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

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 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 Resolution of non-compliance or questions

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 9000 - general quality system requirementISO 14000 - environmental compatibility ISO 13485 - medical device manufacturers QS 9000 - Automobile components AS 9000 - AerospaceTL 9000 - Telecom