1. CA 101 Certification and Registration
ANSI Annual Conference
2002
by:
Gordon Gillerman
Manager Governmental Services
Underwriters Laboratories

2. Certification Definition and Application
Certification - procedure by which a third party gives written assurance that a product, process or service conforms to specified requirements
Generally applied to:
Products
Safety Requirements
Interoperability
Other technical requirements
Personnel
Competence
Processes
However, management system certification is commonly referred to as Registration

3. Elements of Certification
Determination of Conformity
Testing
Examination
Comparison of data with requirements
Report of non-compliance/Attestation of Conformity
Surveillance for continued conformity
Premarket Inspection
Audit
Recertification
Post Market Surveillance

4. Certification Information
Certification in the US:
mostly voluntary
required by regulation narrowly
demand driven by the regulatory and non-regulatory acceptance interests in the sector/market where it meets their confidence needs
Relevant Documents Include:
ISO/IEC Guide 23 - Methods of indicating conformity with standards for third party certification systems
ISO/IEC Guide 28 - General Rules for a model third party certification system for products
ISO/IEC Guide 65 - General Requirements for Bodies Operating Product Certification Systems

5. Registration Definition and Application
Registration - procedure by which a body indicates relevant characteristics of a product, process or service, or particulars of a body or person, in an appropriate, publicly available list
Commonly applied to:
Quality Management Systems (ISO 9000…)
Environmental Management Systems (ISO 14000)

6. Elements of Management System Registration
Assessment
Initial evaluation of written management system procedures against requirements
Communication of non-compliance or questions
On-site evaluation of Implementation of procedures
Exit meeting after assessment
Resolution of non-compliance or questions
Issuing attestation of compliance and publication in list
Audit
Periodic check on procedure and implementation to enhance continuing compliance
Exit meeting after audit

7. Registration Information
Management System Registration in the US is:
Mostly Voluntary
Demand driven by acceptance interests primarily the registered organizations customers
Required by regulation narrowly (ex. FDA currently requires medical device manufacturers to comply with Quality System Regulations (21CFR820), but does not require registration
Relevant Documents Include:
ISO/IEC Guide 62 - General Requirements for Bodies Operating Assessment and Certification/Registration of Quality Systems
ISO general quality system requirement ISO environmental compatibility
ISO medical device manufacturers QS Automobile components
AS Aerospace TL Telecom