The document discusses the fundamentals of standardization, including definitions, principles, and types such as national, European, and international standards. It outlines the processes for developing European standards and their role in certification and accreditation, emphasizing the importance of conformity assessment and the recognition of competence by authoritative bodies. The information presented was part of the crisp final conference held on March 16, 2017, during the 6th Cou meeting in Brussels.

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