MODULE B - PROCESS SUBMODULES B1.

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1 Slide 1 MODULE B - PROCESS SUBMODULES B1. Organizational Structure B2. Standards Development: Roles and Responsibilities B3. Conformity Assessment: Roles and Responsibilities B4. Initiating Standards Projects B5. Consensus Process for Standards Development B6. The Basics of Parliamentary Procedure B7. The Appeals Process B8. International Standards Development B9. ASME Conformity Assessment Programs B10. Performance Based Standards ASME C&S Training Module B9 Module B - Process

2 Slide 2 DATE 4/17/05 SLIDE REVISIONS 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

3 Slide 3 B9. ASME Conformity Assessment Programs B9. ASME Conformity Programs

4 Slide 4 OBJECTIVES This submodule will Describe ASME s conformity assessment activities ASME C&S Training Module B9 Slide 3 Objectives This submodule will describe ASME s conformity assessment programs.

5 Slide 5 AGENDA I. Conformity Assessment II. Accreditation III. Certification IV. Registration V. Conformity Assessment Program Management ASME C&S Training Module B9 Slide 4

6 Slide 6 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 The Importance of the Conformity Assessment Process One of the most important uses of codes and standards is within a conformity assessment process. A conformity assessment process provides a means to ensure that: Products, services, or systems have the required characteristics These 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 This is essential where public health and safety are impacted, as is the case with many of ASME s standards.

7 Slide 7 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 We will be using the definitions for the ISO/IEC standard. The first edition of ISO/IEC Conformity assessment Vocabulary and general principles was published in While this was their first stand-alone document on the subject, conformity assessment terminology had been included in ISO/IEC Guide 2 for several decades, but in a more limited form. The definitions in Guide 2 were generally accepted internationally, and now the more specific ISO/IEC terminology and concepts have been gaining increasing worldwide acceptance. It is expected that the ISO/IEC 1700:2004 definitions will be relied upon for future WTO documents.

8 Slide 8 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 First party is sometimes incorrectly referred to as self-certification. This term should be avoided. An example of second party is a company auditing one of its suppliers. ASME functions in the areas of third part conformity assessment.

9 Slide 9 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 Accreditation The ISO/IEC definitions are not particularly straightforward since the ISO format is to have definitions build upon each other. The example here is that the term attestation is used in the definition of accreditation and then later defined. The key point regarding accreditation is that it only applies to the attestation of a conformity assessment body (e.g. testing, inspection, or certification body). You cannot accredit a manufacturer as we used to do prior to changes made in 2006.

10 Slide 10 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

11 Slide 11 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 ASME Accreditation Accreditation process: ASME uses on-site reviews by an audit team to determine whether or not an applicant should be accredited. Formal recognition: If accreditation is approved, ASME will issue the supplier a Certificate of Accreditation valid for a specified period, ranging from 3 to 5 years.

12 Slide 12 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 Certification One of the problems with product certification is that many people view it only in terms of the manner in which it is carried out in the particular circumstances with which they are familiar. There are actually countless different approaches to product certification, each having legitimacy for its own particular application. For example, a certification systems may include any combination of the following elements (see ISO/IEC Guide 67 for further information): Testing Inspection Design appraisal Quality system audit Licensing of certification marks Surveillance of samples from the factory or on the open market

13 Slide 13 ASME CERTIFICATION Types of ASME Certification Product certification Personnel certification Management system certification (registration) ASME C&S Training Module B9 Slide 12 ASME Certification

14 Slide 14 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 ISO/IEC Guide 65, General requirements for bodies operating product certification systems, defines supplier as the party that is responsible for ensuring that products meet, and if applicable, continue to meet the requirements on which the certification is based, clearly indicating that this is not the responsibility of product certification body.

15 Slide 15 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 These programs used to be referred to as accreditation programs.

16 Slide 16 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 Certificates of Authorization are used in the boiler and pressure vessel (non-nuclear), nuclear components, and reinforced thermoset-plastic tanks (RTP) because ASME marks are applied to certified equipment. In the nuclear materials program, no mark is used so a Quality System Certificate is issued. The nuclear components program also has a provision for the issuance of a Quality Program Certificate where no mark is used.

17 Slide 17 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 Certification should not be confused with licensing which is typically a government function.

18 Slide 18 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

19 Slide 19 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 Certification (cont d) Certification process: To evaluate whether or not an applicant meets the requirements, ASME will typically determine whether the applicant has the required education or experience and will give an oral or written examination to test the applicant s knowledge. Formal recognition: If ASME approves certification, it will give the applicant a certificate or certification card valid for a period of 3 to 5 years. Benefits of certification: In some cases, certification serves as a means of conforming with government regulation, such as those established by the U.S. Environmental Protection Agency (EPA). In all cases, it shows that an individual has demonstrated his or her competence to perform a certain activity, which may be beneficial to both the individual and employer.

20 Slide 20 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 ASME Registration (ASME ISO 9000 Registration) Applicability: ASME Registration is actually the ISO 9000 Registration program, in which ASME acts as a Registrar for certain companies whose products or services are related to mechanical engineering. Meaning of registration: Registration is sometimes referred to as quality system certification. ISO 9000 Registration certifies that a company s quality management system meets standards developed by the International Organization for Standardization (ISO).

21 Slide 21 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 #1 Answers: Product certification Registration (or quality system certification) Personnel certification Accreditation

22 Slide 22 POP QUIZ #2 (Extra Credit) Which program(s) review the applicant s quality management system? a. Accreditation b. Product Certification c. Personnel Certification d. Registration ASME C&S Training Module B9 Slide 21 Pop Quiz #2 Answer: a, b, & d

23 Slide 23 CA PROGRAM MANAGEMENT Codes and Standards Board of Directors Board on Conformity Assessment Board on Conformity Assessment Supervises all ASME conformity assessment activities ASME C&S Training Module B9 Slide 22 Conformity Assessment Program Management Board on Conformity Assessment: ASME conformity assessment activities are supervised by the Board on Conformity Assessment

24 Slide 24 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 Conformity Assessment Program Management (cont d) Conformity Assessment Committees: Some CA programs are managed by committees reporting directly to the Board on Conformity Assessment.

25 Slide 25 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. CA Subcommittee (e.g. Boiler and Pressure Vessel Accreditation) ASME C&S Training Module B9 Slide 24 Conformity Assessment Program Management (cont d) Conformity Assessment Subcommittees: Other Conformity Assessment programs are managed by a subcommittee of the related Standards Committee. Boiler and Pressure Vessel Accreditation is an example. It is managed by a subcommittee of the Boiler and Pressure Vessel Code Standards Committee. If a Standards Committee reporting to a Board other than Conformity Assessment is considering an addition, revision, or deletion of requirements in a standard related to accreditation or certification, they must notify the Board on Conformity Assessment of their plans and seek the Board s input. CSP 58 states: Proposed alternative requirements (e.g. code cases) which will impact ASME conformity assessment programs (i.e. accreditation, registration, and certification programs) of an ASME code or standard shall be reviewed jointly by the responsible supervisory board and the Board on Conformity Assessment (BCA). The proposed alternative requirements shall be submitted to BCA at the same time they are submitted for standards committee vote. All comments, as a result of the above review, shall be submitted to the standards committee. Standards committee members shall be given the opportunity to change their vote after considering the BCA comments and responses from the Project Team.

26 Slide 26 CURRENT ASME CA PROGRAMS Codes and Standards Board of Directors Board on Pressure Technology Board on Nuclear C&S Board on Safety C&S Board on Standardization and Testing Board on Conformity Assessment Boiler and Pressure Vessel (BPV) Reinforced Thermoset Plastic Vessels (RTP) Pressure Relief Device Laboratory (PRD) Nuclear Components (N-type) Nuclear Material Organizations (QSC) Elevator Inspector Certification Organizations (QEI) 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) Accreditation Programs Product Certification Programs Personnel Certification Programs Registration Programs High Capacity Fossil-Fuel-Fired Facility Operator (QFO) ASME C&S Training Module B9 Slide 25 Current ASME CA programs Although all Conformity Assessment programs have at least a dotted-line relationship with the Board on Conformity Assessment, this chart shows the supervisory board responsible for oversight of the criteria upon which the accreditation or certification program is based (with the exception of ISO 9000).

27 Slide 27 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 Committee=A &Action=7609 ASME C&S Training Module B9 Slide 26 References

28 Slide 28 REFERENCES (cont d) Codes and Standards Policy CSP-58, Alternative Requirements Impacting Conformity Assessment* ISO/IEC Conformity Assessment Vocabulary and general principles Conformity Assessment Web site *Available on C&S Web site at Committee=A &Action=7609 ASME C&S Training Module B9 Slide 27 References (cont d)

GUIDELINES FOR EVALUATION OF POTENTIAL NEW ASME CONFORMITY ASSESSMENT AND CREDENTIALING PROGRAMS

GUIDELINES FOR EVALUATION OF POTENTIAL NEW ASME CONFORMITY ASSESSMENT AND CREDENTIALING PROGRAMS 1 PURPOSE These guidelines are intended to supplement the requirements and guidelines in the referenced