Upload
everett-spencer
View
217
Download
0
Tags:
Embed Size (px)
Citation preview
Certification Approaches
EAC MeetingMiami, FL
August 2008
Gordon GillermanConformity Assessment Advisor
Homeland SecurityNational Institute of Standards and Technology
Activity Overview Assist US Federal Government Agencies including the Department
of Homeland Security and the Department of Justice in developing standards and conformity policies and administrative infrastructure
Design and assist in the implementation of homeland security related conformity assessment programs
Assist in the development of standards for homeland security Coordinate and network with standards development
organizations Promote use of available international and national standards Identify standards suitable for homeland security procurement
and grant guidance Participate in the development of key standards
Types of Conformity Assessment
Supplier’s Declaration
Inspection Testing Certification Registration Accreditation
Risk and Conformity AssessmentHow much confidence is needed?P
erce
ived
Ris
k
Independence and Rigor of Conformity Assessment
Supplier’s declaration1st party conformity
assessment
certification3rd party conformity
assessment
Factors in CA System Design
•The risks associated with non-compliance should be proportional to the rigor and independence of the CA system.
•System over-design will add too much cost.
•System Under-design will result in too little confidence of compliance.
•Penalties associated with non-compliance may reduce the needed rigor and independence of the conformity assessment system.
•Timely mechanisms that effectively remove non-compliant products from the market may also reduce the needed rigor and independence of the system.
Applied at the Characteristic level
•The risk based concept that is used to develop the certification system model at the top level can be applied characteristic by characteristic in the certification program
•Each characteristic needs technical requirements.
•The certification program must require that the applicant demonstrate compliance with all of the technical requirements.
•The method of demonstrating conformity with different system characteristics can be varied.
Factors to Consider for required method of demonstrating conformity at the
Characteristic level
•What is the risk associated with non-conformity with individual characteristic requirements (consequence, tolerability)?
•Does current equipment typically comply?
•What is the technical means of demonstrating conformity (test in lab, test in use environment, QMS audit…)?
•What organizations are best positioned to conduct the demonstration of conformity activities?
•What are the cost implications of requiring different methods of demonstrating conformity with individual product characteristics?
•Can the certification program leverage other conformity assessment activities to reduce redundancy (QMS potential opportunity)?
.
Example - Body Armor Certification
Program Surveillance and QMS options • A registered quality management system that
conforms to the requirements of ISO 9000 plus specific body armor quality management requirements (BA 9000) by an (ANAB) accredited registrar and infrequent (typically 3 periodic retests over 5 years) periodic
retesting of production body armor, or• No register BA 9000 QMS and frequent (6
periodic retests over 5 years) retesting of production body armor.
Note - the QMS registration is not conducted by the body armor equipment certifier.
Example - Toy Safety CertificationProgram Flowchart
Accredited certification organization
Test results from accredited lab
• Initial type
•Periodic Retest
Factory production process management system from accredited registrar
•Initial assessment
•Audits
•Registration
•Periodic reassessments
Design hazard analysis and risk management documentation from applicant
Program administrator
(certification mark owner)
License agreement for certification mark
•Authorization to mark certified products
•Applicant and model designation on publicly availably list
Registration
documentation
Test results
Example - Matrix of required methods for demonstrating conformity of
characteristics for system certification
Suppliers Declaration of Conformity
Test Report
Accredited lab test report
3rd Party Accredited Lab Test Report
Other Registration
Or Certification
Accuracy
Security
Accessibility
EMC
Useability
QMS
Back –Up Slides
Typical Use – Testing(1st, 2nd or 3rd Party CA)
Used when the critical characteristics can be evaluated via measurement under specified conditions.
Type test is a test carried out on samples that represent production for the purpose of determining conformity.
May be an element of a suppliers’ declaration or
certification system.
Typical Use – Suppliers Declaration(1st Party CA)
Generally used: when the risk associated with noncompliance is low
there are adequate penalties for placing noncompliant products on the market
there are adequate mechanisms to remove noncompliant products from the market
Typical Use – Inspection(1st, 2nd or 3rd Party CA)
Used when the critical characteristics can be evaluated via physical examination or measurement.
May be an element of a certification system.
May be used to ensure that all parts of a system have been properly installed (ex. code inspection)
Typical Use –Certification(3rd Party CA)
Used when the risks associated with non-conformity are moderate to high.
Includes evaluation, compliance decision, attestation of conformity and some form of surveillance or follow up.
Always conducted by a third party.