MODULE B - PROCESS B1. B2. B3. B4. B5. B6. B7. B8. B9. B10. SUBMODULES Organizational Structure Standards Development: Roles and Responsibilities Conformity Assessment: Roles and Responsibilities Initiating Standards Projects Consensus Process for Standards Development The Basics of Parliamentary Procedure The Appeals Process International Standards Development ASME Conformity Assessment Programs Performance Based Standards ASME C&S Training Module B9 REVISIONS DATE SLIDE 4/17/05 CHANGE Revised in entirety to conform with revised C&S Policy 20, Policy on Conformity Assessment. Revised to remove details on individual programs. ASME C&S Training Module B9 B9. ASME Conformity Assessment Programs OBJECTIVES This submodule will – Describe ASME’s conformity assessment activities ASME C&S Training Module B9 Slide 3 AGENDA I. II. III. IV. V. Conformity Assessment Accreditation Certification Registration Conformity Assessment Program Management ASME C&S Training Module B9 Slide 4 WHY CONFORMITY ASSESSMENT? • Conformity Assessment Process ensures – Products, services, or systems have the required characteristics – Characteristics are consistent from product to product, service to service, or system to system – Individuals can be evaluated to determine whether they meet the qualification requirements of an ASME standard ASME C&S Training Module B9 Slide 5 CONFORMITY ASSESSMENT • Definition (ISO/IEC 17000) – Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled – Examples: testing, inspection, certification, registration, accreditation ASME C&S Training Module B9 Slide 6 CONFORMITY ASSESSMENT • Types of conformity assessment – First party • Supplier’s declaration of conformity – Second party • Conformity assessment activity performed by the user – Third party • Accreditation • Certification • Registration ASME C&S Training Module B9 Slide 7 ACCREDITATION • Definition (ISO/IEC 17000) – third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks attestation: issuance of a statement, based on a decision following review that fulfillment of specified requirements has been demonstrated ASME C&S Training Module B9 Slide 8 ASME ACCREDITATION • Applicability – Organizations which perform some type of conformity assessment activity • ASME Accreditation Programs: – Inspection organizations (ASME QAI-1 Standard for Qualifications of Authorized Inspection) – Organizations that certify elevator inspectors (ASME QEI-1 Standard for Qualification of Elevator Inspectors) – Pressure Relief Device Laboratories (PRD) ASME C&S Training Module B9 Slide 9 ASME ACCREDITATION • Accreditation process – ASME audit team reviews quality system documentation and verifies implementation • Formal recognition – Certificate of Accreditation – Certificate valid for specified period ASME C&S Training Module B9 Slide 10 CERTIFICATION • Definition (ISO/IEC 17000) – third-party attestation related to products, processes, systems or persons attestation: issuance of a statement, based on a decision following review that fulfillment of specified requirements has been demonstrated ASME C&S Training Module B9 Slide 11 ASME CERTIFICATION • Types of ASME Certification – Product certification – Personnel certification – Management system certification (registration) ASME C&S Training Module B9 Slide 12 ASME PRODUCT CERTIFICATION • Definition – ASME product certification means that the capability to fulfill requirements in the applicable standard by the supplier has been reviewed and accepted by ASME – The supplier is responsible for ensuring that products meet the requirements on which the certification is based ASME C&S Training Module B9 Slide 13 ASME PRODUCT CERTIFICATION • ASME Product Certification Programs – Boiler and Pressure Vessel (non-nuclear) – Nuclear components – Nuclear materials – Reinforced thermoset-plastic tanks (RTP) ASME C&S Training Module B9 Slide 14 ASME PRODUCT CERTIFICATION • Certification process – ASME audit team reviews quality systems documentation and verifies implementation • Formal recognition – Certificate of Authorization • For use of ASME mark – Quality System/Program Certificate • No applicable ASME mark ASME C&S Training Module B9 Slide 15 ASME PERSONNEL CERTIFICATION • Definition – ASME personnel certification means that an individual’s qualifications have been reviewed, proficiency has been demonstrated, and the individual has been accepted by ASME as meeting all requirements of an ASME Standard – ASME Certification is not intended as an assertion or implication that ASME accepts any responsibility for the compliance, or liability for the consequences of noncompliance, of any individual’s performance under the issued certification. Such responsibility and liability remain with the individual or employer. ASME C&S Training Module B9 Slide 16 ASME PERSONNEL CERTIFICATION • ASME Personnel Certification Programs – Municipal waste incinerator operators (QRO) – Hazardous waste incinerator operators (QHO) – High capacity fossil-fuel fired facility operators (QFO) – Geometric Dimensioning and Tolerancing Professionals (GDTP) ASME C&S Training Module B9 Slide 17 ASME PERSONNEL CERTIFICATION • Certification process – Evaluation of education and/or experience – Oral or written examinations • Formal recognition – Certificate or Certification Card – Valid for 3 to 5 years ASME C&S Training Module B9 Slide 18 ASME MANAGEMENT SYSTEM CERTIFICATION (REGISTRATION) • Applicability – Certification of an organization’s quality management system to the ISO 9001 standard • Certification Process – ASME audit team review of documentation and implementation • Formal recognition – Certificate or Registration – Product marking not permitted ASME C&S Training Module B9 Slide 19 POP QUIZ #1 For each of the following, what type of conformity assessment program is used: accreditation, certification or registration? a. To assess the conformity of a boiler and pressure vessel manufacturer to the ASME Boiler and Pressure Vessel Code b. To assess the conformity of a boiler and pressure vessel manufacturer to the ISO 9001 standard c. To assess the qualifications of an individual to be a hazardous waste incinerator operator d. To assess the conformity of a company that will provide boiler and pressure vessel inspection services ASME C&S Training Module B9 Slide 20 POP QUIZ #2 (Extra Credit) Which program(s) review the applicant’s quality management system? a. b. c. d. Accreditation Product Certification Personnel Certification Registration ASME C&S Training Module B9 Slide 21 CA PROGRAM MANAGEMENT Codes and Standards Board of Directors Board on Conformity Assessment ASME C&S Training Module B9 • Board on Conformity Assessment – Supervises all ASME conformity assessment activities Slide 22 CA PROGRAM MANAGEMENT Codes and Standards Board of Directors • CA Committees – Report directly to Board on Conformity Assessment Board on Conformity Assessment CA Committee (e.g. ISO 9000 Registration) ASME C&S Training Module B9 Slide 23 CA PROGRAM MANAGEMENT Codes and Standards Board of Directors • CA Subcommittees – Dual reporting Board on Conformity Assessment Board on Pressure Technology CA Committee (e.g. ISO 9000 Registration) Standards Committee* (e.g. Boiler and Pressure Vessel Code) * Note: Proposed alternative requirements shall be reviewed jointly by the relevant Supervisory Board and Board on Conformity Assessment. ASME C&S Training Module B9 CA Subcommittee (e.g. Boiler and Pressure Vessel Accreditation) Slide 24 CURRENT ASME CA PROGRAMS Codes and Standards Board of Directors Board on Pressure Technology Boiler and Pressure Vessel (BPV) Reinforced Thermoset Plastic Vessels (RTP) Board on Board on Nuclear C&S Safety C&S Nuclear Components type) (N- Nuclear Material Organizations (QSC) Pressure Relief Device Laboratory (PRD) Accreditation Programs Product Certification Programs Elevator Inspector Certification Organizations (QEI) Board on Board on Standardization and Conformity Assessment Testing Geometric Dimensioning and Tolerancing Professionals (GDTP) Note: PTC-25 is an integral part of PRD accreditation ISO 9000 Registration Authorized Inspection Agencies (AIA) Resource Recovery Facility Operator (QRO) Hazardous Waste Facility Operator (QHO) High Capacity Fossil-Fuel-Fired Facility Operator (QFO) Personnel Certification Programs Registration Programs ASME C&S Training Module B9 Slide 25 REFERENCES – Codes and Standards Policy CSP-5, Code Symbol Stamps and ASME Markings* – Codes and Standards Policy CSP-19, ASME Designee and ASME Designated Organization* – Codes and Standards Policy CSP-20, Policy on Accreditation, Certification and Registration* – Codes and Standards Policy CSP-53, Policy on Protection of ASME Marks* *Available on C&S Web site at http://cstools.asme.org/csconnect/CommitteePages.cfm? Committee=A01000000&Action=7609 ASME C&S Training Module B9 Slide 26 REFERENCES (cont’d) – Codes and Standards Policy CSP-58, Alternative Requirements Impacting Conformity Assessment* – ISO/IEC 17000 Conformity Assessment – Vocabulary and general principles – Conformity Assessment Web site • www.asme.org/cns/accreditation/index.html *Available on C&S Web site at http://cstools.asme.org/csconnect/CommitteePages.cfm? Committee=A01000000&Action=7609 ASME C&S Training Module B9 Slide 27