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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

Module B - Process
Slide 2

REVISIONS
DATE SLIDE CHANGE
4/17/05 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 1


Slide 3

B9. ASME Conformity Assessment Programs

B9. ASME Conformity Programs


Slide 4

OBJECTIVES

This submodule will


– Describe ASME’s conformity assessment activities

ASME C&S Training Module B9 3

Objectives

This submodule will describe ASME’s conformity assessment programs.


Slide 5

AGENDA

I. Conformity Assessment
II. Accreditation
III. Certification
IV. Registration
V. Conformity Assessment Program Management

ASME C&S Training Module B9 4


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 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.
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 6

Conformity Assessment

We will be using the definitions for the ISO/IEC 17000 standard. The first edition of ISO/IEC
17000 Conformity assessment — Vocabulary and general principles was published in 2004.
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 17000 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.
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 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.


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 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.
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 9

ASME Accreditation
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 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.
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 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
Slide 13

ASME CERTIFICATION

• Types of ASME Certification


– Product certification
– Personnel certification
– Management system certification (registration)

ASME C&S Training Module B9 12

ASME Certification
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 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.
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 14

These programs used to be referred to as accreditation programs.


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 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.
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 16

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


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 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.
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 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).
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 20

Pop Quiz #1

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

Pop Quiz #2

Answer: a, b, & d
Slide 23

CA PROGRAM MANAGEMENT
Codes and Standards • Board on Conformity
Board of Directors Assessment
– Supervises all ASME
conformity assessment
Board on
activities
Conformity Assessment

ASME C&S Training Module B9 22

Conformity Assessment Program Management

Board on Conformity Assessment:


ASME conformity assessment activities are supervised by the Board on Conformity Assessment
Slide 24

CA PROGRAM MANAGEMENT
Codes and Standards • CA Committees
Board of Directors – Report directly to Board on
Conformity Assessment

Board on
Conformity Assessment

CA Committee
(e.g. ISO 9000
Registration)

ASME C&S Training Module B9 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.
Slide 25

CA PROGRAM MANAGEMENT
Codes and Standards • CA Subcommittees
Board of Directors – Dual reporting

Board on Board on
Conformity Assessment Pressure Technology

CA Committee Standards Committee*


(e.g. ISO 9000 (e.g. Boiler and Pressure
Registration) Vessel Code)

CA Subcommittee
* Note: Proposed alternative
requirements shall be reviewed (e.g. Boiler and Pressure
Vessel Accreditation)
jointly by the relevant
Supervisory Board and Board
on Conformity Assessment.

ASME C&S Training Module B9 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.
Slide 26

CURRENT ASME CA PROGRAMS


Codes and Standards
Board of Directors

Board on Board on Board on


Board on Board on
Pressure Standardization and Conformity
Nuclear C&S Safety C&S
Technology Testing Assessment

Boiler and Nuclear Elevator Inspector Geometric ISO 9000


Pressure Vessel Components Certification Dimensioning and Registration
(BPV) (N-type) Organizations Tolerancing
(QEI) Professionals
Reinforced Nuclear Material (GDTP) Authorized
Thermoset Plastic Organizations Inspection
Vessels (QSC) Agencies (AIA)
(RTP) Note: PTC-25 is
an integral part
of PRD Resource
Pressure accreditation Recovery Facility
Operator (QRO)
Relief Device
Laboratory
(PRD) Hazardous Waste
Facility Operator
(QHO)

Accreditation Programs High Capacity


Fossil-Fuel-Fired
Facility Operator
Product Certification Programs (QFO)

Personnel Certification Programs

Registration Programs

ASME C&S Training Module B9 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).
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


http://cstools.asme.org/csconnect/CommitteePages.cfm?
Committee=A01000000&Action=7609

ASME C&S Training Module B9 26

References
Slide 28

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 27

References (cont’d)