD5 IAF Guidance on the Application of ISO/IEC Guide 65:1996 3 2006-12-01 Withdrawn
IAF MD 1

Audit and Certification of a Management System Operated by a Multi-Site Organization

issue 3 2023-10-18 --
IAF MD 10

IAF Mandatory Document for Assessment of Certification Body Management of Competence in Accordance with ISO/IEC 17021:2011

NA- 2013-02-11 Withdrawn
IAF MD 11

IAF Mandatory Document for the Application of ISO/IEC 17021 for Audits of Integrated Management Systems (IMS)

issue 3, v1 2023-09-12 --
IAF MD 12

Accreditation Assessment of Conformity Assessment Bodies with Activities in Multiple Countries

issue 2, v2 2023-06-14 --
IAF MD 15

IAF Mandatory Document for the Collection of Data to Provide Indicators of Management System Certification Bodies' Performance

issue 1, v2 2023-06-14 --
IAF MD 2

IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems

issue 2, v2 2023-06-14 --
IAF MD 4

Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes

issue 2, v4 2023-06-14 --
IAF MD 5

Determination of Audit Time of Quality and Environmental Management Systems

issue 4, v3 2023-06-14 --
IAF MD 7

Harmonization of Sanctions and Dealing with Fraudulent Behaviour

issue 2, v2 2023-07-19 --
IAF MD 9

Application of ISO/IEC/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO/IEC 13485)

issue 5, v1 2023-11-20 --
ILAC G13 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes NA- 2007-08-01 Withdrawn
ISO Guide 67 Conformity assessment - Fundamentals of product certification NA- 2004-09-01 Withdrawn (revised by ISO/IEC 17067:2013)
ISO/IEC 17007 Conformity assessment - Guidance for drafting normative documents suitable for use for conformity assessment 1 2009-10-01 Supersedes ISO/IEC Guide 7:1994
ISO/IEC 17021-1 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements NA- 2015-07-01 --
ISO/IEC 17021-3 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 3: Competence requirements for auditing and certification of quality management systems NA- 2018-12-01 --
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories NA- 2018-01-01 Supersedes NEN-EN-ISO/IEC 17025:2005
ISO/IEC 17025 /C1 (Usage in combination with ISO/IEC 17025:2 General requirements for the competence of testing and calibration laboratories C NA- 2007-01-01 Usage in combination with ISO/IEC 17025:2005. Supersedes ISO/IEC 17025:2005 /C1:2006
ISO/IEC 17065 Conformity assessment - Requirements for bodies certifying products, processes and services NA- 2012-09-01 Replaces NEN-EN 45011:1998 and ISO/IEC Guide 65:1996
ISO/IEC 17067 Conformity assessment -- Fundamentals of product certification and guidelines for product certification schemes 1 2013-08-01 Replaces ISO Guide 67
ISO/IEC TS 17023 Conformity assessment -- Guidelines for determining the duration of management system certification audits B NA- 2013-08-01 --
JCGM 100:2008 Evaluation of measurement data - Guide to the expression of uncertainty in measurement NA- 2008-09-01 GUM 1995 with minor corrections
LAB34 The Expression of Uncertainly in EMC Testing 1 2012-11-01 --
NEN-EN 45011 General requirements for bodies operating product certification systems NA- 1998-03-01 Withdrawn (replaced by ISO/IEC 17065:2012)
NEN-EN 45020 Standardization and related activities - General vocabulary NA- 2007-01-01 Replaces ISO Guide 2:2005
NEN-EN-ISO/IEC 10012 Measurement management systems - Requirements for the measurement processes and measuring equipment NA- 2003-05-01 Supersedes EN 10012- 2:1997
NEN-EN-ISO/IEC 19011 Guidelines for auditing management systems G NA- 2018-07-01 Supersedes NEN-EN-ISO/IEC 19011:2002
NEN-ISO/IEC 10006 Quality management systems - Guidelines for quality management in projects NA- 2017-11-01 Supersedes NEN-ISO/IEC 10006:2003
SAP-C000

Accreditatie van Certificatie van Managementsystemen

5.1 2024-09-10 --
SAP-C021

Certificatie volgens ISO/IEC 13485 (medische hulpmiddelen) (Engelstalig)

NA- 2021-07-06 --
T040

Toelichting op uitvoering van RvA-beoordelingsinstrument ‘schaduwonderzoeken’

NA- 2020-01-07 --
T051

Management of extraordinary events or circumstances affecting RvA accredited bodies and their customers

A 6.0 2020-11-03 --
VR003

Voorschrift voor het gebruik van Accreditatiemerken en logo's

6.0 2020-12-15 --

Let op! Richtlijnen worden vertaald in nationale (Nederlandse) regelgeving en mogen vrij gekopieerd worden. Normen zijn echter beschermd door copyright en moeten worden gekocht. U kunt normen aanschaffen bij bijvoorbeeld NEN.

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Belangrijke mededeling:

Deze pagina’s bevatten de door Kiwa Dare meest gebruikte normen en richtlijnen. Normen die niet in dit overzicht opgenomen zijn, kunnen op aanvraag uitgevoerd worden. Een compleet overzicht van geharmoniseerde normen is opgenomen in het overzicht (indien van toepassing).