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CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
Standardization and certification basics
Ying Ying Lau
Netherlands Standardisation Institute (NEN)
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
The basics
Standardisation
Conformity assessment
Certification
Accreditation
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
Standardisation
A standard is a formal agreement between parties
on a product, service, process, competence or
system.
 Principles of standards development
• All parties concerned
• On basis of consensus
• Open & transparent process
 Aim
• Facilitating international trade & interoperability
• Self-regulation
• Contributing to health, safety, environment, sustainability
• Supporting legislation
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
Standardisation: a joint effort
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
The world of standards
EUROPEAN
STANDARDISATION
NATIONAL
STANDARDISATION
INTERNATIONAL
STANDARDISATION
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
Types of standards
Informal standards
Formal standards
 National
 European
• European Standard (EN)
• Technical Specification (TS)
• Technical Reports (TR)
• CEN Workshop Agreement (CWA)
 International
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
European standards documents
CEN Workshop Agreement (CWA)
 Agreement developed and approved in a CEN
Workshop
 Open to the direct participation of all interested parties
 Fast and flexible development (on average between
10-12 months)
Technical Reports (TR)
 Informative document that provides information on the
technical content of standardization work
 Established by a CEN Technical Body and approved
by the CEN national members (simple majority vote)
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
European standards documents
Technical Specification (TS)
 Normative document
• the development of which can be envisaged when various
alternatives that would not gather enough as to allow
agreement on a European Standard (EN),
• need to coexist in anticipation of future harmonization,
• or for providing specifications in experimental circumstances
and/or evolving technologies
 Established by a CEN Technical Body and approved
by the CEN national members (weighted vote)
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
European standards documents
European Standard (EN)
 Normative document that provides rules, guidelines or
characteristics for activities or their results, for
common and repeated use.
 Adoption by all CEN national members to national
standards
• Conflicting national standards will need to be withdrawn
Basis of developing EN
 Further development of CWA, TS or national standard
 Proposal for new work item by interested party
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
Standards as basis for certification
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
Standards for conformity assessment
Standards provide requirements for
 Product, persons, services, systems, processes, etc
 Assessment and inspection methods
Generic approach conformity assessment
 Conformity assessment bodies
 Competencies of auditors/inspectors
 Accreditation bodies
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
Certification and accreditation
What is certification?
 Certification is when an independent and competent
third party certifies that a product, service, system,
process or material conforms to specific
requirements.
What is accreditation?
 Accreditation is the procedure by which an
authoritative body gives formal recognition that a
body or person is competent to carry out specific
tasks.
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
Levels of Conformity Assessment
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels
Voluntary and regulatory sector
CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels

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Standardisation and certification basics

  • 1. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels Standardization and certification basics Ying Ying Lau Netherlands Standardisation Institute (NEN)
  • 2. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels The basics Standardisation Conformity assessment Certification Accreditation
  • 3. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels Standardisation A standard is a formal agreement between parties on a product, service, process, competence or system.  Principles of standards development • All parties concerned • On basis of consensus • Open & transparent process  Aim • Facilitating international trade & interoperability • Self-regulation • Contributing to health, safety, environment, sustainability • Supporting legislation
  • 4. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels Standardisation: a joint effort
  • 5. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels The world of standards EUROPEAN STANDARDISATION NATIONAL STANDARDISATION INTERNATIONAL STANDARDISATION
  • 6. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels Types of standards Informal standards Formal standards  National  European • European Standard (EN) • Technical Specification (TS) • Technical Reports (TR) • CEN Workshop Agreement (CWA)  International
  • 7. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels European standards documents CEN Workshop Agreement (CWA)  Agreement developed and approved in a CEN Workshop  Open to the direct participation of all interested parties  Fast and flexible development (on average between 10-12 months) Technical Reports (TR)  Informative document that provides information on the technical content of standardization work  Established by a CEN Technical Body and approved by the CEN national members (simple majority vote)
  • 8. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels European standards documents Technical Specification (TS)  Normative document • the development of which can be envisaged when various alternatives that would not gather enough as to allow agreement on a European Standard (EN), • need to coexist in anticipation of future harmonization, • or for providing specifications in experimental circumstances and/or evolving technologies  Established by a CEN Technical Body and approved by the CEN national members (weighted vote)
  • 9. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels European standards documents European Standard (EN)  Normative document that provides rules, guidelines or characteristics for activities or their results, for common and repeated use.  Adoption by all CEN national members to national standards • Conflicting national standards will need to be withdrawn Basis of developing EN  Further development of CWA, TS or national standard  Proposal for new work item by interested party
  • 10. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels Standards as basis for certification
  • 11. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels Standards for conformity assessment Standards provide requirements for  Product, persons, services, systems, processes, etc  Assessment and inspection methods Generic approach conformity assessment  Conformity assessment bodies  Competencies of auditors/inspectors  Accreditation bodies
  • 12. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels Certification and accreditation What is certification?  Certification is when an independent and competent third party certifies that a product, service, system, process or material conforms to specific requirements. What is accreditation?  Accreditation is the procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.
  • 13. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels Levels of Conformity Assessment
  • 14. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels Voluntary and regulatory sector
  • 15. CRISP Final Conference – 16 March 2017 6th CoU Meeting, Brussels

Editor's Notes

  1. Bankpasje
  2. All parties concerned + consensus result in standards/agreements with a high level of support
  3. Informal standards: e.g. company standards Formal standards: explain European standards NEN EN ISO Use of standards: Use on a voluntary basis Use in contractual relationship Provide technical solutions for compliance with legislation Use as a basis for conformity assessment Global level (ISO) 163 members (since1947) NEN-(EN-)ISO standards (>19.000 ISO) voluntary acceptance at national level European level (CEN) 33 members NEN-EN standards (>13.000 EN) mandatory endorsement by members National level (e.g. NEN) NEN standards NEN is the gateway to CEN and ISO SO
  4. A CEN Workshop Agreement (CWA) is a document published by CEN in at least one of the CEN three official languages. A CWA is an agreement developed and approved in a CEN Workshop; the latter is open to the direct participation of anyone with an interest in the development of the agreement. There is no geographical limit on participation; hence, participants may be from outside Europe. The development of a CWA is fast and flexible, on average between 10-12 months. A CWA does not have the status of a European Standard. It involves no obligation at national level. A CWA may not conflict with a European Standard; if a conflicting EN is subsequently published, the CWA shall be withdrawn.
  5. Proposal to develop an EN Any interested party can introduce a proposal for new work. Most standardization work is proposed through the CEN Members.
  6. Which requirement? Casco = worden gemaakt onder dezelfde voorwaarden als dezelfde normen