ASTM E1906-99
(Guide)Standard Guide for General Requirements for Bodies Operating Product Certification Systems (Withdrawn 2004)
Standard Guide for General Requirements for Bodies Operating Product Certification Systems (Withdrawn 2004)
SCOPE
1.1 This guide specifies general requirements that a third party operating a product certification system shall meet if it is to be recognized as competent and reliable.
WITHDRAWN RATIONALE
This guide specifies general requirements that a third-party operating a product certification system shall meet if it is to be recognized as competent and reliable.
Formerly under the jurisdiction of Committee E36 on Conformity Assessment, this guide was withdrawn in May 2004 due to lack of interest and support for continued use.
General Information
Standards Content (Sample)
An American National Standard
Designation: E 1906 – 99
Standard Guide for
General Requirements for Bodies Operating Product
Certification Systems
This standard is issued under the fixed designation E 1906; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Certification of a product, a term used to include a process or service, is a means of providing
assurance that it complies with specified standards and other normative documents. Some product
certification systems may include initial testing of a product and assessment of its suppliers’ quality
systems, followed by surveillance that takes into account the factory quality system and the testing of
samples from the factory and the open market. Other systems rely on initial testing and surveillance
testing while still others comprise type testing only.
This guide specifies requirements, the observance of which is intended to ensure that certification
bodiesoperatethird-partycertificationsystemsinaconsistentandreliablemanner,therebyfacilitating
their acceptance on a national and international basis and so furthering international trade.
The requirements contained in this guide are written, above all, to be considered as general criteria
for organizations operating product certification systems; they may have to be amplified when specific
industrialorothersectorsmakeuseofthem,orwhenparticularrequirementssuchashealthandsafety
have to be taken into account.
Assertion of conformity to the appropriate standards or other normative documents will be in the
form of certificates or marks of conformity. Systems for certifying particular products or product
groups to specified standards or other normative documents, in many cases, will require their own
explanatory documentation.
While this guide is concerned with third-parties providing product certification, many of its
provisions also may be useful in first- and second-party product conformity assessment procedures.
The diversity in certification systems may at first seem unnecessary and even confuse newcomers
in the field, clients, and operators alike.The ISO/IEC publication “Certification and RelatedActivities
is available for background reading and will help to answer questions regarding the practices of the
worldwide conformity assessment community. This standard replaces ANSI Z34.1 Third Party
Certification Programs for Products, Processes, and Services.
NOTE 1—The introduction does not form an integral part of this guide.
1. Scope services.The word standard is used to include other normative
documents such as specifications or technical regulations.
1.1 This guide specifies general requirements that a third-
1.3 The certification system used by the certification body
party operating a product certification system shall meet if it is
may include one or more of the following, which could be
to be recognized as competent and reliable.
coupled with production surveillance or assessment and sur-
1.2 In this guide the term certification body is used to cover
veillance of the supplier’s quality system or both, as described
any body operating a product certification system. The word
in ISO/IEC Guide 53:
product is used in its widest sense and includes processes and
Type testing or examination;
Testing or inspection of samples taken from the market or
from supplier’s stock or from a combination of both;
This guide is under the jurisdiction of ASTM Committee E-36 on Conformity
Testing or inspection of every product or of a particular
Assessment and is the direct responsibility of Subcommittee E36.20 on
product, whether new or already in use;
Ceritification/Registration Bodies.
Batch testing or inspection; and,
Current edition approved Oct. 10, 1999. Published November 1999. Orginally
published as E 1906–97. Last previous edition E1906–97. Design appraisal.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1906–99
NOTE 1—ISO/IPC Guide 28 may be consulted for a model of one form
criminatory and shall be administered in a nondiscriminatory
of a third-party product certification system.
manner. Procedures shall not be used to impede or inhibit
access by applicants, other than as provided for in this guide.
2. Referenced Documents
4.1.2 The certification body shall make its services acces-
2.1 ASTM Standards:
sible to all applicants whose activities fall within its declared
E 548 Guide for General Criteria Used for Evaluating
field of operation. There shall not be undue financial or other
Laboratory Competence
conditions.Access shall not be conditional upon the size of the
2.2 ISO Standards:
supplier or membership of any association or group, nor shall
ISO 8402:1994, Quality Management and Quality Assur-
certification be conditional upon the number of certificates
ance–Vocabulary
already issued.
ISO 10011–1:1990, Guidelines for Auditing Quality Sys-
4.1.3 The criteria against which the products of a supplier
tems–Part 1: Auditing
are evaluated shall be those outlined in specified standards.
2.3 ISO/IEC Standards:
Requirements for standards suitable for this purpose are
ISO/IEC Guide 2:1996, Standardization and RelatedActivi-
contained in ISO/IEC Guide 7. If explanation is required as to
ties–General Vocabulary
the application of these documents for a specific certification
ISO/IEC Guide 7:1994, Guidelines for Drafting of Stan-
system, it shall be formulated by relevant and impartial
dards Suitable for Use for Conformity Assessment
committees or persons possessing the necessary technical
ISO/IEC Guide 23:1982, Methods of Indicating Confor-
competence, and published by the certification body.
mity with Standards for Third-Party Certification Sys-
4.1.4 The certification body shall confine its requirements,
tems
evaluation, and decision on certification to those matters
ISO/IEC Guide 25:1990, General Requirements for the
specifically related to the scope of the certification being
Competence of Calibration and Testing Laboratories
considered.
ISO/IEC Guide 27:1983, Guidelines for Corrective Action
4.2 Organization— The structure of the certification body
to Be Taken by a Certification Body in the Event of
3 shall be such as to foster confidence in its certifications. In
Misuse of Its Mark of Conformity
particular, the certification body shall do the following:
ISO/IEC Guide 39:1988, General Requirements for the
4.2.1 Be impartial;
Acceptance of Inspection Bodies
4.2.2 Be responsible for decisions relating to its granting,
ISO/IEC Guide 53:1988, An Approach tot he Utilization of
maintaining, extending, suspending and withdrawing of certi-
a Supplier’s Quality System in Third-Party Product Cer-
fication;
tification
ISO/IEC Guide 62:1996, General Requirements for Bodies 4.2.3 Identify the management (committee, group, or per-
son), which shall have overall responsibility for all of the
Operating Assessment and Certification/Registration of
Quality Systems following:
ISO/IEC Guide 65, General Requirements for Bodies 4.2.3.1 Performance of testing, inspection, evaluation, and
Operating Product Certification Systems
certification as defined in this guide;
2.4 ISO/IPC Standard:
4.2.3.2 Formulation of policy matters relating to the opera-
ISO/IPC Guide 28:1982, General Rules for a Model Third-
tion of the certification body;
,
3 2
Party Certification System for Products
4.2.3.3 Decisions on certification;
2.5 ANSI Standard:
4.2.3.4 Supervision of the implementation of its policies;
ANSI Z34.1 Third Party Certification Programs for Prod-
4.2.3.5 Supervision of the finances of the body;
ucts, Processes, and Services
4.2.3.6 Delegation of authority to committees or individuals
as required to undertake defined activities on its behalf; and
3. Terminology
4.2.3.7 Technical basis for granting certification;
3.1 Definitions—For the purposes of this guide, the relevant
4.2.3.8 Have documents which demonstrate it is a legal
definitions given in ISO/IEC Guide 2 and ISO 8402 apply,
entity;
together with the following definition:
4.2.3.9 Have a documented structure which safeguards im-
3.1.1 supplier, n—the party that is responsible for ensuring
partiality including provisions to ensure the impartiality of the
that products meet, and if applicable, continue to meet, the
operations of the certification body; this structure shall enable
requirements on which the certification is based.
the participation of all parties significantly concerned in the
development of policies and principles regarding the content
4. Certification Body
and functioning of the certification system;
4.1 General Provisions:
4.2.3.10 Ensure that each decision on certification is taken
4.1.1 The policies and procedures under which the certifi-
by a person(s) different from those who carried out the
cation body operates and their administration shall be nondis-
evaluation;
4.2.3.11 Have rights and responsibilities relevant to its
certification activities;
Annual Book of ASTM Standards, Vol 14.02.
4.2.3.12 Have adequate arrangements to cover liabilities
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036. arising from its operations or activities, or both;
E1906–99
4.2.3.13 Have the financial stability and resources required guide and other methods, standards, and guides relevant to
for the operation of a certification system; testing, inspection, or other technical activities, and is not
involved either directly or through the person’s employer with
4.2.3.14 Employ a sufficient number of personnel having
the design or production of the product in such a way that
the necessary education, training, technical knowledge, and
impartiality would be compromised. The certification body
experienceforperformingcertificationfunctionsrelatingtothe
also shall obtain the applicant’s consent.
type, range, and volume of work performed, under a respon-
sible senior executive;
NOTE 2—Where the certification body subcontracts certain specialized
4.2.3.15 Have a quality system giving confidence in its
activities, it shall have access to a qualified and experienced person who
ability to operate a certification system for products; is able to form an independent assessment of the results of these
subcontracted activities. The responsibility for the determination of
4.2.3.16 Have policies and procedures that distinguish be-
conformity with the requirements rests with the certification body.
tweenproductcertificationandanyotheractivitiesinwhichthe
NOTE 3—Where work related to certification has been undertaken prior
certification body is engaged;
to the application for certification, the body may take account of it,
4.2.3.17 Together with its senior executive and staff, be free
provided it can take responsibility and satisfy itself as detailed in 4.4.
from any commercial, financial, and other pressures, which
NOTE 4—The requirements given in 4.4 also are relevant, by extension,
might influence the results of the certification process;
when a certification body uses, for granting its own certification, work
4.2.3.18 Have formal rules and structures for the appoint-
performed by another certification body with which it has signed an
ment and operation of any committees which are involved in agreement.
the certification process; such committees shall be free from
4.5 Quality System:
any commercial, financial, and other pressures that might
4.5.1 The management of the certification body having
influence decisions; a structure where members are chosen to
executive responsibility for quality shall define and document
provideabalanceofinterestswherenosingleinterestpredomi-
its policy for quality and its objectives for and commitment to
nates will be deemed to satisfy this provision;
quality. The management shall ensure that this policy is
4.2.3.19 Ensure that activities of related bodies do not affect
understood, implemented, and maintained at all levels of the
the confidentiality, objectivity, and impartiality of its certifica-
organization.
tions, and it shall not supply or design products of the type it
4.5.2 The certification body shall operate an effective qual-
certifies; give advice or provide consulting services to the
ity system in accordance with the relevant elements of this
applicant as to guides of dealing with matters which are
guide and appropriate for the type, range, and volume of work
barriers to the certification requested; provide any other prod-
performed. This quality system shall be documented and the
ucts or services which could compromise the confidentiality,
documentation shall be available for use by the certification
objectivity or impartiality of its certification process and
body staff. The certification body shall ensure effective imple-
decisions; and,
mentation of the documented quality system, procedures, and
4.2.3.20 Have policies and procedures for the resolution of
instructions. The certification body shall designate a person
complaints, appeals and disputes received from suppliers or
having direct access to its highest executive level who,
other parties about the handling of certification or any other
irrespective of other responsibilities, shall have defined author-
related matters.
ity for ensuring that a quality system is established, imple-
4.3 Operations:
mented, and maintained in accordance with this guide, and
4.3.1 The certification body shall take all steps necessary to
reporting on the performance of the quality system to the
evaluate conformance with the relevant product standards
body’s management for review and as a basis for improvement
according to the requirements of specific product certification
of the quality system.
system. The certification body shall specify the relevant
4.5.3 The quality system shall be documented in a quality
standards or parts thereof and any other requirements, such as
manualandassociatedqualityprocedures,andthemanualshall
sampling, testing, and inspection requirements, which form the
contain or refer to at least the following:
basis for the applicable certification system.
4.5.3.1 A quality policy statement;
4.3.2 In conducting its certification operations, the certifi- 4.5.3.2 A brief description of the legal status of the certifi-
cation body shall observe, as appropriate, the requirements for
cation body, including the names of its owners and, if different,
the suitability and competence of body(ies) or person(s) names of the persons who control it;
carryingout testing, inspection, and certification/registrationas
4.5.3.3 The names, qualifications, experience, and terms of
specified in ISO/IEC Guides 25, 39, and 62.
reference of the senior executive and other certification per-
4.4 Subcontracting— When a certification body de
...
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